FDA Advisory Committee to Review Novavax COVID-19 Vaccine

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review Novavax’s NVX-CoV2373 COVID-19 vaccine (recombinant, adjuvanted) at a meeting scheduled for June 7, 2022.
The vaccine was created using Novavax’s recombinant nanoparticle technology to generate antigen-derived from the coronavirus spike protein and is formulated with the company’s saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

Novavax had submitted a request in January 2022 for emergency use authorization for the vaccine, which is a protein-based COVID-19 vaccine candidate for immunization of adults.

The phase 3 PREVENT-19 study with about 30,000 participants in the United States and Mexi o showed the vaccine was about 90% effective against variant strains of the virus. The study was published in the New England Journal of Medicine in February 2022.

Novavax conduct two studies: PREVENT-19 and a UK study with about 15,000 participants. The most common side effects were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.

Novavax will continue to collect and analyze real-world data, including monitoring safety and the evaluation of variants. As part of the PREVENT-19 trial, a booster study is ongoing to evaluate the safety and effectiveness of a third does of the vaccine, as well as a study in adolescents aged 12 to 17 years of age.

The vaccine was granted conditional authorization by multiple regulatory agencies worldwide, including the European Commission, and emergency use listing from the World Health Organization (WHO), with additional filings currently under review.