MOSCOW: The World Health Organization (WHO) said on Wednesday its review of Russian vaccine production had found some issues with one manufacturing plant, that is responsible for filling some vials with the Sputnik V coronavirus shot.
The concerns relate to the Pharmstandard-UfaVITA plant, one of four Sputnik V production and filling sites that were reviewed, the WHO said in its preliminary report.
The issues do not relate to the safety or efficacy of the Sputnik V vaccine itself, Pharmstandard-Ufa-VITA said in a statement. The plant is responsible only for pouring the product into vials.
Concerns with the filling lines have subsequently been fully addressed, the company said.
“We invite WHO for another inspection,” it said. “We remain fully transparent and will continue with the WHO pre-qualification process.”
At the site, the WHO’s pre-qualification unit, which is currently reviewing Sputnik V for approval, found issues with the integrity of data and test results produced during quality controls of the shot.
The report also “identified concerns with the implementation of adequate measures to mitigate the risks of cross-contamination,” it said, and with sterility, including with the clothing worn by those operating the lines.
It also found issues with tracing and identifying batches of vaccines manufactured at the site.
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June 23, 2021 at 04:11AM
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