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Re: DewDiligence post# 5409

Wednesday, 05/31/2023 6:43:36 PM

Wednesday, May 31, 2023 6:43:36 PM

Post# of 6443
FDA approves Abrysvo—(PFE’s RSV vaccine)—for adults 60+:

https://www.businesswire.com/news/home/20230530005660/en

Today was the PDUFA date.

GSK’s similar RSV vaccine, Arexvy, was approved for adults 60+ by the FDA four weeks ago (#msg-171831470).

PFE’s separate BLA for its maternal RSV vaccine—to protect newborns for up to six months—has a PDUFA date in August 2023 (#msg-171260623) and was recently endorsed by VRBPAC (#msg-171942839). PFE is the only company with such a vaccine, as far as I know.

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