The World Health Organization (WHO), together with the European Medicines Agency (EMA), will inspect the manufacturing practice of the Sputnik V COVID-19 vaccine in Russia. This was announced on Thursday, April 22, by a WHO representative.
He specified that the inspection will take place from May 10 to the first week of June. After the inspection, a group of experts will assess the possibility of approving the Russian vaccine for emergency use in the EU countries.
“In April, a joint EMA / WHO team is conducting good clinical practice reviews. It is assumed that on-site inspections of good manufacturing practices will be carried out from May 10 to the first week of June – on the dates agreed with the manufacturer, “- said the representative of the WHO” RIA Novosti “.
Earlier, on April 8, Russian Deputy Foreign Minister Alexander Grushko expressed hope for a speedy certification of Sputnik V in the EU.
On March 22, it became known that the European Medicines Agency (EMA) will send experts to Russia to verify clinical trials and production of Sputnik V. In addition, as it became known, the European regulator also plans to start checking the compliance of clinical trials of the Russian vaccine with international ethical norms and scientific standards. It was noted that the EMA will investigate whether good clinical practice guidelines have been followed.
In turn, Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), said that no pressure was exerted on the participants in the Russian vaccine trials.
EMA began the procedure of consecutive examination of the registration dossier of Sputnik V in early March. A month earlier, it was reported that the EU regulator completed scientific advice on Sputnik V and gave the developer the opportunity to apply for registration of the drug in the EU, which RDIF did.
The Russian authorities have repeatedly pointed out that their primary task is to provide vaccines to Russian citizens, and then work in foreign markets.
The first COVID-19 vaccine in Russia and the world was registered on August 11, 2020. Sputnik V was developed by specialists from the Gamaleya Center.