WHO pauses approval process for Russia’s Sputnik V vaccine after factory found in breach of ‘good manufacturing practices’

The World Health Organization has suspended its approval process for Russia’s Sputnik V Covid-19 vaccine, after the UN agency found one of the production facilities for the shots had followed the wrong manufacturing practices.

Answering a journalist’s question during a press briefing, the assistant director of the Pan American Health Organization, Jarbas Barbosa, said the WHO was now awaiting confirmation that the plant had corrected the irregularities so that a new inspection could take place.

“Regarding the approval process of Sputnik V for emergency use, the process has been suspended because, during an inspection of one of the factories where the vaccine is made, it was found that the factory did not adhere to good manufacturing practices,” Barbosa said.

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Last June, the agency reported that it had discovered irregularities at one of the plants near the city of Ufa, where experts criticized the control of conditions at the vaccine filling lines, as well as problems related to potential cross-contamination and sterility levels.

According to the Kremlin, all these complaints had already been “taken into account” before the report was published, and everything had already been corrected.

The Russian authorities applied to both the WHO and the European Medicines Agency for emergency approval earlier this month, but neither organization has yet registered the jab.

In August 2020, Sputnik V became the world’s first registered Covid-19 vaccine. Since then, it has been authorized in 70 countries and has shown a 97.6% efficacy among those in Russia administered both components.

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