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Re: DewDiligence post# 245574

Thursday, 05/18/2023 5:14:01 PM

Thursday, May 18, 2023 5:14:01 PM

Post# of 252486
VRBPAC endorses PFE’s maternal RSV vaccine:

https://www.businesswire.com/news/home/20230518005725/en

The votes were 14-0 for efficacy and 10-4 for safety. The “no” votes on safety were presumably due to a (non-statsig) higher rate of premature births in the vaccine arm than the placebo arm.

PFE’s RSV vaccine for adults and has a 5/31/23 PDUFA date, while PFE’s maternal RSV vaccine (the subject of today’s VRBPAC) has a PDUFA date in Aug 2023.

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