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Medicines and Healthcare Products Regulatory Agency Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine in Great Britain*
Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted)▼ is the first protein-based COVID-19 vaccine authorized in Great Britain Novavax and the U.K. Vaccines
About this update from Novavax, Inc.
[{"type":"text","content":"Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted)▼ is the first protein-based COVID-19 vaccine authorized in Great Britain Novavax and the U.K. Vaccines Taskforce previously announced an agreement for up to 60 million doses Authorization based on data including an ongoing pivotal Phase 3 trial conducted in the U.K. with almost 15,000 participants GAITHERSBURG, Md., Feb. 3, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 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.\n\"We are proud that Nuvaxovid will be the first protein-based vaccine option authorized by MHRA as the United Kingdom tackles this next phase of the pandemic,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"We thank the agency for its thorough review process and are tremendously grateful to the clinical trial participants and trial sites in the U.K., as well as the Vaccines Taskforce, for their ongoing support and vital contributions to this program.\"\nThe MHRA decision was based on the totality of preclinical, clinical, and chemistry, manufacturing and controls (CMC) data reviewed by the agency. This includes two pivotal ongoing Phase 3 clinical trials: PREVENT-19 which enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published in the New England Journal of Medicine (NEJM)i; and a trial with almost 15,000 participants in the U.K., the results of which were also published in NEJMii. In both trials, the vaccine demonstrated efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. No...