FDA authorizes Novavax COVID-19 vaccine for emergency use in US

The vaccine could soon be the fourth available to Americans.

July 13, 2022, 5:34 PM

Americans will likely have one more COVID-19 vaccine to choose from after the Food and Drug Administration issued an emergency use authorization for Novavax's COVID-19 vaccine Wednesday.

The two-shot vaccine was authorized for use in people 18 years and older.

Novavax is the fourth COVID-19 vaccine to receive emergency use authorization in the U.S. by the FDA. The Centers for Disease Control and Prevention is now expected to review data on the vaccine before providing its recommendation for authorization.

"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 Dr. Robert M. Califf said in a statement on Wednesday. "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."

The FDA said it had determined that the Novavax vaccine met the criteria for authorization, and that the data showed that the potential benefits of the vaccine outweighed any potential risks.

"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," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

PHOTO: Ampoules of the new Corona vaccine Nuvaxovid from the manufacturer Novavax sit on a table at a vaccination center in Saxony-Anhalt, Quedlinburg, April 1, 2022.
Ampoules of the new Corona vaccine Nuvaxovid from the manufacturer Novavax sit on a table at a vaccination center in Saxony-Anhalt, Quedlinburg, Germany, April 1, 2022.
Picture Alliance/dpa/picture alliance via Getty I

Some health experts have suggested that some hesitant Americans may be more inclined to get the Novavax vaccine, as it is based on a more traditional protein-based technology, one already used for the flu vaccine and other shots, while Pfizer, Moderna and Johnson & Johnson's vaccine platforms use more modern genetic technology.

The company applauded the agency's decision to authorize the vaccine for emergency use.

"Today's FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine," Stanley C. Erck, president and chief executive officer of Novavax, said in a statement. "This authorization reflects the strength of our COVID-19 vaccine's efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues."

On Monday, the U.S. Department of Health and Human Services announced that the Biden administration had secured 3.2 million doses of Novavax's COVID-19 vaccine. The vaccine will be made available for free to U.S. states and jurisdictions.

If the CDC signs off on use of the vaccine, the shots could be made available shortly thereafter.

To date, approximately two-thirds of the U.S. population has been fully vaccinated against COVID-19, according to federal data. However, more than 26.5 million American adults remain completely unvaccinated.

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