Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have filed paperwork with FDA to authorize their COVID-19 vaccine for all adults 18 and older.
The two companies had filed a supplemental Biologics License Application for a booster dose of the COVID-19 vaccine in adults at least 16 years old.
FDA did not accept the supplemental Biologics License Application, however. Instead, FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine in September to allow individuals with an elevated risk to receive a single booster dose. The EUA required that eligible individuals receive a booster dose at least six months after completing the primary series.
Earlier, an advisory committee had decided there was insufficient evidence to warrant approval for all adults. In particular, the committee expressed concerns about the rare risk of myocarditis in some younger vaccine recipients.
Instead, the U.S. authorized Pfizer booster doses in October for adults 65 and older, those with an increased risk of severe disease and those with an elevated risk of occupational or institutional exposure.
In Pfizer’s most recent study, trial volunteers vaccinated with the BNT162b2 vaccine received either a third dose or a placebo shot. One week afterward, five recipients in the booster group developed symptomatic COVID-19 compared to 109 people in the placebo group. The booster study involved approximately 10,000 individuals overall.
In October, the FDA authorized boosters for Moderna (NSDQ:MRNA) and Janssen (NYSE:JNJ) vaccines.
Pfizer also intends to file for FDA authorization for its Paxlovid COVID-19 pill by Thanksgiving.
BNTX shares dropped 6.69% today to $226.37, and PFE shares dipped 2.15% to $47.30.
Filed Under: clinical trials, Drug Discovery, Infectious Disease