FDA rejects a third dose of Pfizer's vaccine
The FDA has rejected Pfizer's proposal to vaccinate everyone under the age of 65 and without comorbidities.
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On Friday, Sept. 17, a group of vaccine advisors at the U.S. Drug Enforcement Agency (FDA) rejected the possibility of giving Americans under the age of 65 a third dose of Pfizer's coronavirus vaccine to better protect them against the virus. So far, the distribution of a third dose of the vaccine has only been approved for people over 65 years of age and with comorbidities.
Many of the experts who voted against Pfizer's third dose expressed concern about the risk of myocarditis with a third dose for younger people, but said they are open to approving it for limited groups of older and more vulnerable people.
Panel members also complained that Pfizer had not provided sufficient information on the safety of the additional doses, and data provided by Israeli researchers on its booster campaign may not be adequate to predict the U.S. experience.
"I don't think a booster dose is going to contribute significantly to control the pandemic," Cody Meissner, M.D., professor of pediatrics at Tufts University School of Medicine, said during the meeting.
The FDA noted in its briefing documents that Pfizer's vaccine, as well as vaccines manufactured by Moderna and Johnson & Johnson, continue to provide strong protection against severe illness, hospitalization and death, even if antibodies decline over time.
Although the recommendations from the FDA advisory committee are not binding, they are usually taken into account by government authorities. The final decision on the issue will rest with another committee, headed by the Centers for Disease Control and Prevention (CDC), the nation's lead federal health agency.
The CDC team of experts will meet Sept. 22-23.
When do the third doses begin?
President Joe Biden's administration announced last August that it would launch a booster campaign starting Sept. 20 for all Americans who had received their second dose eight months earlier.
Biden's announcement took many experts in the American medical community by surprise.
"It's not clear that everyone needs to get the booster dose, beyond a population group that is clearly at high risk for severe disease," Michael G. Kurilla, a member of the committee and the National Institute of Health, told the New York Times.