FDA Grants Emergency Use Authorization for New Novavax Vaccine Against Omicron Variant

 Today, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for an updated Novavax COVID-19 vaccine that targets the Omicron variant JN1 strain. This updated vaccine is approved for individuals aged 12 and older and is designed to offer improved protection against severe COVID-19 outcomes, such as hospitalization and death. The new vaccine features a monovalent component and will replace the previously authorized Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula).

Eligible individuals include those 12 and older who are either unvaccinated, partially vaccinated with Novavax, or have received prior COVID-19 vaccines from other manufacturers. The updated vaccine requires two doses for unvaccinated individuals, one dose for those partially vaccinated with Novavax, and a single dose for those fully vaccinated with prior COVID-19 vaccines.

In an interview with Contagion, Chijioke Bennett, MD, MPH, MBA, from the Novavax clinical development team, discussed the their vaccine’s efficacy. He highlighted that Novavax’s protein-based vaccine provides comparable protection against the latest variants, like previous vaccines.

“As we see this virus drift, we must adapt to where it’s headed. With the new vaccine, our Gen 1 offering, which is what the CDC has recommended, this family of viruses essentially provides clinically comparable efficacy and immunogenicity to what we had originally received approval and authorization for. These numbers are in the mid to high 90s. It’s an effective vaccine. We have no concerns about that, and we’re seeing good immunogenicity across the board, very similar to what we had seen with our original vaccine that we had when the pandemic began.”

The FDA's decision follows the recent approvals of updated mRNA COVID-19 vaccines for 2024-2025 from ModernaTX Inc and Pfizer Inc. The updated Novavax vaccine is manufactured using a similar process to earlier versions, and side effects may be like those reported with previous formulations.

https://www.contagionlive.com/view/fda-grants-emergency-use-authorization-for-new-novavax-vaccine-against-omicron-variant