FDA Approves Updated Novavax COVID Vaccine

Federal regulators on Tuesday gave the go-ahead to an updated Novavax COVID vaccine, giving Americans a more traditional alternative to two recently revamped mRNA vaccines.

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

“The COVID-19 vaccines have saved countless lives and have prevented serious outcomes of COVID-19 caused by the SARS-CoV-2 virus,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency news release.

“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,” Marks added. “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 shot 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.

“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 shot. It also relied on clinical trial data for safety on the original Novavax vaccine and post-marketing data. This latest vaccine makes Novavax’s original shot obsolete.

Novavax said it plans to ship doses of the updated vaccine soon and make them available at “thousands of locations.”

More information

Yale Medicine has more on the differences between the COVID-19 vaccines.

SOURCE: U.S. Food and Drug Administration, news release, Oct. 3, 2023, Novavax, news release, Oct. 3, 2023

Source: HealthDay