Novavax has been granted conditional marketing authorisation by the European Commission (EC) for Nuvaxovid Covid-19 vaccine.
Context
The vaccine is for active immunisation to prevent Covid-19 caused by SARS-CoV-2 in individuals 18 years of age and older and the authorisation follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation to authorize the vaccine (also known as NVX-CoV2373) and is applicable in all 27 European Union (EU) member states.
Official comments
“We welcome today’s European Commission decision reflecting the first authorisation of a protein-based Covid-19 vaccine for the people of the E.U.,” said Stanley Erck, President and Chief Executive Officer of Novavax. “We thank the European Medicines Agency, the Committee for Medicinal Products for Human Use reviewers and the European Commission for their thorough assessment as we look forward to playing a critical role in helping to address the continued threat of Covid-19. We also thank the thousands of clinical trial participants, our partners and Novavax employees worldwide who have contributed to this historic milestone.”
Background
The EMA opinion and related EC decision is based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two Phase III clinical trials: PREVENT-19 which included 30,000 participants in the US and Mexico, the results of which were published in The New England Journal of Medicine (NEJM); and a trial with 15,000 participants in the UK, the results of which were also published in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and an acceptable safety and tolerability profile. 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.
Previous and future approvals
Novavax and SII recently received emergency use authorisation (EUA) in Indonesia and the Philippines. The companies also received emergency use listing for Covovax from the World Health Organization (WHO). The vaccine is also currently under review by multiple regulatory agencies worldwide, and the company expects to submit its complete chemistry, manufacturing and controls (CMC) data package to the US Food and Drug Administration (FDA) by the end of 2022.
