MOSCOW: The European Medicines Agency (EMA) said it has started a rolling review of Sputnik V, many months after the vaccine was first approved for use in Russia and after dozens of countries around the world have authorised it.
In a statement on Thursday (Mar 4), the European regulator said the review is based on results from lab studies and research in adults, which suggests the vaccine may help protect against coronavirus.
Despite skepticism about Russia’s hasty introduction of the vaccine, which was rolled out before it had completed late-stage trials, the vaccine appears to be safe and effective. According to a study published in the journal Lancet, Sputnik V was about 91 per cent effective in preventing people from becoming severely ill with COVID-19.
The EMA has not set a date for when its expert group might meet to assess Sputnik V data to decide if it should be approved across the European Union, but the rolling review process is meant to expedite the authorisation process, which can typically take several months.