Germaine T. Leftwich, 67, will receive a Pfizer Covid-19 vaccine booster from Dr. Tiffany Taliaferro on the Safeway on Capitol Hill in Washington, DC.
Tom Williams | CQ Roll Call, Inc. | Getty Images
Pfizer said Tuesday it had asked the Food and Drug Administration to approve booster shots of its Covid-19 vaccine for all Americans aged 18 and over, a move that will significantly increase the number of people eligible for the additional vaccinations would.
A third dose of the vaccine, which was developed with German partner BioNTech, was approved by the FDA for the elderly and at-risk adults just six months after the first series of vaccinations was completed.
Booster shots of Moderna’s vaccine have also been approved for the same groups as Pfizer’s, while a second shot by Johnson & Johnson has already been approved for all adults. More than 25 million Americans had an extra dose of one of the three vaccines as of Monday, according to data from the Centers for Disease Control and Prevention.
Pfizer said Tuesday it is asking the agency to revise its approval after data from more than 10,000 people show an additional dose is safe and effective.
The FDA could fulfill Pfizer’s application before Thanksgiving, the New York Times reported, citing unnamed sources.
Booster vaccination has been a controversial issue for scientists – inside and outside of government – especially since many people in the US and other parts of the world have not yet received a single dose of a vaccine. The World Health Organization urges wealthy countries to hold back from distributing boosters. Some scientists say they are not convinced that most Americans need boosters right now.
President Joe Biden said in August that he would introduce booster vaccinations for all adults as early as September. However, an influential FDA advisory committee later rejected this proposal, scaling back plans to unanimously recommend the third vaccination to people 65 and over and other at-risk Americans.
Speaking to CNBC’s Andrew Ross Sorkin at the DealBook Online Summit, Bourla declined to predict when he thought boosters could be authorized for anyone 18 and older, leaving it to federal regulators.
He said he felt that September boosters should have been recommended to all adults and some teenagers, but added that it was not up to him to decide. The company asked the agency in August to approve boosters for anyone ages 16 and up. However, some FDA advisors raised concerns about the risk of myocarditis in younger people and said more research was needed.
“The FDA then felt they should give it 65 and up and 18 to 65 only to those who had high exposure,” he said.
