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Kremlin mum on EMA move to probe ethical standards of Sputnik V’s trials

On April 6, the Financial Times reported that next week the EU drug regulator EMA would launch an investigation into whether clinical trials of Russia’s Sputnik V vaccine "contravened ethical and scientific standards"

MOSCOW, April 7. /TASS/. The Kremlin does not know if a probe into vaccines’ compliance with ethical and international standards is common practice of the EU drug regulator, the European Medicines Agency (EMA), Russian Presidential Spokesman Dmitry Peskov told reporters on Wednesday.

"To tell you the truth, we don’t know if this is common practice of the European agency or not," Peskov said. "I certainly don’t have this information."

The Russian Direct Investment Fund, "which maintains direct contact [with the regulator] and made a decision on preparing all the necessary documents, data and information, which could be related to the process of registering this vaccine in the EU," should be briefed on the matter, he noted. "So, I cannot assess this."

Peskov is unaware whether similar procedures were used in relation to other vaccines. "In the first place, those which have obtained the respective permission in the EU," he explained. "But once again, probably, it makes sense to repeat Sputnik V is still one of the most popular vaccines in the world and it enjoys a huge demand in many states."

The Kremlin spokesman also noted that the assessment of the EMA’s decision should be given depending on "whether this is part and parcel of the registration process." "If this is some extraordinary [case] probably some explanation should be given. Maybe, this concerns all vaccines. I just don’t know and that’s why I cannot give an exact answer," he said.

On Wednesday, the Financial Times reported that next week the EU drug regulator EMA would launch an investigation into whether clinical trials of Russia’s Sputnik V vaccine "contravened ethical and scientific standards."