The EMA delays its visit to Moscow and the authorization of the Spútnik V vaccine in the EU is suspended


Correspondent in Moscow

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Russian Health Minister Mikhail Murashko told Russian President Vladimir Putin on March 22, during a videoconference dedicated to Covid-19, that specialists from the European Medicines Agency (EMA) would arrive in Russia on Saturday 10 April for evaluate the Spútnik V vaccine, prepared by the Gamaleya National Center for Epidemiology and Microbiology of Moscow.

Such a visit has long been expected in the Russian capital, as it constitutes an essential step towards authorizing the use of the Russian vaccine in the countries of the European Union. However, still does not occur. At the end of March, the head of the EMA’s Department of Health Threats and Vaccination Strategy, Marco Cavaleri, announced that the European regulator would send a delegation to Moscow in April. Financial Times said last Wednesday that this week will be when this group of European specialists arrives in the Russian capital.

According to the Russian daily RBK, the EMA intends to carry out at the Gamaleya Center two types of controls: the first will consist, according to the European source consulted by RBK, in verifying that the producers of medicines that want to be admitted to the EU market observe the good manufacturing practices, the quality standards required for its approval.

The second type of inspection has an «ethical» content, it is aimed at verifying that the rights, safety and well-being of the participants in clinical trials have been respected and verifying that the data obtained during these tests are reliable. In this regard, according to information released by Reuters in December, Russian and military officials involved in the clinical trials were not really volunteers.

Kirill Dmitriev, director of the Russian Fund for Direct Investments (RFPI), the organization that has financed the vaccine and is responsible for its commercialization outside Russia, assures that no one was pressured to inoculate the vaccine during the testing phase. Dmitriev says he is not aware “of any concern on the part of the EMA (…) and suggesting that there is such concern is a clear example of how they are trying to undermine the reputation of the Russian drug.”

Registration request

In any case, before starting the homologation process, according to the EMA, Russia must submit the corresponding application for registration of the Spútnik V, something that, apparently, has not happened. Dmitriev stated that on January 29 an application for the registration of the vaccine was submitted, something that the EMA denied days later.

The European Commissioner, Thierry Breton, in charge of managing the EU’s vaccination policy, believes that, even if the EMA approves the Russian injectable and, in his opinion, “it will end up doing it”, it will “still arrive late to the European market” . This is how he estimates it in an interview with the German magazine Der Spiegel. In his words, “the approval of the medicine does not mean that it can be produced in the quantities necessary immediately (…) it will take several months before it is possible to launch its manufacture”.

«And since our objective is vaccinate as many Europeans as possible by summer, Spútnik V will simply be too late (…) the EU already has enough registered vaccines to achieve herd immunity in the summer, ”Breton emphasized.

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