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23 Jun, 2021 14:01

WHO reports issues at plant involved in Russian Sputnik V Covid-19 vaccine production, Moscow says issues fixed & jab unaffected

WHO reports issues at plant involved in Russian Sputnik V Covid-19 vaccine production, Moscow says issues fixed & jab unaffected

All issues discovered by the World Health Organization (WHO) at a facility involved in the production of the Russian Sputnik V Covid-19 vaccine have been fixed and the jab is safe and effective, Moscow claimed on Wednesday.

An inspection team from the UN’s health body arrived in the country last month to assess the process of producing Sputnik V, with the organization looking to decide whether the jab should be approved for worldwide use. Despite being registered in Russia since August of last year, it is yet to get the seal of approval from any large international body.

The report, published on Wednesday morning, revealed that the WHO found issues at Pharmstandard-UfaVITA, a plant in the Russian city of Ufa that fills vials with Sputnik V. The factory does not make the vaccine, and no concerns have been raised over the safety or efficacy of the jab.

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According to Kremlin press spokesman Dmitry Peskov, the complaints from the inspection team have already been “taken into account,” and “everything that needed to be corrected has already been corrected.”

However, according to the text of the report, the team identified multiple concerns at the plant, including issues with the integrity of data and test results, as well as problems related to potential cross-contamination and sterility levels.

Shortcomings were also found in identifying and tracking batches, in a list of six different potential problems.

The preliminary inspection team, which checked four separate sites, noted that the latest report concerns issues found just at the Pharmstandard-UfaVITA plant and does not relate to any of the other three locations. This means that the complaints do not refer to anywhere where the vaccine is actually made, but just the plant that puts the formula into individual vials for distribution.

Following the report’s publication, Russia’s Ministry of Industry and Trade stressed that all doses undergo a three-stage strict inspection, not only during production but also by the vaccine’s creator – the Gamaleya Research Institute – and the country’s health watchdog Roszdravnadzor. The ministry also noted that Russia’s regulatory approach has already been praised by the WHO for previous inoculations.

According to Roszdravnadzor head Alla Samoylova, the country’s laboratories are internationally accredited, and citizens are protected from “any low-quality medicines, including vaccines.”

Moscow is currently seeking Sputnik V authorization from both the WHO and the European Medicines Agency (EMA). According to the Russia Direct Investment Fund (RDIF), the group tasked with marketing the jab, Sputnik V has an efficacy of 97.6%.

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