The European Medicines Agency does not have data on people vaccinated with Sputnik V.

A director of the European Medicines Agency (EMA) has asked EU member states to refrain from authorizing a Russian-developed vaccine against the Sputnik V coronavirus until the agency has reviewed its safety and efficacy. Christa Wirthumer-Hoche, the head of the EMA board of directors, spoke about this on Sunday’s vitamin program on the Austrian public service television ORF.

We need documents that we can review. Currently we do not have data on vaccinated people. This is unknown. Therefore, I would not recommend authorization at the national level,

said the head of the board. He added that testing of the vaccine has begun, with data packages from the Russian manufacturer being tested against European standards for quality, safety and efficacy. If all goes well, the Russian vaccine will also be licensed in the EU, Wirthumer-Hoche said.

The Amsterdam-based agency, which acts as the EU’s pharmacovigilance authority, announced last Thursday that it had begun an ongoing review of Russia’s coronavirus vaccine. The decision to start the pivotal study is based on the favorable preliminary results of laboratory research and the first clinical trials in adults. Research-based studies and studies show that Sputnik V triggers the production of the necessary antibodies and immune cells, thus contributing to protection against the coronavirus. Marketing of the vaccine in the European Union must be formally authorized by the European Commission with a positive recommendation from the EMA.

The EU drug agency has so far recommended a vaccine developed by the American pharmaceutical company Pfizer and its partner, the German biotechnology company BioNTech, a vaccine from the American biotech company Moderna, and a vaccine jointly developed by the British pharmaceutical company. AstraZeneca and the University of Oxford against the new type of coronavirus. For application in the EU. However, Sputnik V is currently licensed or subject to an authorization procedure in three EU member states, in addition to Hungary, in the Czech Republic and Slovakia.

Speaking to the ORF, Christa Wirthumer-Hoche also said that the EMA Committee (CHMP) will hold an extraordinary meeting on March 11 to assess the usefulness of the US Johnson & Johnson vaccine in the EU. He added that a favorable assessment was expected and that the European Commission could then grant the marketing authorization quickly.