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"Sputnik V" under the magnifying glass of EMA

Experts from the European Medicines Agency are checking the production and clinical trials of the Sputnik V vaccine in Russia. Can suspicions about the Russian vaccine in the EU be cleared up?

Experts from the European Medicines Agency (EMA) are currently inspecting the Sputnik V vaccine in Russia. They have already visited two clinics in Moscow, where patients were cared for during the important third phase of clinical trials, the Russian agency Interfax reported yesterday.

"They got all the information they were looking for," Interfax reported, according to which EMA experts also spoke to medical staff.

The Amsterdam-based agency had previously said it was a "normal step in assessing an EU approval application". Emer Cook, director of EMA, announced such an inspection in March. "Clinical studies supporting EU market approval must comply with international ethical and scientific quality standards for human studies. "Compliance with the standard ensures the protection of the rights, safety and well-being of the study participants and that the data of the clinical trials are reliable", states EMA.

The agency will publish the results of the inspection only after the processing of the application for approval of "Sputnik V" in the EU. Hungary and Slovakia have already approved the use of the Russian vaccine. According to yesterday's information from Interfax, these days the EMA experts will visit some of the places of production of the vaccine.

Can Russian data be trusted?

There is distrust in the EU about the Russian vaccine. Five MEPs sent a letter to the EMA on March 17, stressing that Russia had repeatedly proved that it was "more than ready to politicize and falsify medical and scientific data very professionally and largely if it serves political purposes."

He cited the doping scandals of Russian Olympic athletes and the poisoning of opposition politician Alexei Navalny as examples. "I believe the vaccine works because it has a good protective effect and acceptable side effects. "But it is still not clear, because it has not been thoroughly checked step by step," said Peter Liese, a German MEP and spokesman for the People's Party's health policy in the European Parliament.

Lize told DW that it was problematic that Russia rushed to be first last August. Moscow then announced that it had the world's first approved vaccine, although the vaccine was tested on only a hundred people.

"I think Sputnik V is as safe as any other vaccine," Professor Lawrence Young, a British virologist and molecular oncologist, told DW. Based on the published data, he says, the reactions to the Russian vaccine are similar to other vaccines, including "mild arm pain, a slight headache, possibly a slight fever or chills." "But these are short, very mild side effects."

Young says Sputnik V is a "very smart vaccine" that uses an adenovirus with technology similar to the AstraZeneka vaccine. Therefore, he adds, it should be monitored whether the Russian vaccine could possibly cause thrombosis in a small number of cases. "As we know from experience with AstraZeneka, sometimes these side effects are noticeable only after the immunization of millions of people is started."

Does the EU need a "Sputnik V"?

Regardless of political speculation, the EMA treats the Russian vaccine as well as the Western ones that have already been approved. Amsterdam reports that similar inspections to Sputnik V have been carried out at the manufacturers of all four vaccines approved in the EU so far: Biontek / Pfizer, Moderna, AstraZeneka and Johnson & Johnson.

As the rate of vaccination in the EU lags behind some countries in the world, German Health Minister Jens Spann recently announced talks with Moscow to buy it, but only after receiving EMA approval.

It is still unclear how many doses Russia could actually deliver. In this country the vaccination rate is significantly below the EU average and Russia currently has no production facilities for large deliveries. An alternative could be to produce a Russian vaccine in the EU.

The German subsidiary of the Russian pharmaceutical manufacturer R-Farm, based in Bavaria, has already applied to the EMA for testing of the Sputnik V. The Bavarian government has agreed with the company to buy 2,5 million doses of Sputnik V, but only if the vaccine is approved.

The first deliveries are expected in July at the earliest. Peter Lize believes that production facilities are crucial. "If it comes to 1 million doses in July, then we definitely do not need it. But if it is about 20-30 million, it should be included in the strategy. "There is no reason not to import a safe, effective vaccine."

Source: Deutsche Welle

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