Covid-19: the Novavax company files a marketing authorization application for its vaccine in the EU

The American biotechnology company Novavax presented on Wednesday an application for authorization to market its vaccine against Covid-19, Nuvaxovid, in the European Union. The European Medicines Agency (EMA) then indicated that an opinion could be issued in “a few weeks”. “The assessment will be carried out on an accelerated schedule,” the EMA said in a statement.

Last June, Novavax announced that its vaccine candidate was 90.4% effective after a phase 3 clinical trial conducted in the United States and Mexico. This vaccine, which could become the fifth licensed vaccine in the European Union, uses a different technology than those used for vaccines already widely licensed in the world. It is a so-called “subunit” vaccine, based on proteins that trigger an immune response, without viruses. It can be stored at a temperature between 2 and 8 ° C, which could facilitate its distribution.

A vaccine already licensed in Indonesia

“Today’s announcement from the EMA brings Novavax closer to our goal of ensuring broad global access to our protein-based Covid-19 vaccine throughout Europe,” Stanley C. Erck, Novavax President and CEO, said, quoted in a statement. Press release. If the EMA “considers that the benefits of Nuvaxovid outweigh the risks” and grants a marketing authorization to Novavax, it will be up to the European Commission and the EU Member States to approve the vaccine in their territories.

Last August, the European Commission announced that it had entered into a contract with the US company for the advance purchase of 200 million doses of its vaccine once approved by the EMA. In early November, Indonesia was the first country to authorize the Novavax vaccine.

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