Pfizer’s Maternal RSV Vaccine Quest May Hinge On FDA Advisors’ Views of Preterm Birth Data
A numerical – but not statistically significant – imbalance in preterm births was seen in two Pfizer studies of its RSV vaccine when given to pregnant people with the aim of protecting newborns.
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Abrysvo is recommended for use in pregnant people 32-36 weeks gestation if administered from September to January. For infants whose mothers were not vaccinated in this window, nirsevimab is recommended for prevention of respiratory syncytial virus infection.
Advisory committee offers strong support for approval of Pfizer’s RSV vaccine to protect infants while simultaneously offering the agency a handful of suggestions that were directed towards the review and post-market surveillance of all vaccinations.
Arexvy is the first vaccine approved for the respiratory virus, but GSK's RSV program may lose out on a key population due to safety concerns for individuals younger than two. For Arexvy, CDC’s advisory committee could limit recommendation to 65 and up at June meeting.