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Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
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RSV Vaccination in Older Adults:
Work Group Interpretations
Amadea Britton, MD
Advisory Committee on Immunization PracticesFebruary 29, 2024
2This includes follow- up of the implementation and experience of the current shared
clinical decision -making recommendation, understanding uptake of RSV vaccines
across age and demographic groups, consideration of new vaccine products , and
potential expansion of RSV vaccines to younger age groups .
However, the Work Group believes that contextualization and understanding of
current safety data are paramount in determining future preferred policy options
for the adult RSV vaccination program.
Therefore, today’s Work Group interpretations focus primarily on the safety and benefit/risk data reviewed today.
We will then briefly review the proposed roadmap for expected future policy decisions. First, the Work Group would like to acknowledge that there are multiple
concurrent policy issues to consider in the older adult RSV vaccine
landscape.
3Summarize Work Group interpretations of current RSV vaccine safety surveillance
data and the balance of estimated benefits vs potential risks associated with use of RSV vaccines in adults ages 60 years and older
Share updated clinical considerations incorporating timing of RSV vaccine administration in shared clinical decision- making
Update on plans for future policy considerations in the older adult RSV vaccine program Objectives
Work Group interpretation of current RSV
vaccine safety data and benefit/risk of RSV
vaccination in adults ages 60 years and older
5Due to the small number of cases, it was unclear whether the cases observed in the trials represented
a genuine association between RSV vaccination and risk of GBS or whether the cases observed in the
trials were due to chance alone.
The potential for increased risk of GBS was discussed extensively during deliberations for the older
adult recommendation. ACIP concluded that the estimated benefits of RSV vaccination outweighed
potential risks.
However, ACIP recommended RSV vaccines be given using shared clinical decision- making with a
healthcare provider. The shared clinical decision- making recommendation was intended to
facilitate individualized risk -benefit discussions, acknowledging that the balance of risks and
benefits may depend on the characteristics of the individual vaccine recipient.
Clinical guidance advised that a patient’s risk for severe RSV -associated disease should be the core of
shared clinical decision -making, with vaccination targeted to those who are at highest risk for severe
RSV disease and therefore most likely to benefit from vaccination.The initial RSV vaccine recommendation for adults 60 years and older was made in
the setting of a small number of cases of inflammatory neurologic events (particularly GBS) observed in the clinical trials for both GSK and Pfizer’s RSV vaccines for older adults.
6February May June NovemberDecember -
JanuaryFebruaryRSV older adult vaccine safety surveillance timeline
Abbreviations: ACIP = Advisory Committee on Immunization Practices, CISA = Clinical Immunization Safety Assessment Project, C MS = Centers for Medicare & Medicaid
Services, FDA= Federal Drug Administration, GBS = Guillain -Barre syndrome, RSV = respiratory syncytial virus, VAERS = Vaccine Ad verse Event Reporting System, VRBPAC=
Vaccines and Related Biological Products Advisory Committee Meeting; VSD = Vaccine Safety Datalink
*CISA is covered by a CDC Assurance of Confidentiality 2023 2024
ACIP votes to
recommend RSV vaccination for adults aged ≥60 years , using
shared clinical decision- making. Small number of GBS cases observed in the clinical trials in adults aged ≥60 years for GSK
and Pfizer RSV vaccines. Safety data shared at FDA VRBPAC
and ACIP meetings.VAERS scientists
continued monitoring and verifying GBS
reports; CISA continued review.First preliminary safety surveillance data available from CDC V -
safe, CDC VSD and FDA
CMS. Number of GBS cases in VAERS raised possibility
that cases observed might be above expected background rate. CDC
organized CISA calls with
clinical experts inneurology to
review cases of GBS
reported to VAERS.*RSV vaccines licensed for use in adults aged ≥60 years. Information on trial GBS cases included in product package inserts. Safety
monitoring commences immediately post -
licensure.
7Today, CDC’s Immunization Safety Office and FDA shared
preliminary data from multiple surveillance systems: VAERS, VSD, and the FDA -CMS partnership.
The data from these systems have been shared as near real -time
findings and allow us to be immediately responsive to early signals.
Together, the data support a potential increased risk for GBS after RSV vaccination among adults aged ≥60 years .
However, due to uncertainty and limitations in these early data, there is currently insufficient evidence to confirm whether RSV
vaccination is associated with increased risk for GBS in older
adults, or to estimate the magnitude of any increase in GBS risk after RSV vaccination.
Assessing the risk for GBS following receipt of the RSV vaccine among older adults in more robust analyses in active vaccine safety surveillance systems will be crucial and is underway. Surveillance with a focus on early detection of increased risk
of GBS after RSV vaccination began immediately post -
licensure.
+
8Any increase in potential risk of GBS should be placed in the context of the
benefits of RSV vaccination.
Earlier in this session, we summarized what we know about the estimated benefits of RSV vaccine and compared that to what we know currently about potential risk of GBS. This benefit- risk analysis showed that:
–From a population perspective, the estimated benefits of RSV vaccination outweigh the estimated
risks for adults 60 years and older.
–Benefits of RSV vaccination vary by age group and RSV incidence.
–Benefits likely also vary by individual -level risk of severe RSV disease and by timing of vaccination
relative to the RSV season.
We also saw data demonstrating that adults with certain chronic conditions are at increased risk of severe RSV disease, even at younger ages. How do these new data impact the Work Group’s thinking about RSV
vaccine for older adults?
9The Work Group also reviewed examples from other licensed and recommended
vaccines of benefit -risk considerations in practice.
Seasonal influenza vaccine: routine annual influenza vaccination is recommended for all persons aged
≥6 months who do not have contraindications. Adults aged ≥65 years should preferentially receive high -
dose, recombinant, or adjuvanted influenza vaccines.1
–The data on the association between GBS and seasonal influenza vaccination are variable and
inconsistent across influenza seasons. If there is an increased risk of GBS following influenza vaccination
it is small, on the order of 1–2 additional cases per million doses of influenza vaccine administered.
Studies also suggest that it is more likely that a person will get GBS after getting the influenza disease
than after influenza vaccination.2
1. Grohskopf LA, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023 –24 Influenza Season.
MMWR Recomm Rep 2023;72(No. RR -2):1 –25. http://dx.doi.org/10.15585/mmwr.rr7202a1
2. Vellozzi C, Iqbal S, and Broder K. Guillain -Barré Syndrome, Influenza, and Influenza Vaccination: The Epidemiologic Evidence, Clinical Infectious Diseases , Volume 58, Issue 8, 15 April 2014, Pages 1149 –
1155, https://doi.org/10.1093/cid/ciu005 .9
10Summary of RSV and Influenza disease -associated hospitalizations, estimated vaccine-
avertable disease hospitalizations, and potential vaccine -associated GBS risk
Disease -associated
hospitalizations per 1 million
population per year in the U.S.Estimated disease -associated
hospitalizations avertable per 1
million persons vaccinatedPotential vaccine -associated GBS
cases per1 million persons vaccinated
RSV1,700 – 2,800
1
among adults ages 65 and olderOver two RSV seasons, among adults ages 60 and olderGSK: 2,400 (1,800 – 3,700)
2
Pfizer: 2,700 (2,100 – 4,200)2GSK: 10 (2 –18) cases3
Pfizer: 25 (7 –43) cases3
Not adjusted for background rate of GBS
Expected from background rate :
5cases of GBS (95% CI: 4.8,
5.4) per 1million doses given
4
Influenza3,200 – 9,2005
among adults ages 65 and olderOver one influenza season,
among adults ages 65 and older
2,000 (300 – 5,500)6Variable and inconsistent across
influenza seasons. If there is an
increased risk, it is small: ~1–2
additional cases per million doses
given7,8
1. CDC RSV -NET data 2016– 2020, 2022 –2023 (unpublished)
2. Unpublished benefit/risk analysis presented at this ACIP meeting (February 2024).
3. FDA analysis of CMS data. Includes GBS cases in a 42 -day risk interval post -RSV -vaccination, adjusted for claims delay, among be neficiaries 65 and older with Parts A and B coverage who did not have a GBS claim in the 365 days before vaccination. These are rates of GBS identified by inpatient claims data and are decreased
by 29% to account for the positive predictive value of diagnostic codes in identifying chart -confirmed GBS cases. A GBS backgrou nd rate is not subtracted from these rates.
4. FDA analysis of CMS data. Background rate based on GBS cases observed per 100,000 person -years among Medicare beneficiaries 65 and older with Parts A and B coverage in 2022. Beneficiaries must not have had an International Classification of Diseases, 10 th revision, clinical modification (ICD -10-CM) diagnostic code
for GBS in the 365 days preceding January 1, 2022. Rate per 100,000 person -years applied used to estimate cases expected over 42 -day follow -up for 1 million persons.
5. CDC Influenza Burden 2016– 2020, 2022 –2023: https://www.cdc.gov/flu/about/burden/past -seasons.html
6. Ellen KD, Gebremariam A, Rose A, et al. Cost -effectiveness of routine annual influenza vaccination by age and risk status. Vaccine: 41 (29): 4239- 424 8. 2023. https://doi.org/10.1016/j.vaccine.2023.04.069
7. Vellozzi C, Iqbal S, and Broder K. Guillain -Barré Syndrome, Influenza, and Influenza Vaccination: The Epidemiologic Evidence, Clinical Infectious Diseases , Volume 58, Issue 8, 15 April 2014, Pages 1149 –1155, https://doi.org/10.1093/cid/ciu005 .
8. Committee to Review Adverse Effects of Vaccines; Institute of Medicine; Stratton K, Ford A, Rusch E, et al., editors. Adverse Effects of Vaccines: Evidence and Causality. Washington (DC): National Academies Press (US); 2011 Aug 25. 6, Influenza Vaccine. Available from: https://www.ncbi.nlm.nih.gov/books/NBK190013/
Influenza Vaccine - Adverse Effects of Vaccines - NCBI Bookshelf (nih.gov).10
11The Work Group also considered examples from other licensed and recommended
vaccines of benefit -risk consideration in practice.
–
Recombinant zoster vaccine: CDC recommends two doses of recombinant zoster vaccine (RZV,
Shingrix) 2 –6 months apart for adults aged ≥50 years and for adults aged ≥19 years who are or will be
immunocompromised, for prevention of herpes zoster (shingles) and related complications .3,4
–3-6 additional cases of GBS projected per million RZV vaccinated .5
–Risk- benefit analysis incorporated available data on risk of GBS following zoster disease and vaccination with RZV
3. Dooling KL, et al. Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. MMW R Morb Mortal Wkly Rep 2018;67:103 –108. http://dx.doi.org/10.15585/mmwr.mm6703a5
4. Anderson TC, et al. Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advi sory Committee on Immunization Practices — United States, 2022. MMWR Morb Mortal
Wkly Rep 2022;71:80 –84. http://dx.doi.org/10.15585/mmwr.mm7103a2
5. Janusz CB, et al. Projected risks and health benefits of vaccination against herpes zoster and related complications in US ad ults. Hum Vaccin Immunother. 2022 Nov 30;18(5):2060668.
https://doi.org/10.1080/21645515.2022.206066811
12Experience with recombinant zoster vaccine (Shingrix)
In 2019, a statistical safety signal for GBS following
recombinant zoster vaccine was identified in VSD; evidence was insufficient to confirm the initial signal.
FDA, CDC, and collaborators conducted additional extensive safety assessments.
1,2
Using data from this safety surveillance, a formal
analysis evaluating health risks and benefits was
undertaken. Epidemiologic data suggesting a potentially elevated risk of GBS following an
episode of herpes zoster (HZ) in the U.S. adult
population was also included.
3
In this analysis , benefits were assumed to accrue
over a period of 20 years after vaccination.
Vaccination averted 43,000– 63,000 cases of HZ,
including GBS complications, per million
vaccinated per 10-year age cohort compared to 3 –
6 additional cases of GBS projected per million
vaccinated with recombinant zoster vaccine in the same population.
4
Importantly, RSV disease is not directly comparable to herpes zoster disease.
* Projected number of averted cases of postherpetic neuralgia and ocular complications have been rounded to two significant f igures. For exact numbers see Janusz et al. below.
1. Goud R, et al. Risk of Guillain -Barré Syndrome Following Recombinant Zoster Vaccine in Medicare Beneficiaries. JAMA Intern Med. 2021 Dec 1;181(12):1623 -1630. doi: 10.1001/jamainternmed.2021.6227.
2. Nelson JC, et al. Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data. Am J Epidemiol. 2023 Feb 1;192(2):205 -216. doi: 10.1093/ aje/kwac170.
3. Anderson TC, et al. Risk of Guillain -Barré syndrome following herpes zoster, United States, 2010 -2018. Hum Vaccin Immunother. 2021 Dec 2;17(12):5304 -5310. doi : 10.1080/21645515.2021.1985890.
4. Janusz CB, et al. Projected risks and health benefits of vaccination against herpes zoster and related complications in US ad ults. Hum Vaccin Immunother. 2022 Nov 30;18(5):2060668. https://doi.org/10.1080/21645515.2022.2060668Age group (years)Postherpetic neuralgiaOcular complicationsDeaths Incremental
GBS increase Notes
50-59 5,500 4,300 47
3 – 6 • 20-year time horizon
• Incremental GBS increase subtracts background rate of
GBS and HZ -
associated GBS
averted
• Outcomes averted per million 1 -dose or
2-dose series60-69 9,400 5,500 62
70-79 12,000 5,700 171
80-89 12,000 5,200 155
90-99 11,000 3,900 116Projected cases* of postherpetic neuralgia, ocular complications, and
death averted through recombinant zoster vaccine per million vaccinated,
compared to incremental GBS increase per million412
13Based on this review of currently available data, the Work Group
continues to believe that the estimated benefits of RSV
vaccination outweigh potential risks when vaccination is
implemented using the current recommendation: Adults aged
≥60 years may receive RSV vaccination, using shared clinical decision-making.
14However, the Work Group expressed that
estimated benefits most clearly outweigh
potential risks among adults 60 and older who are at increased risk of severe RSV disease.
This includes a dults who are 60 and older with
chronic medical conditions such as chronic lung
diseases, heart failure, immune compromise, those of more advanced age, and those living in long -term care facilities (e.g., nursing homes). A majority of Work Group members expressed that the balance of
estimated benefits outweighed potential risks for all adults 60 and older.
15Estimated age distribution of national RSV -associated hospitalizations, ICU admissions, and in-
hospital deaths among adults ≥18 years, RSV -NET, 2022 –2023, compared with U.S. population
Unpublished data. Underlying rates are adjusted using multipliers for the frequency of RSV testing during each season and for the sensitivity of RSV diagnostic tests. Estimates
from 2022- 2023 are preliminary. These estimates use the same multipliers as for 2019 -2020.
*As of 2022. https://www.census.gov/popclock/ 42.9%
37.1%
58.0%
9.2%23.9%
26.8%
22.8%
13.0%20.4%
22.6%
11.3%
24.1%12.8%
13.6%
7.9%
53.7%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%Hospitalizations
ICU admissions
In-hospital deaths
U.S. Adult Population*≥75 65-74 50-64 18-49
U.S. Adult Population *Age group, years:
16Underlying medical conditions* among non- pregnant adults ≥18 years with RSV -
associated hospitalizations — RSV -NET, 2014 –2015 to 2017 –2018 and 2022 –2023
Major underlying condition categories Unweighted
N=7,479Weighted
%
Cardovascular disease (overall) 5,141 57.4
Obesity 2,798 39.0
Diabetes 2,484 34.1
COPD 2,248 31.4
Heart failure 1,984 28.0
Chronic kidney disease 2,003 27.0
Asthma 1,789 24.0
Coronary artery disease (includes CABG, MI) 1,718 24.0
Neurologic condition 1,628 22.6
Immune compromised 1,567 20.8
Chronic metabolic disease, not including diabetes 1,417 19.3
Other chronic lung disease 995 17.1
Chronic liver disease 538 7.2
Autoimmune/inflammatory disease 310 4.5
Blood disorders 287 4.194.3% of adults ≥18
years with RSV -
associated hospitalization
had at
least one underlying medical condition
:
•31.4%: 1– 2 conditions
•62.9%: ≥3 conditions
*Clinical data, including underlying medical conditions, were collected for all patients with laboratory -confirmed RSV hospitalizations during the 2014 –2015 to 2017– 2018 seasons, and for an
age- and site -stratified random sample of patients with laboratory -confirmed RSV hospitalizations during the 2022 –2023 season. Data are presented as unweighted case counts and weighted
percentages that were weighted for the probability of selection.
17For these adults, the benefit from RSV vaccination may be
lower.
However, the Work Group felt that these adults might still
benefit from vaccination depending on their individual situation and the decision to get vaccinated should be based
on discussion with a healthcare provider .
The shared clinical decision- making recommendation
continues to support this flexibility. The Work Group noted that for older adults who do not have any chronic
medical conditions and who do not live in long -term care facilities , the risk
of severe RSV disease is lower.
18Providers will need support in appropriately framing shared clinical
decision -making discussions with their older adult patients.
Providers may need additional communications materials clarifying which of their patients aged ≥60 years are at increased risk of severe RSV
disease and would benefit most from vaccination.
Providers may need more materials to support discussing current safety
data. The Work Group also stresses that discussion of benefits vs
potential risks should remain the core of shared clinical decision -
making.
19Uncertainty in estimates of risk
–Estimated risk is uncertain and confidence intervals are wide
–Among adults electing to receive RSV vaccine, background rates of GBS are uncertain
•Adults receiving RSV vaccine may differ from those who do not choose vaccines in underlying health status or
other ways that could impact background risk of GBS
•It is unclear if recipients of different RSV vaccine products may also differ in ways that could affect their underlying risk of GBS independent of RSV vaccination
Uncertainty in estimates of benefit
–Although estimated benefits are based on the best available data, we do not yet have estimates of
real -world vaccine effectiveness against RSV -associated hospitalization and death
–The extent to which effectiveness will extend to older adults at highest risk of severe RSV disease
(those aged ≥75 years, those who are frail, those with immune compromise) is also unknown
There may be other important sources of uncertainty
–What do we need to understand about coadministration of RSV vaccine with other recommended
vaccines?
–Is RSV disease itself associated with a risk of GBS? The Work Group acknowledges the challenge of multiple sources of
uncertainty.
20V-safe data monitoring ongoing
VAERS data monitoring ongoing with CISA experts reviewing selected reports
Vaccine Safety Datalink
–Rapid cycle analysis (RCA) will be performed as soon as sufficient data (plan for first RCA March 2024)
–Power may be limited, especially for Pfizer RSV vaccine
FDA -CMS partnership ongoing
–Plan for self-controlled case series as soon as sufficient follow -up time accrued
Both manufacturers (Pfizer and GSK) conducting post -marketing studies
–GSK: Sentinel system self-controlled risk interval active surveillance, final report 2031
–Pfizer: CMS claims data active surveillance, final report 2030
Will conduct more robust risk- benefit analysis once active surveillance analyses are
able to characterize risk and estimates of real- world vaccine effectiveness are
availableSafety surveillance is ongoing and new data will be shared as soon as they
become available. The preliminary data shared today are the first in what
will be a series of rigorous analyses across multiple different platforms.
Abbreviations: CISA = Clinical Immunization Safety Assessment Project, CMS = Centers for Medicare & Medicaid Services, FDA= F ederal Drug Administration, VAERS = Vaccine
Adverse Event Reporting System
21In the interim, the Work Group wishes to affirm the importance of the RSV
vaccination program. RSV is a disease that causes significant morbidity
and mortality among persons across the age spectrum.
The Work Group is cognizant that premature changes in the RSV
vaccination program have the potential to limit access to RSV vaccine.
CDC and the Work Group are committed to incorporating what we are learning from post -licensure data in a transparent way that ensures
safety for the public and clarity for providers.CDC and the Adult RSV Work Group will be engaged in ongoing assessment. Future older adult RSV policy will be responsive to what is learned over the coming months.
Work Group considerations on timing of
RSV vaccination for adults ages 60 years and older
231.RSV seasonality had been disrupted by the COVID -19 pandemic. Based on the two
preceding RSV seasons (2021 -2022 and 2022 -2023), it was not clear when RSV
circulation might start, peak, and decline . Therefore, it was also unclear when to
time RSV vaccination to optimize benefit to an individual. In June 2023, the decision to recommend year -round RSV
vaccination was based on 3 considerations:
24National weekly* RSV percent positivity of PCR results,
NREVSS July 2016 –June 2023
*All results presented from nucleic acid amplification tests which represent >90% of the diagnostic tests reported to NREVSS.
The last three weeks of data may be less complete. NREVSS is an abbreviation for the National Respiratory and Enteric Virus Surv eillance System.
For more information on NREVSS, please visit www.cdc.gov/surveillance/nrevss .
RSV: Respiratory Syncytial Virus. Types A and B are reported but not shown separately in this report.
Results are crude, and therefore may differ from smoothed results reported online. 2016- 20,
pre-COVID -19
2020- 212021- 222022- 23
02468101214161820
2728293031323334353637383940414243444546474849505152123456789101112131415161718192021222324252627
Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun JulPercent Positive
Month and MMWR Week
251.
2.Clinical trial data indicated that both GSK and Pfizer RSV vaccines offered protection
for at least two RSV seasons. Therefore, regardless of when someone received a dose of RSV vaccine it would be expected to protect the recipient at least through the upcoming RSV season. In June 2023, the decision not to specify seasonal
administration of RSV vaccine was based on 3 considerations:
261.
2.
3.There were limited data available to understand if (or when) revaccination would be
beneficial. Not having a seasonal end to administration offered maximum flexibility and opportunity for people to receive protection for the next season. In June 2023, the decision not to specify seasonal
administration of RSV vaccine was based on 3 considerations:
27National weekly* RSV percent positivity of PCR results,
NREVSS July 2016 –February 2024
*All results presented from nucleic acid amplification tests which represent >90% of the diagnostic tests reported to NREVSS.
The last three weeks of data may be less complete. NREVSS is an abbreviation for the National Respiratory and Enteric Virus Surv eillance System.
For more information on NREVSS, please visit www.cdc.gov/surveillance/nrevss .
RSV: Respiratory Syncytial Virus. Types A and B are reported but not shown separately in this report.
Results are crude, and therefore may differ from smoothed results reported online. 2016- 20,
pre-COVID -19
2020- 212021- 222022- 23
2023- 24
02468101214161820
2728293031323334353637383940414243444546474849505152123456789101112131415161718192021222324252627
Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun JulPercent Positive
Month and MMWR Week
28Predictable RSV seasonality makes it possible to anticipate the likely RSV season onset, peak,
and offset.
Maximizing benefits is also desirable as we continue ongoing safety monitoring.The Work Group concludes it is now advisable for providers and patients
to consider timing of RSV vaccination as part of shared clinical decision -
making discussions.
For most older adults, benefits will be highest when RSV
vaccination is given in the late summer or early fall, just before
the onset of RSV season , so that vaccine recipients experience
highest protection during the times of peak RSV transmission over the fall and winter.
Because clinical trial data suggests that protection will wane over
time, vaccinating just before a season starts also maximizes
protection for subsequent seasons for which the vaccine offers
protection.
29For adults ages 60 years and older who remain unvaccinated and
who decide with their healthcare provider to get RSV vaccination,
the best time for vaccination is just before the start of the next
RSV season to maximize the benefits of the vaccine.
NOT a transition to a formal seasonal recommendation for RSV
vaccination.
–Older adults may continue to receive RSV vaccination year -round , using
shared clinical decision -making.
–Intent is to allow providers and patients maximum flexibility. Patients with
infrequent healthcare contact may benefit from every opportunity to vaccinate.
NOT a recommendation for annual re -vaccination.
–RSV vaccine for adults 60 and older is currently still recommended as a one -time
vaccine. What does it mean to include timing of vaccination in shared
clinical decision -making?
In most of the
United States,
RSV vaccination
will have the most
benefit if given in
late summer or
early fall.
30Mean weekly RSV percent positivity of PCR results by census region,
NREVSS*, 2015 –2019
*Data from Florida, Hawaii, and Alaska are excluded.
All results presented from nucleic acid amplification tests which represent >90% of the diagnostic tests reported to NREVSS.NREVSS is an abbreviation for the National Respiratory and Enteric Virus Surveillance System. For more information on NREVSS, please visit www.cdc.gov/surveillance/nrevss
.
RSV: Respiratory Syncytial Virus. Types A and B are reported but not shown separately in this report.
Results are crude, and therefore may differ from smoothed results reported online. Northeast
MidwestSouth
West
0%5%10%15%20%25%Percent Positive
Week ending date
31Mean weekly RSV percent positivity of PCR results by census region,
NREVSS*, 2015 –2019
*Data from Florida, Hawaii, and Alaska are excluded.
All results presented from nucleic acid amplification tests which represent >90% of the diagnostic tests reported to NREVSS.NREVSS is an abbreviation for the National Respiratory and Enteric Virus Surveillance System. For more information on NREVSS, please visit www.cdc.gov/surveillance/nrevss
.
RSV: Respiratory Syncytial Virus. Types A and B are reported but not shown separately in this report.Results are crude, and therefore may differ from smoothed results reported online. Northeast
MidwestSouth
West
0%5%10%15%20%25%
Jul-7
Jul-21
Aug-4
Aug-18
Sep-1
Sep-15
Sep-29
Oct-13
Oct-27
Nov-10Nov-24
Dec-8
Dec-22
Jan-5
Jan-19
Feb-2
Feb-16
Mar-2
Mar-16Mar-30
Apr-13Apr-27
May-11
May-25
Jun-8
Jun-22Percent Positive
Week ending dateRSV season onset varies by
region, from September to
November in most of the
United States.
32Mean weekly RSV percent positivity of PCR results by census region,
NREVSS*, 2015 –2019
*Data from Florida, Hawaii, and Alaska are excluded.
All results presented from nucleic acid amplification tests which represent >90% of the diagnostic tests reported to NREVSS.NREVSS is an abbreviation for the National Respiratory and Enteric Virus Surveillance System. For more information on NREVSS, please visit www.cdc.gov/surveillance/nrevss
.
RSV: Respiratory Syncytial Virus. Types A and B are reported but not shown separately in this report.Results are crude, and therefore may differ from smoothed results reported online. Northeast
MidwestSouth
West
0%5%10%15%20%25%
Jul-7
Jul-21
Aug-4
Aug-18
Sep-1
Sep-15
Sep-29
Oct-13
Oct-27
Nov-10Nov-24
Dec-8
Dec-22
Jan-5
Jan-19
Feb-2
Feb-16
Mar-2
Mar-16Mar-30
Apr-13Apr-27
May-11
May-25
Jun-8
Jun-22Percent Positive
Week ending dateVaccination just prior to the
RSV season means from August to October in most of
the United States.
33Weekly and Cumulative Projected RSV Vaccinations Administered in Retail Pharmacies by
Product, Adults 60 years and older, August 12, 2024 – February 2, 2024. Data Source: IQVIA*
*IQVIA Custom Weekly LRx; File
delivery date 2/8/24 .The weekly number of
RSV vaccine doses
administered appears
to have peaked and
now be declining.
Other upcoming policy considerations for RSV
vaccination in adults ages 60 years and older
35Additional policy issues Adult RSV Work Group plans
to address in June 2024
1.Potential FDA approval of Moderna mRNA- 1345 vaccine for use in
adults aged ≥60 years
2.Potential FDA approval of GSK RSV vaccine for use in adults aged 50 –
59 years “at increased risk for RSV disease” ( regulatory decision expected
June 2024 )
3.Consideration of whether shared clinical decision -making remains the
preferred policy option.35
36The Work Group notes that safety and efficacy were demonstrated in their phase 3
safety & efficacy trial, most notably:
oInterim efficacy analysis with median 9 months follow -up per participant
VE against RSV LRTI with ≥2 symptoms: 63.3% (95% CI 48.7 –73.7%)
VE against RSV LRTI with ≥3 symptoms: 63.0% (95% CI 37.3 –78.2%)
Two recorded RSV -associated hospitalizations, both in the placebo arm. Unable to estimate efficacy against
hospitalization.
No recorded RSV -associated deaths, including in the placebo arm.
oNo reported cases of GBS, ADEM, or other inflammatory neurologic events in clinical trials of mRNA -1345 (N=18,245
vaccine recipients in their pivotal Phase II/III trial).
oNo reported cases of confirmed myocarditis or pericarditis among recipients of mRNA -1345 within 42 days after
vaccination.
If licensed by FDA for use in adults 60 and older, Work Group plans to present full GRADE/ EtR to support ACIP deliberations around adding Moderna mRNA -1345 as an
option for adults 60 and older to protect against lower respiratory tract disease. Work Group interpretations of initial phase 3 safety and
efficacy of Moderna’s mRNA -1345 RSV vaccine
Abbreviations: VE = Vaccine effectiveness, LRTI=Lower respiratory tract infection, GBS=Guillain -Barré Syndrome, ADEM=Acute disse minated
encephalomyelitis
37In October 2023, GSK presented data to ACIP demonstrating that the humoral immune
response to a single dose of GSK RSV vaccine in adults 50 –59 years is non -inferior to that in
adults 60 and older .
The Work Group noted that if FDA licensure is granted for use of GSK’s RSV vaccine in adults aged 50– 59 years at increased risk of RSV disease, then ACIP will likely need to make a policy
recommendation on:
–Whether RSV vaccination should be recommended in this age group?
–And if so, how will CDC define populations at increased risk of RSV disease?
Today we saw data demonstrating the relative risk of severe RSV disease across a range of chronic medical conditions by age group.
Work Group members broadly agree that use of RSV vaccine among adults with certain chronic medical conditions aged 50 –59 years is likely to have public health benefit, however,
upcoming data on safety and effectiveness will be pivotal to determine the preferred policy option in this age group. Work Group interpretations of GSK RSV vaccine for use in
adults 50 –59 at increased risk of RSV disease
38Lastly, the Work Group has begun analyzing the experience with shared clinical
decision -making this season.
Feedback from many partners that shared clinical decision- making has been
challenging to implement.
For the time being, the Work Group continues to endorse shared clinical decision-making as we learn more about the estimated benefits and potential risks associated with the currently available RSV vaccines.
However, the Work Group has begun reviewing evidence to discuss changing the current recommendation for adults ≥60 from shared clinical decision- making to:
–A universal recommendation among adults older than a specific age cut -off AND
–A risk-based recommendation in adults 50 years and older up to that age cut -off Work Group interpretations on whether shared clinical
decision -making will remain the preferred policy option
39The Work Group is considering a shift away from shared
clinical decision -making for multiple reasons.
A universal recommendation among adults over a specific age cut -off may be easier
to message and implement.
A risk -based recommendation among adults 50 and older, but below the universal
age cut -off may be easier to implement (persons at risk would be more concretely
defined) and ensure persons being vaccinated have highest potential to benefit.
Anticipate presenting additional data on these topics at the June 2024 ACIP meeting
The Work Group emphasizes that future preferred policy options will be contingent
on incoming data, including safety analyses and vaccine effectiveness.
40CDC and the Adult RSV Work
Group will continue to
transparently share new
information with ACIP and
the public and incorporate it
into future policy
recommendations to ensure
the greatest benefit and least
risk in the RSV vaccine
program for older adults. The first -ever respiratory virus season in which there were vaccines available to protect
older adults against RSV disease is coming to a close .
This is a new vaccine program and remains an evolving landscape with the potential for
new products and expansion of current products into new age groups.
Data from this season is still incoming. Over the coming months CDC and the Work Group will be analyzing these data to inform discussion of future RSV vaccine policy for
older adults.
Data from pre -licensure clinical trials and early findings from post- licensure vaccine
safety surveillance suggests the potential for increased risk of GBS after RSV vaccination in older adults; however, these early data are insufficient to confirm if there is an
increased risk.
Assessing the risk for GBS following receipt of the RSV vaccine among older adults in more robust analyses in active vaccine safety surveillance systems will be crucial and is
underway.
Currently, the Work Group continues to endorse the benefits of RSV vaccination for
adults 60 and older, especially those at increased risk of severe RSV disease, using shared
clinical decision -making.
Benefits can be maximized by administering RSV vaccine just before the start of RSV
season and the Work Group recommends that timing of RSV vaccination should be a part of the shared clinical decision -making discussion. Summary
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