FDA Approves Updated Novavax COVID-19 Vaccine

WEDNESDAY, Oct. 4, 2023 (HealthDay News) -- Federal regulators on Tuesday gave the go-ahead to an updated Novavax COVID-19 vaccine, giving Americans a more traditional alternative to two recently revamped mRNA vaccines.

Adolescents and adults who have previously received a COVID-19 vaccine, but who have not gotten the newly updated Pfizer or Moderna shots, now have this non-mRNA choice.

"Today's authorization provides an additional COVID-19 vaccine option that meets the FDA's standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization," Peter Marks, M.D., director of the FDA Center for Biologics Evaluation and Research, said in an agency news release. "As we head into the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants."

This updated vaccine is expected to better target variants that are circulating now and help prevent hospitalization and death from the virus. It includes the spike protein from the omicron variant XBB.1.5. Novavax said it plans to ship doses of the updated vaccine soon and make them available at "thousands of locations."

"COVID-19 is once again on the rise with infections and hospitalizations increasing, so it's important that individuals get vaccinated to protect themselves and their loved ones," Novavax President and CEO John Jacobs said in a company news release. "Novavax's authorization today means people will now have the choice of a protein-based, non-mRNA option to help protect themselves against COVID-19, which is now the fourth leading cause of death in the U.S."

The FDA evaluated immune response and manufacturing data from the company before approving the updated vaccine. It also relied on clinical trial data for safety on the original Novavax vaccine and postmarketing data. This latest vaccine makes the original Novavax vaccine obsolete.

More Information