FDA gives emergency use authorization to fourth COVID vaccine: Novavax
Most American adults will now have three COVID vaccines to choose from
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The U.S. Food and Drug Administration on Wednesday gave an emergency use authorization for a fourth COVID-19 vaccine, Novavax, one day after the U.S. government bought 3.2 million doses of the vaccine.
Most American adults will now have three COVID vaccines to choose from after the FDA limited use of the Johnson & Johnson vaccine in May over blood clot concerns.
"Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death," FDA Commissioner Robert M. Califf wrote in a press release.
"Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so," he stated.
Director of the FDA’s Center for Biologics Evaluation and Research Peter Marks said, "The American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review."
The Novavax COVID shot requires the receipt of two doses, three weeks apart.
Novavax said that the government's purchase of its vaccine will "provide the first protein-based vaccine option in the U.S."
The Centers for Disease Control and Prevention will need to approve the vaccine before it becomes fully available. The decision could come as soon as next Tuesday, when the CDC advisory committee is scheduled to meet.
CDC data shows that more than 75% of the U.S. has received at least one COVID-19 vaccination and nearly half of all Americans have received at least one booster dose.
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