FDA clears Pfizer and Moderna boosters for all adults


On Friday, the Food and Drug Administration cleared the COVID-19 boosters from Pfizer-BioNTech and Moderna for all adults, a move that will make the boosters available to everyone from the age of 18.

Pfizer authorization requested last week, citing the results of a Phase 3 clinical trial with more than 10,000 participants, which found the third dose to be safe and effective. Moderna requested permission on Wednesday.

“The FDA has determined that the data currently available supports expanding the eligibility of a single booster dose of Moderna and Pfizer-BioNTech COVID-19 vaccines to people 18 years of age and older,” Dr. Peter Marks, Director of the FDA’s Center for the Evaluation and Research of Biologics, said in a statement Friday.

The FDA did not seek the advice of its independent advisory group, known as the Vaccines and Related Biologics Advisory Committee, when reviewing data from either company.

John Grabenstein, former executive director of medical affairs for vaccines at Merck, as well as a former Defense Department immunologist, said the FDA did not need to ask its advisory committee for a decision during this time.

“It’s not a question of antibody response or safety,” he said. “The FDA can make this decision on its own. “

Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on Tuesday that no safety signals related to booster injections had emerged so far, including for young adults.

The second dose of an mRNA vaccine, from Pfizer and Moderna, has been associated with a low but increased risk of myocarditis or heart inflammation, especially in young men.

“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 haven’t seen any signals that make them feel the risk is. outweighs the advantage for this group, ”Fauci said.

Responsibility now rests with the Centers for Disease Control and Prevention, whose vaccine advisory committee is scheduled to meet Friday afternoon to work out final recommendations for the shots.

Usually, CDC approval is the last necessary step before injections can be given. In an unusual move, however, a number of states and cities chose not to wait for the FDA or CDC to act, choosing instead to allow recalls for all adults in the past week.

COVID cases continue to rise in the United States, and more than 30% of the country has not yet received a single dose of the vaccine.

“The big question for me is, can we get out of this pandemic? Said Norman Baylor, president and CEO of Biologics Consulting, a biotechnology consulting firm and former director of the FDA’s Office of Vaccine Research and Review. “Until we vaccinate the groups that haven’t been vaccinated, I’m not sure we can.”

The Pfizer and Moderna booster shots are given at least six months after the end of the initial two-dose series.

All adults who were originally vaccinated with the Johnson & Johnson vaccine are also eligible for a booster.

As of Thursday, more than 31 million people in the United States received a recall, According to the CDC.

This story originally appeared on NBCNews.com.



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