The Food and Drug Administration is expected to authorize Pfizer-BioNTech’s Covid-19 booster shot for all adults within days, according to a person familiar with the plans.
The FDA’s action could come as early as Thursday. The news was first reported by The New York Times.
The Centers for Disease Control and Prevention’s vaccine advisory committee is scheduled to meet Friday to discuss boosters.
Pfizer requested emergency use authorization for the booster last week, citing results from a Phase 3 clinical trial with more than 10,000 participants, which found that the third dose was safe and effective.
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Still, with case numbers once again rising in the U.S. 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, moving on their own to allow boosters, including Moderna’s, for all adults in the past week.
Pfizer’s booster shot is authorized for certain subsets of adults in the U.S.: people ages 65 and up, people living in long-term care facilities and people ages 18 to 64 at high risk of Covid because of their jobs or underlying medical conditions. It is given six months after completion of the initial two-dose vaccination series.
All adults who were initially 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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