FDA Advisory Panel Approves Booster Shot for Americans 65 and Older, but not 16 to 64
An independent advisory panel of the US Food and Drug Administration (FDA) today unanimously voted to support giving boosters to Americans who are 65 and older, and to those who are at high risk of becoming infected with COVID-19, however, the panel voted against providing boosters to Americans who are 16 to 64.
The FDA advisory panel, which found two shots of the Pfizer vaccine to provide strong protection against the highly contagious delta variant, said more data is needed before the panel can recommend a third shot for people age 16 and older.
“There is a lack of data on effectiveness and duration,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said at the meeting Friday. “Current evidence does not appear to show a need for boosting.”
The FDA, which is not required to follow the guidance of its independent advisory panel, so far, has followed its advice on COVID-19 vaccinations.
After scrutinizing several studies that were compiled in a 23-page FDA briefing document, the panel highlighted research that was published in the New England Journal of Medicine in July that showed that people who have received both doses of Pfizer’s COVID-19 vaccine are still 88% protected against getting sick from the delta variant, even six months after their second dose.
Some of the studies provided by Pfizer, however, presented strong evidence in favor of the booster, but the FDA advisory panel remained unpersuaded to support the third shot for Americans 16 to 64.
For instance, one Pfizer study of 306 people that showed that virus-fighting antibodies tripled after booster shots were administered six to eight months after second doses.
Another study out of Israel, which tracked approximately 1 million people aged 60 and older, found that a third shot was “roughly 95%” effective at protecting against the delta variant.
The panel, however, remained convinced by those studies and others.
The decision of the FDA advisory panel’s decision will thwart the plan of President Joe Biden and the country’s top health advisers who insisted last month that booster shots would be needed and would likely available next week.
While Dr. Anthony Fauci, the nation’s top infectious diseases expert, said he was “certain” that Americans would need booster shots eight months after their second shots, the World Health Organization (WHO)recently argued against boosters.
The WHO said that wealthier nations should not provide third doses when poor countries do not have enough vaccines for their first shots, although it is unclear whether other countries have the mechanisms in place to distribute immunization shots as the US has done.
(Kevin P. Coughlin / Office of Governor Andrew M. Cuomo)