NEW YORK, N.Y. — Pfizer and BioNTech announced Tuesday that they’ve made a request for the Food and Drug Administration (FDA) to authorize their COVID-19 booster shot for all adults.
Specifically, the companies have requested that the FDA amend the emergency use authorization it granted for the booster dose to include all individuals 18 years of age and older.
The request is based on results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-microgram booster dose of the Pfizer vaccine, according to the companies.
Next, the FDA will consider the request and make a final decision in the coming weeks. If the FDA amends its authorization as asked, the Centers for Disease Control and Prevention (CDC) would then need to recommend it.
Under the FDA’s current emergency use authorization granted in September, Pfizer’s booster dose is available to those 65 and older, people between 18 and 64 who are at a high risk of severe COVID-19, and those 18 to 64 whose frequent exposure to the coronavirus puts them at risk of serious complications from COVID-19.
The Pfizer booster is also available for eligible individuals who have completed a primary vaccination with a different authorized COVID-19 vaccine.
That includes people who initially got a Johnson & Johnson vaccine. All adults who got the J&J shot are now eligible for a booster and they can receive any of the three options available in the U.S. As for those who got the Moderna vaccine initially, the criteria to get a booster matches Pfizer’s conditions.