US FDA Says Updated Protein-Based COVID-19 Vaccine Protects Against Currently Circulating Variants

The U.S. Food and Drug Administration today announced it granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating SARS-CoV-2 virus variants to provide better protection against serious consequences of COVID-19, including hospitalization and death.

Novavax's updated COVID-19 vaccine targets the "parent strain" of KP.2 and KP.3, formulated to target the JN.1 variant.

The updated monovalent, protein-based vaccine is authorized for individuals 12 and older.

This FDA approval helps protect Americans and their families during the U.S.'s biggest surge in COVID-19 cases since January 2022.

The FDA has determined that the updated Novavax COVID-19 vaccine has met the statutory criteria for issuance of an EUA, including that the known and potential benefits of the vaccine outweigh its known and potential risks.

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, commented in a press release on August 30, 2024, “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.”

Following the Center for Biologics Evaluation and Research's release of vaccine batches, Novacax vaccines will be available in thousands of locations, including retail and independent pharmacies and regional grocers.