Coronavirus: FDA authorizes Novavax COVID-19 vaccine

WASHINGTON — The U.S. Food & Drug Admininstration on Wednesday issued an emergency use authorization for a COVID-19 vaccine developed by Maryland biotechnology company Novavax.

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The vaccine will be a new option for Americans, The New York Times reported.

The Centers for Disease Control and Prevention’s advisory committee will now consider the vaccine and issue its own recommendation, NBC News reported. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet on Tuesday.

“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 said in a statement. “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.”

The federal government said that Novavax was expected to finish its quality testing “in the next few weeks,” the Times reported. That is a necessary step before the doses are released.

The two-dose vaccine was authorized as a primary immunization series for adults, according to the newspaper. The Biden administration said on Monday that it would buy 3.2 million doses, enough to fully vaccinate 1.6 million people in the United States.

In a Phase 3 clinical trial, Novavax’s COVID-19 vaccine was 90% effective. The company told the Times that its vaccine can generate an immune response against the omicron variant, but it is uncertain how strong the protection is.

The CDC said that about 67% of the U.S. population has been fully vaccinated, defined as two doses of messenger RNA vaccines or one dose of Johnson & Johnson’s vaccine, according to The Wall Street Journal. About 48% of fully vaccinated people have received a first booster dose; even fewer have received a second booster, the newspaper reported.

Novavax’s vaccine is administered in doses three weeks apart and works differently from mRNA vaccines. It provokes an immune response with nanoparticles made up of proteins from the surface of the coronavirus that causes COVID-19, according to the Times.

Protein vaccines have been used to prevent hepatitis B, shingles and other diseases, according to The Associated Press.

The vaccine can be stored at normal refrigeration temperatures and has a shelf life of about nine months, according to CNN.

The shot has already been cleared for use in more than 40 countries, NBC News reported.

The FDA authorization took “longer than we wanted,” Novavax CEO Stanley Erck told the news outlet. “But we’re there and we have gotten the company’s first approval with the FDA for a vaccine in the United States.”

“The FDA’s medical and scientific experts have determined that the vaccine meets the FDA’s high standards for safety and effectiveness for emergency use authorization,” Peter Marks, the FDA’s director for the agency’s Center for Biologics Evaluation and Research. “Novavax COVID-19 vaccine, adjuvanted provides another alternative for adults and adds another vaccine to the COVID-19 vaccine supply for the United States.”

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