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Novavax Files For Conditional Marketing Authorization Of COVID-19 Vaccine In The U.K.

Novavax, Inc. (NVAX) announced the completion of its rolling regulatory submission to the U.K. Medicines and Healthcare products Regulatory Agency for authorization of the company's COVID-19 vaccine candidate. NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant, was engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.

The company expects to complete additional regulatory filings in key markets, including Europe, Canada, Australia, New Zealand, the World Health Organization and other markets around the world shortly following the U.K. submission. In the U.S., the company expects to submit the complete package to the FDA by the end of the year.

"The submission to MHRA leverages our manufacturing partnership with the Serum Institute of India, the world's largest supplier of COVID-19 vaccines," said Rick Crowley, Chief Operations Officer, Novavax.

Shares of Novavax were up 11% in pre-market trade on Wednesday.

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