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Registration of the Russian vaccine against the Sputnik V coronavirus in the European Union has been postponed due to the fact that the drug developers did not provide the necessary data on time, which are considered standard requirements for the drug approval process in the EU. writes Reuters citing sources.
According to an interlocutor of Reuters close to EMA, by the beginning of June, the regulator had received practically no production data on the vaccine, and the provided clinical information is incomplete.
According to Reuters, the European Medicines Agency has yet to receive reports of side effects observed in clinical trial participants, as well as data on how the results of those volunteers who received a placebo were tracked.
Sources of the agency explain the refusal of Sputnik developers to provide data by the lack of experience in working with foreign regulatory bodies.
“They are not used to working with a regulatory body such as the EMA,” explained a source familiar with the situation.
As the agency writes, due to the lack of necessary information, the vaccine registration deadline is postponed at least until the end of summer. At the same time, one of the sources familiar with the work of the European Agency for the evaluation of the Russian vaccine said that they have no reason to doubt that Sputnik V is a safe and effective vaccine.
In mid-June, Reuters reportedthat the registration of “Sputnik V” in Europe is delayed due to the fact that the Gamaleya Center did not provide the EMA with data on clinical trials of the drug. This had to be done before June 10th. The Russian Direct Investment Fund denied such claims.
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