The European Medicines Agency (EMA) has started its review of the “Sputnik V” vaccine developed by Russia’s Gamaleya Research Institute. The vaccine will undergo a “rolling review” based on the results of laboratory and clinical studies in adults. This was announced in press releases from both the EMA and the Russian Direct Investment Fund (RDIF), which has overseen the drug’s development.
The EMA review will determine if Sputnik V meets EU effectiveness, safety, and quality standards. “EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for formal marketing authorisation application,” the regulator stated in its press release.
As the EMA explains, a rolling review is a regulatory tool used to “speed up the assessment of a promising medicine during a public health emergency.” (Typically, the regulator requires all the necessary documents to be ready before an evaluation can begin).
Russia registered Sputnik V as its first vaccine against the coronavirus in August 2020 and then used it to launch the country’s vaccination campaign in December. In total, 42 countries have approved Sputnik V for general use, including two EU countries: Hungary and Slovakia gave the Russian the vaccine the greenlight before it was registered in the union. The Czech authorities have also applied for doses of the Russian vaccine.
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