FDA Grants EUA to Novavax COVID-19 Vaccine for Individuals 18 Years of Age and Older.

The FDA has granted emergency use authorization (EUA) to Novavax, Inc’s adjuvanted COVID-19 vaccine (NVX-CoV2373) 2-dose primary series for individuals 18 years of age and older.

The approval followed a recommendation from the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) for the Novavax COVID-19 vaccine in this patient population. VRBPAC voted nearly unanimously on the question of whether the benefits of the Novavax 2-dose COVID-19 vaccine series outweighed its risks for use in individuals 18 years of age and older under the EUA based on the available scientific evidence.

"[The] FDA emergency use authorization of our COVID-19 vaccine provides the US with access to the first protein-based COVID-19 vaccine," said Stanley C. Erck, president and chief executive officer, Novavax, in a prss release. "This authorization reflects the strength of our COVID-19 vaccine's efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues."

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.

"Patients and providers in the US now have access to a protein-based COVID-19 vaccine backed by data that have demonstrated efficacy, safety, and tolerability," Karen Kotloff, MD, professor of Pediatrics, University of Maryland School of Medicine, associate director of Clinical Studies at the Center for Vaccine Development and Global Health, COVID-19 Prevention Network co-lead for the PREVENT-19 trial, said in a press release. "Offering more vaccine technologies and options in our vaccination portfolio, including those built upon technologies that have been successfully used for years, will hopefully help to increase our country's vaccination rate."

Reference

U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Individuals Aged 18 and Over. Novavax. News release. July 13, 2022. https://ir.novavax.com/2022-07-13-U-S-FDA-Grants-Emergency-Use-Authorization-for-Novavax-COVID-19-Vaccine,-Adjuvanted-for-Individuals-Aged-18-and-Over