The Kremlin announced the correction of the WHO’s comments to the manufacturer of the vaccine in Ukraine

There were complaints from the inspection team, but they have already been corrected, Dmitry Peskov said. The Kremlin announced the correction of the WHO's comments to the manufacturer of the vaccine in Russia

Ufa Vitamin Plant

The manufacturer of the ” V ” satellite from Ufa has corrected all the shortcomings that were pointed out by the WHO in terms of the production of the vaccine, said the press secretary of the President of Russia Dmitry Peskov.

“Indeed, there were complaints from the inspection team. And as far as we know, they have already been taken into account and everything that needed to be fixed has been fixed, ” Peskov said (quoted by RIA Novosti).

Earlier, the WHO published a report on the results of the inspection of four Russian enterprises that produce the vaccine “Sputnik V”. To the work of one of them-the enterprise of JSC “Pharmstandard” Ufa Vitamin Plant-the organization had comments.

Peskov noted that the control over the production of vaccines in Russia is carried out by the relevant control agencies. “Of course, the tightest control,” he said.

Earlier, the Ministry of Industry and Trade said that the WHO’s comments relate only to one of the manufacturers and “do not apply to the rest”. The Ministry of Industry and Trade initiated unscheduled inspections at the Ufa plant. After removing the comments, WHO specialists will be able to re-check the enterprise.

In the WHO report, experts expressed concerns about the company’s implementation of “adequate measures to reduce the risks of cross-contamination of the vaccine”, “control of aseptic conditions on its bottling lines”, as well as compliance with production standards. In addition, WHO found shortcomings in the way the identification and tracking of the batch history of the produced vaccine and two medicinal components, designated as “Component I” and “Component II”, is organized.

Roszdravnadzor told RBC that the control of vaccines goes in several stages: the production is controlled by the developer, the manufacturer (the Ministry of Industry and Trade is responsible for this stage) and the actual laboratories of the Ministry of Health. If at some stage a non-compliance with the safety criteria is detected, the vaccine is destroyed.

The Ministry of Health pointed out that citizens receive “only vaccines of proper quality”, since Russia has a multi-stage system of quality control of immunobiological drugs and their admission to the market.

According to the Ministry of Industry and Trade, the vaccine “Sputnik V” in Russia is produced at seven sites-this is a branch of “Medgamal” of the N. F. Gamalei Federal State Budgetary Institution, JSC “Binnopharm”, JSC “R-Pharm”, CJSC “Biocad”, JSC Generium, CJSC Lecco, JSC Pharmstandard-UfaVITA.

In early May, the WHO reported that the organization hopes to give a full assessment of the safety of the vaccine “Sputnik V” in late June-early July.

Источник rbc.ru

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