Sputnik-V evaluation process suspended

The World Health Organization announced the suspension of the evaluation of the Russian vaccine Sputnik-V.

This was announced a week ago, last Wednesday. The reason for the suspension of registration, according to WHO, was the expectation of missing data and litigation, which the organization hopes will soon be completed. Mariangela Simao, WHO Assistant Director-General for Medicines and Health Products, says:

“We are working with the Russian Ministry of Health almost daily to resolve any outstanding issues that need to be addressed by the Russian Direct Investment Fund.”

She notes that once an agreement is reached, WHO will reopen the file to assess the data provided, “still incomplete,” and will continue with the suspended inspections of the Russian manufacturing facility, ΑΠΕ ΜΠΕ said. Simao emphasizes:

“All the applications we have are processed the same way.”

However, she did not specify when the registration process could be completed on schedule.

Earlier, Mikhail Muraska, the Minister of Health of Russia, said that on the way to registering the Sputnik-V vaccine with WHO, all obstacles were overcome, only some bureaucratic procedures remained. And Kirill Dmitriev, head of the Russian Direct Investment Fund, which finances the production of the vaccine, hopes that by the end of this year, the Russian drug for vaccination against coronavirus will receive WHO approval:

“We have good links with WHO and we see that this process is progressing.”

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