The EMA will examine Sputnik V for “Good Clinical Practice (GCP)” Standards
The European Union (E.U.) drug regulator – European Medicines Agency (EMA) will launch an investigation next week to check if clinical trials of Russia’s Coronavirus (COVID-19) vaccine Sputnik V broke scientific and ethical standards.
The EMA will examine the vaccine for “Good Clinical Practice (GCP)” Standards. The GCP is an internationally agreed standard aimed at ensuring that drug trials are designed and conducted properly.
However, a report by international daily “Financial Times” stated that some people who took part in the trials have said they were forced by their seniors to make it a success. Russia has termed the media report as false.
Taking it to twitter, the official twitter handle of Sputnik V tweeted,
1) Report of a special investigation into #SputnikV clinical trials published in FT today is incorrect. 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.
— Sputnik V (@sputnikvaccine) April 7, 2021
It further tweeted,
Sputnik V specifically invited EMA to conduct a rolling review and is showing full transparency. 59 countries already confirmed Sputnik V compliance with GCP and we expect EMA to do so as well.
— Sputnik V (@sputnikvaccine) April 7, 2021
Claiming its vaccine to abide by all the international standards, Russia said that military servicemen and State employees were involved in trials of the jab developed by a State-run laboratory and funded by the Russian Direct Investment Fund (RDIF), the Kremlin’s sovereign wealth fund.
Speaking to media, the Chief Executive Officer (C.E.O.) of RDIF – Kirill Dmitriev said, “There was no pressure [on participants] and Sputnik V complied with all clinical practices.”
Russia is pitching Sputnik V as a possible solution to the vaccine crisis of E.U. especially after AstraZeneca confirmed it will not be delivering the agreed doses on time. Hungary and Slovakia have already gone against the E.U. protocol and procured Sputnik V.
As per E.U. protocol, the vaccines are to be procured centrally and will be distributed among the Member States. The EMA has so far nit approved the Sputnik V. Germany is also in talks with Russia for procuring the vaccine, if approved by their Health Minister – Jen Spahn.
A statement from EMA read, “Compliance with this standard provides assurance that the rights, safety and wellbeing of trial participants are protected, and that clinical-trial data are credible.”
Dmitriev also said, “We are not aware of any concerns from the EMA regarding GCP and leaks of such concerns are a specific example of people trying to undermine the EMA approval process which is supposed to be unbiased and without discrimination.”
Separately, a scheduled inspection of Sputnik V’s production facilities in Russia by EMA has been delayed because of the need to accommodate visits from inspectors from countries that had placed orders for the jab.
