FDA Advisory Committee Recommends EUA for Novavax COVID-19 Vaccine

The FDA Vaccines and Related Biological Products Advisory Committee voted nearly unanimously for an emergency use authorization for the Novavax COVID-19 vaccine, NVX-CoV2373, for use in individuals 18 years of age and older.

The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) has recommended an emergency use authorization (EUA) for the Novavax COVID-19 vaccine, NVX-CoV2373, for use in individuals 18 years of age and older.

The committee voted nearly unanimously, with 1 abstention, on the question of whether based on the available scientific evidence, do the benefits of the Novavax 2-dose COVID-19 vaccine series outweigh its risks for use in individuals 18 years of age and older under the 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 a press release. "In today's VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, health care organizations, and consumers who are eagerly anticipating a protein-based vaccine option. 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. We look forward to collaborating with the FDA as it makes its final decision."

NVX-CoV2373 is a protein-based vaccine that was engineered from the genetic sequence of the first strain of SARS-CoV-2 and was formulated with the company’s patented saponin-based Matrix-M adjuvant, which enhances the immune response and stimulated high levels of neutralizing antibodies.

In the phase 3 PREVENT-19 trial, the recombinant nanoparticle protein-based vaccine was found to provide 100% protection against moderate and severe disease and 90.4% efficacy overall. During the trial, investigators enrolled 29,960 people across 119 sites in the United States and Mexico to assess the efficacy, safety, and immunogenicity of the vaccine.

Data from the trial demonstrated that NVX-CoV2373 met its primary endpoint with an overall efficacy of 90.4% (95% CI: 82.9, 94.6). During the trial, 77 cases of COVID-19 were observed, with 63 in the placebo group and 14 in the vaccine group. The observed cases in the vaccine group were mild and in the placebo group there were 10 moderate cases and 4 severe cases observed, translating to a vaccine efficacy of 100% (95% CI: 87, 100) against moderate or severe disease.

Myocarditis has been among the major ongoing concerns surrounding mRNA vaccines. During the VRBPAC meeting, it was reported that myocarditis was found in 1321 reports as of May 26, 2022, with 491.9 million primary series and first booster doses administered.

It was noted that the first week of vaccination saw more cases of myocarditis and that males experienced it considerably more than women, at 960 documented cases versus 361 cases, respectively.

In clinical trials, the safety profile of NVX-CoV2373 showed mostly mild to moderate local events that resolved in 1-2 to days, according to Novavax. Pain and tenderness at the injection site was reported the most frequently reported event, at 60% of individuals in the 18-64 years of age group and 38% in the 65 years of age and older population.

In the PREVENT-19 trial, there were 2 myocarditis cases across 2 study populations. After authorization, Novavax reported 35 spontaneous reports of potential myocarditis or pericarditis from a total of 744,000 doses administered worldwide.

The next step in the process is for the FDA and CDC to weigh in on the VRBPAC recommendation.

Reference

FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older. Novavax. News release. June 7, 2022. https://ir.novavax.com/2022-06-07-FDA-Advisory-Committee-Recommends-Emergency-Use-Authorization-of-Novavax-COVID-19-Vaccine-for-People-Aged-18-Years-and-Older