FDA panel rejects Pfizer’s COVID-19 vaccine booster in people 16 years and older
Fox News
A U.S. Food and Drug Administration (FDA) advisory panel on Friday declined to endorse the Pfizer-BioNTech COVID-19 vaccine booster shot for people ages 16 years and older at least six months following the second dose.
During the deliberations, panel members suggested older, vulnerable populations may benefit from boosters, but noted insufficient data among younger groups and concerns over potential increased risk for heart inflammation, particularly among males ages 16-17.
The committee was charged with voting whether the safety and effectiveness data from Pfizer's clinical trial supported approval of the company's booster dose among people 16 years and older.
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