FDA Plans Quick Review of Pfizer/BioNTech COVID-19 Booster For All Adults: NYT

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  • The FDA said it would review Pfizer Inc PFEBioNTech SE's BNTX request to authorize COVID-19 booster doses of COVID-19 vaccine in all adults "as expeditiously as possible," with the New York Times reporting that the nod could come as soon as Thursday.
  • The agency said it does not plan to hold a meeting of the outside experts on Pfizer's request.
  • Related Link: Do You Need A COVID-19 Booster Dose? Pfizer-BioNTech Submit Initial Data To Support Idea.
  • The decision from the FDA will likely come before a U.S. Centers for Disease Control and Prevention (CDC) advisory panel meets on Friday to discuss expanding the eligibility for booster doses of Pfizer/BioNTech's vaccine.
  • Related: FDA Approves Vaccine Booster Dose Of mRNA COVID-19 Vaccines For Small, Vulnerable Group.
  • If both the FDA and the CDC sign off this week, any adult who received a second dose of the vaccine at least six months earlier would be officially eligible to get a booster as soon as this weekend. 
  • Price Action: PFE shares are up 0.85% at $50.02, BNTX stock is up at 3.66% at $267.21 during the market session on the last check Wednesday.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsCOVID-19 CoronavirusCOVID-19 Vaccine
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