FDA Grants Emergency Use Authorization for Updated Novavax COVID-19 Vaccine

The US FDA granted emergency use authorization (EUA) for an updated version of the COVID-19 vaccine manufactured by Novavax that targets the currently circulating Omicron variant JN.1 strain of SARS-CoV-2.

The EUA follows the recent approvals and authorizations from the FDA for updated mRNA COVID-19 vaccinations for 2024 to 2025 manufactured by Moderna and Pfizer.

“The COVID-19 vaccines have had a tremendous positive impact on public health, and vaccination continues to be the most effective method for COVID-19 prevention,” Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA, said in the August 30, 2024, press release.

The updated vaccine is authorized for use by individuals 12 years and older who have never been vaccinated against COVID-19, who may receive 2 doses spaced 3 weeks apart. Individuals previously vaccinated with 1 dose of any Novavax COVID-19 vaccine may receive 1 dose of the updated vaccine at least 3 weeks after the prior dose. In addition, individuals who were vaccinated with a prior COVID-19 vaccine from another manufacturer or with 2 or more doses of a prior formula of the Novavax COVID-19 vaccine may receive 1 dose of the updated vaccine at least 2 months after the last dose of a COVID-19 vaccine, according to the FDA.

The updated vaccine is manufactured using a similar process as previous formulations, according to the press release. Users of the updated Novavax COVID-19 vaccine may experience similar side effects as those observed with previous Novavax COVID-19 vaccines.

“COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible. 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 said.

As part of this action, the 2023 to 2024 Novavax COVID-19 vaccine is no longer authorized for use, according to the press release.

Reference: FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants. News item. FDA. August 30, 2024. Accessed September 3, 2024. https://www.fda.gov/news-events/press-announcements/fda-authorizes-updated-novavax-covid-19-vaccine-better-protect-against-currently-circulating