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www.fdanews.com/articles/205845-novavaxs-covid-19-vaccine-gets-who-emergency-use-listing

Novavax’s COVID-19 Vaccine Gets WHO Emergency Use Listing

December 20, 2021

The World Health Organization (WHO) has granted Novavax’s COVID-19 vaccine an Emergency Use Listing ― a decision that enables the COVAX global vaccine-sharing program to distribute the shot to developing countries.

The listing was supported by two phase 3 studies — a 30,000-person trial in the U.S. and Mexico and a 14,000-person trial in the UK — in which the vaccine, NVX-CoV2373, showed strong efficacy and a positive safety and tolerability profile.

The company is currently evaluating its vaccine against the Omicron variant and is also developing a separate shot targeted specifically at the mutant strain.

Novavax said it plans to seek authorization of the jab in the U.S. by year’s end.

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