FDA Approves Updated Non-mRNA COVID Vaccine From Novavax

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Oct. 4, 2023 – The updated COVID-19 vaccine made by Novavax is now approved for use in the U.S., and millions of the doses are heading to pharmacies and other health care sites. 

Novavax CEO John Jacobs projected that the shots will take a week or less to reach consumers.

“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.,” Jacobs said in the statement. “In the coming days, individuals in the U.S. can go to major pharmacies, physicians’ offices, clinics and various government entities to receive an updated Novavax vaccine.” 

The authorization from the FDA comes as insurance and distribution challenges have hampered the rollout of updated vaccines from Pfizer and Moderna that are already FDA authorized. The CDC has also signed off on the Novavax vaccine. Like the new Pfizer and Moderna vaccines, the Novavax shot has been optimized to target evolved aspects of the virus ahead of colder months, when respiratory illnesses typically spike as people spend more time indoors.

The FDA said the Novavax shot is authorized for anyone age 12 and older. Novavax uses a different technology to trigger protection than the mRNA shots made by Pfizer and Moderna. Novavax works similarly to much older vaccines, including the childhood shot given for tetanus and the vaccines that prevent the human papillomavirus (HPV) and the hepatitis B virus, according to a summary by the Johns Hopkins Bloomberg School of Public Health.

In animal tests, the updated Novavax vaccine generated immune responses against some of the more recently circulating variants, The Wall Street Journal reported.

Novavax has not been as widely used in the U.S. because it was approved much later during the pandemic compared to other COVID vaccines. Nearly 90,000 doses of Novavax were given nationwide through May, compared to more than 400 million doses of Pfizer and about 253 million Moderna doses, CDC data showed. 

At least 2 million people in the U.S. have gotten the updated COVID-19 vaccine so far, according to one federal estimate, although the CDC is not currently publishing regular updates of vaccination counts as it has in the past. 

Last month, the CDC recommended that all people ages 6 months and older get an updated COVID-19 vaccine heading into fall and winter.