The FDA is reconsidering approvals for COVID-19 vaccines for the coming winter, primarily due to a lack of sufficient data about booster shots. Dr. Marty Makary expressed concerns about public trust and called for more substantial evidence rather than opinions. This shift in stance contrasts with prior support for annual vaccine updates. Meanwhile, companies like Novavax face longer approval processes, as the FDA demands additional clinical trials to ensure the efficacy and benefits of new formulations amid widespread population immunity.
"I think there's a void of data. And I think rather than allow that void to be filled with opinions, I'd like to see some good data."
"Today, there is broad population immunity, and the big question is does it provide a benefit? Without a study on the new formulation and product, we can't give an honest evidence-based answer to that question."
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