The FDA’s independent vaccine advisory committee voted to recommend that regulators authorize the Novavax Covid-19 vaccine for emergency use in adults
The Food and Drug Administration’s independent vaccine advisory committee voted 21 to 0, with one abstention, to recommend that regulators authorize the Novavax Covid-19 vaccine for emergency use in adults, finding the benefits of its two-dose primary series outweigh the potential risks.
The committee agreed that the FDA should come to an agreement with Novavax on how the company will identify and evaluate a possible causal link between its vaccine and cases of heart inflammation. FDA reviewers said they suspect such an association based on a handful of myocarditis and pericarditis cases that arose during the clinical trial within days of immunization, though the company has argued there’s not yet enough evidence to establish a definitive link.
“I’m hoping to be proven wrong,” said Arthur Reingold, professor of epidemiology at the University of California, Berkeley, and a temporary voting member of the committee.
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