The World Health Organization (WHO) expressed concern about how one of the plants involved in Russia’s Sputnik V coronavirus vaccine production fills the vials, and whether mitigation measures to reduce risk of cross-contamination are adequately implemented.
WHO, which is currently reviewing the vaccine, conducted the inspection between May 31 and June 4, and also noted issues concerning tracing and identifying batches at the site, which is located in the Russian republic of Bashkortostan, Reuters reported.
In response, Pharmstandard-UfaTIVA said all issues had been resolved, and that none pertained to the safety or efficacy of the vaccine itself.
“We invite WHO for another inspection,” the company said in a statement, according to Reuters.
Sputnik V, which in a February study was found to be safe and 91% effective in trials involving 20,000 people in Russia, is also being reviewed by the European Union’s regulator, but has faced delays due to missing data deadlines, Reuters previously reported.
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In Russia, the two-dose vaccine has already been upgraded to a one-dose version named Sputnik Light. Although the new version was granted regulatory approval in May, studies are ongoing, and the two-dose Sputnik V remains the main source of shots in Russia.
The country has also given approval to EpiVacCorona and CoviVac, although the country has faced criticism over its review process. All three vaccines were granted approval before advanced trials had begun – with Sputnik V even being offered to health care workers while the studies were ongoing.
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Russia’s government has set a goal of vaccinating nearly 69 million people by August.