(Reuters) -The EU drug regulator will begin investigations next week on whether clinical trials of Russia’s Sputnik V COVID-19 vaccine followed global clinical and scientific guidelines, the Financial Times reported on Wednesday.
The FT report https://www.ft.com/content/50031165-1f46-446b-be9a-36d553805fec cited unidentified people familiar with the European Medical Agency’s approval process as having expressed concern that the Sputnik V trials may not have met ethics standards.
The FT did not describe those concerns in detail. Its report referred to allegations that some participants may have been compelled to participate.
The official twitter handle for Sputnik V called the FT report “fake” and “incorrect” in a tweet later on Wednesday.
“Sputnik V team is going through a regular rolling review of EMA, in which good clinical practice (GCP) is a part of the standard procedure for all vaccines,” the tweet https://bit.ly/39Sz149 added.
Kirill Dmitriev, head of Russia’s Direct Investment Fund, told the newspaper, “There was no pressure (on participants) and Sputnik V complied with all clinical practices”.
(Reporting by Aakriti Bhalla in BengaluruAdditonal reporting by Aishwarya Nair in BengaluruEditing by Jacqueline Wong)