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FDA Reveals COVID-19 Booster Advisory Committee Question

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FDA Reveals COVID-19 Booster Advisory Committee Question
  • This week, the FDA released briefing documents from the agency and Pfizer Inc (NYSE: PFE), each outlining their arguments for the COVID-19 booster shot Advisory Committee (AdComm) scheduled for today.
  • See here the FDA document and Pfizer Document.
  • Related Content: Pfizer Builds Case For COVID-19 Booster As Protection Wanes Over Time.
  • Late Thursday, regulators published the question on which panel members would be voting.
  • Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech SE’s (NASDAQ: BNTX) initial Phase 3 study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. 
  • Related Link: COVID-19 Vaccine Booster Shots Will Have To Wait, FDA Tells White House.
  • The question notably excludes the real-world data from Israel and other analyses that Pfizer had said would be a centerpiece of their arguments for boosters.
  • It’s not clear whether this question would be the only one asked.
  • It’s a Phrasing some outside observers struggled to interpret. Walid Gellad, director of the University of Pittsburgh Center for Pharmaceutical Policy and Prescribing, noted the contrast between the question and the “narrow” focus on the Phase III study in a Twitter thread.
  • Read Next: After Pfizer, Now Moderna Touts Data Supporting COVID-19 Booster Dose.
  • Price Action: PFE stock is down 0.83% at $44.10, while BNTX stock is down 4.14% at $357.23 during the market session on the last check Friday.
 

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