Novavax Says Taiwan Grants EUA For Nuvaxovid XBB.1.5 Dispersion For Injection COVID-19 Vaccine

(RTTNews) - Novavax, Inc. (NVAX) announced Monday that the Taiwan Food and Drug Administration has granted emergency use authorization for Nuvaxovid XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 in individuals aged 12 and older.

Doses of Novavax's updated vaccine will be delivered to Taiwan under an existing advanced purchase agreement and will be widely available at vaccination centers across Taiwan.

The authorization was based on non-clinical data showing that Novavax's updated COVID-19 vaccine induced functional immune responses for 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 subvariants BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as 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 induce a broad response against circulating variants.