February 9, 2023

FDA authorizes emergency use of Novavax covid-19 vaccine

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(CNN) — The United States Food and Drug Administration (FDA) has authorized the emergency use of the Novavax covid-19 vaccine in adults. It is the fourth coronavirus vaccine available in the United States and uses a different type of vaccine technology than the shots that are already available.

The Novavax vaccine will be available as a two-dose primary series for people 18 years and older. The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted in favor of licensing the vaccine on June 7, saying the benefits of the vaccine outweigh the risks for adults.

The Novavax vaccine is protein-based, and these vaccines use harmless protein fragments from the virus to teach the immune system how to detect the virus and fight it. The vaccine was created from a genetic sequence of the first variant of the coronavirus.

Late-stage trials found the vaccine’s efficacy against mild, moderate and severe disease to be 90.4%, according to the company. There is insufficient evidence to assess the impact of the vaccine on virus transmission.

Novavax also announced in early July that its vaccine shows a “broad” immune response to currently circulating variants, including the BA.4 and BA.5 subvariants of omicron.

“FDA medical and scientific experts have determined that the vaccine meets the FDA’s high standards of safety and efficacy for emergency use authorization,” said in a statement Press release Dr. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research.

Vaccines cannot be administered until independent vaccine advisors at the Centers for Disease Control and Prevention (CDC) assess whether to recommend the vaccine and the CDC director has approved the recommendation. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet on July 19.

On Monday, the Biden administration announced that it had secured 3.2 million doses of the Novavax vaccine.

Novavax says its vaccine is 90.4% effective 1:17



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