WHO has already inspected nine sites of clinical trials and production of the Sputnik V vaccine, Soumya Swaminathan, the Chief Scientist at the WHO, said in her interview to Izvestia. The WHO is still evaluating the results of the last four inspections.
In general, the manufacturing sites of Sputnik V vaccine do not cause concerns for the WHO. The only exception is the detection of non–compliance with all the requirements of good manufacturing practice in the territory of OAO “Pharmstandart — Ufimskiy Vitaminny Zavod” in Bashkortostan.
“Five clinical trial sites were inspected jointly with the European Medicines Agency (EMA) for good clinical practice, four more production facilities were checked for good manufacturing practice (of the four facilities, two were visited jointly with the EMA),” Soumya Swaminathan said.
Subject to the compliance with certain requirements, the WHO will continue to evaluate Sputnik V vaccines from different production sites and will publish decisions on their EUL status when all data are available and the review is completed.
