The American biotechnology company Novavax filed on Wednesday an application for authorization to market its vaccine against Covid-19, Nuvaxovid, in the European Union.
The European Medicines Agency (EMA) indicated in the wake that an opinion could be issued in "a few weeks".
"The evaluation will take place 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 vaccine authorized in the European Union, uses a different technology from those used for vaccines already widely authorized 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 authorized 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 across Europe,” said Stanley C. Erck, President and CEO of Novavax, cited in a press release.
If the EMA "judges that the benefits of Nuvaxovid outweigh the risks" and grants a marketing authorization to Novavax, it will then be up to the European Commission and EU Member States to approve the vaccine. on their territories.
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Last August, the European Commission announced that it had entered into a contract with the American company for the advance purchase of 200 million doses of its vaccine once it has been approved by the EMA.
In early November, Indonesia was the first country to authorize the Novavax vaccine.