Novavax filed for authorization of its COVID-19 vaccine in the United Kingdom

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On Oct. 27, 2021, Novavax announced the completion of its rolling regulatory submission to the U.K. Medicines and Healthcare products Regulatory Agency for authorization of its COVID-19 vaccine candidate. The company’s application for Conditional Marketing Authorization marked the first submission for authorization of a protein-based COVID-19 vaccine in the UK.

Novavax had completed the submission of all modules required by MHRA for the regulatory review of NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. This includeed preclinical, clinical, and chemistry, manufacturing and controls (CMC) data. Clinical data from a pivotal Phase 3 trial of 15,000 volunteers in the U.K. was submitted to MHRA earlier this year in which NVX-CoV2373 demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall, as well as a favorable safety and tolerability profile. The submission also includeed data from PREVENT-19, a 30,000-person trial in the U.S. and Mexico, which demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. NVX-CoV2373 was generally well-tolerated and elicited a robust antibody response.

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Source: Novavax
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