FDA green lights new COVID vaccine

Published 8:45 am Friday, July 22, 2022

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With an uptick in COVID-19 cases recently reported by the Centers for Disease Control (CDC), a Maryland-based biotechnology company has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for a new COVID-19 vaccine.

The Novavax vaccine is the fourth to be authorized in the United States for the prevention of COVID.

Novavax is still waiting for CDC approval, but that could come as early as this week as the CDC was scheduled to meet and discuss the new vaccine on Tuesday, July 19.

Novavax’s vaccine is the first protein-based COVID vaccine authorized in the U.S. Use will provide a two-dose primary series for active immunization to prevent COVID-19 in individuals 18 years of age and over.

According to a news release from Novavax Inc, the FDA emergency use authorization was based on data from a clinical trial called PREVENT-19, which enrolled about 30,000 participants aged 18 years and over in the U.S. and Mexico.

In the trial, the Novavax COVID-19 vaccine demonstrated 90.4% efficacy among participants 18 through 64 years of age.

“Patients and providers in the U.S. now have access to a protein-based COVID-19 vaccine backed by data that have demonstrated efficacy, safety, and tolerability,” said Karen Kotloff, M.D., professor of pediatrics, University of Maryland School of Medicine, associate director of Clinical Studies at the Center for Vaccine Development and Global Health, COVID-19 Prevention Network co-lead for the PREVENT-19 trial. “Offering more vaccine technologies and options in our vaccination portfolio, including those built upon technologies that have been successfully used for years, will hopefully help to increase our country’s vaccination rate.”

Earlier this week, the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, announced an agreement to secure an initial 3.2 million doses of the Novavax COVID-19 Vaccine.

According to the company, its vaccine uses the same protein-based technology that is used in flu shots and could be the first time a more traditional vaccine is used to fight COVID-19.

It is different than the mRNA technology that Pfizer and Moderna use.

Novavax contains an inactive protein that a person’s body believes is the coronavirus. Basically, the vaccine will trick a person’s body into producing antibodies that protect the individual, precisely the same as the vaccine for influenza.