• This Emergency Use Authorization and CDC recommendation makes Novavax's vaccine the only protein-based non-mRNA COVID vaccine option in the U.S.
• Novavax expects doses will be available in thousands of locations across the U.S. in the coming days, including CVS Pharmacy and Rite Aid

Doses will be available nationwide at thousands of locations, including national and local retail pharmacies and physicians' offices, following the Center for Biologics Evaluation and Research release of vaccine batches, expected in the coming days.

"COVID-19 is once again on the rise with infections and hospitalizations increasing, so it's important that individuals get vaccinated to protect themselves and their loved ones," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Novavax's authorization today means people will now have the choice of a protein-based non-MRNA option to help protect themselves against COVID-19, which is now the fourth leading cause of death in the U.S. In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."

The EUA was based on non-clinical data showing that Novavax's COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to newly emerging subvariants BA.2.86, EG.5.1 FL.1.5.1 and XBB.1.16.6 as well as robust CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.^1,2

In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.

The EUA aligns with globally harmonized guidance from the FDA, European Medicines Agency and the World Health Organization to target the XBB strain this fall.^3-5 Novavax is working with these and other global regulatory authorities on authorizations for its vaccine.

AUTHORIZED USE IN THE U.S.
Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.