Developed using Novavax’ recombinant nanoparticle technology, the vaccine also known as NVX-CoV2373 is a protein-based Covid-19 vaccine candidate which is engineered from the genetic sequence of the initial SARS-CoV-2 virus strain.
The vaccine is indicated for active immunisation to prevent Covid-19 in individuals aged 18 years and above.
The marketing approval follows the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA) recommendation to authorise NVX-CoV2373.
Novavax’s Covid-19 vaccine has also been approved for use in all 27 European Union (EU) member states.
Novavax president and CEO Stanley Erck said: “We welcome today’s European Commission decision reflecting the first authorisation of a protein-based Covid-19 vaccine for the people of the EU.
“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.”
The CMA is based on the totality of manufacturing, preclinical, and clinical trial data submitted by the company.
This includes data from two pivotal Phase III clinical trials: PREVENT-19, and a UK trial conducted on 15,000 subjects.
The Phase III PREVENT-19 clinical trial was conducted on about 30,000 participants in Mexico and the US.
Findings from both the trials showed that NVX-CoV2373 had high efficacy with a favourable safety and tolerability profile.
In August this year, the EC and Novavax have finalised an advanced purchase agreement (APA) to buy up to 200 million doses of NVX-CoV2373.
The company expects to deliver the initial vaccine doses in Europe in January.