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A logo is pictured outside a World Health Organization (WHO) building during a board meeting on the update on the coronavirus disease (COVID-19) outbreak, in Geneva, Switzerland, April 6, 2021. REUTERS / Denis Balibouse
MOSCOW, June 23 (Reuters) – The World Health Organization (WHO) said on Wednesday that its review of vaccine production in Russia revealed problems with a manufacturing plant, responsible for filling some vials with the vaccine against the Sputnik V.
The concerns relate to the Pharmstandard-UfaVITA plant, one of four Sputnik V production and filling sites that have been examined, the WHO said in its preliminary report.
The issues do not relate to the safety or effectiveness of the Sputnik V vaccine itself, Pharmstandard-Ufa-VITA said in a statement. The factory is only responsible for pouring the product into vials.
Concerns about the filling lines were subsequently fully resolved, the company said.
“We invite the WHO for another inspection,” he said. “We remain fully transparent and will continue with the WHO prequalification process.”
At the site, the WHO prequalification unit, which is currently reviewing Sputnik V for approval, discovered issues with the integrity of the data and test results produced during shot quality checks.
The report also “identified problems with the implementation of adequate measures to mitigate the risks of cross-contamination,” he said, and with sterility, including with the clothes worn by those who operate the lines.
He also found problems with the tracing and identification of batches of vaccine manufactured at the site.
Reporting by Andrew Osborn; Written by Polina Ivanova Editing by Andrew Osborn
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