Novavax COVID shot gets USFDA Advisory Committee recommendation for emergency use nod for 18 years and older
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
Gaithersburg: Novavax, Inc. has announced that the U.S. Food and Drug Administration (USFDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
"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," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "In the VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option. 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, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the U.S. and Mexico and was published in the New England Journal of Medicine. In the trial, the Novavax COVID-19 vaccine demonstrated 90.4% efficacy (95% confidence interval [CI], 82.9 to 94.6; P<0.001) with a reassuring safety profile. The data showed that overall the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%) and in the post-crossover portions of Novavax trials the observed cases were all within the expected rate.
The FDA considers the recommendations of VRBPAC when making decisions on EUA.
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 Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use in the U.S.
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