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University of Nebraska Medical Center

How two top FDA officials are quietly upending vaccine regulations

STAT As Tracy Beth Høeg and Vinay Prasad seek to restore public trust, some fear they will undermine public health instead. Health secretary Robert F. Kennedy Jr. has said he does not want to take vaccines away from Americans. But at a closed-door meeting of Food and Drug Administration vaccine scientists in September, a top official suggested doing just that.

Scientists listened as Tracy Beth Høeg, a lieutenant to FDA Commissioner Marty Makary, laid out her plan: She wanted to change the label of all Covid-19 vaccines to say the risks outweighed the benefits for men ages 12 to 24 — a move that would make it prohibitively difficult for men in this age group to receive the vaccine.

Her concerns about myocarditis, or inflamed heart muscle, had been censored before, she said, and now she wanted to take action. Høeg wanted to advance her proposal to a meeting later that month of the Centers for Disease Control and Prevention’s vaccine advisory committee.  

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