MOSCOW
The European Medicines Agency said on Wednesday that despite reports to the contrary, it has not received an application for a rolling review or marketing authorization for the Russian Sputnik V vaccine.
“The developers have received scientific advice from EMA providing them with the latest regulatory and scientific guidance for the development of their vaccine,” the agency said in a statement on its official website.
The agency is in dialogue with Russia’s Gamaleya National Center of Epidemiology and Microbiology before it submits an application for a rolling review, and the Sputnik V developers should reach agreement from the EMA’s Human Medicines Committee (CHMP) and the COVID-19 EMA pandemic Task Force (COVID-ETF), it said.
“EMA is committed to applying the same regulatory approach and scientific rigour to all vaccine applications that meet European requirements for safety, efficacy and quality and is in dialogue with more than 50 vaccine developers from across the globe,” the statement said.
All the new assessments of vaccines are posted on the EMA website, so if there are no announcements, then there is no change in the vaccine status, it said.
Russia was the first country to register a COVID-19 vaccine for public use – the Sputnik V – and was also the first to launch a mass vaccination drive.
The Sputnik V vaccine is to be administered through two injections and can be combined with other antigens, including those used against the flu.
On Wednesday, the Russian Direct Investment Fund (RDIF) said it held a consultation with the EMA on the issue of the Sputnik V registration and planned to submit a relevant application in about 10 days.
