Novavax COVID Vaccine gets conditional marketing nod in Great Britain
NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Gaithersburg: Novavax, Inc. has 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.
"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."
The 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 NEJM. 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 vaccine is stored at 2° - 8° Celsius and has a current assigned shelf life in Great Britain of 9 months.
Novavax previously announced an agreement with the U.K. Vaccines Taskforce for up to 60 million doses of Novavax' COVID-19 vaccine.
The brand name Nuvaxovid has not yet been authorized for use in the U.S. by the FDA.
