“In the context of the evaluation of the Sputnik V vaccine, European inspectors conducted checks of good clinical practice and good manufacturing practice in Russia during 2021. While the assessment is ongoing, the EMA cannot comment on the information studied (including the results of inspections). Detailed information about the inspection, including the inspections carried out, will be contained in the final report of the EMA,” the agency interlocutor said.
He added that the report will be published after the end of the vaccine evaluation procedure.
“The examination continues. The EMA will be able to talk in detail about the possible timing of the decision (on the approval of the vaccine in the EU – ed.), when the task force of the EMA will invite the developer (vaccines – ed.) to submit an application to the agency for a registration certificate. Such a proposal will take into account the reliability of the data obtained as a result of the gradual examination procedure,” the EMA explained.
Earlier, Denis Logunov, deputy head of the Gamalei Center, said that the EMA specialists gave a positive conclusion on the recognition of Sputnik V production standards and conducting clinical trials of the Russian coronavirus vaccine.
Since March 4, 2021, Sputnik V has been undergoing a gradual examination procedure at the European Medicines Agency, which approves drugs for centralized use in the European Union.
Sputnik V has been approved in 71 countries with a total population of 4 billion people, which is more than 50% of the world’s population. In terms of the number of approvals received by state regulators, Sputnik V ranks second in the world.
The effectiveness of the vaccine was 97.6% according to the results of data analysis of 3.8 million vaccinated Russians, this is higher than the data published earlier by the medical journal The Lancet (91.6%), reported in The Russian Direct Investment Fund (RDIF) and SIC Gamalei.
Data on the use of Sputnik V during vaccination of the population in a number of countries (Argentina, San Marino, Serbia, Hungary, Bahrain, Mexico, UAE and others) demonstrate that Sputnik V is one of the safest and most effective vaccines against coronavirus, RDIF reported.