Russian virologist and scientist from the National Research Center for Epidemiology and Microbiology of academician Nikolai Gamaleju, who developed the Sputnik V vaccine, does not believe the reports that the Sputnik V vaccine delivered to the Slovak Republic is not the same as that positively evaluated in The Lancet.
Virologist Viktor Zuyev said this on Thursday in an interview with the Echo Moscow radio station.
“In my opinion, this is only a complete absurdity,” he said, recommending that he turn to the relevant authorities. He also said that Russia does not fall into the “category of countries that do such things.” He added that honor is a rare thing and said that “60 countries” are in line for vaccines.
At the request of Ech Moscow, Zujev responded to an article by the Slovak daily N, which wrote in an article dated April 6 that Sputnik V vaccines imported to Slovakia were not completely identical to the vaccine, the results of which were published in the prestigious magazine The Lancet.
The Russian direct investment fund (RFPI) in its field from Wednesday described the information of Denník N on the substitution of vaccines imported into the Slovak Republic as “false reports”. The daily was based on the opinion provided by the Slovak State Institute for Drug Control (ŠÚKL).
At the same time, RFPI stated in its account on the social network Twitter that it does not rule out the occurrence of other similar false reports and other provocations by opponents of the Russian vaccine in Slovakia.
The Russian news portal RBK, which also informed RFPI about you on Wednesday, asked the Ministry of Foreign Affairs of the Slovak Republic, the Ministry of Health of the Slovak Republic and the Slovak Embassy in Russia for comments. He refused to comment on the matter, the RBK portal informed.
According to RBK, the RFPI also objected to reports that the European Medicines Agency (EMA) would conduct a special investigation into the compliance of Sputnik V with ethical standards. According to the RFPI, such a procedure is standard for all vaccines and was not organized only for Russia.
The Russian fund added that it had itself asked the EMA to assess Sputnik V. It also said that “59 countries have already confirmed that Sputnik V complies with the requirements of good clinical practice.” “We expect the EU regulator to do the same,” the RFPI wrote.
Alexandr Gincburg, director of the Gamalej Research Center, said Wednesday, the EU said the EU was in no hurry to launch Sputnik V for fear of a high-quality Russian product, allowing it to seriously compete with analogous vaccines in Europe.
Meanwhile, on Thursday, the director of ŠÚKL, Zuzana Baťová, stated that according to the documents submitted by the manufacturer to the European Medicines Agency (EMA), the pharmaceutical form of the vaccine imported to Slovakia is not and will not be identical to the finished medicine that EMA is assessing.
“Batches of vaccine used in preclinical trials and clinical studies published in The Lancet do not have the same characteristics and properties as batches of vaccine imported into Slovakia,” she emphasized.
The State Institute cooperated in the evaluation of Sputnik V with 30 official laboratories as well as with the accredited laboratory of the Biomedical Center of the Slovak Academy of Sciences.
He also contacted the Hungarian Medicines Agency during the evaluation, as Hungary is the only country in the European Union where the vaccine is being given. However, it could not provide the data on the basis of a confidentiality agreement with the manufacturer.
The manufacturer of Sputnik V did not supply ŠÚKL with approximately 80 percent of the data necessary for its evaluation. As Baťová informed, the lack of data and risk inconsistencies did not allow the conclusion of a benefit-risk balance. ŠÚKL continues to recommend that it be vaccinated with registered vaccines in Slovakia.
Meanwhile, RFPI informed on its Twitter account on Thursday afternoon that by letter dated April 6, it asked the Slovak government to return the Sputnik V vaccine delivered to Slovakia “due to repeated breaches of contract.” The returned vaccine will be used in other countries according to the RFPI.
According to the TASS agency, RFPI states in its opinion that the Slovak ŠÚKL, in violation of the existing contract, provided for the testing of Sputnik V in a laboratory that is not part of the network of official EU laboratories for drug control.
TASS states that RFPI has asked the Slovak government to send the vaccine to an EU-certified laboratory.
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