The European Medicines Agency (EMA) has received an application for the registration of a vaccine against coronavirus infection from AstraZeneca. This was announced on Tuesday, January 12, by the press service of the EU drug regulator.
“The European Medicines Agency (EMA) has received a conditional marketing authorization application for AstraZeneca’s COVID-19 vaccine,” it said.
It is noted that the procedure for assessing the drug by the agency will be carried out in an accelerated mode. In accordance with it, the conclusion on the permit for the use of the vaccine in the territory of the European Union can be issued until January 29.
The acceleration of the process was made possible by the fact that EMA has already reviewed some data on the vaccine, including laboratory results, information about its components and how it is manufactured, and some evidence of safety and efficacy based on a combined analysis of interim clinical data from four ongoing clinical trials in the UK. Brazil and South Africa.
If the vaccine is approved for use in the European Union, AstraZeneca’s drug will become the third approved product.
On January 7, the European Commission approved the use of the vaccine of the American company Moderna in the EU countries. The contract provides for the supply of 80 million doses with the option to purchase an additional 80 million. In November, the EC agreed on a sixth pre-order contract for 160 million doses.
At the end of December 2020, EMA approved the Pfizer / BioNTech vaccine for use in Europe. The EC issued a final permit for the drug, and a few days later its deliveries to the countries of the union began.
Vaccination against COVID-19 in European countries began on December 27.