EMA Recommends Conditional Authorization for Novavax’s COVID-19 Vaccine

The European Medicines Agency (EMA) announced on Dec. 20, 2021, that it has recommended conditional marketing authorization for Novavax’s COVID-19 vaccine for people ages 18 and older. Conditional marketing authorization is used to fast-track the authorization procedure with fewer data than normally required to fulfill an unmet medical need. The protein-based vaccine, Nuvaxovid, is the fifth COVID-19 vaccine recommended in the European Union.

According to the agency, two main clinical trials, which involved 45,000 people, showed that the vaccine was effective at preventing COVID-19 in people 18 years and older. The first study was conducted in Mexico and the United States and showed a 90.5% reduction in symptomatic cases from seven days after the second dose in those who received the vaccine compared to those who received a placebo. The second study, which was conducted in the United Kingdom, had a similar result with an efficacy rate of 89.7%.

“Taken together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90%. The original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when the studies were ongoing. There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron,” EMA stated in a press release.

The recommendation goes to the European Commission for approval for use in vaccination programs across the EU.