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FDA Authorizes Pfizer and Moderna Boosters For All Adults

FDA Authorizes Pfizer and Moderna Boosters For All Adults

The Food and Drug Administration on Friday (FDA) authorized Pfizer-BioNTech and Moderna’s Covid-19 boosters for all adults, a move that will make boosters available to everyone ages 18 and up.

Pfizer requested authorization last week, citing results from a Phase 3 clinical trial with more than 10,000 participants that found that the third dose was safe and effective. Moderna requested authorization Wednesday. The Centers for Disease Control and Prevention (CDC) vaccine advisory committee is scheduled to meet Friday afternoon to work out the final recommendations for the shots.

The second dose of an mRNA vaccine, from both Pfizer and Moderna, has been linked to a small but increased risk of myocarditis, or heart inflammation, particularly in young men. But Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Tuesday that no safety signals linked to booster shots have emerged thus far, including for younger adults.

“We’re in pretty close contact with our Israeli colleagues, and they say that for the people who get the third dose of an mRNA, in their case, Pfizer, they have not seen any signal that makes them feel that the risk outweighs the benefit for that group,” Dr. Fauci said.

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Typically, the CDC signoff is the final step needed before shots can be administered. In an unusual move, however, a number of states and cities chose not to wait for the FDA or the CDC to act, instead opting to allow boosters for all adults in the past week.

Covid cases continue to rise in the United States, and more than 30 percent of the country has yet to receive a single dose of the vaccine.

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