STAT+: How Marty Makary’s FDA is embracing a more skeptical view of vaccines

FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.

Apr 29, 2025 - 20:55
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STAT+: How Marty Makary’s FDA is embracing a more skeptical view of vaccines

WASHINGTON — When Marty Makary was tapped to lead the Food and Drug Administration, public health experts hoped the Johns Hopkins physician would shield the agency from the vaccine criticism of his boss, health secretary Robert F. Kennedy Jr. 

So far, that hasn’t been the case. Instead, Makary seems just as willing to use his power and position to more harshly scrutinize vaccines and to shift vaccination policy. 

Over the weekend, he signaled that the FDA may depart from longstanding precedent by requiring Covid vaccine makers to submit new effectiveness data before adjusting their products for new strains — a regulatory hurdle that could leave people unprotected from new versions of the disease. 

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