FDA Schedules Adcomm For Pfizer/BioNTech's COVID-19 Booster Shot

The FDA's panel of outside vaccine advisors will meet in two weeks and discuss Pfizer Inc PFE and BioNTech SE's BNTX supplemental application for a booster shot of their COVID-19 vaccine.
The Advisory Committee Meeting is scheduled on September 17, just three days before the Biden administration said it would roll out boosters. Regulators received the supplemental application just a week ago.
Related: Pfizer, BioNTech Now Seeking Full Approval For Third COVID-19 Vaccine Dose.
The announcement for the advisory committee came as Moderna Inc MRNA said it had started the submission process for its booster.
Related: Moderna Seeks FDA Approval For COVID-19 Booster Shot.
Pfizer and BioNTech filed for approval based on a Phase III study data where 306 volunteers received a third dose between 4.8 and 8 months after their second shot and saw "robust" antibodies against the original SARS-CoV-2 strain.
For Moderna, the first batch of data submitted is from a Phase II trial that tested the 50 µg dose. The current Moderna vaccine is a 100 µg dose.
Price Action: PFE stock is up 0.52% at $46.27, while BNTX stock is down 1.07% at $328.94 during the market session on the last check Thursday.
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