Amsterdam, 4 March 2021 (dpa/MIA) — The European Medicines Agency is launching a fast-track procedure to test the Russian coronavirus vaccine Sputnik V.
The decision to proceed was based on results of laboratory tests and clinical trials in adults, the EMA announced in Amsterdam on Thursday.
According to the studies, Sputnik V stimulates the formation of antibodies against the virus and can help protect against the respiratory disease it causes, Covid-19.
The EU experts will evaluate the efficacy of the vaccine according to the rapid “rolling review” procedure. This means that test results are already being examined, even if not all results are available yet and no application for marketing authorization has been submitted.
It is not clear how long the approval process will take.
The Russian vaccine is already being used on the public in several countries outside Russia. Some EU countries have said they want to use it even if there is no official EU approval.
There has been some confusion about the authorization process, with the manufacturer of Sputnik V stating several times that an application had been submitted to the EU authority, but the EMA saying this was not the case.
So far, three coronavirus vaccines have been approved in the EU. They come from the manufacturers Pfizer/BioNtech, Moderna and AstraZeneca.
On March 11, the EMA is also expected to recommend approval of the vaccine from the US manufacturer Johnson & Johnson.