Pfizer Asks FDA to Expand Booster Eligibility to All Adults
Experts are optimistic the request will be granted before the winter holiday season
Pfizer and BioNTech asked federal regulators on Tuesday to authorize their Covid-19 booster shot for all Americans 18 and older. If approved by the Food and Drug Administration (FDA), the move would make every adult in America eligible for an extra injection. Experts are optimistic the request could be granted before Thanksgiving and well ahead of Christmas gatherings, reports Sharon LaFraniere for the New York Times.
The pharmaceutical company says its request is based on study results from more than 10,000 volunteers showing that their Covid-19 booster is safe and effective for adults. Pfizer reported that after a third shot, the vaccine’s efficacy rate against symptomatic disease was up to 95 percent. Unlike Pfizer’s lower-dose jab for kids, the adult booster has the same amount of active ingredient as the first round of adult vaccines. Officials anticipate that request is likely to win the backing of the FDA, a decision that may be filed as soon as this week. If the agency greenlights the booster for all adults, Centers for Disease Control and Prevention director Rochelle Walensky would issue updated recommendations for the shot’s use.
“There’s no indication that there’s something inherently risky about obtaining a booster of this vaccine,” says Christopher Mores, a global health professor at the George Washington University, to CNBC. “There is certainly something inherently risky about becoming infected with Covid.”
This summer, an advisory committee to the FDA recommended against Pfizer's request to authorize its boosters for all adult recipients of that vaccine, based on limited evidence that fully-vaccinated, healthy people needed boosters. The company's recent request is a boon for the Biden administration, which has been eager to expand booster shot eligibility to all adults. If regulators approve Pfizer’s request, around 181 million fully vaccinated Americans will be able to get an additional jab.
Currently, Pfizer and Moderna recipients who are 65 and older or at high risk for Covid-19 because of a job, living situation, or medical condition, can get a booster injection. For the roughly 15 million of Americans who got the Johnson & Johnson shot, the FDA has approved a second dose after determining the vaccine offers less protection. Johnson & Johnson recipients can choose between any of the three vaccines for their booster. Since the additional inoculations were authorized this summer, nearly 25 million Americans have gotten boosters so far, reports NPR’s Joe Palca.
Moderna is expected to submit a similar request for federal approval for its Covid-19 booster. Before making their decision, experts will review safety data including rare cases of a type of heart inflammation called myocarditis, which has been linked to mRNA vaccines in young men. Pfizer had previously asked for booster authorization for Americans 16 and up, but the FDA declined the request partly because there was not enough evidence showing waning vaccine immunity, or the benefits of boosters for younger healthy people, reports Reuters.
“A move of this sort—if it is supported by the data, which I haven’t seen—is a recognition of that reality,” says Nirav D. Shah, president of the Association of State and Territorial Health Officials, to the New York Times. “Provided the data shows that the boost is worth it, this is a good move.”
Some public health officials have pushed back against the booster rollout, saying instead that resources should go toward getting initial shots to countries with low vaccination rates. Most agree that the chief priority in the United States should be vaccinating the roughly 60 million Americans older than 11 who have yet to receive even their first shot.