Europe Covid vaccines: Regulator probes Sputnik V over ethical concerns

EU is investigating claims Russia’s Sputnik V trials contravened ethical and scientific standards and test subjects were ‘forced to take part’

  • European Medicines Agency will probe whether ‘volunteers’ were pressured to take part in Sputnik V vaccine trials in Russia 
  • Comes after texts were uncovered showing boss of government office berating his staff for failing to sign up for the trials 
  • EMA is currently reviewing Sputnik V for use in Europe to speed up jab roll-out 
  • If it is found to have breached ethical standards, it will not be approved for use 

Europe’s drug regulator will investigate whether Russia‘s Sputnik V vaccine violated ethical testing standards because subjects were pressured to take part.

The European Medicines Agency, which is conducting a review into whether Sputnik V can be used in Europe, will begin its probe into the ethical concerns next week. 

If Russia is found to have breached ‘good clinical practice’ guidelines during the trial, then the jab will not be approved for use.

Europe’s drug regulator is set to probe claims that state employees an military servicemen were pressured to take part in trials of its Sputnik V vaccine (file image)

It comes after concerns that state employees and military servicemen were used for trials of a vaccine made by a state-backed laboratory that was funded using state cash, creating a conflict of interest.

In December last year, the Reuters news agency also published texts that it said were sent from the manager of a state office in Moscow pressuring his staff to sign up for the trials.

‘Colleagues!!!… What is this sabotage???,’ Sergei Martyanov is alleged to have told staff when they refused to sign up for the trials – including some who signed up for flu shots which disqualified them from the study.

‘Who are you trying to trick??? The coronavirus vaccine is the absolute priority!!!’ he allegedly wrote, before demanding that staff recruit their friends and family as well.

‘At least two people per employee!’ another text read.

Moscow at the time denied that anybody had been forced to take part in the trial, saying participation was voluntary and happened only after a medical exam.

News that the EMA will be investigating the ethics surrounding Sputnik V trials was first reported by the Financial Times.

Those involved in the probe, which has not been formally announced, said they had concerns that it was not ethically run.

The European Medicines Agency is currently reviewing Sputnik V for use in Europe, but if it is found to have breached ethical standards it will not be approved

The European Medicines Agency is currently reviewing Sputnik V for use in Europe, but if it is found to have breached ethical standards it will not be approved

Kirill Dmitriev, head of Russia’s state-backed investment fund which helped develop the jab, denied the use of coercion.

He said: ‘There was no pressure [on participants] and Sputnik V complied with all clinical practices’. He added the EMA inspection was scheduled to begin next week.

The Sputnik V jab has been touted as a way for Europe to give a much-needed boost to its stuttering vaccine roll-out, which is among the slowest in the world.

But Thierry Breton, who is spearheading the bloc’s roll-out, declared last month that Europe has ‘absolutely no need of Sputnik V’.

Instead, the bloc is hoping to increase the speed of its roll-out from this month by relying on increased deliveries of already-approved jabs such as Pfizer, AstraZeneca and Moderna.

Some EU members states such as Hungary and Slovakia have bypassed the EU and bought up supplies of Sputnik to use in their roll-outs and approved them under emergency medical powers within their own countries.

Hungary, which has also bought jabs from China, has one of Europe’s fastest vaccine roll-outs.