WASHINGTON — The Food and Drug Administration on Friday 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 FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement Friday.
The FDA did not seek the advice of its independent advisory panel, called the Vaccines and Related Biological Products Advisory Committee, when reviewing either company’s data.
The onus now shifts to the Centers for Disease Control and Prevention, whose vaccine advisory committee is scheduled to meet Friday afternoon to hammer out the final recommendations for the shots.
Typically, 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.
Pfizer and Moderna’s booster shots are given at least six months after the completion of the initial two-dose vaccination series.
All adults who were initially vaccinated with the Johnson & Johnson vaccine are also eligible for a booster shot.
As of Thursday, more than 31 million people in the U.S. have received a booster shot, according to the CDC.