WHO team raises concerns on data integrity, quality control at Sputnik V filling plant in Russia

HYDERABAD: A WHO team has flagged concerns on a Sputnik V vaccine filling plant in Russia and other issues after its officials inspected the facility earlier this month.

Pharmstandard-UfaVITA, the firm that fills the vaccine (Gam COVID-Vac), said it has addressed all the issues raised by the WHO inspection team within 48 hours.

The inspection took place during the May 31-June 4 period.

Dr Reddy’s Laboratories is in a pact with Russian Direct Investment Fund to sell the first 125 million people doses (250 million vials) ofSputnikVin India.

The Indian drug regulator gave approval for restricted emergency use of Sputnik V in the country.

Dr Reddy’s Laboratories received nearly three million doses of the vaccine and currently the pilot launch is going on.

“Identified concerns with the integrity of data and test results of microbiological and environmental monitoring during the manufacturing and quality control activities of Gam- COVID-Vac. Identified concerns with the implementation of an appropriate Environmental Monitoring Program to monitor and control the aseptic operation and filling of Gam-COVID-Vac,” the WHO interim report said.

The Russian pharma company said in a statement that WHO did not raise any questions about the safety and efficacy of the product and finished vaccine as the “Sputnik V” undergoes strictest double quality output control of the Gamaleya Institute and the Russian health regulator (Federal Healthcare Service (Roszdravnadzor).

Moreover, the WHO interim inspection did not identify any critical issues with the actual vaccine’s production, quality, clinical studies, possible side effects, nor with the double quality output control by both the Gamaleya Institute and the Russian health regulator, the company said.

“We invite WHO for another inspection. We remain fully transparent and will continue with the WHO pre-qualification process,” it said.

The Russian firm said it is only responsible for filling the vials with the “Sputnik V” vaccine produced at another production plant.

Furthermore, the company runs only four out of 20 filling lines for the “Sputnik V” vaccine.