Novavax has completed the rolling regulatory submission to the U.K Medicines and Healthcare products Regulatory Agency (MHRA) for authorization of the first protein-based COVID-19 vaccine.
The NVX-CoV2373 vaccine is engineered from the genetic sequence of the first strain of SARS-CoV-2. Using Novavax recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and is formulated with Novavax patented saponin-based Matrix-M ™ adjuvant to stimulate high levels of neutralizing antibodies.
Clinical data from Phase 3 trials included over 15,000 participants and demonstrated that NVX-CoV2373 elicited a strong immune response with an overall efficacy of 89.7% as well as a favourable safety and tolerability profile.
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Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom