Novavax (NVAX) Receives Full Marketing Authorization for Prototype COVID-19 Vaccine Nuvaxovid in United Kingdom – StreetInsider.com

Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has granted full marketing authorization for its prototype COVID-19 vaccine Nuvaxovid (NVX-CoV2373) for individuals aged 12 and older for active immunization to help prevent COVID-19.

"Full marketing authorization of our prototype COVID-19 vaccine in the U.K. is a stepping stone to enable authorization of updated strains of our vaccine in the future," said John C. Jacobs, President and Chief Executive Officer, Novavax. "We are working with the MHRA to provide the information needed for the rapid review of our updated protein-based non-mRNA COVID-19 vaccine as an important step to ensuring access to vaccine options in the U.K. this coming vaccination season."

Authorization was based on two Phase 3 trials, PREVENT-19 conducted in the U.S. and Mexico and a Phase 3 trial in the U.K., as well as a Phase 2a/b trial in South Africa. In these trials, Novavax demonstrated the efficacy and safety of its prototype vaccine as a primary series in individuals aged 12 and older, and the immunogenicity and safety of the vaccine as a booster in individuals aged 18 and older.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. If you are concerned about an adverse event, it should be reported on a Yellow Card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. When reporting please include the vaccine brand and batch/Lot number if available.

i. Additional efficacy and safety data are being collected.

Trade Name in the U.S. The trade name Nuvaxovid has not been approved by the U.S. Food and Drug Administration.

Important Safety Information: U.K.

For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, adverse event reporting instructions, or to request additional information, please visit the following websites:

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Novavax (NVAX) Receives Full Marketing Authorization for Prototype COVID-19 Vaccine Nuvaxovid in United Kingdom - StreetInsider.com