CDC Data More Positive on Myocarditis Benefit-Risk Than FDA’s Assessment of Pfizer’s Vaccine
Updated modeling on heart events in young adults presented to CDC’s vaccine advisors points towards much lower rates of the adverse event from mRNA vaccines than some of FDA’s modeling.
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Moderna fell behind Pfizer after receiving EUA for Spikevax, as it took three months longer to file its BLA and had an extra two months of FDA review for full approval. Novavax files request for FDA emergency use authorization of its vaccine.
US government does not have an adequate system to monitor vaccine safety in real time, Nicole Lurie, former assistant secretary for emergency preparedness says. Low-income countries sometimes do not receive same COVID product that FDA reviewed, a former agency official notes.
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.