In an interview with Izvestia, a virologist and head of the MIPT genomic engineering laboratory Pavel Volchkov explained why the Russian Sputnik V vaccine has not been registered in Europe so far.
“Unfortunately, lately, drugs or vaccines have been so rarely brought to the world market in Russia that we do not have a culture of processing these data. And this direction is difficult. In fact, we have to learn how to do it de novo, ”the expert said.
According to him, in Russia, and earlier in the USSR, the task was never to synchronize the rules for testing drugs with the standards of the FDA, CDC, EMA, WHO. Now, if Russian medicines or need to be brought to the world market, then the tests should be carried out according to the rules existing in the world.
“This mechanism has not been worked out in our country. The first time you do something, it is very difficult. In addition, the creators of Sputnik were not faced with the task of entering the world market. The vaccine was created for their country, and it was necessary to make it as soon as possible, ”noted Pavel Volchkov.
According to the expert, the preclinical and clinical trials of Sputnik may have to be repeated.
“Unfortunately, many experiments will have to be repeated. We’ll have to go all the way again. The fact that there is already such a volume of data on the clinical use of the vaccine in different countries is a huge plus. I think this request should be made to an independent organization that the EMA or the FDA has confidence in, which has done this many times for large corporations. And it’s not even a matter of distrust. The specialists of this organization must be able to simply meet all the requirements of the EMA or the FDA, ”said the virologist.
According to Pavel Volchkov, all these procedures will take a year at best.
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Source: IZ
Jane Stock is a technology author, who has written for 24 Hours World. She writes about the latest in technology news and trends, and is always on the lookout for new and innovative ways to improve his audience’s experience.
