CDC Vaccine Advisors Must Fill In Missing Holes On Pfizer’s COVID Booster Plan
ACIP will get a chance to further restrict and tailor the US booster plan for COVID vaccinations. Among other things, CDC's advisors may have to define what constitutes being at high risk of severe COVID-19 post-primary vaccination, occupations at high risk of COVID exposure, and whether people who didn’t receive Pfizer’s primary vaccine series could get the company’s mRNA booster shot.
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Age limit wasn’t part of advisory committee’s vote on third shot of the COVID vaccine, but aligns with concerns about myocarditis in younger recipients.
US FDA Panel Rejects Pfizer's Broad COVID Booster Plan But Backs Narrower Authorization For Third Vaccine Shot
Advisory committee meeting reflected internal tensions among FDA staff on need for boosters and adequacy of the data; mRNA vaccine Comirnaty should be authorized for a third dose in populations at high risk for severe disease or exposure, panel says after overwhelmingly rejecting Pfizer's bid for booster approval in the 16-and-older population.
With potentially less flexibility and a simpler calculation on the benefit-risk of approving COVID vaccine boosters, FDA could punt the more challenging questions like whether boosters are needed now and for which populations, along with global equity and public health considerations to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices.