Novavax Seeks FDA Emergency Authorization for COVID-19 Vaccine

An illustration picture shows vials with COVID-19 Vaccine stickers attached and syringes with the logo of U.S. biotech company Novavax, on Nov. 17, 2020. Justin Tallis/AFP via Getty Images

Novavax announced Monday it has formally submitted a request to the U.S Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for its two-dose vaccine, NVX-CoV2373, for people 18 years and older.

If granted, NVX-CoV2373 would become the fourth COVID-19 vaccine to be made available in the United States. Currently available COVID-19 vaccines are the mRNA-based vaccines—one from Pfizer-BioNTech and the other from Moderna—as well as the non-replicating viral vector vaccine from Johnson & Johnson.

Novavax’s protein-based vaccine was engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes the disease COVID-19, also referred to as the CCP (Chinese Communist Party) virus. The vaccine is intended to be administered in two doses 21 days apart.

NVX-CoV2373 showed a “reassuring safety profile” in results from two large Phase 3 clinical trials, with an overall efficacy of about 90 percent, the company announced in a release.

Both trials were conducted before the emergence of the Omicron variant in November 2021. One trial, the PREVENT-19 trial, involved 30,000 participants in the United States and Mexico, and another trial involved almost 15,000 participants in the United Kingdom, both of which were published in the New England Journal of Medicine.

“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 company stated in its release.

“Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed in authorized markets. As part of the PREVENT-19 trial, a booster study is ongoing to evaluate the safety and effectiveness of a third does of the vaccine, as well as a study in adolescents aged 12-17.”

The company, which had faced months of development and manufacturing challenges, was granted its first authorization from Indonesia in November 2021. Although protein-based vaccines take longer to develop than newer mRNA vaccines, they may be cheaper to produce and easier to transport without the need for ultra-cold storage.

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More recently, the vaccine was granted conditional authorization by the European Commission, and became the 9th COVID-19 vaccine granted emergency use listing by the World Health Organization.

“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,” Stanley Erck, Novavax’s president and CEO, said in a statement.

“I'd like to also extend our thanks for the support of the U.S. Department of Health and Human Services and the U.S. Department of Defense for their partnership leading up to today’s milestone of EUA request submission.”