RSV Pediatric 07 Fleming Dutra 508

CDC ACIP — Vaccine Advisory Committee

Acip

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208
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Work Group considerations regarding maternal RSV 
vaccine
Katherine Fleming -Dutra, MD FAAP
Co-lead, Maternal/Pediatric RSV Work 
Group 
ACIP General Meeting
February 23, 2023

209Should the Pfizer RSV bivalent prefusion F vaccine be recommended for 
all pregnant people as a single dose given at 24 ‒36 weeks gestation?
This recommendation would be considered in the context of the current 
standard of care for prevention of RSV disease in infants at the time of 
ACIP vote. Policy question being considered by the work group
210Dosing window in the trial was 24 through 36 weeks gestation
Currently there are no data available on efficacy stratified by gestational age at time 
of administration 
Majority of infants in phase 3 trial were born ≥37 weeks gestation (94% in RSV 
bivalent preF arm and 95% in placebo arm)
Most doses in the phase 3 trial were given at ≥28 weeks gestation
–25% doses given at ≥24 to <28 weeks
–30% doses given at ≥28 to <32 weeks
–45% doses given at ≥32 to <37 weeks
–0.1% doses given at ≥37 weeksKey considerations regarding RSV bivalent prefusion F 
vaccine: timing of dose within pregnancy
Data provided by Pfizer
211All pregnant people in the trial received their first and only dose of RSV 
vaccine
Currently there are no data available on
–Efficacy of the first lifetime dose during subsequent pregnancies
–Safety of additional doses given in subsequent pregnanciesKey considerations for RSV bivalent prefusion F vaccine: 
number of total lifetime doses 
212June 2023
–Summary of GRADE
–Cost effectiveness analysis
–EtR
October 2023
–ACIP vote (if product is licensed by this time)Proposed timeline of future ACIP presentations (tentative)
213