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Maternal/Pediatric Respiratory Syncytial Virus (RSV)
Session
Advisory Committee on Immunization Practices Meeting
June 25, 2025
1U.S. Centers for Disease Control and Prevention
Session Introduction
•RSV can infect the small airways in the lungs,
particularly in infants
•Most (68%) infants are infected in the first year of
life and nearly all (97%) by age 2 years2
•2-3% of young infants are hospitalized for RSV3,4,5
-~80% of children hospitalized with RSV age <2 years
have no underlying medical conditions3
•Prior to 2023, no long -acting* products were
available for the prevention of severe RSV disease
*Long -acting is defined as any product that requires one dose to provide protection during an RSV season
References: 1) Suh et al, JID (2022): https://doi.org/10.1093/infdis/jiac120 2) Glezen et al, Arch Dis Child (1986): https://doi.org/10.1001/archpedi.1986.02140200053026 3) Hall
et al, Pediatrics (2013): https://doi.org/10.1542/peds.2013 -0303 4) Langley et al, PIDJ (2011): https://doi.org/10.1097/INF.0b013e3182184ae7 5) Curns et al, Pediatric s (2024):
https://doi.org/10.1542/peds.2023 -062574RSV is the leading cause of hospitalization in U.S. infants1
Image: Goncalves et al. Critical Care
Research and Practice 2012
2
In 2023 two products were approved by FDA and subsequently
recommended by CDC and ACIP
Maternal RSV
vaccine
Abrysvo, Pfizer
*Either maternal RSV vaccine or nirsevimab is given to protect infants against severe RSV disease
– only one is needed in most instances
Pregnant women 32 through
36 weeks’ gestation
Administer September
through January in most of
thecontinental United
States†All infants ages <8 months*
Second season dose for children
ages 8 –19 months at increased
risk of severe RSV disease
Administer October through
March in most of the continental
United States†(as early as
possible¥)
† Timing of administration for RSV immunization may differ in jurisdictions with RSV seasonality that differs from most of th e continental United States; ¥ The optimal timing for nirsevimab
administration is shortly before the RSV season begins (e.g., October –November), or within a baby's first week of life if born O ctober through March (ideally during the birth hospitalization.)Nirsevimab
Beyfortus , Sanofi & AstraZeneca
3
Today the committee will be considering a recommendation
for a newly FDA -approved product
Maternal RSV
vaccine
Abrysvo, Pfizer
*Either maternal RSV vaccine or an infant antibody is given to protect infants against severe RSV
disease – only one is needed in most instances
Pregnant women
32 through 36
weeks’ gestation
Administer
September through
January in most of
thecontinental
United States†All infants ages <8
months*
Second season dose for
children ages 8 –19
months at increased risk
of severe RSV disease
Administer October
through March in most of
the continental United
States † (as early as
possible¥)Nirsevimab
Beyfortus , Sanofi &
AstraZeneca Clesrovimab
Enflonasia , Merck
Approved by FDA on
6/9/2025
All infants ages <8
months*
Administer October
through March in most of
the continental United
States † (as early as
possible¥)
† Timing of administration for RSV immunization may differ in jurisdictions with RSV seasonality that differs from most of th e continental United States; ¥ The optimal timing for nirsevimab
administration is shortly before the RSV season begins (e.g., October –November), or within a baby's first week of life if born O ctober through March (ideally during the birth hospitalization.)4
•September 2024 : Maternal/pediatric RSV work group reviewed and discussed data from Merck on
safety and efficacy of clesrovimab
•October 2024: ACIP reviewed and discussed data from Merck on safety and efficacy of clesrovimab
and the maternal/pediatric work group’s interpretation of these data
•November 2024 – April 2025: Maternal/Pediatric RSV work group reviewed and discussed
-GRADE1,2 (Grading of Recommendations, Assessment, Development, and Evaluations) for
clesrovimab
-Evidence to Recommendation Framework2 for clesrovimab
•April 2025: ACIP reviewed and discussed the Evidence to Recommendation Framework and GRADE
for clesrovimab
•June 2025 (Today): ACIP will be presented with recap of the Evidence to Recommendations
Framework and vote on clesrovimabTimeline of work group and ACIP review of clesrovimab
References : 1) Ahmed et al, Vaccine (2011 ): https://doi.org/10.1016/j.vaccine.2011.08.005 2) Lee et al, MMRW (2018): https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a4.htm 5
•April – June 2025: The work group reviewed data on uptake, safety, and
effectiveness of maternal RSV vaccine and long -acting monoclonal antibody
from the 2024 -2025 season
•June 2025 (Today): ACIP will be presented with these data as well as the
work group interpretationAdditional data reviewed by the work group since the
April 2025 ACIP meeting
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•Updates on administration and uptake of maternal RSV vaccine and long -acting
monoclonal antibody — Dr. Georgina Peacock (CDC/NCIRD)
•Updates on effectiveness and impact of maternal RSV vaccine and long -acting monoclonal
antibody — Dr. Adam MacNeil (CDC/NCIRD)
•Safety of maternal RSV vaccine and long -acting monoclonal antibody — Dr. Malini DeSilva
(HealthPartners Institute) & Dr. Matthew F. Daley (Kaiser Permanente Institute for Health
Research)
•Evidence to Recommendation Framework: Clesrovimab — Dr. Adam MacNeil (CDC/NCIRD)
•Clinical considerations and work group interpretation — Dr. Adam MacNeil (CDC/NCIRD)Today’s agenda: June 25, 2025
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For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY: 1 -888-232-6348 cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position
of the U.S. Centers for Disease Control and Prevention.
Thank you