The Food and Drug Administration is expected to approve Pfizer-BioNTech’s Covid-19 booster syringe for all adults within days, according to a person familiar with the plans.
The FDA’s action may come as early as Thursday. The news was first reported by The New York Times.
The Centers for Disease Control and Prevention’s advisory committee for vaccines is scheduled to meet Friday to discuss boosters.
Pfizer requested emergency booster approval last week, citing the results of a Phase 3 clinical study with more than 10,000 participants, which found the third dose to be safe and effective.
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Still, with the number of cases rising in the United States as winter approaches, several states, including Arkansas, California, Colorado and New Mexico, along with New York City, chose not to wait for the FDA’s official signoff, and move on their own to allow boosters. including Modernas, for all adults in the last week.
Pfizer’s boostershot is authorized for certain subgroups of adults in the United States: people aged 65 and over, people living in long-term care institutions, and people aged 18 to 64 at high risk for Covid due to their job or underlying medical conditions. It is given six months after completion of the first two-dose vaccination series.
All adults who were first vaccinated with the Johnson & Johnson vaccine are also eligible for booster shots. Moderna has not yet asked the FDA to authorize its booster for all adults; it is limited to older adults and those at high risk.
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