EC Head: EMA does Not Have Sufficient Data on the Safety of Sputnik V for Its Approval
OREANDA-NEWS. The European Medicines Agency (EMA) does not have sufficient data on the safety of the Russian vaccine against the Sputnik V coronavirus, said the head of the European Commission, Ursula von der Leyen.
Since March 4, the Russian vaccine has been undergoing a gradual examination procedure at the EMA, which is engaged in the approval of vaccines for use on the European market.
The Russian Federation said earlier that Moscow had submitted all documents for the approval of its vaccine in the EU. On the eve of the Russian Ambassador to Austria Dmitry Lyubinsky said that EMA is constantly looking for new excuses not to register Sputnik V.
"It has become very quiet around Sputnik. The application has been submitted to EMA for a long time. However, the supplier has not yet provided sufficient reliable data confirming safety. This raises questions," the politician said in an interview with the Redaktionsnetzwerk Deutschland (RND) media group.
The European Commission announced on Monday that it had agreed on the mutual recognition of coronavirus electronic certificates with the Vatican and San Marino. At the same time, the decision distributed by the EC notes that the Republic of San Marino informed the commission that it is vaccinating residents with the drugs Comirnaty, Moderna, Vaxzevria, Janssen and Sputnik V.
At the same time, the representative of the European Commission told RIA Novosti that the recognition by the European Union of the equivalence of electronic COVID certificates of third countries does not automatically mean the recognition of the vaccines indicated in them, the countries themselves decide whether to let the vaccinated "Sputnik" in.