Document text
Implementation and Uptake of Nirsevimab and
Maternal Vaccine
Shannon Stokley, DrPH
Deputy Director for Science Implementation
Immunization Services Division
National Center for Immunizations and Respiratory Diseases (NCIRD)
June 2024National Center for Immunization and Respiratory Diseases
2023 -2024 Coverage for Nirsevimab and
Maternal Vaccination
Percent of pregnant persons ages 18 –49 years vaccinated with RSV vaccine
overall and by race and ethnicity, Vaccine Safety Datalink
•17.8% of pregnant persons vaccinated overall
•Vaccination coverage ranged from 10.3% among Black pregnant persons
to 24.8% among Asian pregnant persons
Data source: https://www.cdc.gov/vaccines/imz -managers/coverage/rsvvaxview/pregnant -persons -coverage -intent.html
Monthly nirsevimab receipt and intent among women ages 18 –49 years who
have an infant <8 months, National Immunization Survey -Adult COVID
Module (NIS -ACM)
13.520.628.740.5 43.0 41.340.0 26.931.421.7 16.7 22.835.7 47.330.131.530.024.310.95.29.86.310.3 11.6
0102030405060708090100
Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24Percent
Data source: https://www.cdc.gov/vaccines/imz -managers/coverage/rsvvaxview/nirsevimab -coverage.html
•51.2% of infants are estimated to be protected from RSV by either receipt of nirsevimab or maternal RSV
vaccination.
•Infants eligible for nirsevimab : 3,900,000
-Those 0 –7 months old during October 2023 –March 2024
-Born March 2023 –March 2024
-Assume 300,000 babies born each month
-43.0% received nirsevimab (from February NIS-ACM)
•Infants eligible for protection by maternal vaccination (a subset of infants eligible for nirsevimab ): 1,800,000
-Born October 2023 –March 2024
-Born to mot hers 32 -36 weeks' gestation and eligible for RSV vaccination September 2023 –January 2024
-17.8% of mothers received RSV vaccination (from VSD data through January 2024)
•Estimated number of infants who received nirsevimab = .430*3,900,000 = 1,677,000
•Estimated number of infants protect by maternal RSV vaccination = .178*1,800,000 = 320,400
•Percent protected by either = 1,677,000 + 320,400 / 3,900,000 = 51.2%Proportion of infants protected from RSV by receipt of nirsevimab or
maternal RSV vaccination
Data sources: https://www.cdc.gov/vaccines/imz -managers/coverage/rsvvaxview/nirsevimab -coverage.html , https://www.cdc.gov/vaccines/imz -
managers/coverage/rsvvaxview/pregnant -persons -coverage -intent.html , https://wonder.cdc.gov/
•IQVIA* data:
-Among women ages 18 -49 years in the U.S., during September 30, 2023, through April 20, 2024:
•A total of 223,466 projected RSV vaccine doses were administered
–96,611 (43%) in physician medical offices**. Using a sample of 2,866 office -based physicians,
vaccinations are projected to the ~700,000 office -based physicians in the U.S.
–126,865 (57%) in U.S. retail pharmacies. Using a sample of 40,469 pharmacies , vaccinations
are projected to the ~57,000 pharmacies in the U.S .
•NIS-ACM:
-National survey data
-Among 1,483 pregnant women <50 years surveyed between December 2023 -March 2024,
80(5.4%) had already received the RSV vaccine
•15% in a pharmacy or drug store
•85% in a medical office (doctor’s office/clinic/hospital/health dept)Location of Maternal RSV Vaccine Administration
*Data sources: Immunization Services Division’s custom IQVIA Longitudinal Prescription Claims ( LRx) + Medical Claims (Dx) data files (delivery date April 20,
2024). ** The projection to office -based physicians uses a list of US licensed office -based MDs and DOs maintained by the AMA.
•IQVIA data limitations
-May not be representative
•Uninsured pregnant people are not represented in medical office estimates.
•Projected physician medical office estimates are based on a small sample of physicians.
•Data do not include vaccinations administered at other medical settings such as public health clinics
and other settings including workplaces and community locations.
-There is no pregnancy variable in these IQVIA data
•Estimates include women of reproductive age who received an RSV vaccine during September
2023 –January 2024. This could include women who were not pregnant when vaccinated or were
pregnant but vaccinated outside the recommended 32 -36 weeks gestation period.
•NIS-ACM data limitations:
-Small sample size
-Gestational age at the time of vaccination is unknown
•Pregnancy status at time of interview was known, but not gestational age; only some of those
identified as pregnant would have been eligible for RSV vaccine at 32 -36 weeks gestation during the
September -January window for maternal RSV vaccination in most of the U.S. (e.g., in each month,
many would have been at <32 weeks gestation when interviewed)Location of Maternal RSV Vaccine Administration: Limitations
Implementation
Prospective 2024 RSV immunization timeline
Aug Sep Oct Nov Dec Jan
Maternal RSV vaccination
resumes in most of continental
U.S. (9/1)Nirsevimab administration resumes in most of continental U.S.; broad
availability (10/1)Limited availability
of nirsevimab (9/1)
•New immunization products
•Licensure/launch occurred in
Aug/Sep, which prevented planning
in advance of the season
•Complex clinical recommendations,
nuanced communications
•Lack of awareness among
healthcare providers
•Challenging have provider/patient
conversations about vaccination in
the context of nirsevimab shortages•Cost and reimbursement issues
during the first year
•Access issues —lack of supply at
many OBGYN offices, denial at
pharmacies, requirement of
prescription
•Lack of data on coadministration
•No ability to link maternal and infant
immunization records
•Concerns about safety, efficacyChallenges with maternal RSV vaccination during the 2023 -2024 season
•There is no anticipated supply/demand mismatch.
•The Pfizer RSV vaccine is already available in the field.
-However, providers who will vaccinate only pregnant persons may need to
rebuild inventory for the 2024 -2025 season.
-Plans are to have vaccine available for administration September 2024 –January
2025 for most of the U.S.Maternal vaccine supply for the 2024 -2025 season
CDC Campaign: From Me, To You
•Timing of policy decision
-FDA licensure (July 17) of nirsevimab required special session of ACIP (August 3) leaving <2 months for distribution and roll out
planning for October 1 launch
-Limited time for engagement with key stakeholders and implementing partners to ensure healthcare workers were aware of new
product recommendations and could start procurement processes
•Procurement and insurance coverage
-Vaccines for Children (VFC) procurement expedited to ensure availability of nirsevimab for eligible infants and young children (~50%
of US children); maternal vaccine for eligible pregnant people aged <19 years
-Healthcare providers were uncertain of need/demand given that private insurance companies have 12 months to adopt ACIP -
endorsed vaccine recommendations
-Demand was strong from parents of young children, many of whom were willing to pay for nirsevimab /vaccine if insurance would not
cover
-Nirsevimab orders exceeded anticipated demand rapidlyChallenges in initial implementation of nirsevimab
targeting infants during the 2023 -2024 season
•Limited supply of nirsevimab (100mg and 50mg
formulations) meant clinicians were uncertain
how to ration or prioritize few available doses
•CDC issued an official Health Advisory notice via
the Health Alert Network to prioritize available
doses to high -risk infants and younger infants
•By January, demand had decreased and
additional supply was available allowing return
to original recommendationsInsufficient supply of nirsevimab to meet demand in
2023 -2024 season
Health Alert Network (HAN) - 00499 | Limited Availability of Nirsevimab in the United States —Interim CDC Recommendations to Protect
Infants from Respiratory Syncytial Virus (RSV) during the 2023 –2024 Respiratory Virus Season
•National shortage during 2023 -24 due to faulty assumptions about uptake, presentation mix
•Manufacturer supply plan for 2024 -25 is focused on
-Increased volume of product
-Frontloading of supply
-Revised mix of presentations
•Requirements of supply plan include significant logistical actions, regulatory input and
approvals, careful risk management
•Limited availability beginning early Sep, ramping up during Sep, broadly available by Oct 1
•Broadly available supply essential to promote confidence in vaccines/vaccine supply
and program implementation
•Promoting vaccination prior to broadly available supply risks confusion, disappointment, and
decreased confidence among providers and the publicNirsevimab supply for the 2024 -2025 season
Birthing Hospital Enrollment into VFC: Strategy
291 291 293307332348 351 355 359 364 367
050100150200250300350400
July 2023 Aug 2023 Sept 2023 Oct 2023 Nov 2023 Dec 2023 Jan 2024 Feb 2024 Mar 2024 Apr 2024 May 2024
(2)Birthing Facilities Enrolled in VFC: August 2023 - May 2024
Birthing Facilities Enrolled in VFC: August 2023- May 2024
Linear (Birthing Facilities Enrolled in VFC: August 2023- May 2024)
(1) These newly enrolled provider counts include 7 providers who were previously enrolled in the VFC program.
(2) Data for May 2024 is through May 8, 2024.
•Engaging in data gathering activities:
-Held series of focus groups to identify facilitators and barriers to enrolling hospitals in VFC
-National survey of birthing hospitals
-Mapping hospitals by number of VFC -eligible births, VFC enrollment, and nirsevimab administration
history
•Planned activities to scale -up enrollment:
-Disseminating promising practices and success stories
-Development of “Promising Practices” FAQ document
-Working closely with immunization awardees to track process and provide support
•Implementing activities to reduce enrollment burden:
-Awardees can enroll birthing hospitals as “specialty providers”; this allows birthing hospitals to offer only
nirsevimab and HepB vaccination birth dose
•Collaborating with partnersActivities to Increase Hospital VFC Enrollment
For more information, contact CDC/ATSDR
1-800-CDC -INFO (232 -4636)
TTY: 1 -888-232-6348 www.cdc.gov www.atsdr .cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
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