Novavax Seeks U.S. FDA Emergency Use Authorization for Its COVID-19 Vaccine

Novavax has formally submitted a request for the United States Food and Drug Administration (FDA) to grant emergency use authorization for its COVID-19 vaccine for adults.

The vaccine, taken in two doses 21 days apart, demonstrated an overall efficacy of about 90% and a “reassuring safety profile, according to clinical trial results published in the New England Journal of Medicine in December.

“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 Chief Executive Officer Stanley Erck said in a statement on Jan. 31.

The FDA is expected to take several weeks in reviewing Novavax’s application.

The Novavax vaccine has already been approved in at least 170 countries, including Indonesia, South Korea, and the Philippines.

Novavax also said that a booster study is ongoing to evaluate the safety and effectiveness of a third dose, as well as a study in adolescents aged 12 to 17 years.

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