Swissmedic grants conditional marketing authorisation to Nuvaxovid

Swissmedic, the Swiss agency for therapeutic products, has granted conditional marketing authorisation for Nuvaxovid COVID-19 vaccine (recombinant, adjuvanted) for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The vaccine, also known as NVX-CoV2373, is the first protein-based vaccine to be authorised for use in Switzerland, Novavax notified in a statement.

It also said that the Swissmedic decision was based on the totality of pre-clinical, manufacturing and clinical trial data submitted for review. This includes 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 vaccine demonstrated efficacy and a reassuring safety and tolerability 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 analyse real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed, the statement added.

Novavax previously announced an agreement with the government of Switzerland for up to six million doses of Novavax’s COVID-19 vaccine, concluded the statement.