Europe’s medicines regulator said on March 4 that it had started a rolling review of Russia’s Sputnik V COVID-19 vaccine, an important display of confidence in the shot that paves the way for its potential approval across the 27-nation bloc. Reuters reported this.
Hungary became the first EU country to grant the Russian vaccine emergency national approval in January, Slovakia has ordered shipments, and Czech Prime Minister Andrej Babis has said his country could move to use Sputnik V.
The European Medicines Agency (EMA) said in a statement it would review data from ongoing trials of the vaccine until there was enough evidence for a formal marketing authorisation application. EMA’s ‘rolling reviews’ are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data is ready.
“While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review,” it said.
The shot’s efficacy was initially greeted with scepticism by some Western scientists after Russia approved it in August last year without waiting for the results of full clinical trials.
However, scientists said it was almost 92% effective in fighting COVID-19, based on peer-reviewed late-stage trial results published in The Lancet medical journal last month.