European Medicines Agency (EMA) has recommended granting conditional marketing authorization for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age, as was announced by Emer Cooke, Executive Director of EMA during the press conference.
EMA’s human medicines committee (CHMP) has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety, and efficacy of the vaccine are now available to recommend a formal conditional marketing authorization. According to Emer Cooke, the EU is aware of the responsibility for making the vaccine available on the market.
EMA’s scientific opinion paves the way for the first marketing authorization of a COVID-19 vaccine in the EU by the European Commission, with all the safeguards, controls, and obligations this entails.
“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards. However, our work does not stop here. We will continue to collect and analyze data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU,” the Executive Director of EMA said.
There is a significant increase in the number of infected people on the territory of the European Union. Therefore, the government needs to take immediate steps. It is possible to roll-out a vaccination in the European countries on December 27. However, the resolution of the European Commission is needed which might take up to two days. Italian, German and Austrian governments are already ready to begin the vaccination process.
As was reported earlier by ‘Apostrophe’, the President of Ukraine Volodymyr Zelensky recognized that Ukraine's position in the world and Europe in terms of the priority of countries has been lost and therefore, Ukraine is not on the list of countries that receive the vaccine first.