The decision is based on the results of laboratory tests and clinical studies in adults, as the EMA announced on Thursday in Amsterdam. According to the studies, Sputnik V stimulates the formation of antibodies against the virus and could help protect against Covid-19. It is not yet clear when approval could take place.
EMA experts will evaluate the vaccine’s effectiveness using the rapid rolling review process. Test results are already checked, even if not all results are available and no application for approval has been submitted. The Russian vaccine is already being injected in several countries outside Russia. Some EU countries also want to use the preparation without EU approval.
The manufacturer of Sputnik V had already stated several times that an application had been made to the EU authority. According to the EMA, this has not yet been the case. The Russian manufacturer had specified R-Pharm Germany GmbH as an EU partner at the EMA.
So far, three corona 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. The final decision on approval is made by the EU Commission, but this is a matter of form.
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