This is the first application for approval of a so-called protein-based vaccine: Biotech company Novavax announced Friday that it has completed its ongoing application for approval with Britain’s Medicines and Health Products Regulatory Authority (MHRA) for approval of a COVID-19 vaccine candidate.
“The application brings Novavax much closer to delivering millions of doses than the first protein-based COVID-19 vaccine,” said Stanley C. “It is based on a well-tried and well-studied vaccine platform that is highly effective against multiple strains of coronavirus.” Erk, President and CEO of Novavax. “We look forward to reviewing the MHRA and are ready to provide vaccine doses following the positive decision we believe. We thank the UK clinical trial participants and the UK Vaccine Task Force for their support and important contribution to this programme.”
Developed from genetic material
NVX-CoV2373 is a protein-based candidate vaccine developed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes Covid-19. NVX-CoV2373 was developed using Novavax’s recombinant nanoparticle technology to generate an antigen derived from the coronavirus (S) protein and is formulated with Novavax’s patented M(TM) Matrix to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains a purified protein antigen and cannot replicate or cause Covid-19.
Novavax has now submitted all units required by the MHRA for the regulatory review of NVX-CoV2373, the company’s recombinant COVID-19 vaccine based on a protein nanoparticle with a Matrix-M(TM) adjuvant. This includes preclinical and clinical data, as well as chemistry, manufacturing, and control (CMC) data. Clinical data from a pivotal phase III study with 15,000 volunteers in Great Britain were submitted to the MHRA at the beginning of this year, with the efficacy of NVX-CoV2373 being 96.4% against the original virus strain, and 86.3% against the alpha(B) variant. .1.1.7) and showed a total of 89.7% effectiveness, as well as a favorable safety and tolerability profile. The app also includes data from PREVENT-19, a study of 30,000 participants in the United States and Mexico that showed 100% protection against moderate to severe disease and an overall efficacy of 90.4%. NVX-CoV2373 was generally well tolerated and elicited a strong antibody response.
Novavax expects to have more regulatory filings in key markets soon after filing in the UK, including Europe, Canada, Australia, New Zealand, the World Health Organization and other markets around the world. In the United States, Novavax expects to be able to submit the entire package to the FDA by the end of the year. The company continues to work closely with governments, regulators, and NGOs to ensure equal access to the COVID-19 vaccine worldwide.
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