Will WHO finally approve Sputnik V? Body to restart tests of Russian Covid-19 vaccine following discovery of production issues
The World Health Organization has resumed the approval procedure of the Russian Sputnik V Covid-19 vaccine, just over a month after it was revealed that the process was paused due to the discovery of irregularities at a factory.
That’s according to the Russian Direct Investment Fund (RDIF), the body responsible for marketing the jab worldwide.
“WHO confirmed Sputnik V pre-qualification process is on track and entering its final stage,” a tweet on the vaccine’s official page said. “A group of WHO inspectors is due to visit Russia shortly to round up all necessary inspections & paperwork on Sputnik V, one of the world’s safest & most efficient vaccines.”
According to RDIF head Kirill Dmitriev, the fund expects the vaccine to be approved in the coming months.
In September, it was revealed that approval of the jab had been halted following a WHO inspection of a vaccine-making facility in Ufa in June. The organization suspended procedures due to the factory “not adhering to good manufacturing practices.” The experts criticized the control of conditions at the vaccine-filling lines and problems related to potential cross-contamination and sterility levels.
Also on rt.com WHO pauses approval process for Russia’s Sputnik V vaccine after factory found in breach of ‘good manufacturing practices’Sputnik V was announced as the world’s first registered vaccine on August 11 last year and is now approved for use in 70 different countries. The jab demonstrated an efficacy of 97.6% in a “real-world” study, according to data published by the Gamaleya Center, the body that developed it.
Russia is also hoping that the vaccine will be recognized by the European Medicines Agency, the EU body responsible for approving drugs for the bloc. However, according to anonymous sources cited by news agency Reuters, it is “absolutely impossible” that any registration could take place in 2021, but regulators may decide “in the first quarter of next year.” The EMA’s formal review of the jab started last March.
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