CDC Endorses ACIP Recommendation of Novavax COVID-19 Adjuvanted Vaccine

The FDA granted the vaccine series Emergency Use Authorization on July 14, based on clinical trial data showing significant efficacy and safety.

Officials from the CDC have unanimously recommended vaccination with the 2-dose Novavax COVID-19 vaccine series, adjuvanted, in individuals 18 years of age and older, agreeing with the earlier recommendation from the Advisory Committee on Immunization Practices (ACIP).1

NVX-CoV2373 is a protein-based vaccine that was first engineered using the genetic sequence of the original SARS-CoV-2 strain. It was formulated with Novavax’s patented saponin-based Matrix-M adjuvant, which strengthens the immune response and stimulates high levels of neutralizing antibodies.2

The FDA granted the vaccine series Emergency Use Authorization on July 14, based on clinical trial data showing significant efficacy and safety. In the phase 3 PREVENT-19 trial, the vaccine was found to provide 100% protection against moderate and severe disease as well as 90.4% efficacy overall. The trial enrolled 29,960 individuals to assess the efficacy, safety, and immunogenicity of the vaccine.2

During the trial, researchers observed 77 cases of COVID-19, including 63 in the placebo group and 14 in the vaccine group. The observed cases in the vaccine group were mild, whereas there were 10 moderate cases and 4 severe cases observed in the placebo group.2

Myocarditis has been an ongoing safety concern with mRNA vaccines, with a reported 1321 cases as of May 26, 2022, among 491.9 million primary series and first booster doses administered. Experts have noted that males appear to experience myocarditis considerably more often than women, with 960 and 361 cases, respectively.2

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

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

“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, 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.”2

REFERENCES

1. US Centers for Disease Control and Prevention Endorses Advisory Committee on Immunization Practices’ Recommendations for Novavax COVID-19 Vaccine, Adjuvanted. News release. Novavax. July 19, 2022. Accessed July 21, 2022. https://ir.novavax.com/U-S-Centers-for-Disease-Control-and-Prevention-Endorses-Advisory-Committee-on-Immunization-Practices-Recommendation-for-Novavax-COVID-19-Vaccine,-Adjuvanted

2. US FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Individuals Aged 18 and Over. News release. Novavax. July 13, 2022. Accessed July 21, 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