Novavax Continues Progress Towards Delivery of its Protein-based Non-mRNA XBB COVID Vaccine to U.S.

 Doses of the updated protein-based non-MRNA Novavax COVID-19 Vaccine, Adjuvanted (Formula 2023-2024) arrived in the U.S. today and are ready to distribute for the fall vaccination campaign, pending FDA and CDC action

·      When authorized, Novavax's protein-based vaccine candidate will be the only non-mRNA COVID vaccine available in the U.S.

Doses of the updated protein-based non-MRNA Novavax COVID-19 Vaccine, Adjuvanted (Formula 2023-2024)  arrived in the U.S. today and will be ready for release pending Emergency Use Authorization (EUA) and recommendation from the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (CDC) (ACIP) and the CDC. Novavax will present the latest data on its vaccine at ACIP’s September 12, 2023, meeting to discuss fall COVID vaccination.

Novavax’s updated XBB version of its COVID vaccine is currently under review by the U.S. Food and Drug Administration (FDA) for EUA to prevent COVID-19 in individuals aged 12 and older. Novavax is currently responding to the FDA’s requests to facilitate final review, and timing is ultimately at the discretion of the FDA.

"Novavax is ready for the commercial delivery of our updated protein-based non-mRNA COVID vaccine this fall, and we are working closely with the FDA on its review of our Emergency Use Authorization application," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Pending FDA authorization and CDC recommendation, Novavax’s vaccine will be widely available in major U.S. pharmacies, through Group Purchasing Organizations and through various government entities such as Vaccines for Children, as an option for individuals aged 12 and older to protect themselves against new variants this fall.”

Novavax is working with other global regulatory authorities, including the European  Medicines Agency and Health Canada, on authorizations for its vaccine.

Use of the updated Novavax COVID-19 Vaccine, Adjuvanted in the U.S.

The updated version of the Novavax COVID-19 Vaccine, Adjuvanted targeting the XBB strain is currently under review by the U.S. FDA for EUA to prevent COVID-19 in individuals aged 12 and older.

https://ir.novavax.com/press-releases/Novavax-Continues-Progress-Towards-Delivery-of-its-Protein-based-Non-mRNA-XBB-COVID-Vaccine-to-US