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Re: dewophile post# 245650

Tuesday, 02/28/2023 5:49:57 PM

Tuesday, February 28, 2023 5:49:57 PM

Post# of 257470
PFE’s RSV vaccine_for_adults_60+_endorsed_by VRBPAC in_dual 7-4 votes_on_safety_and_efficacy:

https://finance.yahoo.com/news/pfizer-receives-positive-fda-advisory-214000244.html

The crux of the matter for the panel was whether the Guillain-Barre risk warrants another pre-approval trial or whether a post-approval trial, which PFE has consented to run, is sufficient.

PFE’s PDUFA date is 5/31/23.

VRBPAC debates GSK’s RSV vaccine tomorrow. (GSK has a PDUFA date of 5/3/23.)

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