Novavax again delays seeking US approval for COVID-19 vaccine

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Novavax on Thursday (Aug 5) again delayed its timeline for seeking US authorisation for its two-dose COVID-19 vaccine, and the company now expects to file for its emergency use in the fourth quarter of 2021. It had previously said it would seek emergency use authorisation (EUA) from the US Food and Drug Ad

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Novavax on Thursday (Aug 5) again delayed its timeline for seeking US authorisation for its two-dose COVID-19 vaccine, and the company now expects to file for its emergency use in the fourth quarter of 2021.

The company said it has filed for regulatory authorization of NVX-CoV2373 in India, Indonesia and the Philippines and expects to file for the World Health Organization's emergency listing for its shot this month, a prerequisite for exports to numerous countries participating in the COVAX international vaccine sharing program.

Separately, Novavax said a single booster shot of its vaccine given six months after an initial two-dose regimen, elicited a 4.6-fold increase in antibodies.

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