Novavax Files For Conditional CMA Of COVID-19 Vaccine In Switzerland - Quick Facts

(RTTNews) - Biotechnology company Novavax, Inc. (NVAX) announced Monday 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.

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 as well as and a trial with almost 15,000 adult participants in the U.K.

In both trials, the vaccine demonstrated efficacy with a reassuring safety profile. 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 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. It has already been granted conditional authorization by multiple regulatory agencies worldwide.