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Key highlights:
- This Emergency Use Authorisation 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.
Novavax, Inc recently announced that the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) has received Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA) for active immunisation to prevent COVID-19 in individuals aged 12 and older. Immediately upon authorisation, Novavax's vaccine has also been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on September 12, 2023.
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 hospitalisations 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 authorisation 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 neutralising 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.
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 harmonised guidance from the FDA, European Medicines Agency and the World Health Organisation to target the XBB strain this fall. Novavax is working with these and other global regulatory authorities on authorisations for its vaccine.