Novavax COVID-19 Vaccine Receives FDA Emergency Use Authorization for 2023-2024 Formula
Key Insights
The FDA has granted Emergency Use Authorization (EUA) for Novavax's COVID-19 (search) vaccine (NVX-CoV2601) for individuals aged 12 and older.
The updated vaccine targets current variants, including XBB.1.5 (search), XBB.1.16 (search), and XBB.2.3 (search), offering a protein-based, non-mRNA option.
Non-clinical data showed the vaccine induced neutralizing antibody responses and robust T-cell responses against emerging subvariants.
Novavax's COVID-19 (search) vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601), has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older. This authorization provides a protein-based, non-mRNA option as the updated vaccine targets current variants. The vaccine is expected to be available at thousands of locations nationwide in the coming days.
Immune Response and Variant Coverage
The FDA's decision was based on non-clinical data demonstrating that Novavax's COVID-19 (search) vaccine induced functional immune responses against the XBB.1.5 (search), XBB.1.16 (search), and XBB.2.3 (search) variants. Additional data showed neutralizing antibody responses to emerging subvariants such as BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6, along with robust CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These findings indicate the vaccine's potential to stimulate a broad immune response against circulating variants.
Clinical Trial Adverse Effects
In clinical trials of Novavax's prototype COVID-19 (search) vaccine (NVX-CoV2373), the most common adverse effects included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue, and malaise.
Current Vaccination Strategies
The updated COVID-19 (search) vaccination formulations, including mRNA vaccines, were previously approved for emergency use in September, targeting circulating variants to enhance protection against serious infection. The FDA anticipates that COVID-19 vaccines may require annual updates, similar to influenza vaccines, due to the continuous emergence of new variants.
Novavax's Perspective
"COVID-19 (search) 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."