Novavax announced that its updated protein-based XBB COVID vaccine candidate induced neutralizing antibody responses to the EG.5.1 and XBB.1.16.6 subvariants in small animal and non-human primate studies. XBB sublineage variants are overwhelmingly responsible for the majority of current COVID cases in the U.S. and European Union.
"Our data have shown that Novavax's protein-based COVID vaccine induces broadly neutralizing responses against XBB subvariants, including EG.5.1 and XBB.1.16.6," said Filip Dubovsky, President of Research and Development, Novavax. "We have a lot of confidence in our updated COVID vaccine and are working diligently with global regulatory bodies to ensure our protein-based vaccine is available this fall."
Non-clinical data previously showed that Novavax's COVID vaccine candidate induced functional immune responses for XBB.1.5, XBB.1.16 and XBB.2.3 variants, indicating a broad response that could potentially be applicable for forward-drift variants. Novavax is in the process of submitting applications for its XBB.1.5 COVID vaccine candidate to regulatory authorities globally.
Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.
The Novavax COVID-19 Vaccine, Adjuvanted vaccine has not been approved or licensed by the U.S. FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) as a primary series in individuals 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
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