Are Russian public sector workers getting coerced into participating in the Phase 3 Sputnik V COVID-19 vaccine trial in that country? If a recent Reuters report is correct, the answer is unfortunately affirmative. Although actual visits to clinical trial sites where individuals are getting jabs reveal most Russians are voluntarily participating, a handful appear to be getting pressured at the workplace from bosses who threaten them with peer pressure at best and potential loss of economic livelihood in worse case scenarios. Although there are no reports of anyone getting jabbed completely against their will, nonetheless ongoing pressure on state employees pushes the ethical boundaries associated with good clinical practices (GcP). This type of behavior should outrage the clinical research community.
Although an aid at the health ministry which oversees Gamaleya Institute, the state-owned research and development center where Sputnik V was developed shared that all participation in this ongoing clinical trial is on a “voluntary basis.” Alexei Kuznetsov didn’t of course share what Reuters reports on the ground are hearing about: that “some officials have outright ordered staff to receive the shots.”
For example, Olga Tsvetkova, deputy chief medical officer at Moscow’s Clinic Number 3 instructed staff there: “Our clinic has been issued with a compulsory anti COVID-19 vaccination order for all employees. This is being supervised by the Moscow Health Department.” She continued, “If you refuse to get vaccinated, you could be suspended from work. There is a legislative basis for this” as was included in a WhatsApp message seen by Reuters staff.
Trying to Finish the Phase 3 After Regulatory “Registration”
The Russian health authorities actually authorized or approved Sputnik V, on an emergency basis before even starting their Phase 3 clinical trial. As TrialSite has written, Russia even rushed the Phase 1 and 2 studies for Sputnik V. Helping the research teams accelerate the collection of data was unorthodox and unethical inoculation of “volunteers” prior to even the start of Phase 1 studies in some cases. Many people have been inoculated in Russia with an unproven drug even though the Russian claim that the Sputnik V vaccine has an effective rate of just over 90%.
Call to Action: Follow the link to Reuters to read more. Search TrialSite for more stories on Sputnik and some of the unorthodox behavior that has occurred with the Sputnik V program.