EU regulator launches rolling review of Sputnik V vaccine

So far, two EU countries, Hungary and Slovakia, have already gone ahead with Sputnik on a national basis.

EU regulator launches rolling review of Sputnik V vaccine

The European Medicines Agency on Thursday announced that it has launched a rolling review of Russia’s Sputnik V vaccine, following months of back-and-forth with its producers.

The vaccine, created by Russia’s Gamaleya National Centre of Epidemiology and Microbiology, has prompted confusion after its funders, the Russian Direct Investment Fund, continually claimed they sent data for a rolling review to the EMA. But the agency denied that claim, saying it was only providing scientific advice to the developers.

Thursday’s announcement means the process to approve Sputnik across the EU has now begun.

The EMA wrote that its human medicines committee decided to begin the rolling review of the two-shot adenovirus vaccine “based on results from laboratory studies and clinical studies in adults.”

“These studies indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against COVID-19,” the EMA wrote in a press release.

Rolling reviews allow the EMA to review trial data as it comes in. Drug producers must still complete a conditional marketing authorization application before the EMA can finally recommend the vaccine for use in the EU. Afterward, the European Commission must sign off on the regulator’s decision.

So far, two EU countries, Hungary and Slovakia, have already gone ahead. Hungary has been using the vaccine after approving it on a national basis, and Slovakia has already received orders of the shot.

The agency is also currently undergoing a rolling review of the Novavax vaccine from the U.S. and CureVac from Germany, and it should make a decision on whether to recommend the Johnson & Johnson vaccine next week.

Source : Politico EU More