The first deliveries of NVX-CoV2373 (to be known as Nuvaxovid in the EU) are set to start in January, with up to 200 million doses covered by an advance purchase agreement set up in August.
The authorisation covers doses made by Serum Institute of India (SII), which will supply the initial doses for the EU. Deliveries will later be supplemented by additional manufacturing sites in Novavax’ global supply chain.
The vaccine has already received emergency use authorisation in Indonesia and the Philippines, where it is marketed by SII as Covovax.
Novavax expects to submit its complete chemistry, manufacturing and controls (CMC) data package to the US Food and Drug Administration (FDA) by the end of the year
Nuvaxovid is the fifth COVID-19 vaccine authorised in the EU. It is given as two injections, three weeks apart.
In recommending the vaccine for authorisation, the European Medicines Agency (EMA) said the data on the vaccine ‘were robust and met the EU criteria for efficacy, safety and quality’.
The agency assessed results from clinical trials covering 45,000 people aged 18+.
Phase 3 trials across the US, Mexico and UK showed vaccine efficacy of around 90%. The agency notes that the original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating during the studies; with limited data on the efficacy of Nuvaxovid against Omicron.
Reacting to the emergence of Omicron at the beginning of December, Novavax said it was evaluating the vaccine against the variant; as well as initiating development of an Omicron specific vaccine.
"We welcome the European Commission decision reflecting the first authorization of a protein-based COVID-19 vaccine for the people of the EU," said Stanley C. Erck, president and CEO, Novavax.
"We thank the EMA, 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."