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FDA may expand any Covid-19 vaccine booster decisions, Fauci says

The US Food and Drug Administration is likely to expand any authorizations it may give for Covid-19 vaccine booster recommendation if new data supports wider use, Dr. Anthony Fauci said Monday.

FDA vaccine advisers voted Friday to recommend emergency use authorization of a booster dose of Pfizer’s vaccine for people 65 and older and those at high risk of severe Covid-19. The FDA has yet to act on that recommendation.

But Fauci told CNN’s Wolf Blitzer that the FDA will be following incoming data from the US and Israel in real time and will adjust any authorizations accordingly.

“The waning of protection, particularly against severe disease in younger groups, would trigger the FDA to look at that and see if they want to expand the recommendation to go much younger than 65,” Fauci said.

Fauci said that people will be carefully considering the risk of myocarditis, a rare heart complication associated with the vaccine, seen particularly in young men. 

“When you get down to the younger group, particularly young men, where the potential for the rare adverse effect of myocarditis exists, then it’ll be very important to get good safety data in younger people, particularly men,” Fauci said.

If that data does come in, “then I think it’s likely, as we go on over the coming weeks, we’ll see more and more of an expansion of the recommendation for the boosters for those individuals,” Fauci said.

Those who received the Moderna or one-dose Johnson & Johnson vaccine for their initial vaccine “have not been forgotten,” Fauci, director of the National Institute of Allergy and Infectious Diseases, noted.

“The data associated with the boosters in those individuals will be coming to the FDA, I would imagine in a couple to three weeks,” he said. “They will examine it in the same way as they did before, and hopefully, they will get a recommendation that would provide equity among people who have had different products in their vaccination regimen.”

Reporting by CNN.

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