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


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  • The FDA's panel of outside vaccine advisors will meet in two weeks and discuss Pfizer Inc (NYSE:PFE) and BioNTech SE's (NASDAQ: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 (NASDAQ: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.
  • Photo by Johaehn from Pixabay

Crypto Whales Are Loading Up — Are You?

New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.


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Posted In: BiotechNewsHealth CareFDAGeneralBriefsCOVID-19 CoronavirusCOVID-19 Vaccine