Novavax Seeks FDA Authorization for its COVID-19 Vaccine as Booster

Novavax announced on Monday afternoon it was seeking an EUA for its COVID-19 vaccine, NVX-CoV2373, to be used as a homologous and heterologous booster in individuals ages 18 years and older. If authorized, it would become the first protein-based COVID-19 booster for adults.

"It's important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations," Novavax President and CEO Stanley C. Erck, said in a statement. "Based on the data presented to the FDA's VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants."

This application for this EUA is supported by data from the company’s phase 3 PREVENT-19 trial conducted in the United States and Mexico, and from the UK-sponsored COV-BOOST phase 2 trial. As part of an open-label booster phase of the PREVENT-19 trial, a single booster dose of the Novavax adjuvanted COVID-19 vaccine was administered to healthy adult participants at least 6 months after their primary two-dose vaccination series of the Novavax vaccine.

The third dose produced robust antibody responses comparable to or exceeding levels associated with the efficacy data in the primary series phase 3 clinical trials. In the COV-BOOST trial, the vaccine, induced a significant antibody response when used as a heterologous third booster dose.

Last month, the FDA granted an EUA for the Novavax COVID-19 vaccine as a two-dose primary series against COVID-19 in individuals 18 years of age and older.

That EUA was based on findings from the same trial, in which investigators assessed NVX-CoV2373 in approximately 30,000 participants aged ≥18 years old in the US and Mexico. PREVENT-19 data showed a 90.4% vaccine efficacy (95% CI, 83.8 - 94.3; P <.001) versus placebo.