February 7, 2022 -- Novavax announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization for its Nuvaxovid COVID-19 vaccine for active immunization in individuals 18 years of age and older in Great Britain. The vaccine, also known as NVX-CoV2373, is the first protein-based vaccine to be authorized for use in Great Britain.
The MHRA's decision was based on the totality of preclinical; clinical; and chemistry, manufacturing, and controls data reviewed by the agency. This includes two pivotal, ongoing phase III clinical trials including Prevent-19. The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. The vaccine is stored at 2° to 8° Celsius and has a current assigned shelf life in Great Britain of nine months.
Novavax previously announced an agreement with the U.K. Vaccines Taskforce for up to 60 million doses of Novavax's COVID-19 vaccine. Novavax is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.
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