Novavax’s Updated COVID Shot Authorized by FDA

The FDA authorized the updated Novavax COVID-19 vaccine to protect against hospitalization and death from circulating variants, the agency announced on Tuesday.

Targeting the XBB.1.5 strain as required by the FDA, the protein-based shot represents a non-mRNA option for the 2023-2024 season, following the agency’s authorizations and approvals of Pfizer and Moderna’s new vaccines last month for people ages 6 months and up.

For the Novavax authorization, individuals age 12 years and older previously vaccinated with a COVID-19 vaccine (and who have not already received a dose of a recently updated mRNA vaccine) are eligible to receive one dose of the adjuvanted protein-based vaccine; unvaccinated individuals can get two doses.

“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “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.”

Regulators determined that the benefits of the updated Novavax shot outweigh its risks in individuals 12 years of age and older. This was based on manufacturing and non-clinical immune response data on top of the older clinical trial data supporting the original Novavax vaccine’s authorization.

The CDC recently recommended updated, monovalent, XBB-targeting COVID-19 shots authorized or approved for the 2023-2024 season by the FDA.

With the amended emergency use authorization for Novavax, the original monovalent Novavax COVID-19 vaccine is no longer authorized for use in the U.S.

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