Health regulators in Europe are set to investigate whether volunteers participating in Russia’s Sputnik V vaccine trials were pressured to take part, according to reports.
The European Medicines Agency (EMA) is already evaluating whether Sputnik V can be used in Europe and it is also expected to investigate whether the vaccine trial adhered to accepted international standards known as “Good Clinical Practice” (GCP).
It comes after text messages were published in December that newswire Reuters said was from the manager of a state office in Moscow pressuring his staff to sign up for the trials.
Staff had been accused of signing up for flu shots which precluded them from being injected with the trial vaccine. The manager Sergei Martyanov is alleged to have texted: ‘Colleagues!!!… What is this sabotage???,’
‘Who are you trying to trick??? The coronavirus vaccine is the absolute priority!!!’ he allegedly wrote, asking staff to recruit friends and family.
The EMA is expected to announce next week it will look into whether the Sputnik trials were conducted ethically, according to a report in the Financial Times newspaper, which said participants comprised of state employees and servicemen. The trial was part funded by the Kremlin’s Russian Direct Investment Fund (RDIF)
The boss of the RDIF Kirill Dmitriev, told the newspaper the EMA inspection was scheduled to begin next week adding: “There was no pressure [on participants] and Sputnik V complied with all clinical practices”.
The EMA said: “While the evaluation of Sputnik V vaccine is ongoing we cannot comment on planned or ongoing inspections. The need for GCP inspection of the conduct of a clinical trial is considered on a case by case basis by EMA’s scientific Committee for Human Medicines, CHMP.”
Other vaccines being used around the world include ones developed by AstraZeneca
Johnson & Johnson