Novavax 2023-2024 COVID-19 vaccine now FDA authorized and recommended for use in the U.S.
Novavax, Inc. a global company advancing protein-based vaccines with its novel Matrix-M adjuvant, announced that the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) has received Emergency Use Authorization (EUA) from the FDA for active immunization to prevent COVID-19 in individuals aged 12 and older
Immediately upon authorization, 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.
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.
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.
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