EMA wants to investigate if Sputnik V clinical trials were ‘ethical’

Next week the European Medicines Agency (EMA) plan to start investigate the clinical tests of Sputnik V, in order to verify that it has respected ethical and scientific criteriaargued the Financial Times.

The regulatory body will review whether the Russian vaccine complies with the Good Clinical Practices (GCP), a source close to the FT told the FT. verification process this EMA It started at the beginning of March.

The agency will be concerned about the ethical factor in trials: an important source of volunteers, in particular for the trials of Phase 1, came from military and public employees and it is suspected that some may have been in a hurry to participate. For this time, Russia I was looking to become first country to develop a vaccine against coronavirus.

Macron, Merkel and Poutin assess joint production of Sputnik V

Kirill Dmitriev, executive director of the Russian Direct Investment Fund (RDIF), the sovereign wealth fund of the country that financed the vaccine, denied any kind of coercion. “There was no pressure [sobre los participantes] and Sputnik V followed all clinical practices“he told the FT.

“We are not aware of any concerns regarding the EMA related to PCBs and the leaks of these concerns are a specific example of people trying to undermine the EMA approval process, which is meant to be impartial and non-discriminatory, ”Dmitriev added.

Link between clots and Astrazeneca coronavirus vaccine confirmed

The Sputnik V has a division of the European Union (EU): the Commissioner for Internal Trade, Thierry bretton, who runs the immunization program, said the block does not need it, and the President of the European Council, Charles Michel, use a Russia to use with for propaganda purposes. On the other side, the German Chancellor, Angela Merkel, and the French president, Emmanuel Macron, they spoke days ago with Vladimir Poutine joint production of the vaccine within the EU.

In fact, according to Reuters, Germany will be ready to buy the Sputnik V if it is approved by the EMA.