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Novavax Requests FDA Emergency Use Authorization for COVID-19 Vaccine

Novavax on Monday requested FDA emergency use authorization for its COVID-19 vaccine. The request was based partially on results from two large clinical trials of approximately 30,000 participants in the U.S. and Mexico that the company said demonstrated approximately 90 percent efficacy, The Hill reports. “We’re extremely proud of the work of our teams and […]

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Novavax on Monday requested FDA emergency use authorization for its COVID-19 vaccine.

The request was based partially on results from two large clinical trials of approximately 30,000 participants in the U.S. and Mexico that the company said demonstrated approximately 90 percent efficacy, The Hill reports.

"We're extremely proud of the work of our teams and we look forward to FDA's review of our EUA request. We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," Novavax president and CEO Stanley Erck said.

The Novavax vaccine has been granted conditional authorization by multiple regulatory agencies worldwide, including the European Commission, and is listed for emergency use by the World Health Organization.

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