EU watchdog to launch investigation into Sputnik trials
The European Medicines Agency (EMA) is set to look into whether or not the clinical trials conducted on Russia's Sputnik vaccine were done in a safe and ethical way and to specific scientific standards.
The agency wishes to know if the vaccine trials were conducted in good faith after fears the trials had not been conducted ethically.
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The FT reports sources within the EMA are concerned the vaccine was not conducted under "good clinical practice" (GCP) - an internationally agreed metric by which clinical trials are conducted as a way of attempting to standardise procedures.
Russia has been prepping the Sputnik vaccine for international, primarily EU, launch following shortages that have hampered the EU's efforts to inoculate its population.
Italy has been chosen as the hub for production of the jab after signing an agreement with Swiss-based Adienne.
The jab was sent in for EMA certification last month, and it is likely these probes will have to be completed before rollout can commence.
In a statement, the EMA said: “Compliance with this standard provides assurance that the rights, safety and wellbeing of trial participants are protected and that clinical trial data are credible."
The Russian state has said the military and state employees were involved in the trials run by the Russian Direct Investment Fund (RSIF).
It was later reported by Reuters that people involved in the project were pressured to do so by their superiors.
However the head of the RDIF, Kirill Dmitriev denied coercion.
He told the FT the vaccine trials were conducted under GCP and there was no pressure on participants.
He also added that regulators in most EU nations had already approved the vaccine.
However, scepticism towards the vaccine has resurfaced following Argentinian president Alberto Fernández's recent diagnosis of Covid-19 despite receiving the Sputnik jab back in January.
His diagnosis was confirmed over the weekend.
There has also been controversy within Greek politics as Prime Minister Kyriakos Mitsotakis has clashed with opposition leader Alex Tsipras over whether or not the nation should order the vaccine.
Tsipras has urged the Prime Minister to follow suit with other EU nations and order doses of the vaccine.
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Furthermore, a separate EU investigation into the Sputnik production facilities in Russia next month has been delayed by a few days owing to the need to accommodate inspectors representing nations who have already ordered the vaccine, such as Hungary or Slovakia.
The EU's vaccine shortage has coincided with a third-wae of coronavirus which prompted further lockdowns over the Christmas period.
This has caused some level of anger within the population of countries such as Germany, whose industry has been gripped by the crisis.
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