Novavax submits EUA request to FDA for COVID-19 vaccine

Feb. 1, 2022

Novavax said it has submitted an emergency use authorization (EUA) request to the U.S Food and Drug Administration (FDA) for its COVID-19 vaccine candidate.

If approved, the vaccine would be available to immunize adults against SARS-CoV-2.

The company’s two-dose vaccine is protein-based and engineered from the genetic sequence of the first strain of SARS-CoV-2. It 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.

"We're extremely proud of the work of our teams and we look forward to FDA's review of our EUA request. We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," said Stanley C. Erck, President and Chief Executive Officer, Novavax.

Novavax conducted two pivotal Phase 3 clinical trials: PREVENT-19 which enrolled approximately 30,000 participants in the U.S. and Mexico and published results in the New England Journal of Medicine (NEJM) and a trial with almost 15,000 participants in the U.K. which was also published in NEJM. In both trials, serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.

The overall efficacy was approximately 90%.

The vaccine already has been granted conditional authorization by the European Commission and emergency use listing (EUL) from the World Health Organization (WHO).

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