FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for Persons Aged 18 Years and Older

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The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend that the agency grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine for persons aged ≥18 years.

The VRBPAC met on June 7, 2022, and voted 21-0, with 1 abstention, to recommend the FDA grant EUA for the experimental vaccine, dubbed NVX-CoV2373, Novavax announced the same day. The FDA considers the recommendations of VRBPAC when making decisions on EUA.

"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 announcement.

In the committee’s meeting, “we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option,” stated Erck. “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.”

When making the decision, the VRBPAC considered data from the pivotal phase 3 clinical trial, PREVENT-19, that enrolled 29 960 adults across 119 sites in the US and Mexico from January 25 to April 30, 2021. Participants were randomized 2:1 to receive 2 doses of NVX-CoV2373 or placebo. The primary endpoint was the development of PCR-positive, symptomatic mild, moderate, or severe COVID-19 illness diagnosed 7 days after the second vaccine dose.

Overall, results showed NVX-CoV2373 was 90.4% effective (95% confidence interval [CI]: 82.9-94.6; P<.001) with a favorable safety profile. NVX-CoV2373 was generally well-tolerated, with serious and severe adverse events comparable between vaccine and placebo cohorts. The most common adverse events observed during the trial (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. These adverse events were predominantly mild to moderate and transient.

Investigators found that the overall rate of myocarditis was balanced between the vaccine and placebo cohorts (0.007% and 0.005%) and in the post-crossover portions of the Novavax trials the observed cases were all within the expected rate, according to the manufacturer’s press statement.

NVX-CoV2373 has received authorization for use in individuals aged ≥18 years from more than 40 countries in addition to Emergency Use Listing from the World Health Organization, noted Novavax in the press release.