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FDA committee recommends Novavax vaccine for those aged 18 and older

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Study finds 90.4% efficacy and low incidence of adverse effects for two-dose regimen.

The vaccine advisory committee of the U.S. Food and Drug Administration (FDA) has recommended the Novavax COVID-19 vaccine for people aged 18 years and older.

The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21-0, with one abstention, to recommend FDA grant emergency use authorization (EUA) for the vaccine, NVX-CoV2373, for adults. The meeting was held June 7 and Novavax announced the result.

"The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology," Novavax President and CEO Stanley C. Erck said in a news release.

In the meeting, “we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option,” Erck said. “Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision."

The VRBPAC considered data from the pivotal Phase 3 clinical trial titled the Pre-fusion protein subunit Vaccine Efficacy Novavax Trial – COVID-19, which was published in the New England Journal of Medicine.

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From December 2020 to February 2021, the study enrolled 29,949 participants aged 18 years and older in the U.S. and Mexico and found the Novavax COVID-19 vaccine demonstrated 90.4% efficacy with a reassuring safety profile.

Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during the trial were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.

“NVX-CoV2373 was safe and effective for the prevention of Covid-19,” the study said.

The vaccine is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19. The vaccination regimen calls for two, 0.5 ml doses given intramuscularly 21 days apart, according to Novavax.

The Novavax COVID-19 vaccine has received authorization for use in individuals aged 18 and over from more than 40 countries in addition to Emergency Use Listing from the World Health Organization.

The vaccine would be the fourth authorized for emergency use or FDA-approved for use in the United States. The agency has allowed use of the Pfizer-BioNTech vaccine Comirnaty, the Moderna vaccine Spikevax, and the Janssen vaccine.


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