The US Food and Drug Administration (FDA) amended the emergency use authorization of the Novavax COVID-19 vaccine, adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula, making it the third COVID-19 vaccine available this fall.
Individuals 12 years of age and older previously vaccinated with a COVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine) are eligible to receive one dose, and unvaccinated individuals receive two doses.
The updated vaccine addresses currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. Consistent with the totality of the evidence and input from the FDA’s expert advisors, the Novavax COVID-19 vaccine, adjuvanted, a monovalent vaccine, has been updated to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5 (2023-2024 formula).
Novavax’s vaccine is protein-based, making it the only non-mRNA XBB.1.5 vaccine available in the US.
This authorization follows the FDA’s recent approvals and authorizations of updated mRNA COVID-19 vaccines for 2023-2024 manufactured by ModernaTX Inc and Pfizer Inc.
“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,” says John C Jacobs, president and CEO of Novavax, in a release. “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 US. In the coming days, individuals in the US can go to pharmacies, physicians’ offices, clinics, and various government entities to receive an updated Novavax vaccine.”
The authorization 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.