The European Medicines Agency (EMA) will send an inspection to Russia in April to check the Russian Sputnik V coronavirus vaccine. This was stated by the head of the department of health threats and vaccination strategy of the agency Marco Cavaleri, quoted by RIA Novosti.
Cavaleri explained that the audit will touch upon issues related to clinical trials and the production of the Russian drug. “Then we will try to understand by what time we will have all the data necessary for the possible approval of this vaccine in the end,” – added a spokesman for the EU regulator.
On March 4, the European Medicines Agency (EMA) began an examination of the Russian Sputnik V vaccine. The European regulator expects that the assessment will take place in a short time. Hungary and Slovakia have already approved the use of “Sputnik V” on an individual basis, without waiting for the registration of the drug in the EU.
Earlier, RIA Novosti reported, citing a source, that the Russian drug could be approved in the EU in the second half of May. Swedish vaccination coordinator Richard Bergström also said that the Russian vaccine can be approved in the EU no earlier than May.
