EMA To Look Into Compliance With Ethical Standards In Sputnik V Clinical Trials - Reports

The European drug regulator is set to launch a probe into compliance with ethical and scientific standards during the clinical trials of Russia's Sputnik V coronavirus vaccine next week, the Financial Times reported on Wednesday

MOSCOW (UrduPoint News / Sputnik - 07th April, 2021) The European drug regulator is set to launch a probe into compliance with ethical and scientific standards during the clinical trials of Russia's Sputnik V coronavirus vaccine next week, the Financial Times reported on Wednesday.

According to the newspaper, the EMA plans to review whether Sputnik V clinical trials followed the international "good clinical practice" standards that enforce due process.

Marco Cavaleri, a senior official at the EMA, announced earlier in March that the agency would send a team of experts to Russia in April to review clinical trials and the production of the Sputnik V coronavirus vaccine.

In early February, scientific journal Lancet published the results of the third phase of clinical trials of Sputnik V which confirmed its safety and 91.6 percent efficacy. The trials showed that the vaccine provides complete protection against severe cases of the coronavirus infection.

Sputnik V vaccine has been approved for use in nearly 60 countries with a total population of over 1.5 billion people. Sputnik V ranks second in the world in terms of the number of approvals received by government regulators.