Novavax, Inc. announced its submission to Swissmedic, the Swiss Agency for Therapeutic Products, for conditional marketing authorization (CMA) of NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant, for use in adults.
"We remain committed to delivering our COVID-19 vaccine, built on a well-understood protein platform used in common vaccines for decades," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We look forward to Swissmedic's review and, if authorized, delivering the vaccine to Switzerland to help fill the continued gap in vaccination and global distribution channels."
The submission for the regulatory evaluation by Swissmedic of NVX-CoV2373 includes data from two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the U.S. and Mexico and was published in the New England Journal of Medicine (NEJM); and a trial with almost 15,000 adult participants in the U.K. which was 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 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. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.
NVX-CoV2373 has been granted conditional authorization by multiple regulatory agencies worldwide, including the European Commission, the Medicines and Healthcare products Regulatory Agency, and emergency use listing from the World Health Organization. The vaccine is also currently under review by multiple regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA).
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