FDA Makes Long-Awaited Decision
An advisory board for the U.S. Food and Drug Administration has overwhelmingly rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans.
The panel voted 16-2 against distributing booster shots to people ages 16 and older.
During discussion, some panel members noted booster shots might be helpful to older, immunocompromised populations but argued there’s little evidence to suggest the same for younger people. Additionally, there are looming concerns over the potential increased risk of heart inflammation among the vaccinated, particularly for younger males.
The committee was tasked with determining whether the data from Pfizer’s clinical trial supported approval of the pharmaceutical brand’s booster dose for people ages 16 years and older, according to Fox News.
While there is some research to suggest immunity levels in vaccinated people does decline with time—a trend boosters could potentially reverse—the Pfizer inoculation nevertheless remains highly protective against severe illness, hospitalization, or death.
FDA advisers heard Friday from Pfizer and health officials from Israel, which has been offering booster shots to its citizens since July.
Sharon Alroy-Preis, director of public health services for Israel, claimed the third shot improves protection against infection for people ages 60 years and older.
“It’s like a fresh vaccine,” she said, according to the Associated Press, noting the shots have helped the Jewish state “dampen severe cases in the fourth wave.”
Several doctors on the panel, however, noted concerns about myocarditis. Dr. Paul Offitt, a vaccine expert with the Children’s Hospital of Philadelphia, said he would “really have trouble” supporting booster shots for everyone over 16 years old.
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