The president of the European Medicines Agency advised against approving the use of Russian vaccine Sputnik V

A senior representative of the European Medicines Agency (EMA) advised member countries of the European Union refrain from approving the domestic use of the Russian vaccine Sputnik V, while the block agency verifies the safety and development effectiveness of the Gamaleya Institute.

On March 4, the European authority began a process of “continuous review”, real-time analysis, data on the safety, efficacy and quality of the Russian vaccine against covid-19 Sputnik-V, process which could lead to the authorization of the use of this medicine in the European Union (EU).

Despite the examination started, The agency’s board chairman, Christa Wirthumer-Hoche, told a talk show on Austrian channel ORF that data for the analysis is not available.

“We need documents that we can review. We still have no data […] on vaccinated people. There is a stranger. That’s why I advise against granting a national authorization in an emergency“Said the official.

The European regulator, based in Amsterdam, had explained that the decision to go to approval “was based on the results of laboratory studies and clinical studies in adults” that the developer of the drug had shared. Following the statements of Wirthumer-Hoche, this is doubtful, at least because of the quality of the information received.

“We may have Sputnik V on the market in the future, when the appropriate data has been investigated. Real-time review has already started at EMA, ”he added, referring to the announcement from the European agency.

The Sputnik V vaccine has already been approved or is in the process of being approved for use in three EU member countries: Hungary, Slovakia and the Czech Republic. EU officials have indicated that Brussels could start negotiations on vaccines if at least four member states so request.

Pressed by the lack of vaccines, pressure from member countries is increasing. The Italian Minister of Health, Roberto Speranza, raised the possibility of adopting the Russian vaccine Sputnik V.

The official also announced that the country could collaborate on its production. Without prejudice but, as for other vaccines, this will only be done after checks and the green light from the EMA and the AIFA, recognize the Italian health authorities.

“If a vaccine works and is safe, I don’t care much about the nationality of the scientists who worked on it, So I’m open to Sputnik as well as other vaccines around the world, as long as the agency checks the load correctly. If Ema and Aifa are doing well, we are ready to collaborate with Russia even in a short period of time, ”Speranza said.

Contacts with the European Medicines Agency

Reports that the designers of the Russian Covid vaccine made an erroneous or insufficient data request for approval in the EU “is not consistent with reality,” Sputnik V’s Twitter account noted.

The Russian Fund for Direct Investment (RFPI) had announced that it was in contact with the European Medicines Agency (EMA) for the review of its covid vaccine, and to collaborate with the authorities of the 27 European partners.

“The RFPI is working with the EMA to initiate the review of the Sputnik V vaccine,” the designers noted, adding that the agency had received the request.

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