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Novavax files for Conditional Marketing Authorisation of COVID-19 vaccine in Switzerland

The submission for the regulatory evaluation of the vaccine includes data from two phase-III clinical trials

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Novavax yesterday announced its submission to Swissmedic, the Swiss agency for therapeutic products, for Conditional Marketing Authorisation (CMA) of NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant, for use in adults, a statement from Novavax said.

“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.

He added, “We look forward to Swissmedic’s review, and, if authorised, delivering the vaccine to Switzerland to help fill the continued gap in vaccination and global distribution channels.”

The statement also said that the submission for the regulatory evaluation by Swissmedic of NVX-CoV2373 includes data from two pivotal phase-III clinical trials: PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the US and Mexico, and was published in the New England Journal of Medicine (NEJM); and a trial with almost 15,000 adult participants in the UK, which was also published in NEJM.

In both the trials, the v