FDA Granted Emergency Use Authorization to Novavax Covid Vaccine

The two-dose Covid-19 vaccine of Novavax was finally granted emergency use authorization (EUA) by the Food and Drug Administration (FDA) on Wednesday as a protein option for adults ages 18 and older who have not received immunization against the virus due to their hesitance or allergy to components of the mRNA vaccines.

Authorized for people as a primary series, the vaccine doses are administered three weeks apart.

Novavax vaccine is made using different and older vaccine technology and contains synthetic coronavirus spike protein made with moth cells and an adjuvant- compound that encourage an immune response – obtained from the bark of a tree native to Chile.

More than two months after the second shot, the jab caused and showed no serious side effects or safety concerns in patients included in clinical trials, which established 90% effectiveness of the vaccine at preventing symptomatic disease that slid to 78% for adults 65 and older.

FDA Commissioner Robert Califf said in a statement that with the latest EUA, the agency offers individuals who have expressed hesitancy toward other Covid-19 vaccines another option that meets its rigorous standards for safety, effectiveness, and manufacturing quality.

As part of its decision to authorize the shot, the FDA had conducted a thorough analysis of Novavax’s production capacity, the press release noted. Novavax, however, is now expected to continue clinical trials in order to obtain the data that would support full approval of the vaccine by the FDA.

The next step for Novavax before entering the market is getting the endorsement of the Centers for Disease Control and Prevention (CDC), whose Advisory Committee on Immunization Practices is scheduled to convene on July 19. However, its agenda hasn’t been published yet.

Earlier this week, the Biden administration announced it had purchased 3.2 million doses of the Novavax vaccine which will be made available at no cost to states, jurisdictions, federal pharmacy partners, and federally qualified health centers as soon as it gets a favorable recommendation from the CDC.


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