Novavax Files for FDA EUA for its COVID-19 Vaccine

Late yesterday, Novavax submitted a request to the Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for its COVID-19 vaccine, NVX-CoV2373, for people 18 year of age and older.

"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," Novavax CEO Stanley Erck, said.

The company conducted 2 phase 3 clinical trials with one using nearly 30,000 participants who were randomized between December 27, 2020 and February 18, 2021, and the other using nearly 15,000 participants who were randomized between September 28, to November 28, 2020.

Both studies’ results were published in the New England Journal of Medicine.

In the former, which was name the PREVENT-19 trial, they had participants in the US and Mexico and the latter had people from the UK participating.

It is important to note, both studies were conducted before the development of the Delta and Omicron variants as the predominant strains in the US, Mexico, and the UK.

According to Novavax, the vaccine demonstrated efficacy with a reassuring safety profile, 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.

Novavax’s NVX-CoV2373 vaccine is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2. 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.