FDA Committee Recommends EUA for Novavax’s COVID-19 Vaccine

Novavax’s COVID-19 vaccine demonstrated 90.4% efficacy with a low number of serious and severe adverse events, including myocarditis.

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend the agency grant Emergency Use Authorization (EUA) for Novavax’s COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.

“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 CEO of Novavax, in a statement.

At the June 7, 2022, VRBPAC meeting, Novavax “heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option,” Erck said.

The VRBPAC considered data from Novavax’s phase 3 clinical trial, PREVENT-19, which enrolled around 30,000 participants 18 years and older in the United States and Mexico and was published in
the New England Journal of Medicine.

In the trial, the Novavax COVID-19 vaccine demonstrated 90.4% efficacy. Additionally, serious and severe adverse events were low in number and balanced between vaccine and placebo groups.

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 most common adverse reactions observed during the trial were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.

Novavax’s COVID-19 vaccine has already 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.\However, the FDA said it will not make a decision the approval of the vaccine until it has an opportunity to review Novavax’s manufacturing process, per CNBC. Novavax informed the agency of changes to its manufacturing process on June 3, days before the committee was scheduled to review its vaccine's safety and efficacy data, Abby Capobianco, an FDA spokesperson, told CNBC.

"FDA will carefully review this and any additional information submitted by the firm as part of its ongoing assessment and prior to authorizing the vaccine for emergency use," she said.

If authorized in the United States, the vaccine will be manufactured by the Serum Institute of India, Novavax Chief Medical Officer Filip Dubovsky said, per Reuters.