The European Union’s drug regulator will investigate Russia’s clinical trials of the Sputnik V vaccine and whether those tests followed “good clinical practices,” the Financial Times reported.
The U.K.-based paper on April 7 cited anonymous sources familiar with the European Medicines Agency’s (EMA) approval process as saying there were ethical concerns over how Sputnik V was tested before it was released for general use.
Approval of the vaccine for the European Union will hinge in part on determining whether the Russian clinical trials met so-called GCP standards, the paper reported.
Sputnik V, which has been backed by the Russian sovereign wealth fund known as RDIF, has been dogged by controversy after it was approved for use in Russia in August 2020 despite not undergoing full Phase III testing procedures that are used for all vaccines, including other COVID-19 vaccines.
According to a study published in February in The Lancet, a prestigious peer-review publication in the U.K., the vaccine is as effective as other major vaccines being used around the world.
Hours after the Financial Times report, the Twitter handle for Sputnik V, controlled by RDIF, called the report “fake” and “incorrect.”
“Sputnik V team is going through a regular rolling review of EMA, in which good clinical practice is a part of the standard procedure for all vaccines,” the tweet said.
The newspaper, meanwhile, quoted RDIF head Kirill Dimitriev as saying: “there was no pressure [on participants in testing] and Sputnik V complied with all clinical practices.”
It is being used in Russia and dozens of other countries have granted emergency use despite the early misgivings.
But it has yet to receive EU regulatory approval, although EU members Hungary and Slovakia have purchased it, and begun rolling out its use.
U.S. regulators have also not approved it.
Russian President Vladimir Putin personally oversaw the announcements last August touting its approval. However, when he himself finally received a COVID-19 vaccine last month, neither Putin, nor the Kremlin, revealed what exact vaccine he had received.