(Reuters) – The EU drug regulator is unlikely to decide whether to approve Russia’s Sputnik V coronavirus vaccine until at least the first quarter of 2022 because some data needed for the review is still missing, a source with knowledge of the matter said.
“An EMA decision by the end of the year is now absolutely impossible,” the source said, referring to the European Medicines Agency.
If the required data is received by the end of November, “then the regulators may well decide in the first quarter of next year”, he said. He declined to be identified due to the sensitivity of the matter.
The EMA, which launched its formal review of the Russian vaccine in March, had previously been expected to decide in May or June whether to approve use of the shot.
The results of Phase III trials published in The Lancet in February have shown it is almost 92% effective. Russia said later Sputnik V is around 83% effective against the Delta variant.
The vaccine is widely used in Russia and approved for use in more than 70 countries. The source said there was no reason to doubt its effectiveness or safety.
Gamaleya Institute, which is supervised by Russia’s health ministry, developed the vaccine and oversaw the clinical trials, while Russia’s sovereign wealth fund, the Russian Direct Investment Fund (RDIF), markets Sputnik V overseas.
In a response to the story, RDIF said its vaccine showed superior efficacy and longer-lasting immunity compared to mRNA vaccines and reiterated that its one-dose “Sputnik Light” vaccine could be used as a booster.
RDIF also complained of what it called press attacks against Sputnik V based on what it said was incorrect information.
Alexei Kuznetsov, an aide to the Russian health minister, said the ministry was finalising paperwork required by the EMA and discussing dates for site visits which it expects to happen this year.
Kremlin spokesman Dmitry Peskov, commenting on the EMA’s certification process for Sputnik V, said there were technological disagreements between the regulator and the Russian side regarding the completeness of submitted documents and information for registration.
“We are only talking now about technical formalities and they will be resolved,” Peskov said.
The EMA said in an email the vaccine remains under rolling review until sufficient evidence is available for a formal marketing authorisation application.
