Wednesday 20th January 2021
Examination probably in February
Russia wants EU approval for Sputnik V
The application was submitted to the European Medicines Agency (EMA) on Tuesday, said a spokesman for the Russian state fund RDIF, which financed the development of the vaccine. It is “an important milestone”.
The EMA confirmed a meeting with the Russian vaccine developers on Tuesday. She plans to provide more information as soon as the scientific reviews begin.
The vaccine was approved in Russia in August – before the completion of the third and therefore final phase of the clinical studies. This approach met with sharp criticism and reservations internationally.
According to the government, 1.5 million Russians are said to have been vaccinated with Sputnik V without any major side effects. And approval has also been granted in other countries, especially in the former Soviet republics, South America, Asia and Africa. According to Russian information, which has not yet been verified by an independent party, Sputnik V is more than 90 percent effective.