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MEETING OF THE ADVISORY 
COMMITTEE ON IMMUNIZATION 
PRACTICES (ACIP) 
SEPTEMBER 22 , 2023 
MEETING SUMMARY 
CONTENTS  
FRIDAY: SEPTEMBER 22, 2023 .................................................................................................................. 2 
WELCOME AND INTRODUCTIONS ........................................................................................................ 2 
Call to Order/Roll Call ........................................................................................................................... 2 
Announcements .................................................................................................................................... 2 
MATERNAL/PEDIATRIC RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINES ................................ 3 
Session Introduction .............................................................................................................................. 3 
RSVpreF Vaccine Safety Surveillance in Pregnancy from the VSD ..................................................... 4 
Maternal RSV Vaccine Safety Monitoring in VAERS and v -safesm....................................................... 8 
An Economic Analysis of RSVpreF Mater nal Vaccination .................................................................. 10 
Economics of Preventing RSV Disease among US Infants by Maternal Vaccination Prior to Birth ...13 
EtR Framework Updates : Pfizer Maternal RSVpreF Vaccine.............................................................17 
Updat
ed Clinical Considerations for Use of Both Nirsevimab and Pfizer RSVpreF Vaccine .............. 28 
Implementation Considerations for Maternal RSV Vaccine ................................................................ 32 
Vaccines for Childrens Resolution ...................................................................................................... 34 
Pfizer Statement .................................................................................................................................. 36 
Liaison Organization Statements ........................................................................................................ 37 
ACIP Discussion Points, Observations, Suggestions for RSV Vaccine .............................................. 38 
PUBLIC COMMENTS .............................................................................................................................. 47 
Overview ............................................................................................................................................. 47 
Public Comments ................................................................................................................................ 47 
VOTES ..................................................................................................................................................... 49 
Vote #1 RSV Maternal RSV Vaccine Recommendation ..................................................................... 49 
Vote #2 VFC Resolution Maternal RSV Vaccine ................................................................................ 49 
ADULT AND PEDIATRIC IMMUNIZATION SCHEDULE ADDENDUM .................................................. 52 
Presentation ........................................................................................................................................ 52 
Liaison Statements .............................................................................................................................. 54 
CERTIFICATION ......................................................................................................................................... 58 
ACIP MEMBERSHIP ROSTER .................................................................................................................. 59 
ACRONYMS USED IN THIS DOCUMENT ................................................................................................. 68 
 
  
  
 
  
 
      
     
   
    
    
 
 
 
      
     
 
   
     
 
  
  
    
  
   
 
 
 
  
  
  
  
    
    
   
  
         
    
  
  FRIDAY : SEPTEMBER 22 , 2023  
WELCOME AND INTRODUCTIONS 
Call to Order/Roll Call 
Dr. Grace Lee (ACIP Chair) called to order and presided over the September 22, 2023 
Advisory Committee on Immunization Practices (ACIP ) meeting. Dr. Lee conducted a roll call, 
which established that a quorum was present. A list of Members, Ex Officios , and Liaison 
Representatives is included in the appendixes at the end of this summary document. No 
conflict s of interest (COIs) were identified. 
Announcements 
Dr. Melinda Wharton (ACIP Executive Secretary, CDC) noted that copies of the slides for the 
meeting were available on the ACIP website and were made available through a ShareLink ™ 
file for ACIP Voting, Ex O fficios , and Liaisons Members . The ACIP is, at its heart, a public body. 
Engagement with the public and transparency in all of its processes are vital to the committee’s 
work. She indicated that there would be 1 oral public comment session during this meeting, 
which was scheduled for 2:30 PM Eastern Time ( ET). To create a fair and more efficient 
process, individuals interested in making an oral comment were asked to submit a request 
online in advance of the meeting. Priority is given to these advance requests. If more people 
make requests than can be accommodated, a blind lottery is conducted to determine who the speakers will be. Speakers selected in the lottery for this meeting were notified in advance of 
the meeting. Members of the public also may submit written comments via 
https://w ww.regulations.gov using Docket Number ID CDC- 2023-00 76. Information on the 
written public comment process, including information on how to make a comment, can be 
found on the ACIP website. 
As noted in the ACIP Policies and Procedures manual, ACIP members agree to forgo 
participation in certain activities related to vaccines during their tenure on the committee. For 
certain other interests that potentially enhance a member’s expertise while serving on the 
committee , CDC may issue limited COI waivers. Members who conduct vaccine clinical trials or 
serve on data safety monitoring board s (DSMB s) may present to the committee on matters 
related to those vaccines, but those members are prohibited from participating in committee 
votes on issues related to those vaccines. Regarding other vaccines of the concerned company, 
a member may participate in discussions with the provision that he/she abstains on all votes 
related to that company. ACIP members state any COIs at the beginning of each meeting. 
Applications and nominations are being accepted for candidates to fill upcoming vacancies on 
the committee. 
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 MATERNAL/PEDIATRIC RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINES 
Session Introduction 
Sarah S. Long, MD (Chair, Maternal/Pediatric RSV WG) reminded everyone that each year in 
the United States (US) children less than 5 years of age, RSV is associated 100 to 300 deaths,1 
50,000 to 80,000 hospitalizations,2 approximately 500,000 emergency department (ED) visits ,3 
and about 1.5 million outpatient visits.3 RSV is the leading cause of hospitalization in US 
infants .4 Most (68%) infants are infected in the first year of life and nearly all (97%) have been 
infected by 2 years of age.5 Approximately 2% to 3% of young infants will be hospitalized for 
RSV.6 RSV is the most common cause of lower respiratory tract infection (LRTI) in infants. The 
highest RSV hospitalization rates occur in the first months of life and risk declines with 
increasing age in early childhood.7 About 79% of children hospitalized with RSV under 2 years 
of age had no underlying medical conditions,8 which is very important to keep in mind . 
Topics of previous WG presentations to the ACIP regarding RSV prefusion F protein (RSV preF) 
vaccine have included epidemiology and burden of RSV in infants ; virology and immunology of 
RSV; safety and efficacy of RSVpreF; c ost-effectiveness analysis for RSVpreF (CDC model); 
cost-effectiveness analysis for RSVpreF (comparison with the manufacturer model); Evidence to 
Recommendations (EtR) framework for RSVpreF; and clinical considerations for RSVpreF . 
On August 21, 2023, the Food and Drug Administration (FDA) approved Pfizer ’s RSV preF 
vaccine for use in pregnant people for the prevention of lower risk for RSV lower respiratory 
tract disease (LRTD) and severe LRTD in infants born and from birth to 6 months of age.9 The 
vaccine is approved as a single- dose to begin at 32─ 36 weeks of gestation. In Phase 2b and 
Phase 3 trials , vaccination was given during 24─ 36 weeks gestation . A numerical imbalance in 
preterm births was observed in RSVpreF vaccine compared to placebo recipients in 2 clinical studies. Available data are insufficient to establish or exclude a causal relationship between 
preterm birth and RSVpreF. Additionally, a numerical imbalance in hypertensive disorders of 
pregnancy was observed in RSVpreF vaccine compared to placebo recipients. Starting dosing 
at 32 weeks gestation can reduce the potential risk of and complications from preterm birth until 
additional safety data are available. This avoids the risk of extremely preterm births, where there is substantive morbidity and mortality, and very preterm births. Similar vaccine efficacy (VE) in 
32─36 weeks gestation compared to the overall study population. FDA has required the 
manufacturer to conduct post -marketing studies to assess preterm birth and hypertensi ve 
disorders of pregnancy, including pre- eclampsia. 
1 Thompson et al, JAMA, 2003; and Hansen et al, JAMA Network Open, 2022 
2 Hall et al, NEJM, 2009; and McLaughlin et al, J Infect Dis, 2022 
3 Hall et al, NEJM, 2009 
4 Suh et al. JID 2022 
5 Glezen et al, Arch Dis Child, 1986 
6 Hall et al, Pediatrics, 2013; Langley & Anderson, PIDJ, 2011; and CDC NVSN data 
7 Hall et al, NEJM, 2009; and CDC NVSN data 
8 Hall et al, NEJM, 2009 
9 https://www.fda.gov/news- events/press -announcements/fda- approves -first-vaccine -pregnant -individuals -prevent -rsv-infants ; 
https://www.fda.gov/media/171482/download?attachment; and https://www.fda.gov/media/171492/download?attachment 
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   RSVpreF vaccine is one of two available preventive products for RSV in infants. On August 3, 2023, ACIP recommended nirsevimab for RSV prevention in infants . Infants aged <8 months 
born during or entering their first RSV season are recommended to receive 1 dose of 
nirsevimab (50 mg for infants <5 kg and 100 mg for infants ≥5 kg). Children 8 ─19 months of age 
who are at increased risk of severe RSV disease and en tering their second RSV season are 
recommended to receive 1 dose of nirsevimab (200 mg) . 
Both nirsevimab and maternal RSV vaccine provide passive immunity .
10 A person develops 
active immunity from infection or vaccination, which triggers an immune respons e. Immunologic 
memory provides prolonged protection that may be lifelong. Passive immunity is the transfer of 
preformed antibody produced externally to provide protection to the recipient, such as from mother to baby through transplacental or breastmilk transfer; or through direct administration of 
antibodies, such as i ntravenous immunoglobulin (IVIG) t herapy or monoclonal antibodies. 
Passive immunity provides temporary protection that wanes with time. 
This meeting included presentations on the following: 
RSVpreF Vaccine Safety Surveillance in Pregnancy from The Vaccine Safety Datalink 
(VSD) 
Maternal RSV Vaccine Safety Monitoring in the Vaccine Adverse Event Reporting System 
(VAERS) and v -safe
sm 
An Economic Analy sis of RSVpreF Maternal Vaccination 
Economics of Preventing RSV Disease among US Infants by Maternal Vaccination Prior to 
Birth 
EtR Framework Updates: Pfizer Maternal RSVpreF Vaccine Updated Clinical Considerations for Use of Both Nirsevimab and Pfizer RSVpreF V accine 
Implementation Considerations for Maternal RSV Vaccine 
Vaccines for Childrens Resolution 
In closing, Dr. Long presented the Policy Question under consideration: 
“Should Pfizer RSVpreF vaccine be recommended for pregnant people to be given during 32 
through 36 weeks gestation to prevent RSV lower respiratory tract infection in infants?” 
RSVpreF Vaccine Safety Surveillance in Pregnancy from the VSD 
Malini DeSilva, MD, MPH (HealthPartners Institute) reminded everyone that the VSD is a 
collaborative project between CDC ’s Immunization Safety Office (ISO) and integrat ed health 
care organizations in the US. The VSD monitors the safety of vaccines used in the US through 
real-world data of rare and serious events following vaccination. The project includes data on 
approximatel y 15.5 million individuals across all sites annually, with approximately 115,000 
annual live births. Data are organized using a common data model with standardized coding 
systems. There are 13 VSD sites across the country that provide clinical, methodological, and data expertise, 11 of which provide data for the project . 
10 https://www.cdc.gov/vaccines/vac -gen/immunity -types.htm 
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  The VSD’s data structure is based on a distributed data model in which each VSD site creates 
standardized data files used in multi- site studies. Each VSD site defines a cohort for inclusi on 
based on enrollment in the site’ s health plan and/or care received at the VSD site. Once a 
cohort has been defined, files for vaccine administrations, medical diagnoses, and procedures 
from inpatient , outpatient, and ED visits and birth and death files are created. The dynamic 
pregnancy episode files uses validated algorithms for identifying ongoing and completed 
pregnancies. This file is updated weekly. Information in this file includes the pregnancy start 
date, or last menstrual period (LMP), gestational age of the pregnancy, and pregnancy 
outcomes when available. A mom baby linkage file allows for evaluation of infant outcomes 
following prenatal vaccinations. Ancillary drug or laboratory files are available on an ad hoc 
basis for specific studies . Automated data files are supplemented with chart reviews as needed. 
The VSD has been evaluating the safety of vaccines administered during pregnancy for more 
than 10 years. The RSV preF vaccine manufactured by Pfizer has been shown to be effective 
against severe RSV -associated LRTIs in infants. RSV preF clinical trial data on safety in 
pregnant persons identified injection site pain as the most common reactogenicity event and 
identif ied an imbalance in preterm births in the vaccinated group. Most preterm births are late 
preterm, meaning they occurred at 34 to less than 37 weeks gestation, and most occurred more 
than 30 days after receipt of the RSVp reF vaccine. Preterm birth imbalance was most prominent 
in a single country. Of note, GSK also was working on an RSV preF prenatal vaccine, but the 
clinical trials halted due to an imbalance in preterm birth in the vaccinated population. The 
etiology for preterm birth associated with RSV prenatal vaccine is unknown. 
The goal of prenatal RSV vaccine surveillance is to evaluate the safety of RSV preF vaccine 
administered during pregnancy in the VSD ’s large real -world population. Challenges are that as 
vaccine uptake is unknown , which makes it difficult to provide any power estimates. Additionall y, 
there may be healthy vaccin ee bias, meaning that healthier individuals or those with lower risk 
pregnancies may be the first to be vaccinated. This is considered in the analyses and when 
interpreting results. There is uncertainty regarding recommendations for RSVpreF use in 
administration of this vaccine, which may impact who receives the vaccine. If persons at higher 
risk for preterm delivery are recommended to receive RSV preF early in the vaccination window, 
more preterm births may be identified the vaccinated group. Alternatively, these individuals may 
be counseled to not receive the vaccine and wait to have their infant receive n irsevimab. The 
timing of administration during pregnancy overlaps with Tdap recommendations and vaccine 
administrations are also likely to overlap with influenza and COVID -19 vaccines. 
To review the pregnancy outcomes and expected timing for the RSVp reF vaccine during 
pregnancy , pregnancies are considered “ non-viable ” prior to 20 weeks gestation, “periviable” 
from and from 20 through 26 weeks (e.g., meaning there is a reasonable chance of extra uterine 
survival ), “preterm” if the pregnancy end s in a live birth before 37 weeks gestation, and “term” if 
the pregnancy ends in a live birth at gestational age 37 weeks or thereafter . Intrauterine fetal 
demise outcomes (IFDOs) include spontaneous abortions that can occur up to 20 weeks 
gestational age, or a stillbirth that occurs at 20 weeks gestation or later. The yellow box in the 
following diagram shows the time period during pregnancy when the RSV preF vaccine has 
been approved for use. When considering pregnancy outcomes and the RSV preF vaccine, only 
outcomes that are possible will be included. Spontaneous abortion is not a possible outcome 
because of t he timing of vaccine and pregnancy : 
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The primary approach for prenatal RSV preF surveillance will be through bimonthly surveillance. 
Validated algorithms will be applied to electronic health data in the VSD population to identify 
pregnant persons 16─ 49 years of age at ≥20 weeks gestation. Excluded pregnancies include 
those that end in therapeutic abortion, multiple gestation pregnancies, and those with 
insufficient information to determine the start date of the pregnancy. The exposure being 
evaluated is RSV preF vaccination at or after 28 weeks gestation. This is to account for any 
inaccuracies in gestational age estimation. Pregnant persons vaccinated with RSVpreF are 
matched to pregnant persons unvaccinated 1:1 based on VSD site and gestational age at 
vaccination. Propensity scores were created to account for confounding using readily available 
variables (e.g., pregnant person’ s age, pregnancy start date, race, ethnicity , and medical 
comorbidities ). 
Adverse outcomes evaluated include a cute outcomes and pregnancy -related and birth 
outcomes. These outcomes were chosen based on biologic plausibility and data from clinical 
trials, as well as being used in prior vaccine safety studies. To identify these outcomes, an 
algorithm will be used that wa s developed for other VSD safety surveillance work, which has 
been modified for a pregnant population. The algorithm uses diagnoses associated with 
outpatient , ED, and hospital encounters. Chart confirmation will be used for selected outcomes. 
The pregnanc y-related and birth outcomes that will be evaluated include preeclampsia or 
eclampsia based on International Classification of Diseases (ICD)- 10 codes, preterm birth 
based on the gestational age at birth, and stillbirth identified from ICD -10 codes with c hart-
reviewed confirmation. 
The next 2 tables show the acute outcomes that will be monitored following vaccination, the risk 
window for which each outcome will be evaluated, and the VSD background rate per 10,000. 
These background rates are based on data f rom COVID -19 studies using the rate in the 
unvaccinated group. In the first table, the risk window for anaphylaxis is limited to the day of and 
first day following vaccination and will be studied only in the vaccinated group. The next 3 
outcomes (fever, malaise/ fatigue, and skin and soft tissue or local allergic reactions ) are limited 
to 7 days following vaccination. All other outcomes listed alphabetically will be evaluated during 
the 1─21 days and 1─ 42 days following vaccination. The second table is a continuation of the 
first. 
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The next table shows the pregnancy -related and birth outcomes that will be evaluated, the 
outcome is listed in the left column, followed by the risk window during which each outcome will 
be evaluated, and the number and percentage of vaccinated clinical trial participants who 
experienced the outcome from the Phase 3 RSVpreF clinical trial. The outcomes that will be 
evaluated are preeclampsia and eclampsia, preterm b irth, and stillbirth at 1─21 days and 1─42 
days . 
¥ RSVPreF Phase 3 clinical trial: Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants | NEJM 
∆Preterm birth rate in high- income countries (Slide 23 Evidence to Recommendations Framework: (cdc.gov)) 
The risk window for preterm birth will vary based on the age of vaccination and will end up to 37 
weeks gestation, given that births after 37 weeks gestation are considered term. The 
percentages shown for the RSVp reF Phase 3 trial are based on all study participants for 
preeclampsia and eclampsia and stillbirth. For preterm birth, the rate was used from high-
income countries since this seemed most applicable to the VSD population. 
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     For the analysis, risk ratios will be determined with corresponding 95% confidence intervals 
using Poisson distribution with robust variance using a generalized estimating equation (GEE) . 
Censoring within risk windows will be applied when an individual is no longer at risk for the 
event, due to pregnancy outcomes that occur, or if an unvaccinated match is vaccinated. 
Adjustments will be included for known confounders . If a preterm birth signal is detected, further 
exploration into the etiology will be performed. A sensitivity analysis will be performed using 
alternative matching strategies. Because the RSV preF vaccine is recommended for use during 
the same time period when Tdap is recommended, an assessment we will be done to explore 
whether it is possible to evaluate coadministration of Tdap and RSV preF. 
In terms of an example timeline for the planned bimonthly surveillance, i f vaccination started in 
October 2023 , the plan would be to capture 2 months of vaccinations followed by a 42- day 
follow- up period and a 2- month data lag before pulling any data. The first data pull would be in 
March 2024. Bimonthly surveillance would continue every 2 months. 
Maternal RSV Vaccine Safety Monitoring in VAERS and v -safesm 
Pedro L. Moro, MD , MPH (CDC/NCEZID) described maternal RSV vaccine safety monitoring in 
VAERS and v -safesm. As a reminder, VAERS is a national passive surveillance system that is 
the frontline surveillance system that monitors all licensed vaccines in the US. Created in 1990, 
VAERS is co-managed by the CDC and FDA. A couple of the important s trengths of VAERS are 
that it can rapidly detect safety signals and it can detect rare adverse events (AEs) . However, 
one of its important limitations is that it is not designed to assess causality. VAERS is a 
hypothesis -generating system that can identify potential vaccine safety concerns that can be 
studied in more robust systems. 
In terms of some of the approaches that can be used to analyze various data in pregnancy 
reports , VAERS has been used for more than a decade as part of vaccine safety surveillance 
for vaccines used in pregnancy (e.g., influenza, Tdap, COVID -19). One type of analysis that can 
be performed using VAERS data is a descriptive analysis, which includes clinical review of 
individual reports , aggregate descriptions of automated data (e.g., counts of reported AEs).11 
Another is calculation of reporting rates for pregnancy outcomes if doses of RSV vaccine administered in pregnancy or vaccination coverage data are available. Regarding the statistical 
analyses that may be done, historical approaches have included data mining to assess for 
disproportionate reporting. This is under discussion for RSV vaccines. 
The search for RSV pregnancy reports involves  a number of strategies . One strategy is to 
search Medical Dictionary for Regulatory Activities (MedDRA) codes for the specific terms: 
exposure during pregnancy, drug exposure during pregnancy, maternal exposure during 
pregnancy.  Another approach is t o search for an affirmative answer to Question 8 that asks the 
patient whether they were pregnant at the time of vaccination. In addition, a string search can 
be done of text fields (e.g., symptoms, pre -existing illness, medical history ) for the term “preg .” 
Medical records will be requested for all pregnancy reports, including serious and non -serious. 
Clinicians will review these reports to confirm that they are pregnancy reports and to categorize 
the main AE of interest. 
11 Reported adverse events are coded using Medical Dictionary for Regulatory Activities terms ( https://www.meddra.org/ ) 
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   VAERS will conduct surveillance of adverse events of special interest (AESIs) after RSV 
vaccination. Primary AESIs have been selected for historical , theoretical, or observed safety 
concerns (i.e., in clinical trials) . VAERS will obtain medical records for all reports (serious12 and 
non-serious) . CDC will review records and abstract clinically important information. AESIs may 
be added to or removed from the list as appropriate. Secondary AESIs will be monitored via periodic (e.g., weekly) automated data tables, but the information will not be abstracted. If a secondary AESI is identified that is being reported frequently under suspicion of a safety 
concern, that may be added to the primary AESI list. The current listing of primary and 
secondary AESIs that will be monitored in VAERS for all RSV vaccines, including for reports 
among pregnant persons, are as follows: 
Pregnancy -specific  outcomes to be monitored in VAERS and abstracted after maternal RSV 
vaccine include: 
Premature/preterm birth 
Stillbirth 
Spontaneous abortion 
Gestational diabetes 
Preeclampsia/eclampsia/gestational hypertension 
Birth defects 
Maternal and infant deaths 
Other selected adverse infant outcomes/AEs 
Development of a new version of v-safesm began in Summer 2023. This system leverages the 
existing CDC IT infrastructure and includes e- mail and text messaging options . The first use will 
be for RSV vaccines received by persons ≥60 years of age in the Fall . Use for maternal RSV 
vaccines is planned for later in the Fall. The v-safesm objectives are to: 1) characteriz e local and 
systemic reactogenicity during day s 0─7 zero to seven after vaccination; 2) characterize health 
impacts during a 6-week post -vaccination follow -up period; and 3) identify participants who 
report medically -attended events after vaccination and encourage completion of  a VAERS 
report. 
12 Based on the Code of Federal Regulations if one of the following is reported: death, life-threatening illness, hospitalization or 
prolongation of hospitalization, permanent disability, congenital anomaly or birth defect 
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   An Economic Analysis of RSVpreF Maternal Vaccination 
David W. Hutton, PhD, MS (University of Michigan) provided some updates since his June 
2023 presentation to the ACIP to report the findings of an additional vaccine efficacy scenario, 
additional timing scenarios for which the vaccine might be administered in specific months of the 
year, a gestation scenario from 32─36 weeks,  and an updated cost per vaccine dose scenario. 
The initial efficacy scenario has not changed,13 with sigmoid downward sloping efficacy during 
the 6 months, using the average efficacy during these periods based on average 6 months 
efficacy. Hospitalization efficacy was based on hospitalization efficacy from the trial and efficacy 
against outpatient visits was based on efficacy and medically -attended LRTIs . A scenario also 
was evaluated with flat efficacy during those 6 months, and then back down to 0 efficacy after 
that. In both of the last 2 scenarios, 0 efficacy was assumed after 6 months. The new scenario 
is more optimistic, with slightly higher efficacy in the first 6 months. The efficacy against 
hospitalization in this scenario was based on efficacy against severe -medically attended RSV 
LRTI observed in the trial , which was slightly than the efficacy used in the base-case. In this 
optimistic scenario, it was assumed that there is declining efficacy for months 6─9. 
In the initial base- case, RSV preF given year -round was evaluated. The new scenarios assessed 
cost- effectiveness if RSV preF is given during specific months of the year and if RSVpreF is 
administered in specific ranges of months throughout the year : April- February , May-February , 
June- February , August -January , September -January , and September -December . Another 
change was a scenario in which the mother was vaccinated from the beginning of week 32 
through the end of week 36 of the pregnancy , which is a narrower range than was used in the 
trial but is what the FDA has settled on. In the new scenario, it was assumed that the vaccine 
must be given within 2 weeks before birth for the vaccine to confer protection. It was assumed 
that for a baby born within 2 weeks of administration, the re would be no efficacy of the vaccine. 
If it is assumed that for 100 pregnant persons, 50 intend to vaccinate, 48 actually get vaccinated 
because 2 might give birth before that, and 3 of the 48 would be vaccinated within 2 weeks of 
delivery —that would res ult in 45 being vaccinated in time (e.g., within 2 weeks before delivery) . 
In June, Dr. Hutton presented numbers based on 1000 births. During this session, he present ed 
the results based on the entire US birth cohort per year assuming 50% uptake of the RSVpreF 
vaccine across the first RSV season. Another major update for this scenario is a cost of $295 
per dose. That is an increase from the $200 per dose estimate used in June, which is a 
significant increase in the price per dose. In terms of the results,  the number needed to 
vaccinate (NNV) to avoid an outpatient visit (40), an ED visit (115), an inpatient stay (242), an 
ICU admission (1100), an inpatient day (45), or an intensive care unit ( ICU) day (367) was very 
similar to what was shown in June. It was about 4% higher because of the later timing of 
vaccination in weeks 32 ─36 due to slightly more people being vaccinated within 2 weeks of 
birth. But basically, this is very similar to what was reported in June. 
In the updated scenario, the total cost were higher due to evaluating a larger cohort of 3.66 
million births, assuming 50% intended uptake in RSVpreF group. The intervention cost is higher 
relatively -speaking because the vaccine price per dose increased by just under 50% from the 
previous scenario. The cost per event averted also was higher than show n in June because the 
price per dose is a little bit less than 50% higher than what was assumed in June. For example, 
the cost to avert an inpatient stay would be about $68,000 per inpatient stay averted. The 
13 Kampmann et al 2023 
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  incremental cost-effectiveness ratio (ICER) in the updated scenario is now about $400,000 per 
quality -adjusted life year (QALY) gained. This is driven primarily by the increased cost of the 
vaccine dose compared to the cost used in June. 
Looking at sensitivity analyses showing how various changes in the assumptions will change 
the ICER, the rankings of which parameters are most important are similar to those seen in 
June. Prematurity potentially can increase the ICER dramatically , though hopefully that is less 
likely with later administration of RSVpreF . The QALY impacts of RSV also are likely to have 
large impact on the ICER . The vaccine price is an important driver of cost -effectiveness. The 
cost of inpatient care also can have a large impact on the cost -effectiveness of vaccination. VE 
also can have a large impact on cost-effectiveness . One of the scenarios was varying how VE 
was modeled. When flat efficacy was assumed, the ICER was about $365,000 per QALY 
gained. The updated scenario used a m ore optimistic higher and longer efficacy. The ICER 
under this scenario was about $286,000 per QALY gained. 
In a sensitivity analysis varying efficacy, hospitalization cost, and mortality the base cost was 
$11,000 per hospitalization. Varying the hospitalization cost from the base cost to higher costs, 
the cost -effectiveness ratio would decrease as hospitalization costs increase. With a more 
optimistic VE (e.g., higher and longer efficacy ) the cost- benefit ratio would decrease as well. 
With m ore deadly RSV, there would be a 1% risk of dying in the hospital instead of 0.1%. The 
cost per vaccine dose also can have a major impact on cost -effectiveness. With a base-case 
price of $295 per dose, the cost per QALY is close to $400,000 . If the vaccine cost per dose 
was lower, the ICER would decrease as well. 
Everything just show n was assuming the vaccine is given year -round. Now looking by month 
and by specific ranges of months to determine the cost- effectiveness ratio if RSVpreF is given in 
a particular month of the year, it is important to remember that RSV is seasonal and there are 
many infections in the wintertime. If RSVpreF is given right before wintertime so that it has 6 
months of efficacy during that peak, the cost of that administration would decrease dramatically . 
For instance, if RSVpreF is given during any month between February ─July, the cost -benefit 
ratio would be over $500,000 per QALY. If given during October ─November, the cost -
effectiveness ratio would range from approximately $111,000 to $115,000 per QALY. The cost 
of administration could be dramatically lower if RSVpreF is given right before the peak of the 
RSV season. Looking at ranges of months and recalling that the base -case was about $400,000 
per QALY if given year-round,  if it was given during the range of September ─December, the 
ICER would be approximately $141,000 per QALY. 
To summarize, the limitations of this updated analysis are similar to the ones reported in June. 
The model structure does not include risk groups or dynamic transmission. Given that this is a 
new vaccine, the impact of the vaccine on transmission and indirect effects is unknow. Inputs 
also are still uncertain with respect to RSVpreF costs , QALYs lost , impact URTIs , and 
prematurity. All of these scenarios assumed that no infants will be receiving nirsevimab. 
RSVpreF may improve RSV outcomes, but it also will increase costs. RSVpreF has the potential 
to be cost -effective , but the results are sensitive to a wide variety of assumptions, including r ate 
of prematurity ; cost per dose (~ $65,000─$68,000/QALY) ; hospitalization costs ( cost-
saving─$440,000/QALY) ; efficacy (~ $280,000─$680,000/QALY); QALYs lost 
(~$100,000─$800,000/QALY) ; and m onth of administration (~ $110,000─ Millions/QALY) . 
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   Looki
ng now at the economics of the combined use of Pfizer maternal RSVpreF vaccine and 
nirsevimab , ACIP recommended the use of nirsevimab On August 3, 2023. This raises the 
following questions about how to think about combinations of RSVpreF and nirsevimab : 
If it is known that RSVpreF has been administered to the pregnan t person in time, how cost -
effective is it also to provide nirsevimab to the infant ? 
If it is known that the infant definitely will receive nirsevimab, how cost -effective is it to 
provide RSVpreF to the pregnant person? 
In terms of updates since the June ACIP meeting, the assumption was made in the updated 
analysis that RSVpreF would be administered in weeks 32─36. Because of this, the assumption 
also was made that the infant is full- term and there would be no need for palivizumab for any 
newborns considered in this analysis. The updated analysis also considered some higher risk 
populations and assumed that they were not premature. In addition, the new timing of RSVpreF 
administration was considered. There is no evidence of efficacy with the combined use of these 
products. Therefore, the assumption was made that efficacy would be equal to the highest of 
nirsevimab or RSVpreF, which is higher. That is, efficacy would not be higher than from the 
most effective product and there would be no combined synergistic efficacy. That is the same 
assumption that was made in June. 
Assuming administration of nirsevimab at birth to the infant of someone who received RSVpreF , 
nirsevimab would provide additional efficacy on top of what RSVpreF would provide. If the baby 
was born in August, they would have some RSVpreF efficacy. If nirsevimab was given on top of 
that in October, there would be an increase in efficacy. A s a reminder, peak infections are 
typically in the December ─February timeframe, and additional efficacy would be desired during 
that peak timeframe. 
To highlight the incremental benefit of adding nirsevimab on top of RSVpreF for infants of 
persons vaccinated with RSVpreF during pregnancy at least 2 weeks prior to delivery , there 
would be a higher risk or increased multiplier on the risk of hospitalization. There would be no 
change in outpatient incidence, ED inciden ce, costs per outcome, or QALY per outcome. 
Looking at the incremental benefit of adding nirsevimab on top of RSVpreF by m onth and risk if 
nirsevimab is given at birth during October ─March compared to a baby born in 
April─September who would not be given nirsevimab at birth but would receive it at the start of 
the RSV season in October or November , the incremental cost-effectiveness of adding 
nirsevimab looks better if given to babies born in April, May, June, July, August, and September. 
If given at the beginning of the season in October and November, the cost- effectiveness ratios 
would be much lower. The ICERs are much higher for infants who are at 3-, 6-, and 10 -times 
higher risk of hospitalization. That is, it is much more valuable to give them nirsevimab on top of 
RSVpreF . 
Particularly for babies born in the summer, giving nirsevimab at the beginning of the season 
would result in an ICER $150,000 per QALY gained and lower . For potentially higher risk 
individual s born during the season, the ICERs for n irsevimab given at birth might look good for 
higher risk populations. Assuming that nirsevimab is given to all infants born year -round to 
vaccinated mothers, the NNV to avoid an inpatient visit for an average risk child would be over 
200 infants to avoid 1 inpatient visit. Adding nirsevimab to all infants born year -round to 
vaccinated mot hers would be quite expensive for people at average risk at $400,000 per QALY . 
Providing nirsevimab to infants at 6 times the risk born to vaccinated mothers would be about 
$40,000 per QALY gained and might be cost -effective . 
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 In a scenario of giving nirsevimab in October ─November to babies born in April─ September, 
rather than at birth, born to mothers who received RSVpreF at least 2 weeks prior to delivery, 
the NNV was similar but slightly lower than if giving n irsevimab year -round. It would be more 
cost- effective to provide nirsevimab to infants born since April─ September at the beginning of 
the RSV season at about $300,000 per QALY for infants at the lowest risk and about $200,000 
per QALY for infants at 3-, 6-, and 10- times higher risk. In a scenario of adding nirsevimab 
during the season for infants born October─March to mothers who received RSVpreF at least 2 
weeks prior to delivery, the NNV would be higher because they already would have a lot of 
RSVpreF protection during that time period. The ICER would be $600,000 per QALY if given to 
average risk babies. That is, it would be less cost -effective to give these babies nirsevimab on 
top of their RSVpreF protection. 
Regarding the incremental benefit of adding n irsevimab on top of a baby’s RSVpreF protection, 
there is some additional benefit beyond RSVpreF protection. The ICERs are high, but could be 
lower for higher -risk populations, particularly born if they are born off -peak. In terms of the 
incremental benefit of adding RSVpreF on top of nirsevimab if it is known the infant will be 
receiving nirsevimab, the ICERs are very high. Similar to what was seen previously, this scenario would be over $10 million per QALY for many months of the year . The best month of 
the year would be April, although the ICER still would be $2.4 million per QALY gained if 
nirsevimab was given to babies whose mothers received RSVpreF at least 2 weeks prior to 
delivery . The incremental benefit of adding RSVpreF on top of nirsevimab would be very 
marg inal beyond nirsevimab protection and the ICERs would be extremely high. 
In summary of scenarios involving combinations of RSVpreF on top of nirsevimab, a limitation is 
that there are no efficacy data on these combined products. Therefore, these scenarios are all 
based on assumptions about what the efficacy might be. Nirsevimab may add additional 
protection on top of RSVpreF , particularly for high -risk infants . Adding RSVpreF on top of 
Nirsevimab would add marginal effectiveness at a very high cost in the general population. 
Economics of Preventing RSV Disease among US Infants by Maternal Vaccination Prior
to Birth 
Ismael R. Ortega- Sanchez, PhD (CDC/NCIRD) summarize d the key elements and findings of 
2 economic studies , the Pfizer Model and the University of Michigan- CDC ( UM-CDC) M odel, 
focused on the economics of preventing RSV disease among US infants by maternal 
vaccination prior to birth. In the last 8 to 9 months, the 2 models were updated several times. In 
this summary, Dr. Ortega -Sanchez focused only on the vaccine so there was no discussion 
about the last component of Dr. Hutton’s presentation regarding nirsevimab . For full disclosure, 
Dr. Ortega -Sanchez indicated that he has been part of the team conducting the CDC model. 
The starting point of the 2 economic models was the policy question regarding potential 
recommendations for the use of RSV vaccine in pregnant mothers , “Should Pfizer RSVpreF 
vaccine be recommended for pregnant mothers to be given during 32 through 36 weeks 
gestation to prevent RSV lower respiratory tract infection in infants?” To consider the economics 
of the policy question is to consider simultaneously the health benefits and costs of vaccination, 
namely, “Is vaccinating pregnant mothers prior to birth to protect infants against RSV ’s cost -
effective?” To address this question, the 2 models used the same comparator , unvaccinated 
mothers and the standard of care (SoC) for infants. They focused on analyzing the cost -
effectiveness of vaccinating pregnant mothers 32 ─36 weeks of gestation ≥2 or more weeks 
prior to the birth with RSV preF vaccine compared to no vaccine. 
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     The policy question has important implications for 2 groups of elements . The comparison of the 
2 economic models focus es on the appropriateness of the modeling approach selected; the 
inputs for RSV disease burden, RSVpreF, VE, and costs ; and how the strength and influence of 
the assumptions on the outcomes. The 2 models followed similar designs. Both used a static 
analytical decision- making approach , relied on sensitivity analys es and probabilistic simulation, 
model ed a hypothetical cohort of all pregnant mothers in the US year-round, selected a 
timeframe of the first year after birth, accounted for loss of income associated with temporary 
productivity loss and the loss of premature RSV -associated infant mortality. Once the modeling 
study was set, the 2 models were fed by different types of input data, including clinical, 
epidemiological, economic, QALY, vaccine characteristics, health care resource utilization 
(HCRU) and cost, and indirect costs . Across models, the source and specific values and 
assumptions of these parameters have some overlaps, but there were marked differences as 
well. The boxes below list the standard outcomes estimated and reported by the 2 models : 
Dr. Ortega -Sanchez emphasized that once the models are built this way, it is necessary to work 
in reverse in order to go first with the outcomes and then analyze what happens with the inputs. 
The base case estimate for vaccinating pregnant mothers in the vaccination window of 32 ─36 
weeks gestational age year-round would be approximately $400,000 per QALY gained when 
vaccine costs are $295 per dose. Additionally, the CDC model reports cost per specific type of 
health outcome prevented and the NNV to prevent hospitalization , ED visits, outpatient visits, 
and deaths associated with RSV LRTI . the base case estimate for maternal vaccination in the 
vaccination window of 32─36 weeks gestational age year -round would be approximately 
$85,000 per QALY gained when vaccine cost is $295 per dose. The Pfizer cost per QALY is 
supported wit h its probabilistic sensitivity analysis (PSA) when simultaneously providing the 
input and variables in the model. Most of the simulations included in the base case were 
somewhat costly, but with gains in QALY. Approximately 65% of the simulations in the P fizer 
model had a cost -effectiveness ratio that was less than $100,000 per QALY . Even though both 
models assumed the same vaccine cost per dose, vaccination window of 32─ 36 weeks of 
gestational age, and year-round vaccination administration, the CDC results costs per QALY 
were still much higher than those of Pfizer. Specifically, the CDC estimates of the cost per 
QALY and the cost per hospitalization of births were about 5 times higher than those of Pfiz er 
and about 10 times higher for the cost per death prevented. The CDC model report ed a 65% 
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    higher NNV to prevent hospitalization and 300% higher in the number needed to prevent an 
RSV-associated death. The first takeaway for the committee is that both models agree that 
maternal vaccination will be relatively costly, but it also will prevent LRTI and hospitalization and 
will save QALY s among infants and caregivers. 
To understand these persistent discrepancies in the UM -CDC model and the Pfizer model , an 
effort was made to i dentify the sources of these differences. The CDC model’s 1 -way sensitivity 
analysis ranked the most influential input variables. The probability of prematurity ranks first, 
followed by RSV QALYs lost , disease -specific inpatient cost, and VE against hospitalization. In 
a similar fashion, Pfizer also report ed one -way sensitivity analy ses. T he most influential 
variables were VE , followed by medical costs for hospitalization, vaccine duration of protection 
when truncated at 6 months, and the case fatality rate among hospitalized infants with RSV 
LRTI. Except for RSV hospitalization risk and seasonality and vaccine- associated AEs, the 
other elements identified in the Pfizer and UM -CDC models included, which were explored 
further : 
Vaccine efficacy Duration of protection and waning RSV Case fatality rate 
Medical cost of RSV hospitalization, ED and Outpatient care QALYs lost by patients and caregivers 
First, 2 elements that did not explain these differences were the risk of hospitalization and RSV 
seasonality as input data used in both model s were practically the same. Specifically, the risk of 
RSV hospitalization data used in both models was based on laborator y-confirmed RSV -
associated hospitalization by age in months from the New Vaccine Surveillance Network 
(NVSN). This includes only RSV cases that manifests as LRTI. Therefore, unlike the uncertainty 
in RSV hospitalization that was a question for discussion for older adults, it is not what could 
explain the difference in outcomes in infants . Likewise, RSV seasonality was based on data 
from the National Respiratory and Enteric Virus Surveillance System (NREVSS) . The 2 main 
explanatory factors turn out to be VE and case definition. Although both models use the same 
source for VE,
14 which reports the data from the P hase 3 clinical trials from Pfizer , each model 
picked different data points from this source mainly because none of the Pfizer Phase 2 
endpoint definitions overlap ideally with a case definition used by the US burden data. For 
hospitalizations, the CDC model used average VE over months 0─6 reported by RSV LRTI 
hospitalization, with an average value of 56.8%. The Pfizer model used VE for severe RS V-
positive MA -LTRI as a proxy for VE against RSV -LRTI requiring hospitalization, and efficacy 
against RSV -positive MA -LRTI was used as a proxy for VE against RSV -LRTI treated in the ED. 
VE for late preterm infants was assumed to be 83.3% of corresponding values for full- term 
infants. 
This also will help to understand the duration of protection. Although assessing the difference 
about the initial VE is important, it is more about the assumption of performance over time. In 
the Pfizer model, the linear assumption was based on 4 data endpoints reported from Phase 3 
data until 180 days after vaccinat ion, or the equivalent of 6 months, followed by the assumed 
impact from the 6th to the 9th month. That is discriminated by a full -term versus late -term. The 
CDC model use d a 6-month efficacy against hospitalization or MA RSV-associated RTI. The 
duration of protection reached 0 at 6 months . They noted a higher level of uncertainty of the 
14 Kampmann et al New England Journal of Medicine. 2023 Apr 
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  waning assumption beyond available Phase 2 data. The CDC model trie d to minimize this 
uncert ainty impact  on its outcomes. Therefore, there was no effectiveness after the 6th month. 
Although the base- case case fatality rate s for hospitalization were basically the same in both 
models, the distinction is that Pfizer inputs used a higher case fatality rate for late preterms 
using mortality rates for all pre- terms. Therefore, the same rate included for extremely early, 
early , and late preterms were used as the dominator for the case fatality rate for all preterms. 
Regarding medical costs, the input values using the Pfizer model were 2 times higher for 
hospitalization to about 4 times higher for ED and outpatient visits than the ranges used by the 
CDC model to reach the average cost value using. While the source of t he CDC model is a 
publicly available meta- analysis review of many publications. The source of the Pfizer model is 
reported as data on file and not yet available for examination. The committee members should 
bear in mind that the higher the input values , the lower the ICER would be, or the equivalent, 
the more cost -effective the vaccination program would be. 
Cost-effective analysis programs should include not only the cost of vaccines or vaccine 
administration, but also the risk of vaccine- associated AEs and associated costs. Using data 
reported from the Pfizer P hase 3 trial , both models included the rate of injection site reactions 
and associated costs, including the cost of outpatient visits. The difference was when dealing 
with hypothetical serious adverse events ( SAEs ) or when considering the incremental risk of 
prematurity . The potential increased risk of AEs considered in the CDC model, when modeled in 
the base case or as a potential scenario could influence the ICERs and significantly increas e 
the cost of the intervention. 
In terms of the QALY impact of RSV outcomes in both patients and caregivers , the point 
estimates scores used in both models were the same for the caregivers. The difference was in 
the patient scores, which were somewhat higher in the CDC model. The second difference was 
that the CDC model also relied on ranges from each of these scores, which allowed for the 
analysis and sensitivity analysis of the impact of them. Unlike CDC, the Pfizer model consider ed 
only the point estimate f or the base case without viability, and as a consequence quality loss 
was not identified as an influential variable in the Pfizer model . 
Up to this point, the comparisons focus ed on the inputs used in the models. The idea at this 
point was to determine how sizeable differences in cost per QALY could be explained from 
outcomes estimated using different input values and assumptions. One way to cross -validate 
the models is to see if one model could imitate the other by selecting some input values and 
assumptions. Looking at the cost per QALY for selected scenarios using a CDC model focusing 
on combining Scenarios A (c ost of RSV -LRTI hospitalization: $20,000 or $50,000) and B ( UM-
CDC model with same VE duration of protection as Pfizer) that included price, medical costs, 
and assumptions of duration of protection, the specific impact on the cost per QALY drops to 
$234,000 per QALY. That is still 2 times higher than the cost per QALY reported by Pfizer. Two 
other important scenarios reported were Scenario E with a potential increase in the risk of 
prematurity in 1% or 2% points, which could range from about $900,000 if it is only 1% point 
increase in the risk of prematurity to more than $1.3 million per QALY if it is a 2% point incr ease 
in the risk of prematurity. Scenario F deals with the timing of vaccination. CDC is the only model 
that present ed timing of vaccination. Vaccinating mothers with births in September ─January 
would provide a cost per QALY of less than $200,000 as opposed to February ─July, which will 
be in the millions per QALY. 
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  By the same token, Pfizer attempted to replicate the CDC outcomes by sequentially using CDC 
inputs and assumptions. For Scenario A, the cost per QALY estimate with selected CDC inputs 
and the cost per QALY value were close to what was reported by CDC at approximately 85%. 
Scenario A was $343,000 per QALY in the Pfizer model , which was very close to the $400,000 
per QALY reported by CDC. When Pfizer used its own model with some of the select ed CDC 
inputs and returned most of its own inputs and assumptions piece- by-piece and cumulatively , 
Pfizer return ed to his initial VE. It returned to the duration of protection and medical costs that 
Pfizer used and to approximately $83,000 per QALY, which is basically the same one that was 
reported by them in the base case scenario. Since they were able to replicate some of the 
analys es, it seems that the inputs and the assumptions that are being used in the models are 
crucial. 
In terms of limitations, the factors not considered may result in overestimating the ICER, under -
estimating the cost -effectiveness of maternal vaccination, by both models. In the base case, 
both models assumed no protection against upper respiratory tract infection (URTI), no benefits 
of vaccination for vaccinated pregnant mothers, and no out -of-pocket costs accrued by 
caregivers during an infant RSV illness. Neither model included RSV-related costs incurred after 
discharge from RSV -associated hospitalization or ED department v isits, such as p roductivity 
losses incurred by caregivers after discharge. Both models assumed no indirect effects of 
vaccination (e.g., no protection against RSV transmission among unvaccinated people). 
In conclusion, difference s in key inputs among the Pfizer and CDC models explain differences in 
the results. Among the key differences are initial VE and assumptions about protection waning, 
medical cost data, QALYs associated with RSV LRTI outcomes for patients and caregivers, and 
vaccine- related AEs. In addition, the CDC model identified 2 important factors that could drive 
the results and make the difference—hy pothetically severe v accine- associated AEs and timing 
of vaccination for RSV when it targeted to specific periods in the RSV season. In terms of the 
base case in both models, maternal vaccination would significantly reduce RSV disease burden 
and disease costs in infants. Data from clinical trials used in both models support the reduction 
in RSV disease and associated costs. However, the economic value of vaccinating pregnant 
people to protect infants could increase costs. Reasonable vaccine price and duration of 
protection, combined with careful design of seasonal interventions , will determine the cost -
effectiveness value of routine vaccination of pregnant people during the 32─ 36 weeks of 
gestational age. 
EtR Framework Updates: Pfizer Maternal RSVpreF Vaccine 
Katherine E. Fleming -Dutra, MD (CDC/NCIRD) presented EtR Framework updates for the 
Pfizer Maternal RSVpreF vaccine. She reminded everyone that the policy question before the 
ACIP was, “Should Pfizer RSVpreF vaccine be recommended for pregnant people to be given 
during 32 through 36 weeks gestation to prevent RSV lower respiratory tract infection in 
infants ?” Notably, the dosing window represented a change from the policy question discussed 
during the June ACIP meeting. The reason for this change was because On August 21, 2023,15 
FDA approved the Pfizer RSVpreF vaccine for use in pregnant people as a single dose to be 
given at 32 through 36 weeks gestation. In the Phase 2b and 3 trials, vaccination was given 
during 24 through 36 weeks gestation. The change was made to avoid the risk of extremely 
preterm births where there is substantive morbidity and mortality and very preterm birt h. FDA 
considered that the benefit of vaccine efficacy when the Pfizer RSVpreF vaccine is administered 
15 https://www.fda.gov/news- events/press -announcements/fda- approves -first-vaccine- pregnant -individuals -prevent -rsv-infants ; and 
https://www.fda.gov/media/168185/download 
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   between 32 and 36 weeks outweighed the risk of vaccination, including the potential risk of 
preterm birth and hypertensive disorders of pregnancy. Throughout the presentation, these 
were denoted as the approved dosing interval (32 –36 weeks gestation) and the trial dosing 
interval (24– 36 weeks gestation) . In terms of the PICO question, the intervention was updated 
to reflect the approved dosing interval at 32─36 weeks gestation. Otherwise, the population, 
comparison, and outcomes remained the same. 
In terms of the Public Health Problem domain, RSV infection is the leading cause of 
hospitalization in US infants. Most (68%) infants are infected in the first year of life and nearly all 
(97%) by age 2.16 Approximately 2% to 3% of young infants will be hospitalized for RSV.17 RSV 
is a common cause of LRTI in infants. The highest RSV hospitalization rates occur in the first 
months of life, all young infants are at risk, and risk declines with increasing age in early 
childhood.18 Approximately 79% of children hospitalized with RSV who are less than 2 years of 
age had no underlying medical conditions.19 The WG agree unanimously that RSV among 
infants is of public health importance . 
Moving to the Benefits and H arms domain, the WG had data for all 11 outcomes for the Grading 
of Recommendation Assessment, Development and Evaluation ( GRADE ) for this analysis . Data 
were available from 2 trials, Pfizer ’s Phase 3 trial and an earlier Phase 2b trial in pregnant 
people. In terms of how these data were used for GRADE and the benefits and harms domain 
overall, there were data from both trials on the dosing interval and from the FDA approved 
dosing interval. The number of maternal participants by vaccine and placebo arms in the Phase 
2b and Phase 3 are shown in this table: 
*For phase 2b trial and phase 3 trial safety set, number of maternal participants are listed. For phase 3 trial efficacy set, number of 
infants participants are listed. 
1 Data provided by Pfizer 
2 Kampmann et al. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants -PubMed (nih.gov) 
3 Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Briefing Document -FDA 
In both phases, less than half of the maternal participants receive the intervention in the 
approved dosing interval, meaning that the power to assess safety and efficacy was reduced. 
Therefore, for GRADE , the outcomes as assessed in the full trial population with the trial dosing 
interval of 24 ─36 weeks were used consistent with the trial design. The post-hoc analysis using 
data from the approved interval was used as supplemental data. To summarize the effect, 
estimates , and concerns in uncertainty of the assessment for the benefits for this vaccine 
assessed at 0─180 days of life, VE against medically attended RSV -associated LRTI in infants 
was 51%, and efficacy against hospitalization for RSV -associated LRTI in infants was 56.8%. 
16 Suh et al. JID 2022 
17 Hall et al, Pediatrics, 2013; Langley & Anderson, PIDJ, 2011; and CDC NVSN data 
18 Hall et al, Pediatrics, 2013; and CDC NVSN data 
19 Hall et al, Pediatrics, 2013 
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  Additional data received since June included the important outcomes of ICU admission for RSV 
hospitalization in infants with an efficacy of 42.9% , and mechanical ventilation with an efficacy of 
100%. Both estimates had very wide confidence intervals, and thus the certainty assessments 
were downgraded due to very serious concerns for imprecision. Additionally, there are now data 
for all -cause hospitalization for LRTI with an efficacy of 28.9%, with a confidence interval that 
crossed the null. Therefore, the certainty assessment was downgraded for seri ous concern for 
imprecision. 
Regarding the certainty of assessments for harms, changes from June included the 
downgrading of 3 outcomes (e.g., SAEs in pregnant people, SAEs in infants, and preterm birth) 
for serious concerns about indirectness due to the difference in the trial dosing interval 
compared to the approved dosing interval. This was done because 55% of the Phase 3 trial 
population and 62% of the Phase 2b trial populations did not receive vaccine doses during the 
approved dosing interval. There is likely less opportunity for SAEs during pregnancy to occur , 
including preterm birth , when dosing starts at 32 weeks gestation as compared to 24 weeks 
gestation. In particular, the risk of preterm birth likely would be lower with dosing starting at 32 
weeks than with a dosing window that starts at 24 weeks gestation. 
Overall, the summary of GRADE showed that the Pfizer RSV maternal vaccine is effective in 
preventing medically attended RSV -associated LRTI in infants with high certainty in the 
evidence. This vaccine may be effective in preventing hospitalization for RSV -associated LRTI 
in infants , with moderate cert ainty. The vaccine may be effective in preventing ICU admission 
for RSV hospitalization in infants , with low certainty. The vaccine may be effective in preventing 
mechanical ventilation for RSV hospitalization in infants , with low certainty. The vaccine is not 
effective in preventing all -cause medically attended LRTI in infants , with moderate certainty. The 
vaccine may be effective in preventing all -cause hospitalization for LRTI in infants , with 
moderate certainty. SAEs in pregnant people were balanced between the vaccine and placebo 
groups, with low certainty. Reactogenicity in pregnant people was balanced between vaccine 
and placebo groups , with moderate certainty. SAEs in infants were balanced between the 
vaccine and placebo groups , with low certainty . Preterm births were unbalanced between the 
vaccine and placebo groups , with very low certainty in the evidence. This result ed in an overall 
evidence type of “Very Low.” In GRADE , the overall evidence type is driven by the lowest quality 
of evidence for critical outcomes, and here was driven by the evidence rating for the critical 
harm of preterm birth being very low. Comparing the effect estimates for benefits for each of the GRADE outcomes from the full 
Phase 3 trial using the pre- specified trial dosing interval (24–36 weeks gestation) and the 
efficacy estimates for the same outcomes from the Phase 3 trial limited to participants who 
received doses during the approved dosing interval (32–36 weeks gestation) , the point 
estimates were relatively similar for each of the outcomes. The confidence intervals were much 
wider when limited to the approved dosing interval, which is to be expected given the smaller 
number of participants who received vaccination in the approved dosing interval. 
The Phase 3 efficacy against severe medically attended RSV -associated LRTI was a co -primary 
trial endpoint but was not included in GRADE . The reason for this is that this outcome was not 
included by the WG as an a priori critical or important outcome for vaccine policy decisions. 
However, the WG felt that this was important to present as part of the supplemental data in the 
EtR F ramework. Shown here side- by-side are the Pfizer definitions of severe medically -
attended RSV LRTI on the left and medically attended RSV LRTI on the right, which was 
included by the WG as a critical outcome for GRADE . The differences in these two definitions 
are highlighted in blue: 
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   Pfizer Trial Definition WG Definition 
Severe medically -attended RSV -associated LRTI* 
required at least 1 of the following signs/ symptoms: 
− Fast breathing (respiratory rate ≥70 (<2 month of 
age [60 days]) or ≥60 (≥2 to 12 months of age) 
breaths per minute 
− SpO2 measured in room air <93% 
− High -flow nasal cannula or mechanical 
− Ventilation 
− ICU admission for >4 hours 
− Unresponsive/unconscious Medically -attended RSV -associated LRTI* required at 
least 1 of the following signs/symptoms: 
− Fast breathing: respiratory rate ≥60 (<2 months of 
age [60 days]) or ≥50 (≥2 to 12 months of age) 
breaths per minute 
− SpO2 measured in room air <95% 
− Chest wall indrawing 
*Medically attended visit includes inpatient and outpatient encounters. Additionally, definition also required RT -PCR or nucleic acid amplification (NAAT) test 
positive for RSV. Blue text denotes differences between the two definitions. SpO2= Peripheral capillary oxygen saturation 
1.Kampmann et al. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants -PubMed (nih.gov) 
2.Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Briefing Document -FDA 
In terms of VE against severe medically -attended RSV LRTI in the trial dosing interval and the 
approved interval, at 0─ 180 days after birth efficacy was 69.4% in the full interval and 76.5% in 
the approved interval. It is important to note t hat not all of the 81 infants who met the severe 
RSV definition within 0─180 days after birth were hospitalized, n or did all infants who were 
hospitalized for RSV meet the severe definition. Comparison for estimates from the full Phase 3 
trial dosing interval to the approved dosing interval, the point estimates for relative risk were 
similar but the confidence intervals were wider. Specifically for preterm birth, the relative risk in 
the vaccinated group compared to the placebo group using the full trial dosing interval was 1.20 
with a 95% confidence interval of 0.99 to 1.46. The relative risk with the approved dosing 
interval was 1.15 (0.82, 1.61) with a wider confidence interval consistent with decreased power 
to detect this outcome. The confidence intervals were overlapping between the 2 estimates. 
As a reminder, the WG chose preterm birth as a critical outcome because a trial for a similar 
GSK maternal RSV vaccine,20 also a stabilized prefusion F- protein vaccine, was halted due to 
an imbalance of preterm births , with higher numbers in the vaccine compared to the placebo 
group. In that trial, there also was an imbalance in neonatal deaths, which was determined to be 
a consequence of the preterm birth imbalance. The imbalance in preterm births was seen in 
low- and middle- income countries (RR: 1.57, 95% CI: 1.17, 2.10), but not high- income countries 
(RR: 1.04, 95% CI: 0.68, 1.58). The imbalance was observed from April ─December 2021, but 
not consistently after December 2021. The reason for the imbalance in preterm births in the trial 
remains unclear. 
To describe the Pfizer RSVpreF vaccine P hase 3 trial data comparing the trial versus the 
approved dosing interval in more detail, in the full trial with the trial dosing interval, 5.7% of 
births were preterm in the vaccinated group compared to 4.7% in the placebo group. When 
dosing is limited to the approved interval, 4.2% of births in the vaccine arm compared to 3.7% in 
the placebo arm were preterm, showing that the rate of preterm birth decreased as there was 
less opportunity to be born preterm . Also, the imbalance between the vaccine and placebo 
groups narrowed with the approved dosing interval. In terms of low birth weight (≤2500 grams ) 
and neonatal jaundice, low birthweight and neonatal jaundice were both more common in the 
full trial population in the vaccinated group compared to placebo group. However, the 
confidence intervals between tho se 2 groups overlapped and the differences were not 
significant. When limited to the approved dosing interval, 4.1% of infants in the vaccine arm had 
low birth weight compared to 3.4% in the placebo group. Neonatal jaundice was slightly less 
20 https://www.fda.gov/media/165621/download 
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    common among the vaccinated group compared to the placebo, but the confidence intervals overlapped. 
During the June ACIP meeting, ACIP members requested additional data regarding the Pfizer 
maternal RSV vaccine, including the rate of preterm birth by calendar month of birth, birth by 
week of gestational age, percent of births that were preterm by country, and adverse pregnan cy 
outcomes. Enrollment in the Pfizer Phase 3 trial started in June 2020. The earliest births in the 
trial were inevitably preterm , so the rate was high in both the vaccine and placebo groups. For 
Pfizer, the imbalance was more prominent during August ─Dece mber  2021 and then again in 
April─May of 2022.
21 As a reminder, the GSK imbalance was present in April ─December 2021. 
Looking at preterm birth rates by calendar time in the approved dosing interval, preterm birth was less common overall and the temporal patterns were less clear. 
Additionally, ACIP requested a histogram on the number of births by week of gestational age 
from the full Phase 3 trial with the trial dosing interval (24–36 weeks gestation), shown here with 
the vaccine arm in blue and the placebo arm in gray : 
The next histogram shows preterm births only (<37 weeks gestation), which illustrates that the 
imbalance in preterm birth begins at 33 weeks gestation: 
21 Data source: Pfizer response to ACIP, unpublished data, July 2023 
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   Looking at a histogram of births by gestational age limited to participants who received doses 
during the approved interval (32– 36 weeks gestation) , the imbalance is less prominent and is 
only clearly present at 36 weeks : 
The ACIP also requested the percent of preterm births by country in the Phase 3 trial. 
Importantly, the US data was the single largest country contributing to the trial and accounted 
for just under half of all trial participants. In the full trial dosing interval of 24 ─36 weeks in the 
US, 5.7% of births in the vaccine arm were pre- term compared to 5.3% in the placebo arm. 
However, in the approved dosing interval in the US, the direction of this imbalance reversed with 
4% of births in the vaccine arm being preterm compared to 4.4% in the placebo arm. 
The ACIP also requested data on adverse pregnancy outcomes. Looking at select pregnancy -
related SAEs occurring at any time after vaccination up to 6 months after delivery for the full 
Phase 3 trial population,22 maternal SAEs occurred in 16.2% of the vaccine arm compared to 
15.2% of the placebo arm , with overlapping confidence intervals. FDA is requiring post -
marketing studies to assess hypertensive disorders of pregnancy, including pre -eclampsia. In 
the full trial population, pre-eclampsia occurred in 1.8% of the vaccine recipients versus 1.4% of 
the placebo recipients. Gestational hypertension occurred in 1.1% of vaccine recipients and 1% 
of placebo recipients. Hypertension occurred in 0.4% of vaccine recipients and 0.2% of placebo 
recipients. 
Another consideration of interest is inflammatory neurologic events.23 The Pfizer maternal RSV 
vaccine is the same formulation and dose approved for use in adults ≥60 years of age . Within 
the trials for this product, a potential safety signal of inflammatory neurologic events was 
identified among adults ≥60 years of age. A total of 3 cases of interest were recorded among 
20,255 investigational vaccine recipients ≥60 years of age and no cases were observed among 
placebo recipients. The details of these cases were discussed during the June ACIP meeting 
during the session on RSV vaccines in older adults. As a reminder, these cases included 1 case 
of Guillain -Barré Syndrome (GBS), 1 case of Miller Fisher syndrome (MFS; a GBS variant ), and 
1 case of undifferentiated motor -sensory axonal polyneuropathy with worsening of pre- existing 
22 Table 3 ABRYSVO package insert Package Insert -ABRYSVO (STN 125768) (fda.gov); Includes all SAEs from vaccination to 6 
months post -delivery (up to approximately 10 months, depending on the gestational age at the time of vaccination). In the phase 
3 RCT, eclampsia occurred in 5 participants (3 in the RSVpreF group and 2 in the placebo group) and HELLP syndrome occurred 
in 5 participants (2 in the RSVpreF group and 3 in the placebo group). 
23 Melgar et al. Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on 
Immunization Practices — United States, 2023 | MMWR (cdc.gov) 
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   symptoms. No GBS or other demyelinating events were reported in the Phase 2 or 3 trials 
among pregnant people.24 The background rate GBS syndrome in pregnant people is much 
lower than that among older adults.25 In the VSD during 2004─2015, there were 2 cases of G BS 
in pregnant people with an incidence rate of 2.8 per million person years.26 
In summary of the Benefits and Harms domain, the WG felt that this is an efficacious vaccine 
that can prevent RSV LRTI in young infants. However, there was no consensus among the WG 
regarding the clinical importance of the preterm birth imbalance observed in the clinical trials. 
WG members found several points concerning preterm birth. Although not statistically 
significant, an imbalance in preterm births was seen in the full trial population. The trial was 
powered for efficacy outcomes and was not designed or powered to detect a 20% increase in 
preterm birth. There may have been less precise dating of gestational age in some sites and 
countries in the trial, but there is no reason that this should bias towards a preterm birth 
imbalance among vaccinated compared to placebo recipients. The pre -term birth signal in the 
GSK maternal RSV vaccine trial, which also is a stabilized prefusion F- protein vaccine, added to 
the WG’s concern. 
WG members also found several aspects of the data to be reassuring regarding the preterm 
birth imbalance. When using the full trial dosing interval, most preterm births (60%) were more 
than 30 days after vaccination. T here is no known biologic mechanism for vaccines to cause 
preterm birth, particularly more than 30 days after vaccination. When assessed among those 
vaccinated during the approved dosing interval of 32─ 36 weeks, data on preterm birth were 
reassuring to the WG. Specifically, the imbalance in preterm birth was still present but lessened. 
Most infants born preterm in the vaccine group were born at 36 weeks. In the US, which was the 
single largest contributing country in the trial, the imbalance in preterm births reversed from the 
trial dosing interval (trial dosing interval: 5.7% in vaccine vs. 5.3% in placebo recipients ; 
approved dosing interval: 4.0% in vaccine vs. 4.4% in placebo recipients ). Overall, the majority 
of the WG members felt that the approved dosing interval of 32─ 36 weeks gestation could 
reduce the potential risk of preterm birth and the potential for complications from preterm birth, 
both by preventing preterm birth and because babies born late preterm are less likely to have 
complications from preterm birth. This was their major safety concern. 
When asked how substantial the desirable anticipated effects are of the Pfizer maternal RSV 
vaccine for the critical and important outcomes, the WG was split between “Large” and 
“Moderate, ” with a narrow majority choosing “Large. ” When asked how substantial the 
undesirable effects are of the Pfizer maternal RSV RSVpreF vaccine for the critical and 
important outcomes, the WG responded that they were “S mall. ” When asked about the balance 
of desirable and undesirable effects, the WG determined that the balance favored the 
intervention of the Pfizer maternal RSVpreF vaccine. 
24 https://www.fda.gov/media/168185/download 
25 Myers TR, McCarthy NL, Panagiotakopoulos L, Omer SB. Estimation of the Incidence of Guillain- Barré Syndrome During 
Pregnancy in the United States. Open Forum Infect Dis. 2019 Mar 15;6(3):ofz071. doi: 10.1093/ofid/ofz071; and Sejvar JJ, 
Baughman AL, Wise M, Morgan O. Population Incidence of Guillain- Barré Syndrome: A Systematic Review and Meta- Analysis. 
Neuroepidemiology 2011;36:123– 133 
26 Myers TR, McCarthy NL, Panagiotakopoulos L, Omer SB. Estimation of the Incidence of Guillain- Barré Syndrome During 
Pregnancy in the United States. Open Forum Infect Dis. 2019 Mar 15;6(3):ofz071. doi: 10.1093/ofid/ofz071 
23 
 
      
    
   
    
  
    
    
     
   
   
 
      
    
 
      
      
      
   
 
 
    
   
   
   
   
     
    
  
 
     
    
    
     
   
      
   
  
  
 
    
     
   
          
   
    
     
   Moving to the Values domain, the results of a values survey of pregnant and recently pregnant 
people conducted during December 2022─ January 2023 conducted by the University of Iowa, 
RAND, and the CDC were presented during the June ACIP meeting. Among the respondents, 
68% had knowledge of RSV prior to taking the survey and 61% of respondents said they 
“definitely ” or “probably ” would get an RSV vaccine while pregnant. Among those who did not 
respond that they “definitel y” would get an RSV vaccine while pregnant, safety concerns, lack of 
RSV knowledge, and concerns about vaccination causing or intensifying RSV infection were the 
top reasons for not wanting an RSV vaccine during pregnancy.27 It also is important to look at 
the uptake of other vaccines in pregnancy. In the US, coverage for recommended vaccines 
among pregnant people decreased during the pandemic and varies by race and ethnicity.28 
TDAP vaccination coverage was 53.5% in the 2020─2021 season and 45.8% in the 2021─2022 season. Rates of TDAP coverage were higher in White, non-Hispanic women than among 
Black, non-Hispanic  women during the 2020─2021 and 2021─2022 seasons. 
When asked whether the WG felt that pregnant people feel the desirable effects are large 
relative to the undesirable effects , the answered “probably yes. ” When asked if there is 
important uncertainty about , or variability in, how much pregnant people value the main 
outcomes , the WG was evenly split between “ probably important uncertainty or variability ” and 
“probably not important uncertainty or variability. ” 
There were limited data to inform the Acceptability domain and no updates since the June ACIP 
meeting. A study in England
29 assessed support of an RSV vaccine among maternity health 
care professionals (HCP) , specifically obstetricians and midwives . If the vaccine was routinely 
recommended , 47% of responders said they “ definitely ” would recommend the vaccine, 34% 
“likely ” would support a routinely recommended RSV vacci ne, 14% were “not sure,” 4% said 
“unlikely,” and 0.5% said “very unlikely .” When asked i f RSV prevention with the Pfizer maternal 
RSV vaccine was acceptable to key stakeholders, the majority of the WG answered “yes” and a 
minority answer ed “probably yes. ” 
In terms of the F easibility domain, the storage and handling requirements, the vaccine is 
supplied as single 0.5 mL dose or as a 5- pack or 10- pack of single- dose kits . Reconstitution is 
required, with  a single dose vial of lyophilized powder and reconstitution supplies included in the 
kits. The p roduct should be refrigerated (2° –8°C) in the original container and protected from 
light. After reconstitution, the product should be administered within 4 hour s and otherwise 
discarded.30 Additionally, most pregnant patients receive Tdap vaccine in an obstetrician’ s or 
midwife ’s office. Therefore, it is likely that pregnant patients also most often would receive RSV 
vaccine at their prenatal care provider ’s offi ce.31 
27 CDC and University of Iowa/RAND survey, unpublished 
28 Flu, Tdap, and COVID -19 Vaccination Coverage Among Pregnant Women – United States, April 2022 | FluVaxView | Seasonal 
Influenza (Flu) | CDC; https://www.cdc.gov/flu/fluva xview/pregnant -women- apr2022.htm 
29 Wilcox CR, Calvert A, Metz J, et al. Attitudes of Pregnant Women and Healthcare Professionals Toward Clinical Trials and 
Routine Implementation of Antenatal Vaccination Against Respiratory Syncytial Virus: A Multicenter Questionnaire Study. The 
Pediatric Infectious Disease Journal. 2019 Sept;38(9):944- 951. DOI: 10.1097/INF.0000000000002384. 
30 Package Insert -ABRY SVO (STN 125769/26) (fda.gov) 
31 https://www.cdc.gov/flu/fluvaxview/pregnant -women- apr2022.htm 
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  Another important consideration for feasibility is simultaneous administration of RSV vaccine 
with other vaccines in pregnant people. Pregnant people potentially may be eligible to receive 
RSV, T dap, COVID -19, and influenza vaccines during the same visit. There are limited data 
regarding simultaneous administration, but there was a Pfizer study32 in healthy non- pregnant 
women 18─49 years of age on simultaneous administration of Tdap and Pfizer RSV vaccine 
that found decreased immune response to pertussis components, meaning that the non-
inferiority criteria were not met. However, given the lack of correlates of protection for pertussis, 
it is unclear how this might impact protection against pertussis from maternal Tdap when 
simultaneously administered with RSV vaccine. Tdap is recommended every pregnancy, 
preferably during the early part of gestational weeks 27─ 36,33 which means that Tdap preferably 
would be given before 32 weeks and RSV vaccine would be given at or after 32 weeks. 
However, in MarketScan data from 2018─2021,34 about half of captured Tdap doses were given 
before 32 weeks gestation. 
Another important consideration is that RSV vaccine is 1 of 2 available preventive products for 
RSV in infants. Either RSV vaccination during pregnancy or nirsevimab administration for the 
infant after birth can be used to prevent RSV disease in infants. The WG felt strongly that both 
products are not needed for most infants. The pregnant person and their prenatal care provider 
will need to make the decision during pregnancy regarding which RSV prevention product to 
use. Many prenatal care providers may not have time to discuss options for RSV prevention 
with their patients. In addition, prena tal care providers may not feel equipped to discuss 
nirsevimab since this product will be given to the infant after birth. 
Regarding the timing of RSV vaccine dosing during the calendar year, RSV vaccine dosing 
could be implemented for pregnant people as a seasonal campaign or year-round.  The WG 
unanimously supported the use of a seasonal dosing strategy for maternal RSV vaccine 
because this would maximize cost -effectiveness , maximize the benefits for infants, and target 
RSV vaccine dosing to inf ants who will be in the first months of life during the RSV season. 
Importantly, nirsevimab is available for infants who are born out of season for whom maternal 
vaccine protection would have waned by RSV season. The WG supported seasonal dosing 
beginning in September and going through January in most of the continental US based on 
typical pre -pandemic seasonality. This aligns with implementation of influenza vaccine and 
would simplify implementation for prenatal care providers. The WG felt that jurisdictions in which 
RSV seasonality differs from most of the continental US should have flexibility regarding start and stop of administration of RSV vaccine in pregnant people. These jurisdictions include 
Alaska and jurisdictions with tropical climates (e.g., parts of Florida, Puerto Rico, US Virgin 
Islands, Hawaii, Guam, and US -affiliated Pacific Islands ). 
When asked whether the Pfizer maternal RSV vaccine is feasible to implement , the majority of 
the WG answered “yes” and a substantial minority answered “probably yes. ” 
32 Peterson et al. Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F Vaccine When CoadministeredWith a 
Tetanus, Diphtheria, and Acellular Pertussis Vaccine.The Journal of Infectious Diseases. 2022 June 15; 225(12): 2077– 2086. doi: 
10.1093/infdis/jiab505 
33 CDC, https://www.cdc.gov/vaccines/vpd/dtap- tdap- td/hcp/recommendations.html 
34 MarketScan data, 2018- 2021 
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   Regarding the R esource Use Domain, the ACIP heard presentations earlier from D rs. Hutton 
and Ortega -Sanchez on economic analyses. Dr. Hutton showed scenarios for cost -effectiveness 
by months of RSV vaccine dosing during the calendar year. The base case was about $400,000 
per QALY. If the months of dosing were limited to target dosing to pregnant people whose 
infants would be in the first months of life during the RSV season, the ICER decreased and the 
cost- effectiveness improved. Importantl y, the ICER would be $167,000 per QALY is dosing is 
provided during the September ─January timeframe. The WG interpretation was that while RSV 
vaccine may improve outcomes, it also would increase costs. The base case model showed an 
icer of about $400,000 p er QALY and assumed year -round dosing of this vaccine and typical 
RSV seasonality in most of the continental US. The WG felt that this vaccine would not be cost -
effective under the base case conditions. However, cost -effectiveness would be improved by 
using a seasonal dosing strategy during September ─January in most of the continental US. 
Thus, the WG unanimously supported the use of a seasonal dosing strategy. 
When asked whether Pfizer maternal vaccine use would be a reasonable and efficient allocation 
of resources , a substantial majority of the WG answered “ probably yes ” and a substantial 
minority answered “yes.” It is important to note that the WG responses were based on seasonal 
dosing for RSV vaccine specifically during September ─January in most of the continental US. 
Data for the final domain of Equity have been presented before. National studies of death 
certificates found higher rates of RSV -associated deaths among non- Hispanic Black children 
compared with non -Hispanic White infants in children 1-4 years of age.35 ICU admission rates 
for RSV among non- Hispanic Black infants <6 months of age were 1.2 to 1.6 times higher than 
among non -Hispanic White infants.36 In one study, RSV hospitalization rates were 4 to 10 times 
higher among Alaska Native and American Indian (AI/AN) children <24 months than the rate in 
the general population.37 However, it is important to note that the study was limited to specific 
populations and might not be broadly representative of risk in all A I/AN children. 
Regarding Medicaid coverage for pregnant people and vaccines during pregnancy , by federal 
law, all states provide Medicaid coverage for pregnancy -related services to pregnant women 
with income levels up to 138% of the federal poverty level.38 In 2021, 41% of mothers had 
Medicaid at the time of birth,39 making Medicaid the largest payer for maternity care in the US. If 
recommended, ACIP would vote on a Vaccines for Children (VFC) resolution for the vaccine for 
pregnant people < 19 years of age. B eginning on October 1, 2023, when the Inflation Reduction 
Act of 2022 (IRA) provisions become effective, state Medicaid agencies will be required to 
recover vaccines and their administration without cost -sharing for nearly all adult beneficiaries 
covered under traditional Medicaid, if the CDC recommendations apply. Regarding other 
insurance coverage, meaning commercial insurance for vaccines during pregnancy under the Affordable Care Act (ACA) and its implementing regulations, ACIP recommendations that have 
been adopted by CDC and are listed on CDC’s I mmunization Schedules generally are required 
to be covered by group health plans and health insurance issuers without any cost -sharing 
requirements. 
35 Hansen et al. The Use of Death Certificate Data to Characterize Mortality Associated With Respiratory Syncytial Virus, 
Unspecified Bronchiolitis, and Influenza in the United States, 1999- 2018 J Infect Dis. 2022 Aug 15;226(Supplement 2): S255– 
S266. 
36 Unpublished data from RSV -NET, CDC. 
37 Atwell et al. RSV Among American Indian and Alaska Native Children: 2019 to 2020 Pediatrics. 2023 Aug 1;152(2):e2022060435 
38 https://www.kff.org/womens -health- policy/issue -brief/medicaid- coverage- for-women/ 
39 https://www.medicaid.gov/sites/default/files/2023- 04/beneficiary -profile -2023.pdf 
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     When asked what the impact of the Pfizer maternal RSV vaccine on health equity would be , the 
WG’s answers ranged and there was no clear majority . The most common answer among the 
WG was “probably increased, ” the second most common was “probably no impact, ” and the 
third most common was “increased. ” 
In summar y, regarding the use of the Pfizer maternal RSV vaccine to prevent RSV in infants , 
the WG judged this is an important public health problem, the desirable anticipated effects are 
large, the undesirable anticipated effects are small, the balance of desirable and undesirable 
effects favor the intervention, and that the target population probably feels the desirable effects 
are large relative to the undesirable effects. Half of the WG chose that there is probably 
important uncertainty or variability in how patients value the outcome, and half chose there is 
probably not important uncertainty or variability. The WG judged that the intervention is 
acceptable to key stakeholders , is feasible to implement, and is probably a reasonable and 
efficient allocation of resources with seasonal dosing. The WG had varied answers as to 
whether the intervention would increase health equity, ranging from probably no impact to increased health equity. The majority of the WG felt that the desirable consequences probably 
outweigh the undesirable consequences in most settings, and a substantial minority felt that the 
desirable consequences clearly outweigh the undesirable consequences in most settings. The 
majority opinion was in favor of recommending the Pfizer maternal RSV vaccine, and there was 
a minority opinion to recommend the intervention based on shared clinical decision- making. 
To summarize the WG’s considerations overall, for benefits and harms, the majority of the WG 
was supportive of the intervention with the Pfizer maternal RSV vaccine for pregnant people 
with the approved dosing interval of 32─ 36 weeks gestation. They found the data on preterm 
births, when assessed among those vaccinated during the approved interval, to be reassuring. 
They felt the approved dosing interval of 32─ 36 weeks gestation would reduce the potential risk 
of preterm birth and the potential for complications from preterm birth, which was their major 
safety concern. All WG members endorsed the importance of post -introduction vaccine safety 
monitoring. The WG unanimously supported the use of a seasonal dosing strategy, which would 
maximize benefits and cost -effectiveness. The WG supported that RSV vaccine dosing should 
occur during September ─January in most of the continental US and felt that jurisdictions in 
which RSV seasonality differs from most of the continental US should have flexibility regarding 
start and stop of administration of RSV vaccine in pregnant people. 
The WG also considered the implications of RSV vaccine being 1 of 2 available preventive 
products for RSV in infants. The WG expressed that pregnant people should have options for 
RSV prevention, given that nirsevimab may not be readily available in all settings. In addition, 
pregnant people and their providers may have preferences regarding these 2 products. The WG 
also stated that pregnant people should be made aware that they either could receive RSV 
vaccine during pregnancy or that nirsevimab could be given to the infant, but that most infants 
would not need both. The WG expressed that pregnant people should be informed regarding 
the risks and benefits of both products before making a decision. 
The WG had extensive discussions regarding a full recommendation versus a shared clinical 
decision- making recommendation. Most WG members support a full recommendation. They felt 
the approved dosing interval would reduce the potential risk of , and complications from , preterm 
birth. They stress ed the importance of clear vaccine recommendations and noted that providers 
who will help pregnant people decide which product to receive generally have less familiarity 
with the data than ACIP does. They expressed that shared clinical decision- making 
recommendations can be confusing, hard to implement for providers , can lead to lower vaccine 
confidence and uptake of vaccine, and potentially could influence support for the vaccine in 
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  lower -and middle- income countries where nirsevimab may not be available. A minority of WG 
members supported a recommendation with shared clinical decision- making. They noted that 
without shared clinical decision- making, a full recommendation could result in some providers 
recommending RSV vaccine during pregnancy without discussing with pregnant patients that 
nirsevimab is an option. They cited the potential risk for preterm birth and neuroinflammatory 
events and cited that the same vaccine is recommended under shared clinical decision- making 
for adults ≥60 years and older. It is important to note that ACIP generally makes shared clinical 
decision- making recommendations when individuals may benefit from vaccination, but broad 
vaccination of people in that group is unlikely to have population- level impacts. As discussed 
during the June ACIP meeting, the WG noted that currently there are no data available on the 
efficacy of the first lifetime dose during subsequent pregnancies, or the safety of additional 
doses given in subsequent pregnancies. The WG felt that it was too early to decide whether 
additional doses should be given in subsequent pregnancies due to the lack of data, that 
additional data are needed to inform whether additional doses in subsequent pregnancies would 
be indicated, and that recommendations can be updated in the future. 
With all of th is in mind, the proposed voting language put forward for a potential vote during this 
meeting was as follows: 
“Maternal RSV vaccine is recommended for pregnant people during 32 through 36 weeks 
gestation, using seasonal administration, to prevent RSV lower respiratory tract infection in 
infants.” 
Updated Clinical Considerations for Use of Both Nirsevimab and Pfizer RSVpreF Vaccine 
Jefferson Jones MD, MPH, FAAP, CDR USPHS (CDC/NCIRD) discussed the updated clinical 
considerations for the use of maternal RSVpreF vaccine and nirsevimab. Beginning with the 
proposed clinical considerations for use of the maternal RSV vaccine, as Dr. Fleming -Dutra 
reviewed, the WG discussion points that shaped these considerations included that as 
proposed, the maternal RSV vaccine would be recommended for pregnant people during 32─ 36 
weeks gestation with seasonal administration or during September ─January in most of the 
continental US in jurisdictions with seasonality that differs from most of the continental states, 
including Alaska and jurisdictions with tropical climates (e.g., parts of Florida, Hawaii, Puerto 
Rico, Guam, US Virgin Islands, and the US- affiliated Pacific Islands ). In those jurisdictions, 
providers would follow state, local, or territorial guidance on the timing of administration. The 
maternal RSVpreF vaccine may be administered simultaneously with other eligible 
vaccinations.40 
Before reviewing the clinical considerations for use of both the maternal RSV vaccine and 
nirsevimab, Dr. Jones summarize d the considerations of the WG. He first discussed 2 groups of 
infants born to vaccinated mothers who were previously considered for nirsevimab during the 
June ACIP meeti ng, preterm infants and infants born outside of the RSV season. As proposed 
regarding infants born prematurely, the maternal RSV vaccine recommendation is for 
administration beginning at 32 weeks gestation. F rom the time of maternal vaccination, 14 or 
more days are likely needed for development and transplacental transfer of maternal antibodies 
to protect the infant and nirsevimab is recommended for infants born within 14 days of 
vaccination. The earliest an infant can be born and hav e maternal vaccine- induced protection is 
40 https://www.cdc.gov/vaccines/hcp/acip -recs/general -recs/index.html 
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   34 weeks gestation. This means that all infants born at <34 weeks gestation will be 
recommended to receive nirsevimab.41 
Regarding infants born outside of the RSV season, protection from maternal vaccination may 
begin to wane after 3 or more months. For example, this has been seen with the influenza and 
COVID -19 vaccines .42 WG members initially were concerned that some infants born outside of 
the RSV season and born to vaccinated mothers may benefit from nirsevimab in order to boost protection when entering the RSV season. However, because maternal RSV vaccine 
administration is now proposed to be recommended during September ─January, most infants of 
vaccinated mothers will be born during the RSV during October ─March . Mothers of infants born 
outside of the RSV season during April ─September will not have been vaccinated, and 
nirsevimab will be recommended for these infants. 
Other WG considerations regarding the use of both maternal RSV vaccine and nirsevimab 
included that there are 2 products available to protect infants from RSV LRTI . For infants born to 
vaccinated mothers , the addition of nirsevimab may provide incremental protection, but there 
are no efficacy data on the use of nirsevimab in infants born to vaccinated mothers, so this is 
unknown. There also are no safety data on the use of nirsevimab in infants born to vaccinated 
mothers , but nirsevimab trials included infants with maternal infection- induced antibodies and 
the risk is likely minimal. The WG felt that for most infants, administering both products is not 
needed and would not be a reasonable and efficient allocation of resources based on the cost -
effectiveness analysis presented earlier in the day. Of note, documentation of maternal 
vaccination status may not be available to the infant ’s HCP. 
Most WG members felt that pregnant people should be aware that both maternal vaccination 
and nirsevimab are options when deciding whether to be vaccinated. However, HCP of 
pregnant people may not have the time or feel equipped to discuss nirsevimab when 
counseling. The WG felt that in rare situations, flexibility is needed for providers to be able to 
administer nirsevimab when it is clinically warranted for infants born to vaccinated mothers. 
Examples include conditions in pregnant people resulting in an inadequate immune response to 
vaccine or decrease in transplacental antibody transfer.
43 Also, infants who have undergone 
cardiopulmonary bypass leading to a loss of maternal antibodies44 and infants with su fficiently 
increased risk for severe disease to warrant nirsevimab because of the potential increased benefit. 
The following are the proposed clinical considerations for the use of the maternal RSV vaccine 
and nirsevimab : 
Either maternal vaccination or use of nirsevimab in the infant is recommended to prevent 
RSV LRTI , but administration of both products is not needed for most infants. 
Health care providers of pregnant people should provide information on both products and 
consider patient preferences when determining whether to vaccinate the pregnant patient or 
to not vaccinate and rely on administration of nirsevimab to the infant after birth. 
41 https://www.cdc.gov/vaccines/pregnancy/vacc- during- after.html 
42 Kampmann NEJM 2023; Nunes F1000Res 2018;and Zerbo Nat Commun 2023. 
43 Palmerira Clin Dev Immunol 2012 
44 Feltes J Pediatr 2003 
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   It is important to note that both products are safe and effective in preventing RSV LRTIs in 
infants. The following displays potential information that could be shared with patients on the 
relative risks and benefits of a maternal RSV vaccine and nirsevimab: 
Relative benefits of maternal vaccination include that a maternal vaccine provides protection 
immediately after birth, when infants are at the highest risk for severe RSV disease. A maternal 
vaccine may be more resistant to virus mutation compared w ith monoclonal antibodies, 
although RSV does not mutate rapidly. While both products require an injection, use of a 
maternal vaccine avoids injection of the infant. Relative risks of maternal RSV vaccination 
include that maternal vaccine- induced protection is reduced if fewer vaccine- induced antibodies 
are produced or are transferred from the mother to the baby (e.g., mother immunocompromised 
or the infant is born soon after vaccination. There is a potential risk of preterm birth , but 
administration at 32─ 36 weeks reduces this risk. 
The relative benefits of nirsevimab include studies of antibody levels suggest ing that protection 
from nirsevimab might wane more slowly. Administration of nirsevimab can provide antibodies directly if an infant receives less antibodies from the mother. Since nirsevimab is provided after 
birth, there are no risk of adverse pregnancy outcomes. Relative risks of nirsevimab include that 
there may be potential limited availability of nirsevimab during the 2023─2024 RSV season. In 
the setting of a maternal vaccine, nirsevimab would be recommended for infants <8 months of 
age born during or entering their first RSV season if the mother did not receive the RSV vaccine 
or it is unknown if the mother received an RSV vaccine or mother was vaccinated, but the infant 
was born <14 days after vaccination. Nirsevimab is not needed for most infants born ≥14 days 
after maternal vaccination. 
Nirsevimab can be considered in circumstances when the mother has received RSV vaccine 
≥14 days prior to birth . Nirsevimab can be considered in rare circumstances, per the c linical 
judgment of the HCP , the potential incremental benefit of administration is warranted. One 
example is infants born to pregnant people who may not mount an adequate immune response 
to vaccination (e.g., people with immunocompromising conditions ) or have conditions 
associated with reduced transplacental antibody transfer (e.g., people living with HIV 
infection).
45 Other examples include infants who have gone undergone cardiopulmonary 
bypass, leading to a loss of maternal antibodies46 or infants with substantial increased risk for 
45 Palmerira Clin Dev Immunol 2012 
46 Feltes J Pediatr 2003 
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  severe RSV disease (e.g., hemodynamically significant congenital heart disease or ICU 
admission requiring oxygen at discharge ). Recommendations for nirsevimab can be 
summarized in the following algorithm . 
Nirsevimab is recommended to all infants aged <8 months on the day of administration who 
meet all 3 of the following criteria : 
Details on timing, including special situations and flexibility, are described in the footnotes: 
These were previously presented during the August ACIP meeting under nirsevimab and 
described in the published nirsevimab recommendation in the Morbidity and Mortality Weekly 
Report (MMWR ). 
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   Implementation Considerations for Maternal RSV Vaccine 
Georgina Peacock, MD, MPH (CDC/NCIRD) presented m aternal RSV vaccine implementation 
Considerations , including the following: 
Vaccine storage, handling, and administration 
Cost of vaccine 
Insurance coverage 
Supply and availability 
Complexity of immunization schedule 
Vaccine demand and coverage in pregnant people Obstetric and pediatric provider roles in vaccination decisions 
Immunization information systems 
Communication challenges 
For Pfizer RSV vaccine storage, handling, and administration, the overall clinical implementation 
is similar to other vaccines. It is stored at 2◦ to 8◦ C and administered as a single dose through 
an intramuscular ( IM) route. Additional steps are required for dilution, including reconstitution of 
the lyophilized antigen component with the sterile water diluent component.
47 The proposed 
recommendations to ACIP allow for simultaneous administration with other recommended 
vaccines,  and there is som e consideration that increasing the number of vaccines could lead to 
limited storage space. 
There has been a lot of conversation already about cost of the vaccine at $295 a dose for the 
Pfizer RSV compared to Tdap that is approximately $46 to $52.48 This cost is lower than the 
infant nirsevimab cost of $495 for the private sector cost. Reimbursement and cost recovery 
challenges already have been identified by providers and practices as implementation barrier s 
for maternal immunization. Among providers, f inancial concerns are a leading barrier to 
maternal immunization.49 
Related to insurance coverage, most pregnant people are covered by some form of private 
payer or Medicaid. About 52% of pregnant people have private insurance, 41% have Medicaid, 
and about 4% are likely uninsured and are considered “ self-pay.”50 If recommended, ACIP 
would vote on a V FC resolution for maternal RSV vaccine in people aged <19 years . For people 
≥19 years of age, there would be limited availability through the 317 program in jurisdictions. In 
terms of i nsurance coverage for infant nirsevimab , the ACIP already recommended nirsevimab 
as a routine immunization. Therefore, it will be covered under the ACA without cost -sharing by 
the patient starting in the effective plan year .51 Anecdotally, plans are starting to let people know 
that they will start covering nirsevimab when it becomes available in the coming weeks. 
Nirsevimab is included in the V FC program for eligible children, so about 50% of children in the 
US will be able to access nirsevimab at no cost. 
47 https://www.fda.gov/media/168889/download?attachment 
48 Current CDC Vaccine Price List | CDC 
49 https://www.sciencedirect.com/science/article/abs/pii/S0749379717306396#f0010 
50 https://www.cdc.gov/nchs/products/databriefs/db468.htm 
51 https://www.law.cornell.edu/uscode/text/42/300gg- 13 
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   With regard to supply and availability of maternal RSV vaccine and nirsevimab during the 2023– 
2024 RSV season , there are no anticipated supply/demand mismatches . Because the Pfizer 
maternal RSV vaccine is the same product in use for adults ≥60 years of age, availability is 
expected shortly after ACIP recommendations. Nirsevimab likely will be available in late 
September or early October . There were some conversations during the last ACIP meeting 
about delivery in birthing hospitals versus outpatient settings. Efforts are underway to increase 
the number of birthing hospitals that will administer nirsevimab , particularly under the VFC 
program. 
It is important to point out the increas ing complexity of the maternal immunization schedule as 
illustrated in this figure: 
The maternal immunization schedule is increasingly complex in terms of d ifferent timing of 
vaccines based on the season and/or gestational age, with seasonal timing varying in some 
locations. In addition, there is a limited window for RSV vaccine administration. The willingness 
of pregnant people to accept multiple vaccines in pregnancy also is unclear. In a survey of 
pregnant people, approximately 12% said they would accept no vaccines and about 49% said 
they would accept 1 or 2 vaccines .52 Uptake of vaccines among pregnant people has declined 
and disparities persist.53 
Important decisions will need to be made regarding w hether to administer maternal RSV 
vaccine or infant nirsevimab. Studies continue to demonstrate that HCPs are pregnant people’s 
most trust ed source of information on vaccines, and that provider recommendation is a strong 
predictor of vaccination.54 However, one survey show ed that two- thirds of obstetricians did not 
feel comfortable providing information about routine childhood immunizations or that that was 
their role.55 In terms of pediatric provider roles in immunization decisions, recommendations for 
nirsevimab that are contingent upon knowledge of maternal vaccination status could be challenging if the pediatric provider does not receive the maternal record. Verbal report s of 
vaccines received during pregnancy may not be reliable.
56 Therefore, pediatric providers may 
need to make decisions on nirsevimab administration without having complete information on maternal vaccination status. 
52 CDC and University of Iowa/RAND survey, unpublished 
53 https://www.cdc.gov/flu/fluvaxview/pregnant -women- apr2022.htm 
54 Lutz C, et al. Understanding barriers and predictors of maternal immunization: Identifying gaps through an exploratory literature 
review. Vaccine 36 (2018): 7445- 7455 
55 https://link.springer.com/article/10.1007/s10995-011- 0936-0 
56 https://www.cdc.gov/mmwr/volumes/66/wr/mm6641a3.htm 
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 Moreover, s tate Immunization Information System s (IISs) vary in what they capture related to 
adult immunization. Pregnancy status is not identified in IIS, though potentially RSV vaccine 
administrations in adult women <age 60 years of age could be used as a proxy for RSV vaccine 
administration. There is not a way currently to link maternal and infant i mmunization records in 
IISs, so it is not possible through these systems at this point to use that to forecast whether 
infant nirsevimab immunization is needed. In some state policies, there is not an ability for 
pediatric providers to review adult records or records of individuals who are not their patients. 
As always in immunization implementation, there are some communication challenges. This 
includes use of t erms like “vaccine” for the maternal product versus “immunization” for the infant 
product . Conveying potential risks and benefits of each approach and helping the pregnant 
person make an informed decision, including the potential but undetermined risk of preterm birth 
with maternal immunization, is going to take time for providers. D iscussing financial implications 
with a patient in a setting of uncertainty related to coverage in the first year of implementation 
may be challenging. 
A lot of work is being done at CDC to address communication activities. There has been 
formative research and message testing, including with focus groups and in- depth interviews to 
help inform the ultimate communication activities that will be done for the public. There have 
been surveys of parents of young children and also pregnant and recen tly pregnant people. 
With that information, patient and provider education materials are being developed. There also 
are some partnerships with HCP organizations and organizations that serve pregnant people. 
There also is an intention to utilize social media across all of CDC’ s platforms. 
Vaccines for Childrens Resolution 
Jeanne Santoli, MD, MPH (CDC/NCIRD) indicated that the purpose of this resolution was to: 1) 
add an RSV vaccine for pregnant people aged <19 years to the program ; and 2) update the 
language regarding the recommended vaccine schedule for nirsevimab to take into account 
RSV vaccine for use during pregnancy. The eligible groups include pregnant people aged <19 
years. The recommended vaccination schedule and intervals included the language that was 
reviewed during this session: 
During 32 through 36 weeks gestation, with seasonal administration. This would be during September through January in most of the continental United States. In jurisdictions with 
seasonality that differs from most of the continental Unites States (e.g., those with tropical 
climates, Alaska), providers should follow state, local, or territorial guidance on timing of administration. 
Either RSV vaccination during pregnancy at 32 through 36 weeks gestation or nirsevimab administration for infants age <8 months shortly before or during the RSV seasons is 
recommended to prevent RSV lower respiratory tract infection, but both products are not 
indicated for most infants. 
Recommended DosageRefer to product package inserts. 
Contraindications and Precautions 
Contraindications can be found in the package inserts available at: 
https://www.fda.gov/media/168889/download?attachment 
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     For t
he nirsevimab component, the only change was that now there are 2 components to the 
eligible gr oups: 
Infants aged <8 months born during or entering their first RSV season 
Children aged 8- 19 months as noted in Table 1 who are at increased risk of severe RSV 
disease and entering their second RSV season 
No changes were made to the Table 1: 
Language was added to Table 2 for the first season stating, “whose mother’s receipt of RSV 
vaccine is unknown or who was born within 14 days of maternal vaccination” and the rest of the resolution is the way it appeared in August 2023 : 
This recommended vaccination schedule and intervals language also has been added and there 
is some language in each component of the resolution that refers to the other components: 
“For most infants aged infants aged <8 months born during or entering their first RSV season 
whose mother received an RSV vaccine 14 or more days prior to birth, nirsevimab is not 
needed. Nirsevimab can be considered in rare circumstances when, per the clinical judgment of 
the healthcare provider, the potential incremental benefit of administration is warranted. ” 
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 The recommended dosage, contraindications and precautions, and standard documents 
statement about ACIP recommendations or notices within 6 months remained unchanged: 
Recommended Dosage
Refer to product package inserts. 
Contraindications and Precautions 
Contraindications and Precautions can be found in the package inserts available at: 
https://www.accessdata.fda.gov/spl/data/2f08fa60 -f674-432d- 801b -1f9514bd9b39/2f08fa60-
f674- 432d -801b- 1f9514bd9b39.xml 
[If an ACIP recommendation or notice regarding RSV prevention is published within 6 months 
following this resolution, the relevant language above (except in the eligible groups sections) will 
be replaced with the language in the recommendation and incorporated by reference to the publication URL] . 
Pfizer Statement 
Luis Jodar, MD (Chief Medical Officer , Vaccines & Antivirals, Pfizer) thanked the ACIP for 
the opportunity to speak. Pfizer is excited about the recent FDA approval of the maternal 
indication for RSV vaccine, ABRYSVO ™. Last Fall, the US experienced a triple epidemic of 
RSV, influenza, and COVID -19 infections , making national headlines. With the threat of another 
triple epidemic, having multiple options for RSV prevention for infants will be more important 
than ever. As shown in the from the data on efficacy in the randomized controlled trial s (RTCs) , 
the maternal RSV vaccine provides infants with a high degree of protection against RSV immediately from birth when infants are at highest risk for severe disease and maintains this 
protection for at least 180 days. This is even more important when considering equity. Medicaid recipients miss or cancel a substantial proportion of their well -child visits in the first 6 months of 
life, with only 25% attending all recommended well -child visits. In contrast, more than 90% of 
Medicaid mothers attend at least 1 visit prior to delivery . With an estimated 41% of pregnant 
individuals on Medicaid, maternal immunization provides a secure, stable, and equitable 
approach to RSV prevention for newborns. 
Regarding the concern raised about an imbalance in pre -term birth s, the totality of the data 
supports a favorable benefit -risk profile for maternal vaccination as supported by the external 
Data Monitoring Committee ( DMC ), the FDA’s Vaccines and Related Biological Products 
Advisory Committee (VRBPAC), and FDA licensure. The US indication of 32─36 weeks is 
reassuring about the potential risk of preterm birth. Pfizer has committed to 4 post-licensure 
pharmacovigilance studies. The safety surveillance systems in place through Pfizer’s post -
marketing commitments, a long with the CDC and FDA systems presented during this meeting, 
are sensitive, timely, powerful , and can detect any safety signals should any arise. Pfizer want s 
to assure the committee that a robust supply of vaccine is already available to providers and is 
ready to be implemented through existing vaccine programs. The RSV season is already 
starting and, for the first time, there potentially could be 2 important routinely recommended 
options for RSV prevention for infants. Pregnant persons now will be able to have an informed 
discussion with their obstetricians and other maternal health providers, as they do for all 
routinely recommended maternal vaccines , and make an informed decision on which option is 
best for them and their baby. Dr. Jodar emphasized that the RSV vaccine would be a lower cost 
option and overall could result in a lower budget impact for the US healthcare system. Pfizer 
thanked ACIP and the WG for their careful deliberations and dedication to preventing infectious 
diseases. 
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  Liaison Organi zation Statements 
Brenna Hughes, MD, MSc, FACOG (ACOG) thanked the leadership of ACIP and the WG on 
behalf of the American College of Obstetricians and Gynecologists (ACOG) for their 
collaboration on this topic and for inviting ACOG to share its position and expert opinions 
regarding the maternal RSV vaccine. It is critical that the O B-GYN voice be considered 
particularly as implementation considerations are discussed. ACOG remains unequivocally 
supportive of a full recommendation for maternal RSV vaccine for pregnant individuals. This 
RSV vaccine is efficacio us and could decrease the risk of severe disease in many infants. While 
nirsevimab is clearly highly efficacious, it may not be available or may not be preferred by a 
parent or health care facility as the primary intervention. Therefore, ACOG believes it i s critical 
to ensure that pregnant individuals can access this RSV vaccine to give their newborns 
protection after birth. As a practicing obstetrician and member of the RSV Vaccine W G, Dr. 
Hughes has reviewed these data extensively, along with the other ex perts on the WG , and has 
discussed these data with ACOG experts and leadership. They have evaluated all of the 
available data regarding the risk of premature delivery, and currently consider this outcome to 
be a theoretical risk , with the benefits of vaccination outweighing the hypothetical risk of AEs. 
Therefore, ACOG feels that this vaccine should be recommended. Finally, ACOG continues to 
encourage the collection of additional data to inform future policy considerations, and look s 
forward to collaborating with the CDC and other organizations to ensure optimal implementation of strategies to decrease the burden of RSV disease in infants. 
Carol Hayes, CNM, MN, MPH, FACNM (ACNM) provided comments on behalf of the American 
College of Nurse Midwiv es (ACNM), the largest professional association representing certified 
nurse midwives and certified midwives in the US. ACNM sets the standard for excellence in 
midwifery education and practice in the US and strengthens the capacity of midwives in 
developing countries. ACNM members are primary care and sexual and reproductive health 
providers for people throughout their lifespans , with a special emphasis on pregnancy, 
childbirth, gynecological, and reproductive health. ACNM has participated actively in the ACIP and the CDC Task F orce on Maternal Immunizations and regularly update s and encourages 
members to recommend the 3 standard maternal immunizations throughout a shared decision-
making model. The midwifery model of care puts women and pregnant people at the center of 
care and encourages members to share scientific evidence on choice surrounding 
immunizations so that pregnant families can make the best decisions for themselves. After 
reviewing the evidence on the safety and efficacy of the maternal vaccine, as well as the 
incidence of RSV cases in newborns and infants, ACNM strongly recommends that ACIP 
support the availability of this vaccine to all pregnant people from 32─ 36 weeks of gestation. 
ACNM believes that pregnant individuals should be informed of the benefits and the risks of 
maternal RSV vaccine, and the vaccine should be available to those who choose it without any 
barrier to access, such as cost , referral , or approval by a third party. Given the rise and the 
prevalence of RSV cases among newborns, ACNM believes that pregnant people should be 
able to access a vaccine that is proven to prevent LRTD and severe LRTD caused by RSV in 
infants from birth to 6 months of age. 
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   ACIP Discussion Points, Observations, Suggestions for RSV Vaccine 
Following Presentations by Dr. DeSilva and Dr. More 
• ACIP expressed gratitude to Drs. DeSilva and More for sharing the proactive plans to 
monitor RSV vaccines. 
• In terms of an inquiry about how pregnancies with multiple gestations (e. g., twins, 
triplets, et cetera) would be monitored since they have a risk for being preterm , Dr. 
DeSilva indicated that multiple gestations will be excluded from the initial planned 
evaluation. However, a more c omprehensive end-of-season evaluation is being planned 
and consideration will be given to how to account for multiple gestation births . 
• In response to a request about a status update on how the v-safesm monitoring of RSV 
vaccines received by persons ≥60 years of age is going, Dr. Anne H ause from the v -
safesm program indicated that the new version of v-safesm is still in the final stages of 
development, with a launch planned in Fall 2023 for RSV vaccines among older adults 
and anticipated for maternal RSV later in Fall 2023. Dr. Shimabukuro added that while 
they have received a small number of reports for the older adult population, no unusual or unexpected patterns have been seen at this point. 
• Regarding whether any “back of the envelope” calculations have been done yet using different assumptions for uptake to understand what would be expected in terms of accrual of pregnancies in the VSD, Dr. DeSilva indicated that there is uncertainty about 
vaccine uptake, and they are awaiting recommendations for use, but it is anticipated that 
they will be well- powered to detect significant differences in preterm birth within 6 
months of vaccine eligibility. Additionally, there are plans to perform some preterm and stillbirth surveillance that will be separate from this plan by monthly surveillance that 
would only be descriptive, but it would be limited to the vaccinated population and can 
be performed somewhat more quickly. These results lack a control population, so this 
would not statistical comparisons. 
• In terms of whether there would be monitoring of infant pertussis infection in the first 2 months of age given the lower pertussis antibodies with simultaneous vaccination with 
an RSVpreF vaccine and Tdap for which the clinical significance is unknown, Dr. 
DeSilva indicated that the VSD focuses on safety and not necessarily effectiveness of 
vaccines. vaccine effectiveness. There are other groups within the agency who have 
plans in place to study post -licensure effectiveness of maternal RSV vaccine. 
• Regarding whether there is a systematic way to capture illnesses other than RSV or 
concomitant illnesses that occur during pregnancy that could increase risk of outcomes 
of interest, Dr. DeSilva replied that they will be capturing medically -attended events. If an 
illness rises to the level of seeking medical attention, there could be some information about concomitant infection with RSV or other infections that are not RSV. This would be 
dependent on how the provider codes what they are seeing. Consideration can be given 
to how some additional covariates potentially could be included, such as diagnosed respiratory illnesses —especially if testing is involved. 
• Regarding a comment that it would be beneficial to capture respiratory illnesses other than or concomitant with RSV and coadministration of vaccines among pregnant people, 
Dr. Moro indicated that VAERS will capture other vaccines received at the time of vaccination with RSV. 
• A lesson learned from COVID -19 vaccines is that when vaccines were received in public 
settings (e.g., pharmacy, grocery store), people often were not informed about v-safe
sm 
and no paperwork was provided. It would be beneficial for the v-safesm team to 
implement a campaign with the chain pharmacies, grocery stores, the American College 
of Obstetricians and Gynecologists (ACOG ), and the American College of Nurse-
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 Midwives (ACNM) to promote v-safesm. It is an incredibly valuable tool for monitoring 
side effects . 
Following Presentation by Dr. Hutton and Dr. Ortega -Sanchez 
• It is clear that the cost of the vaccine is a very important determinant in terms of cost -
effectiveness, but RSV is a prevalent and costly disease. With that in mind, Pfizer was 
given the opportunity to speak to whether $295 was going to be the or if there would be 
any decrease in cost. 
• Donna Altenpohl , Pfizer , confirmed that the original price was $295 per dose for both the 
maternal and older adult indications and that the Pfizer vaccine is the same product and 
formulation for both indications. The product has one National Drug Code ( NDC) and 
one Current Procedural Terminology (CPT) code for reimbursement, which Pfizer took 
into consideration. Pfizer’s pricing strategy is guided by the value that their innovation 
brings to patients and society, with the goal of achieving the broadest possible access 
for patients. Based on the results of the Pfizer cost -effectiveness analysis, they priced 
their vaccine to be both cost -effective and reflect the value that it will bring to helping 
prevent RSV for older adults and infants. As they shared with the ACIP WG, the RSV maternal  vaccine will be a lower cost option and could result in a lower budget impact to 
the US healthcare system . 
• The expense of this vaccine is very disappointing, particularly in the context of making a recommendation for all pregnant people to receive the vaccine. It would be beneficial for the ACIP to know the cost of this vaccine to countries outside of the US to understand 
whether it is overpriced in the US or if the price is standardized throughout the world. 
• Donna Altenpohl , Pfizer, indicated that they have a tiered pricing strategy outside the US 
that allows the price to be contingent upon the affordability of each individual country. As they are beginning to launch the RSV maternal vaccine, the pricing will be decided at 
that point. Given that Pfizer has not confirmed all of its pricing, it would be inappropriate 
to try to comment or speculate on that at this point beyond saying that they have not 
finalized the price depending on whether there is separate pricing for the older adult 
indication and the maternal vaccination. The global pricing strategy is tiered based on 
the affordability of each and every country, with the goal of making sure there is affordable access for all eligible patients. 
• Slides 6 and 7 in Dr. Hutton’s presentation show the difference in waning between 1, 6, and 9 months. Since maternal antibodies fade away by 6 months, it was not clear which 
of the 2 slides was a more realistic representation of efficacy and whether there would 
still be antibodies between 6 and 9 months or a dramatic decrease at 6 months. There 
are maternal antibody data for other illnesses. 
• Dr. Hutton replied that during their conversations, they thought 6 months was a 
conservative assumption and that there are a lot of data to suggest that antibodies would be gone after that. Because that is not known for certain, they had a couple of different scenarios. 
• Referring to Slide 15 in his presentation, Dr. Ortega- Sanchez added that the 2 
assumptions about duration of protection were shown side -by-side. The pink shaded 
area in each model denotes a higher level of uncertainty of the waning assumption beyond available Phase 3 data. There are no data that that support whatever the 
vaccine efficacy to say that there will be some protection. The CDC model assumed a 
more conservative assumption to minimize the uncertainty about whatever vaccine protection will be received after 6 months. 
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  • To the point about other maternal antibody data, Dr. Fleming Dutra confirmed that there 
are data from other vaccines (e.g., Tdap, influenza, and COVID vaccines) that indicate 
that post -maternal effectiveness of these other vaccines usually has waned by 6 months. 
• It is important to understand that while maternal antibodies can persist in the infant as late as 18 months, the protective level of antibody is the issue. With other vaccines, the antibody level is significantly reduced after 3 to 6 months. Although some antibodies can 
be detected, the levels probably are too low to be considered efficacious for whatever 
disease one is trying to prevent. 
• Dr. Jessica Atwell, Pfizer, provided more context regarding the data that inform antibody persistence in infants beyond 6 months. In addition to the data from Pfizer’s Phase 3 
clinical trial, they also have data from their Phase 2b study that measured antibody 
persistence in infants out to 6 months and compared those levels between infants born to vaccinated individuals and unvaccinated individuals. They were significantly higher 
among infants born to vaccinated individuals compared to infants born to women who 
received placebo in the Phase 2b trial. They used the half -life of antibody decay from 
those data to then extend the potential antibody persistence beyond the 6- month time 
point. That modeling, which was shared with the WG, showed persistence even beyond 9 months out to 12 months. Because there is no correlative of protection for RSV, it is it 
is difficult to make direct assumptions about how those antibody levels may translate, 
but certainly Pfizer has data to support persistence in infants beyond 6 months, which 
were critical for informing th e assumption about persistence of antibodies and potential 
benefit. If a pregnant person r eceived RSVpreF 3 weeks before delivery, the practitioner 
would have to weigh the question of what the additional value would be of adding 
nirsevimab on top of that. If it is known the infant will definitely receive nirsevimab, it would be reasonable to consider the value of adding RSV preF on top of that. 
• Regarding an inquiry about whether, with the information about the monoclonal antibody and the vaccine on top of that having some benefit but at a very costly rate, there ever 
would be a scenario in which monoclonal antibody could not be given to infants and 
there would have to be reliance on mother ’s immunization, there is no known 
contraindication to giving both. Dr. Hutton said it would be a reasonable intuitive 
assumption that there would be some added incremental benefit. Dr. Long added that it was very perceptive for ACIP members to be asking these questions, and that later 
presentations would later “thread the needed” pertaining to what circumstances would 
allow a physician to give nirsevimab after a pregnant person has been properly 
immunized. 
• Hearing that the cost per QALY for RSVpreF is about $400,000 at a dose of $295 per 
dose and recalling that during the August 3, 2023 ACIP meeting the cost per QALY for 
nirsevimab was $100,000 at a cost of $495 per dose , the difference was unclear. 
• Dr. Hutton responded that there is a lot going on. The major element in the simulation 
modeling of nirsevimab is that efficacy is slightly better at the beginning, so slightly higher efficacy is one difference. Another difference is that nirsevimab can be given at 
the peak of the RSV season. An infant born in April, May, June, or July would be given 
nirsevimab to have peak efficacy during the season. Those are a couple of the factors 
that affect the differences in the cost -effectiveness of nirsevimab versus what was 
shown regarding RSVpreF during this session. The cost- effectiveness of RSVpreF looks 
much better when it is given right before the peak of the RSV season when it will confer 
the highest levels of efficacy. 
• Regarding an observation that there did not seem to be a comparison of the cost of 
either the pregnant person receiving maternal vaccine or the baby receiving nirsevimab, Dr. Long indicated that there are no head- to-head comparisons because these are 
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   standalone products that have been assessed. The recommendation for a possible vote 
during this meeting pertained on to the vaccine product. However, that did not preclude 
the possibility of occasional unusual situations in which a vaccine would be given before 
delivery followed by nirsevimab after delivery. Dr. Jones added that the base case 
scenario of giving the vaccine alone is the cost -effectiveness when not giving nirsevimab 
on top of it. E ssentially, it was being presented as if either RSVpreF or nirsevimab was 
given. 
• In terms of an inquiry about projected uptake rates, Dr. Hutton responded that the UM-
CDC model assumed 50% uptake. A nice round number like 50% typically suggests that 
it is an assumption. There are limited data about uptake at this point beyond the surveys 
that have asked people about their intent, which suggests that 50% might be a 
reasonable assumption. Given the anticipated implementation challenges, Dr. Long 
thought 50% uptake would be optimistic for the vaccine this year. 
• In an ideal world, it seemed that the precision public health approach of considering seasonality would be the best -case scenario. However, there are issues of the 
complexity of implementation in terms of such tight timing, the cost and burden on teams 
who are trying to deliver the vaccine in a precise manner, and so forth—even if that 
precision might lead to a better investment in health overall . 
• ACIP members continued to struggle with the cost of RSVpreF vaccine. While they 
acknowledged and understand that the studies were expensive and Pfizer needs to 
recoup their costs, $295 per dose is a hard cost to swallow. It is known that the higher the price of a vaccine, the higher the disparities. 
Following Presentations by Dr. Fleming- Dutra,  Dr. Jones, Dr. Peacock 
• To set the stage for this discussion session, Dr. Long made a few comments on the underpinnings of the WG considerations and recommendations for ACIP’s consideration. The WG was very concerned about the imbalance in prematurity, especially in the 
shadow of the GSK vaccine that was not pursued. The WG likely would not have come 
to consensus on a non -suffixed recommendation for 24─36 weeks. “Non- suffixed” 
meaning with shared clinical decision- making. The data on vaccination at 32─36 weeks 
gestation, coupled with the information that the prematurity that occurred in the trials was an average of 4 plus weeks after immunization was not associated with reactogenicity at 
the time of immunization, made the WG more sanguine with 32─36 weeks gestation. 
They thanked the FDA for making that restriction and not having the WG have to do that as a first potential restriction. The second restriction of the seasonal administration, 
although this is not terribly popular, goes with the influenza season. That also, for most of WG, was based on a safety consideration. Given the potential risk of prematurity, 
year-round administration may not benefit the infants born in April ─September. That was 
the reason for that restriction. Regarding cost in terms of the base case, she did not 
think the WG would have come to consensus for a recommendation. It was only the 
seasonal use that, while it may be somewhat off -putting to some, that was the only way 
in which this could get down to a QALY that was acceptable in their minds or similar to 
other vaccine or preventions that allowed the WG the ability to present a non- suffixed 
recommendation to the ACIP. In addition, there are no head- to-head trials of these 
products or of safety. The WG thought that there would be mitigation of the potential risk 
of prematurity, et cetera. In terms of how ACIP considers the WG’s very restricted 
suggestions for the use of nirsevimab after the receipt of appropriately timed vaccine, 
that the ACIP takes into consideration that these are both “antibody paint ” and that the 
“antibody paint ” will wear off. They do not change the epidemiology of RSV disease and 
the goal is not to prevent RSV infections in every individual. This can only r educe the 
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  morbid consequences of RSV by a certain degree. Pediatricians and others already 
have already expressed concerned about the cut -points for nirsevimab and the vaccine. 
The cut -points are based on data. Because this is not a vaccine that will chang e the 
epidemiology, prevent herd, provide long -term protection, the cost must be acceptable 
as possible because these are extraordinarily and probably unreasonably priced 
products. The WG would say , “Bring on the competition to bring the costs down in the 
US.” 
• Dr. Talbot said she thought this might be the most complicated vaccine recommendation 
for young adults that ACIP has had in a long time. She is worried about the complication 
of the time period. While influenza and COVID vaccines are given during that season, 
they are given to everybody regardless of where they are in their pregnancy. She also is 
concerned that in the adult world if someone gets the same vaccine twice, the same 
vaccine may be paid for twice. That is, if a mother has gotten the RSV vaccine but is confused because she received 4 vaccines, 2 vaccines, or 3 vaccines and the 
pediatrician is left in a position to give the child the antibody, someone is going to have 
to pay because that is double- dipping since ACIP would be recommending one or the 
other. She wondered what the benefit would be of this vaccine if every child would be 
given antibody. 
• Dr. Long emphasized that it is always good to have 2 products . It is not known what 
manufacturing will be like in the future or if after the first year of use, one or the other 
would make them more hesitant to use one or the other. 
• Dr. Poehling said that in speaking to parents who have recently given birth, some would 
prefer to take a vaccine rather than have their child get a shot. She also has had cases 
recently, including one in which the father of the child had a significant bleeding disorder, 
who did not want the child to have any sticks for any reasons because it would be 
unknown at that point whether the child was going to have a bleeding disorder. There 
will be multiple cases like that. T here is a lot of complexity . Clearly document ing the 
information so that everybody knows what has and has not been received is going to be 
extraordinarily important. It also builds upon what has been said repeatedly during 
previous meetings that having an immunization registry for all is desperately needed. 
She recalled that Dr. Peacock ’s presentation showed that 52% of persons who are 
pregnant have private insurance, 41% have Medicaid, and 4% are self -pay. She thought 
they needed to dive deeper into this. The ACA states that private insurance has to cover 
the vaccine, but that is not immediately. She wondered whether there are any data on 
how many private insurances are paying for the RSV vaccine for adults ≥60 years of 
age. 
• Dr. Grubb (AHIP) said that while she did not have those data readily available, she 
would try to obtain the information for the ACIP. 
• Dr. Poehling emphasized the importance of the people listening to understand that there is a delay before insurance companies actually pay for the vaccine. In addition, it was her understanding the 317 funds recently have been decreased, which could impact 
individuals 18─19 years of age who do not fall under Medicaid or the VFC program. 
• Dr. Peacock confirmed that while the 317 funds have not decreased, the re is limited 
availability of funds since there are more vaccines that potentially could be paid for 
uninsured adults through this program. For context, 317 program funds are allocated t o 
all immunization awardees so that they can purchase some vaccine. Typically, this 
program is used for uninsured adults , sometimes fills in gaps related to children, and 
also is used for outbreak funds. 
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  • Ms. Hance (CMS) confirmed that Medicaid will cover t he vaccine for adults who have 
Medicaid who are covered under a CDC ACIP recommendation. That coverage is 
separate from the 317 program. 
• Dr. Sanchez said he favored a shared clinical decision- making recommendation 
because there are 2 options that need to be discussed with the pregnant individual. The 
first would be by her obstetrician who will need to discuss vaccination at 32─36 weeks 
gestation, but also will need to discuss that the other option is nirsevimab. Pediatricians who will be taking care of the infants would have to tell the mother the baby cannot get 
nirsevimab if she chose to receive the RSVpreF vaccine. Regardless of whether those 
discussions are easy or hard, they must be had. With that in mind, he asked whether 
there would be an option to vote on shared clinical decision- making. 
• Dr. Lee requested that the team display the proposed vote language. She said that in 
her opinion, every recommendation should be a shared decision similar to all medical 
care that clinicians provide. To her, the distinction about the recommendation was not 
about whether the process occurred. It was more about a universal recommendation 
versus more of a selective recommendation. Even a full recommendation would not 
mean that this discussion should not happen. In fact, this discussion should occur with every pregnant person to make sure that they are aware of the options. She did not think 
that a shared clinical decision- making recommendation would change that. She noted 
that while there always is an opportunity to amend proposed voting language, she would 
like to focus on the displayed proposed language from the WG to make sure everyone 
had an opportunity to comment. 
• Ms. Bah ta agreed that the feasibility of having 2 products that would be given at 2 
different times to 2 different audiences would be challenging. Colleagues in her own health department are struggling with how to implement nirsevimab and how to reconcile 
that if the RSVpreF vaccine also is recommended. She also cautioned that because 
RSVpreF is being implemented among older adults and the vaccine is very costly, there could be competition over a limited supply and/or limited availability if maternal vaccine 
is recommended. Given that there were 2 wonderful options, it was extremely difficult not 
to be supportive of the recommendation as proposed. While she supported it and agreed that every vaccine provided to patients should be explained, she wanted to highlight her 
concern about the feasibility of implementation. 
• Dr. Loehr strongly supported the seasonal nature of the recommendation. He noted that one insurance company that typically has been slow to implement recommendations is 
covering nirsevimab effective immediately, and he expressed gratitude to all of the 
insurance companies that are doing likewise in order to get it administered within this 
season. He asked whether the WG considered adding a sentence stating that this 
recommendation is for pregnant persons not intending for their infants to receive 
nirsevimab, or if there was a reason not to include such language. For instance, if he 
knows an infant will receive nirsevimab, he would not recommend maternal RSV 
vaccine. 
• Dr. Poehling noted that one insurance in North Carolina has agreed to pay for nirsevimab in the outpatient setting. They are still awaiting word on the inpatient setting. 
She continues to remain concerned about the cost and who is going to cover it. 
• Dr. Long responded that including that language might be a tacit implication that ACIP 
might not prefer this vaccine. At this point this year, not knowing more than what they do 
about efficacy and safety, they probably would not want to do this. She agreed with others that while it did not rise to the level of a policy decision, this absolutely should be 
a shared decision between a doctor and patient. That is best addressed in the clinical 
considerations. If anyone was wondering why in the world a decision ever would be 
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 made to withhold nirsevimab or give the vaccine on top of the plan for nirsevimab, they 
occur at different times in the pregnancy and there may be compelling reasons. For 
example, if it was identified in utero that a baby had significant congenital heart disease 
and no safety issues had been identified, she would want to save that person for 
nirsevimab and not risk any potential AEs by giving the vaccine during pregnancy. While 
she favored the spirit of Dr. Loehr’s suggestion, she did not favor including it in the language per se. 
• Dr. Sanchez suggested that there could be another angle. For example, a fetus diagnosed with severe congenital heart disease or other malformation may stay in the 
neonatal intensive care unit (NICU) for an extended period of time. While every effort is 
made to prevent RSV infection in the NICU, it does occur. If nirsevimab is not going to be given until discharge, this could be a compelling reason to vaccinate the pregnant 
person to ensure that the baby benefits from maternal antibody at least through the time of discharge. In any case, they have recommended that nirsevimab be given irrespective 
of whether the mother was vaccinated. He thought that should be kept as a clinical 
consideration. 
• Dr. Long expressed gratitude to Dr. Sanchez for raising this issue and stressed that he 
has been instrumental in helping the WG understand all aspects, especially of 
perinatology. However, she did not think monoclonal antibody or anything else should be 
given in the NICU to protect infants in the nurser y. Infection control should do that. If 
infection control fails, then monoclonal antibody can be given. She also thought protection from maternal antibody could be long gone before an infant with severe congenital heart disease was discharged from the NICU . 
• Dr. Sanchez clarified that he was not suggesting giving nirsevimab to infants in the NICU until the time of discharge and agreed that infection prevention and control is preferable. 
However, some infections do occur. His thinking was that if a term baby had maternal 
antibodies, at least for the first several weeks before they have their surgery or bypass, 
that it might also be beneficial, and the risk should be low because of infection 
prevention practices. 
• Dr. Kotton expressed her support for the proposed recommendation language as 
presented. She thought it was easy to understand and that it is imperative for the public to clearly understand what the ACIP is recommending. Shared clinical decision- making 
has been very confusing, so she would not support that. 
• Regarding the shared clinical decision- making comments, Dr. Hughes (ACOG) 
emphasized that obstetricians are highly experienced with and routinely perform counseling for all patients who receive vaccines, and this would be no different. She 
agreed with Dr. Long’s assertion that for this reason, the recommendation did not rise to 
the level of shared decision- making policy and she would support the full 
recommendation on behalf of ACOG. 
• Dr. Talbot pointed out that it seemed this recommendation was telling their obstetric 
colleagues that all pregnant persons should receive the RSVpreF vaccine between 
32─36 weeks and unless the fetus has a condition , and the infant then could not get 
monoclonal antibody if the pregnant person was vaccinated. If a pregnant person was 
32─36 weeks near the end of the RSV season, it was not clear what this would mean for 
the infant in terms of qualifying for monoclonal antibody. 
• Dr. Jones clarified that there was voting language and the clinical considerations. The 
WG discussed all of this at length and there were some differing opinions among the 
WG members. The majority felt that the voting language proposed for the vaccine would 
be appropriate. The voting language for the vaccine was to convey that either product is 
recommended and administration of both is not needed. The decision of which option to 
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 choose should occur at the time when deciding whether to vaccinate the pregnant 
person. 
• Dr. Long added that if the pregnant person chooses the vaccine, then the practitioner would indicate that at birth, the baby would not need nirsevimab except in rare 
instances. It is true that the mother has a choice, but it is merely a choice like choosing different colored shoes with different heights of heels. Some will choose to protect their 
infant by vaccinating themselves, and others will choose for their baby to have 
nirsevimab. Given the anticipation that this season will be messy in terms of who 
receives what and who pays for what, whether there are risks, and what the 
effectiveness of these products will be , the WG wanted to offer the best possible 
accommodations . 
• Dr. Jones confirmed that all of the details that should occur in discussions with patients 
would be covered in the clinical considerations and emphasized in the suite of educational materials, the MMWR , the Vaccine Information Statement (VIS), et cetera. 
This includes specification of the rare situations in which there are insufficient antibodies 
either because they were not produced after vaccination in a pregnant person or there is 
decreased transplacental transfer. For those who will have potential waning of 
antibodies and waning protection by the time RSV season peaks, because the 
recommendat ion would be from September─January and infants would be born to those 
mothers during the RSV season. 
• With regard to the vote, Dr. Lee said she believes this is a good vaccine product with a 
favorable benefit -risk balance, particularly with the efforts to mitigate potential risks. This 
is an excellent option to protect infants from hospitalization. If there was not a 
monoclonal antibody available such as nirsevimab, she thought the cost- effectiveness 
conversation might have been slightly different. In terms of the struggle with cost -
effectiveness, which always is an important domain, the decision is sensitive to this 
domain.  The intervention itself and maternal vaccine development in general are 
incredibly important investments with regard to future directions with the US vaccination 
programs as a country . She wanted to recognize that cost -effectiveness is about the 
value of the vaccine and the value of the investment. The proposed vote the WG asked 
the ACIP to consider in terms of seasonal dosing of RSV vaccine seemed extremely helpful to ensure that they are making the investment as worthwhile as possible. The 
cost- effectiveness ratio is still high -ish, recognizing that they do not have an explicit 
threshold by any means. This will be one of the more expensive interventions the ACIP 
has recommended,  so she wanted to call out that seasonal dosing is a way to at least 
get into a more reasonable range. Recalling an earlier conversation, she said she 
thought the ACIP’s role is only to comment on the value of this vaccine in the US. As 
they learned during COVID, having products available such as these RSV vaccines or 
passive immunization become more available to low -and middle- income countries that 
might not otherwise have access is som ething they need to consider. She encouraged 
their manufacturing sector colleagues to consider how such innovative products can be 
made available in countries at an affordable price, recognizing that each country is 
different, but also recognizing that there is a greater responsibility from a public health 
perspective. 
• Dr. Sanchez said he thought one of the problems was that it was impossible to consider 
this vaccine in isolation, because the fact is, there is another product. Unfortunately, there is not a head- to-head trial comparison of the 2 products with respect to either 
efficacy or effectiveness. Discussions must be had with the pregnant person because there are options, and each medical decision should be shared decision- making. There 
should be a lot of education about both products. 
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  • Dr. Loehr said he wanted to go on record that he believes an infant receiving nirsevimab 
is better based on the evidence that it has better efficacy. It also is more cost -effective. 
Therefore, he did not want it to be an equal representation. He recognized that they 
were not going to make a preferential  statement and that a lot more data would 
accumulate over the next couple of years to determine in the long- run which is better. He 
doubted they ever would have head -to-head information. If he was presenting this to a 
pregnant person , he would recommend giving nirsevimab to their child if that is what 
they wanted. If not, then the vaccine would be another option. This is just a small nuance. 
• Dr. Sanchez emphasized that to him, the signal for prematurity was a major concern for him and the WG. The FDA did help with this issue by approving vaccine administration 
at 32─36 weeks gestation. Nevertheless, mothers should be made aware that this needs 
to be monitored and there will be post -licensure and post -recommendation surveillance. 
• Dr. Bell emphasized that one complication is going to be that the pregnant person is 
likely going to be seeing a different doctor during pregnancy than the doctor who will be 
taking care of their child. Tools must be made available quickly to physicians, which is 
something the partners and professional organizations can help to facilitate. It is difficult to make a choice without all of the tools. 
• Dr. Talbot emphasized that her feeling was that this would be incredibly complicated. There is a great option that can be given to children, which will protect more children and 
that is more cost -effective. The vaccine seems like an incredibly complicated, way out of 
the atmosphere expensive option that would not result in much benefit and would 
increase confusion in terms of whether the pregnant person received vaccine or 
received it and then delivered too early. She did not believe this would improve care and 
would make providing care more difficult. If they simply say the child should receive the 
monoclonal, the recommendation would be a very simple and cost -effective mechanism. 
With an adult immunization registry in every state, using this mechanism may put 
children at risk and/or leave the parent stuck with a $500 bill because only one method 
would be paid for. 
• Dr. Poehling emphasized that as a newborn provider, she evaluates the charts of the moms and babies. It may not be easy, but it is definitely doable. 
• Dr. Hughes (ACOG) emphasized that it is absolutely routine for obstetricians to collaborate with their pediatric colleagues to review maternal charts. It is done every day 
regarding testing like hepatitis B testing. Those results are always communicat ed. While 
ACOG recognizes that there are some complexit ies to ensuring that the charts are 
complete related to receipt of vaccine, it is quite doable. Also acknowledging the fact that 
this is fairly complex , ACOG and its colleagues at the Society for Maternal Fetal 
Medicine, plan to partner with other entities like AAP, AAFP, and ACNM to ensure that 
there is a solid implementation strategy to assure that these challenges are met. 
• Dr. Poehling made a motion to approve the language as presented, which Dr. Loehr 
seconded. 
Following Dr. Santoli’s Presentation 
• For Table 1, it was suggested that the additional language be revised to read, “whose mother did not receive the vaccine, whose mother’s vaccine status is unknown, or who 
was born within 14 days of maternal vaccine.” 
• Dr. Santoli indicated that the language could be updated for clarity. 
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    PUBLIC COMMENTS 
Overview 
The floor was opened for public comment on September 22, 2023 at 2:30 PM ET. Given that 
many more individuals registered to make oral public comments than could be accommodated 
during this meeting, selection was made randomly via a lottery. Dr. Lee provided a gentle 
reminder that the ACIP appreciates diverse viewpoints that are respectful in nature and issue-
focused rather than comments directed at individuals. The comments made during the meeting 
are included in this document. Members of the public also were invited to submit written public 
comments to ACIP through the Federal eRulemaking Portal under Docket Number ID CDC -
2023- 0076.  Visit http://www.regulations.gov for access to the docket or to submit comments or 
read background documents and comments received. 
Public Comments 
Mr. Paul Hennessy 
Individual 
Hi. I was supposed to comment at the meeting on the 12th, but I think only 1 person spoke 
during public comments. So, I definitely urge you to look into that issue. I know there are a lot of 
commenters who didn’ t get to speak. But, yeah, I ’m here to talk about the future of vaccine 
rollouts, not just RSV, but COVID as well. You know, I thank the ACIP for approving those 3 
vaccine options last week. But a once-a- year shot does not go far enough, considering 
protection wanes after about 5 months and there’ s multiple waves of COVID per year. COVID is 
not the flu, so a shot schedule like the flu just isn’ t working. A once -a-year vaccine just isn ’t 
enough to protect us from a virus that fuses brain cells, causes blood clots, is linked to diabetes, 
dementia, and more. Furthermore, COVID and RSV are airborne illnesses , so the vaccine- only 
approach doesn’ t properly reduce transmission as much as it can. You know, clean- air tech and 
masking must be encouraged along with vaccines and even required in places like medical 
settings. Pediatric approval for the Novavax COVID vaccine is also needed as soon as possible. 
You know, I definitely appreciate that the RNA has been approved, but children, like adults, deserve the choice. Novavax was shown to wane less quickly than mRNA and offer broad 
immunity against variants. Successive doses actually enhance protection as well as offer some 
upper respiratory protection. Children deserve this excellent choice as well. Finally, just going 
forward, I ’d definitely like to urge ACIP to approve vaccines before surges . That includes both 
COVID and RSV. Moderna ’s and Pfizer ’s COVID vaccines were ready, and I believe submitted 
a number of months ago , but it took until September to get approval. It ’s so important to approve 
both COVID and RSV vaccines before the school year so children are protected going to 
school. Thank you. 
Jane Hull, PT, MPH 
TRAIPAG 
I’m Jane Kaplan H ull I’m speaking on behalf of TRAIPAG, which is a patient advocacy group 
whose members are transplant recipients and/or are immunocompromised. We strongly urge 
the committee to recommend the RSV maternal vaccine and to add it to the Vaccines for 
Children Program so as to immunize the child through the mother. Our TRAIPAG Advocacy 
Group commends the committee for placing the mAb, nirsevimab, not sure I ’m saying that right, 
on the Vaccines for Children Program and taking the groundbreaking step of recommending 
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  passive immunization, which ensures that it will be covered . We u rge the committee to do 
likewise if and when a monoclonal antibody or antiviral prophylaxis against COVID is authorized 
by the FDA. This would be especially crucial to the population of immunocompromised people 
who do not respond to vaccines and will greatly benefit from effective vaccine or prophylactic 
treatments that can both save lives and improve quality of lives for those affected. We would 
also hope that the committee in future deliberations recommend the RSV vaccines, not just for 
the 60 and over, but give access to the RSV vaccines for those who are immunocompromised 
or high risk and those living or working with vulnerable populations. Thank you for giving me the 
opportunity to speak. 
Dr. Roselie Bright, ScD
COBID Safe Maryland 
Hi. Good afternoon. I’m Roselie Bright. I have a Doctor of Science in Epidemiology and had a 
30-year career as a Federal Medical Product Epidemiologist. For meaningful consideration of 
public input, the substantive materials for CDC Advisory Committee meetings, the slides, whit e 
papers, et cetera, should be available to the public for at least a week before the meetings to allow adequate time for thoughtful, in- depth public review and comment. People who have 
already signed up for comment should be notified the same day the materials become available. 
The oral public comment session needs to be expanded to at least an hour and occur before 
motions and votes. RSV vaccines have been approved by the FDA for older adults and infants a 
month ago. The one under consideration today was also approved by FDA for pregnant people and infants. I support expanding the use of RSV vaccines and have several points regarding the 
specific RSV vaccine under consideration and RSV vaccines in general : 1) for non- pregnant 
adults, the RSV vaccine has been approved for people 60 years old and over. I urge the 
sponsors to quickly study the usefulness of the [ inaudible] all people at high- risk from RSV and 
all people in professions and situations that often interact with people who are at high risk of RSV, that is, health care workers, patients and visitors, and childcare and school staff and 
children, etc. ; 2) RSV infections have risen significantly year over year during the COVID -19 
pandemic. If the rise is due to immune damage from COVID -19, the potential benefit of offering 
the [inaudible] ; 3) Three, RSV circulation is seasonal, typically starting during the fall and 
peaking in the winter. The peak RSV hospitalization season has been moving to earlier in the calendar year in the specific surveillance areas of the US. Please offer the RSV vaccine in the 
summer to prevent the surges that have recently been starting in September ; 4) because getting 
the RSV vaccine is recommended for a narrow window of pregnancy, 32 to 36 weeks of 
gestation, availability for pregnant people needs to be speedy to help as many pregnant people 
as possible this fall ; 5) RSV vaccine efficacy wanes. That’s fine for pregnancy and infancy. 
However, please consider recommending that pregnant people should be revaccinated during each subsequent pregnancy. In addition, older adults should be offered semiannual 
vaccinations ; and 6) RSV is part of the trio of airborne viruses that CDC is already campaigning 
about. While the COVID -19, influenza, and RSV vaccines reduce the risk and severity of 
infection, they don’ t entirely eliminate infections and some people should not take them. I ask 
CDC and the vaccine sponsors to include other precautions against airborne viruses in your 
public messages, including N95 or higher quality masks, otherwise known as respirators, and 
air cleaners with h igh-efficiency p articulate air (HEPA ) filters and fresh air ventilation [inaudible] 
especially if those that vulnerable patients must attend as staff or clients, including health care 
facilities, schools, and prisons. Thank you for this opportunity to comment. 
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  VOTES 
Dr. Grace Lee (ACIP Chair) requested that the language for the votes be displayed for the 
recommendation and VFC votes. 
Vote #1 RSV Maternal RSV Vaccine Recommendation 
Maternal RSV vaccine is recommended for pregnant people during 32 through 36 weeks 
gestation, using seasonal administration, to prevent RSV lower respiratory tract infection in 
infants. 
Motion/Vote #1 Maternal RSV Vaccine 
Dr. Poehling made a motion to approve the proposed Vote #1 recommendation stating , 
“Maternal RSV vaccine is recommended for pregnant people during 32 through 36 weeks 
gestation, using seasonal administration, to prevent RSV lower respiratory tract infection in 
infants. ” Dr. Loehr seconded the motion. No COIs were declared. The motion carried with 11 
affirmative votes, 1 negative votes, and 0 abstentions. The disposition of the vote was as 
follows: 
11 Favored: Bahta, Chen, Daley, Lee, Loehr, Long, McNally, Poehling, Sanchez 
1 Opposed: Talbot 
0 Abstained: N/A 
Vote #2 VFC Resolution Maternal RSV Vaccine 
Approve the Vaccines for Children (VFC) resolution for RSV maternal vaccine. 
Motion/Vote #2: VFC Resolution Maternal RSV Vaccine 
Dr. Loehr made a motion to approve the proposed Vote # 2 recommendation for the VFC 
Resolution stating , “Approve the Vaccines for Children (VFC) Resolution for RSV maternal 
vaccine. ” Dr. Poehling seconded the motion. No COIs were declared. The motion carried with 
11 affirmative votes, 1 negative votes, and 0 abstentions. The disposition of the vote was as 
follows: 
11 Favored: Bahta, Chen, Daley, Kotton, Lee, Loehr, Long, McNally, Poehling, Sanchez 
1 Opposed: Talbot 
0 Abstained: N/A 
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       Discussion Points : Voting Members 
Dr. Poehling emphasized what an exciting day this was because throughout her career, RSV 
has been a difficult disease, given that there have been no options beyond supportive care 
treatment. There were over 1.5 million outpatient visits, over half a billion ED visits, and 58 ,000 
to 80,000 RSV hospitalizations last year, which was a dramatic example. The vast majority, 
almost 80% , of children less than 2 years of age have no underlying conditions. There is nothing 
simple about this RSV vaccine or nirsevimab, but they both offer hopes. They have done this 
before with COVID vaccine. She think s that if everybody is willing to chip in and do their part , 
this is feasible and will improve the well -being of many families throughout the nation. 
Dr. Bell said she wanted to take advantage of her gray -haired status and reflect for a moment 
on the issue of complicated recommendations for which implementation is unclear and there are 
a lot of challenges. To Dr. Lee’s point earlier that in looking back over the decades, these types 
of recommendations have provided opportunities for innovation, availability of options, and 
improvements over the longer term even if the beginning is extremely bumpy . This is another 
example that perhaps will lead to improvements in physician education, patient decision-
making, communication between the obstetrical and pediatric worlds, and addressing 
disparities. Even though ACIP members may be feeling at the moment that this is very 
complicated and will be difficult to implement, in the longer term it will result in new options that 
will improve children’s health. 
Dr. Sanchez agreed completely. He thought the discussions throughout the day had been 
extremely helpful because he certainly has struggled with his decision throughout the time that 
he has been on the RSV WG. He has fluctuated back and forth, but thought the day’s 
discussions steered him clearly through the amazing work that has been done. There are 
challenges and complexities, but there are options for mother s and HCPs . Physicians also have 
personal preferences that are part of the physician- patient discussion. He thought the options 
were great. Pediatricians , infectious disease specialist s, and neonatologist s have to prevent 
serious RSV disease in babies. He thought it was fantastic that they had achieved this vote , as 
well as the nirsevimab vote. He could not have imagined better options for infants and children , 
which is what they have been striving for —especially for high- risk babies. He urged more 
discussions with obstetricians, mothers ’ healthcare provider s, and pediatric family practices. 
Just like they need to know the mother ’s syphilis, HIV, and hepatitis B status, they also will need 
to know whether the mother received the RSV vaccine. Hopefully, this will ultimately improve 
care and communication with obstetric providers. 
Dr. Brooks said he was reflecting back on the days when they thought PCV discussions were 
complex . Yes, RSV has been very complex. However, they likely are going to have more 
complex decisions to make moving forward. Dovetailing on what Dr. Sanchez said, one of the 
things that struck him was that a large number of obstetricians feel uncomfortable with 
discussing vaccine decisions. Looking at the schedule, there are 4 vaccines that theoretically 
could be available or needed for a pregnant person (RSV, COVID, influenza, and Tdap) 
between October through March. That is half of the year —a significant amount of time where 
there are going to be some really interesting discussions. They need to lean on the American 
College of Obstetricians and Gynecologists (ACOG ) to work with their members to feel more 
comfortable with these discussions. To him, one of the benefits is a fundamental concept of 
vaccination, which is that generally speaking, the ideal is for a person to get vaccinated at the 
earliest opportunity or the concept of immediate protection. The earliest opportunity would be 
before the mother deliver s. People’s situations may change. Someone might leave the country, 
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   their insurance status may change, t heir perspective on protection of a child from RSV may 
change, et cetera. It is very important to get them vaccinated as soon as possible. 
Notwithstanding Dr. Loehr ’s statement that nirsevimab seems to be a more efficacious and cost -
effective , it is excell ent to have this option of the vaccine for the pregnant person prior to the 
birth of the child. 
Ms. McNally said she struggled with this recommendation for the reason that she does not know 
what the counseling looks like for the mother who asks her obstetrician if she should get this 
vaccine and the mother who ask s the child’ s pediatrician what she should do. Because of that, 
she agreed with Dr. Lee that the stakeholder medical associations could get together and 
prepare a statement about this issue. She thought that would be immensely helpful for the 
consumer. She also observed that it seemed like the ACIP had discussed shared clinical 
decision- making recommendations a lot more lately. That gives her a certain level of discomfort 
as a consumer because while she believes there is a place for shared clinical decision- making, 
it makes her n ervous that there could be some baseline assumptions about the knowledge that 
consumers have for risk of disease. She wondered whether there is a way to talk about best 
practices to revisit the idea of shared clinical decision- making in order to help ACIP arrive at 
better decisions of the future regarding vaccine recommendations. 
Dr. Talbot reiterated how important it is that medical societies work on this process. The 
pneumococcal vaccines have been complicated for years and had to be written out of the 
infectious disease boards because they were too complicated. She worries that this has created 
another very complicated recommendation. W hat happened with pneumococcus was low 
immunization rates. She implored every society to talk. There needs to be massive education 
and it has to be better than what was done for pneumococcus. Dr. Kotton said that while she appreciated how complicated the decision- making was through all 
of this, she was excited to see that they were at a time in which there is a shared clinical 
decision- making recommendation for adults ≥60 years of age, an RSV vaccine for pregnant 
people, and monoclonal antibodies for infants. This is a horrible disease for many, especially 
immunocompromised persons. She is cautiously optimistic that there will be diminished rates of 
disease in multiple communities that hopefully will result in decreased transmissions to 
vulnerable populations. This is an exciting time in the medical world, and she is excited to see 
what things will look like with multiple protective vaccines for many different populations. Dr. Long said that she was outrageously grateful for the ACIP to think this through again with 
the WG . She could not add up all of the hours that they have struggled with this. She 
appreciated everyone’s comments and thought this was the right decision to make. They w ill 
see, through what may be a very messy year, whether one rises to a preference over the other 
and hopefully that both will become less expensive. 
Discussion Points: Liaisons 
Patsy Stinchfield (NAPNAP) commented that during the 20 years she has been participating in 
the ACIP, this has got to be one of the more complex decisions that has been before this 
committee . As a member of the RSV WG, she acknowledged the phenomenal work they did . 
There were intense deliberations during the WG meetings, and the presentations and 
conversation during the meeting were very good in terms of highlighting the difference of 
opinion and complexities. Having listened to so many of these conversations over the years , 
she agreed that this is complex and challenging. However, it was one of those times when they 
needed to focus on the policy questions before them . Is it safe? Is it effective? Is it feasible? 
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   They did not get to ask whether it is easy, but they know it is not going to be easy? What will 
happen is that practice will follow ACIP policy , and the committee will re-review , discuss, and 
measure in the future. The practice barriers are what they need to be working on at this time. 
The clinician is the linchpin and is the one who is going to be discussing the options  available. 
They will need to be prepared for their own educational needs, attending the Clinician Outreach 
and Communication Activity (COCA) calls, listening to National Foundation for Infectious 
Diseases (NFID ) webinars, and making sure they are prepa red to share this with families. She 
very much agreed with Dr. Lee’s observation about the quality improvements and that they 
cannot wait until they have all of the technical , financial , and other reimbursements in place 
when they have a very good product before them . They must make sure that they are 
communicating with their peers and parents alike, taking the barriers into consideration but not 
letting the barrier s stop them from advancing a very good product. 
ADULT AND PEDIATRIC IMMUNI ZATION SCHEDULE ADDENDUM 
Presentation 
Sarah Schillie, MD, MPH, MBA, CAPT USPHS discussed the addition of an addendum to the 
immunization schedules . As a reminder, the immunization schedules are published on an 
annual basis, typically every February.57 There are two separate schedules , the Child and 
Adolescent Immunization S chedule that covers birth through 18 years of age and the Adult 
Immunization S chedule that covers ≥19 years of age. There are multiple sections in each of 
these schedules that summarize the approved ACIP policy, including the Cover Page, Tables 
that contain graphic rows of recommendations, Notes, and an A ppendix. The schedules are 
published in 3 formats: PDF, webpage, and app. The 9 professional organizations listed here 
partner with CDC to approve the schedules, and some of these professional organizations 
publish the schedules : 
American College of Physicians ( www.acponline.org ) 
American Academy of Family Physicians ( www.aafp.org ) 
American College of Obstetricians and Gynecologists ( www.acog.org ) 
American College of Nurse- Midwives ( www.midwife.org ) 
American Academy of Physician Associates ( www.aapa.org ) 
American Pharmacists Association ( www.pharmacist.com ) 
Society for Healthcare Epidemiology of America ( www.shea -online.or g) 
American Academy of Pediatrics ( www.aap.org ) 
National Association of Pediatric Nurse Practitioners ( www.napnap.org ) 
Traditionally, the schedules are published in February each year, but the publication process 
starts in October with the ACIP vote. In November and December, professional organizations 
approve the schedule. In December and January, the draft s are developed and cleared for the 
MMWR reports and Annals of Internal Medicine report for the adult schedule. In February, the 
schedules are published along with the accompanying MMWR Notice to Readers and Annals of 
Internal Medicine report. The timeliness of schedule publication has several important 
implications. First, some insurers link vaccine reimbursement to the vaccine listed on the 
immunization schedules. Second, the ability of certain HCP to administer immunizations also is 
related to the schedule. For example, some states link pharmacist s’ immunization authority to 
the schedule. Third , HCP knowledge and practices are related to the immunization 
57 www.cdc.gov/vaccines/schedules/index.html 
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  recommendations.  For example, if a HCP is referring to a schedule that is several months old, 
they may not be aware of the most recent ACIP recommendations. 
The ACA addresses immunization coverage and is interpreted by CMS. According to the ACA, 
insurers must provide coverage for and must not impose cost -sharing restrictions for 
immunizations that have a routine recommendation and that are listed on the immunization 
schedules of the CDC. Of note, the AC A does not specify the layout of the immunization 
schedule. Legally, CDC has discretion regarding the design of the immunization schedules. The 
entire document constitutes the schedule, not just the graphic bars or the tables. 
CDC takes a 3-pronged approach to address schedule timeliness. The immediate strategy 
consists of the addition of addenda to help bring the schedule up -to-date. The short -term 
strategy involves publication of the entirety of the schedule shortly after the October ACIP vote. 
The longer -term strategy is to consider sustainable approaches to ensure the schedules remain 
dynamic and responsive, and to engage partners in the planning process. Regarding the 
addition of the addenda to the 2023 immunization schedules, the addenda will contain ACIP 
recommendations that occurred after the 2023 schedule was published. The plan was to 
release the 2023 immunization schedules with the addenda the week following this meeting. 
With this addition, all ACIP recommendations will formally be part of the CDC Immunization 
Schedules. 
To describe the changes related to adding the addenda to the schedules, a red bar will be added to the top of the cover page to refer users to the addendum. A fifth step, also referring 
users to the addendum, will be added to the steps of to how to use the document. Any new 
vaccine recommendations will be added to the table on the cover sheet. Here is the addendum for the Adult Immunization Schedule,  which consists of 1 page and includes vaccines for which 
recent recommendations have been made, a synopsis of those recommendations, and the 
effective date of the recommendation: 
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   The addendum for the Pediatric Schedule is similar. It also is also 1 page, and is depicted here : 
In summary, the release of the 2023 Immunization Schedules with the Addenda is anticipated 
during the week following this meeting. This will formally incorporate all ACIP recommendations 
into the 2023 CDC Immunization Schedules. There are also plans for short -and long- term 
sustainable strategies to address schedule timeliness and will ensure partner engagement with 
this process. 
Liaison Statements 
Jason Goldman , MD, FACP (ACP) provided a statement on behalf of the ACP. The American 
College of Physicians, with over 160, 000 members and the largest single specialty medicine 
organization representing all internal medicine specialists, greatly appreciates the work of the 
CDC and the Advisory Committee on Immunization Practices, especially the willingness to work 
with the vaccine schedule. The ACP understands the challenges of analyzing copious amounts 
of data to put forth the best evidence- based recommendations. However, there is a need for 
timely updates to the vaccine schedule so that practicing physicians can have guidance in implementing those guidelines. Obviously, one of those challenges is the delay created between 
approval by the committee, sign- off by the CDC director, and final publication of the schedule. 
The ACA allows insurance companies to have up to a year to cover these life- saving vaccines , 
but many will start that year at final publication and not at approval by the commi ttee. It is 
imperative that the schedule be updated, approved, and published as quickly as possible to 
avoid unnecessary delays in implementation. The ACP appreciates the willingness of the CDC 
to expedite this process. The lack of insurance coverage creates unnecessary barriers to 
access to care and further exacerbates healthcare disparities as uninsured and underinsured 
patients will not have access to these vaccines. The ACP also strongly agrees with the need for 
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    a Vaccine for Adults program to address those gaps in coverage so patients can get the 
vaccines they need. Finally, the ACP would ask the vaccine manufacturers to provide vaccines 
fairly and equitably without preferential distribution to large systems and non- physician entities 
so that the physicians can vaccinate patients in their offices in a timely manner. Specifically, the 
delays in distribution of influenza vaccines this season to many physician offices has created 
hardships for patients and decreased access to care. Once again, the ACP is supportive of the 
good work of the committee and look s forward to continued collaboration to advance health 
equity and access to life- saving vaccines. 
Sean O'Leary, MD, MPH (AAP) provided a statement on behalf of the AAP. The immunization 
delivery system is complex, with many interrelated parts that need to work together to ensure 
that the nation’ s children can receive timely and equitable access to vaccines. This is 
particularly true when new vaccines are recommended by the Advisory Committee on Immunization Practices. Once the ACIP makes a recommendation for a new vaccine and the 
CDC director signs off on the recommendation, this prompts a series of steps that are critical to ensuring smooth and equitable rollout. The publication of official CDC recommendations is an 
essential step in this process. As an example, consider the PCV20 vaccine, the pneumococcal 
conjugate vaccine, which was recommended by the ACIP during its June meeting. AAP 
members have recently reported that some VFC programs are providing only PCV20 and that 
some vaccine- buying groups are directing people to use this vaccine over other pneumococcal 
vaccines. However, this is problematic because a lack of formal recommendations in an 
updated immunization schedule or publication in MMWR is leading to payment denials for 
PCV20, as well as delays in TRICARE coverage for children in military families. Timely updates 
to the immunization schedule would provide pediatricians with an authoritative source for the 
latest immunization recommendations, which is invaluable at the point -of-care to maximize 
every opportunity to vaccinate. The American Academy of Pediatrics strongly supports the 
efforts of the CDC to update the immunization schedule on an as -needed and timely basis. 
Jean- Venable “Kelly” Goode, PharmD, BCPS, FAPhA, FCCP (APhA) provided a statement 
on behalf of the nation’ s 330,000 pharmacists for the American Pharmacist Association. APhA 
is pleased to provide supportive comments on the importance of timely updates to the vaccine 
schedules. APHA, representing the profession of pharmacy, is honored to be one of the 
organizations granted the opportunity to review and indicate support of the adult vaccine 
schedule. Over the past 20- plus years, pharmacists and their teams have protected the public 
from vaccine -preventable diseases by recommending and administering vaccines, most notably 
of late, administering well over half the COVID -19 vaccines during the pandemic. APhA 
recommends updating the schedules as recommendations and clinical guidance are approved by ACIP. It is important for policy and patient access to vaccines. An example is the RSV 
vaccine. ACIP voted on the recommendations in June for the vaccine to be administered as 
soon as vaccine becomes available and throughout the RSV season. However, currently, it will 
not be on the vaccine schedule until February. States regulate vaccine administration by 
pharmacists and pharmacy personnel. Several states require that vaccines must be on the 
CDC/ ACIP  recommended schedule for pharmac ists or pharmacy personnel administration. The 
gap means that many thousands of patients will not have access to the RSV vaccine until 
February if the schedule updates are not accelerated. Given the number of patients who receive 
their vaccines from a pharmacy team member, especially those in rural and medically underserved areas, it is imperative that the vaccine schedules be updated as new vaccines 
become available and recommended by CDC ACIP. Therefore, AP hA strongly supports timely 
updates to the vaccine schedule for newly recommended vaccines to facilitate access to 
vaccination by pharmacists and pharmacy team members , and that payers be strongly informed 
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  that they do not need to wait for publishing of the MMWR for the updated schedule to begin 
coverage for the ACIP recommended vaccines. 
Pamela Rockwell , DO (AAFP) provided a statement on behalf of the AAFP . Family physicians 
provide care for people of all ages from birth through end of life, including care for those who 
are pregnant. AAFP feels strongly that timely updates to the vaccination schedules are 
extremely important to allow family physicians and other health care professionals determine 
who is due for vaccination and quickly. Many of the newly updated recommendations are scattered throu ghout CDC web pages and not easily accessed. As we enter the fall respiratory 
season, many family physicians have expressed disappointment that updates on several 
vaccines, including influenza, pneumococcal, RSV, and COVID -19, are not easily accessible on 
the Harmonized Child, Adolescent, and Adult Vaccination 2023 schedule. It was encouraging to 
hear from Dr. Schillie about the addendum to be added to the immunization schedules next 
week. To summarize, AAFP encourages continuous and additional timely updates to the 
schedules as new vaccine recommendations are added or amended, as these are essential to ensure continued prevention of disease and improve public health through vaccination. 
Robert H. Hopkins, Jr., MD (Medical Director, NFID) provided an update on behalf of the 
National Foundation for Infectious Diseases. NFID thanked the ACIP for its ongoing work to 
ensure the availability of safe and effective vaccines and monoclonal antibodies to help protect 
the most vulnerable individuals from RS V, and f or the addition of the ACIP schedule and plans 
to continue to update these schedules in the future to avoid some of the challenges with reimbursement and coverage. RSV impacts individuals of all ages, including premature infants and infants younger than 6 months. Each year in the US, RSV is estimated to cause more than 
2 million outpatient visits ; 58,000 to 80,000 hospitalizations ; and 100 to 300 deaths among 
children under 5 years of age. While immunizing pregnant women will be a tremendous step 
toward RSV pr evention, healthcare professionals will continue to need clear guidance and 
education to inform their decisions with patients and parents about the use of vaccines in 
pregnant women and/or nirsevimab in infants. NFID is committed to collaborating with CDC and 
partners in educating healthcare professionals and the public to help facilitate the effective use of these active and passive tools in RSV prevention. The low uptake among pregnant women of 
vaccines to prevent influenza and COVID -19 underscores the importance of building confidence 
in all recommended vaccines. As partners in protecting public health, we must focus on using all 
available tools to prevent RSV and protect those most at risk. For 50 years, NFID has been 
dedicated to educating and engaging the public, communities, and healthcare professionals 
about infectious diseases across the lifespan. NFID commends the tireless efforts of ACIP in 
guiding US immunization policy and stands ready to support the work of ACIP and CDC, which 
is instru mental in saving lives and protecting public health. 
Patsy Stinchfield RN, MS, CPNP (NAPNAP) provided a statement on behalf of NAPNAP, the 
National Association of Pediatric Nurse Practitioners to add her v oice to so many of the other 
association colleagues to say how important the updated schedule is. It is our tool. It is an 
outline. It is not all of the details, but it is critical for us to practice. Also, the great work that we 
have had with our RSV vaccines and products will make that schedule even more important. On 
behalf of pediatrics, we all know that RSV, in that in the infant age group as well as the older 
age group, can be a devastating disease. Today is a very, very great day in the pre
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