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MHRA Authorizes Novavax’s Nuvaxovid COVID-19 Vax

NVX-CoV2373 is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Novavax Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, was granted full marketing authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for its prototype COVID-19 vaccine Nuvaxovid (NVX-CoV2373) for individuals aged 12 and older for active immunization to help prevent COVID-19.
 
Authorization was based on two Phase 3 trials, PREVENT-19 conducted in the U.S. and Mexico and a Phase 3 trial in the UK, 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. Events of anaphylaxis have been reported with Nuvaxovid. Additionally, there is an increased risk of myocarditis and pericarditis following vaccination with Nuvaxovid. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. 
 
NVX-CoV2373 is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. 
 
Singapore’s Health Sciences Authority (HSA) has also granted full approval for Novavax’s prototype COVID-19 vaccine Nuvaxovid.

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