The two-dose protein-based vaccine NVX-CoV2373, which uses a modified spike protein of SARS-CoV-2, is currently undergoing Phase III testing in both North America and the United Kingdom with the support of Novavax. Novavax is also running a Phase IIb trial in South Africa.

On 28 January, Novavax reported interim results from its UK Phase III and South Africa Phase IIb trials, which includes a point estimate of 89% efficacy in the UK and 60% efficacy in South Africa. As of 3 February, Novavax has not said when it expects to file with the FDA for an emergency use authorization (EUA) but a 3 February New York Times article indicates that authorization might occur "as early as April" — implying that Novavax might wait for results from the larger PREVENT-19 phase III trial that is currently ongoing in the US and Mexico before filing. However, Fierce Biotech is reporting that Novavax is "talking to the FDA but is yet to say whether it will be possible to seek approval before the U.S.-Mexico trial is complete.".

When will the Novavax SARS-CoV-2 vaccine be granted emergency use authorization by the US FDA?

This question retroactively closes when the first credible media report is published stating that NVX-CoV2373 has been submitted to the FDA for EUA. It resolves on the date when the FDA issues a statement reporting the issuing of an emergency use authorization for NVX-CoV2373. If an EUA is never granted, this resolves as > 31 December 2021. If the EUA application is rejected, and later resubmitted, the close date will not change.