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FDA’s initial assessment of Pfizer’s vaccine is that it meets their criteria, commissioner says

Published in 10 December, 2020

It’s possible that the US Food and Drug Administration could issue advisories similar to the UK in regard to people with allergies, if and when the Pfizer vaccine receives authorization, FDA Commissioner Dr. Stephen Hahn said Thursday. But FDA’s initial assessment, he said, is that the vaccine meets their criteria.

“We’re working with our UK partners now to understand exactly what happened with respect to those reactions. We take this seriously,” Hahn told NBC’s Savannah Guthrie. 

Hahn said one of the reasons that they do “such a careful review, line by line, of the patient data is because our label around a vaccine will not just say who should get it, but who should not receive the vaccine.”

Guthrie then asked if allergic reactions like the ones in the UK were seen in the clinical trials.

Hahn said that was being discussed today – “so stay tuned for that.”

“What I can tell you is that the side effects associated with the vaccines are very carefully recorded,” he said. FDA data was put out on Tuesday and will be discussed in the meeting Thursday.

 “We think that, our initial assessment is that this is a vaccine that is, that does meet our criteria, but we do want to hear from the vaccine advisory committee,” he said.

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