COVID-19 Vaccines: Updated FDA EUA Gave CDC Wiggle Room In Defining Population For Third Shot
Updated EUA for mRNA COVID-19 vaccines left CDC room to define the type of conditions that meet the immunocompromised level described by the FDA. The recommendation for a third shot for immunocompromised patients was based on small studies using surrogates for vaccine efficacy, not hard clinical outcomes.
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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.
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.
Focus should remain on primary vaccines and boosters for populations not protected from severe outcomes with initial vaccination, CDC advisors say, potentially contradicting Biden administration plans for widespread allowance of third COVID-19 shots. A booster authorization by the White House’s planned 20 September timeline would also compromise Pfizer’s ability to finish a placebo-controlled study evaluating the impact of its booster on clinical outcomes.