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[Moscú, 4 de Reuters]- Sergei Martinov, director of the Moscow City Assets Authority, sent an email to his subordinates in late September. “What the heck is this negligence?”
Martinov expressed disappointment when his subordinates were clearly reluctant to volunteer in a clinical trial of the new Russian coronavirus vaccine, Sputnik V. The vaccine’s name is named after the artificial satellite that was launched by the former Soviet Union. for the first time in the world and unleashed space competition with the United States.
He noted that many of the clinical trial participation quotas for subordinates remain unmet. He also accused him of hearing that some people had taken steps to get the flu vaccine and were urging them to disqualify them from the new Corona vaccine. “Who is cheating?” “The Corona vaccine is a top priority,” he said.
He argued that even after receiving the influenza vaccine, he had to request a trial of the corona vaccine, which would be possible at one-month intervals. I also asked my friends and family to participate in the trial. “At least two people per employee,” he said.
Martinov has not responded to requests for comment. The Moscow Municipal Health Department said that Sputnik V had already passed the first two stages of the trial and was shown to be safe, and that participation in the trial was decided voluntarily by Moscow citizens and a medical examination. Said it is a prerequisite for passing.
However, Martinov’s email, read by Reuters, reveals how some Russian government officials are under heavy pressure to approve their participation in the trial. This could be contrary to the ethical code of voluntary participation required in clinical trials, according to experts in medical ethics.
A source close to the Moscow Municipal Assets Department admitted to Reuters that some 20,000 employees from all Moscow Municipal Departments were assigned to participate in the trial.
The Russian vaccine trial began in early September this year. It is currently in the final stages at 29 clinics in Moscow. The number of participants is already about 200,000. The Russian government says interim results show 92% effectiveness of the vaccine. The country aims to produce more than 1 billion inoculation doses at home and abroad next year.
Russian citizens have already been vaccinated before the end of the trial. The country’s regulators officially approved the vaccine in August. The number of new corona infections in Japan is the fourth highest in the world. According to the government, more than 100,000 people have already been inoculated, including military personnel, doctors and teachers, who are considered to be at high risk of infection.
President Putin said the vaccine “passed all tests” but has not yet taken it himself. According to the government, Putin’s position means that he cannot inoculate what is still under investigation. Putin said in August that one of his daughters had been vaccinated and the course has been good ever since.
Officials were mobilized in Moscow for the vaccine trial. Workers who depend on the government for their wages. A Reuters reporter visited 13 clinics for a total of 6 days in October and a total of 3 days in November, and interviewed 32 clinical trial participants. Thirty of them said they had discussed the trial at work. Twenty-three of the 32 responded that they were purely volunteers. Many of them spoke enthusiastically about the importance of participating in the clinical trial.
However, nine responded that they were not really volunteers. All of them were civil servants. Some said they felt they could not refuse the employer’s request for participation. However, after they arrived at the clinic, medical examinations showed that they were not eligible to participate in the trial, or the clinic staff gave them an excuse to avoid participating.
Some said they went to the clinic but refused to participate in the trial. No one responded that they were vaccinated against their will.
However, medical ethicists believe that these pressures on public officials may be abusing the ethical guidelines of clinical trials.
According to Julian Sablesque, a professor of ethics at the University of Oxford, UK, generally speaking, if you think that refusing to participate in a trial will come at a cost, it is mandatory and is never justified in the United States or Western countries. It is said that.
Jonathan Ives, associate professor at the Center for Medical Ethics at the University of Bristol, said it depends on the relationship between the parties. “If pressure is applied from the employer to participate in the trial, however slight, and if the employee feels that the pressure may not be accepted, work and well-being may be threatened, this is mandatory. I am very concerned about this “.
The “Russian Direct Investment Fund,” which is responsible for supporting Sputnik V development and selling abroad, declined to comment. Officials from the Ministry of Health, which has jurisdiction over the Gamalaya Institute, which develops the vaccine, have stated that participation in the trial is only possible on a voluntary basis.
＜Mandatory＞
With Sputnik V now approved by regulators, some officials have directly ordered staff to be vaccinated. In a message sent to Wattsup in October, Olga Tuvetkova, deputy director of Medical Affairs at Moscow City Clinic No. 3, said: “This clinic has issued a mandatory vaccination order for all staff with the new corona vaccine. It is based on the supervision of the Moscow City Department of Health. ” Reuters read the statement: “If you refuse to be vaccinated, you can be suspended. There is a legal basis for this.”
When we asked the third clinic for a comment, Moscow is one of the few areas where medical workers have the opportunity to receive corona vaccination, and the vaccination order for staff cares about staff. There was a response of which it was a sign. The statement stated that “the staff voluntarily decides on vaccination, only if they pass a medical examination.”
According to Sabresque of the University of Oxford, if there is sufficient scientific evidence for the safety of the vaccine, it can be ethically inoculated during the trial. It is of the opinion that the mandatory vaccination policy can only be justified after safety has been sufficiently confirmed.
He also said that he could not comment on the Russian government’s decision because he had no data on the safety of Sputnik V. The Russian researcher said there have been no unexpected side effects so far and that he is also observing the participants. However, details of the safety data have not been released.
Mandatory vaccination is common in the US healthcare business In the past, the US Department of Occupational Safety and Health (OSHA) has stated that employers have the right to enforce vaccination.
In Europe, vaccine regulations vary from country to country. Some countries require vaccinations for children, but experts say there is generally little space between employers and employees to require vaccinations from employees.
＜ National officials ＞
In the international community, standards have been established to ensure the ethical aspects of participation in clinical trials. The “Declaration of Helsinki” guidelines of the World Medical Association (WMA) are governed by most countries in the world, but the people participating in the trial voluntarily accept and accept all possibilities related to the trial. It says that participation must be guaranteed.
Russia will adopt another guideline established by the International Conference on Harmonization of Drug Regulation (ICH). This guide also states that participation in clinical trials must be voluntary. It also includes the signing of notification-based consent documents (informed media). In Moscow, participants sign a 16-page consent document declaring that participation is voluntary and unpaid and that “it is impossible to rule out the possibility of unexpected and unwanted effects.”
Employees of the Moscow Municipal Assets Authority, like employees of other organizations funded by the Russian National Budget, are “reliable means” to mobilize when the government needs to increase turnout in presidential elections and referendums. It is often spoken as.
According to Dennis Borkov, deputy director of the Levada Center, an independent voting agency in Russia, many Russians in jobs where the government has the tax source feel compelled to do what the government wants. They feel that it is part of the social contract between them and the country.
“The country asks me. Instead, the country takes care of me and provides me with financial wealth.” “This is a delicate game. The country does not force it, but it convinces and convinces or makes some recommendations,” he said.
According to a recent estimate by the National Statistical Office of the Russian Federation, there are about 19 million such employees working in schools, hospitals and community health agencies in the country. That’s just 26% of Russia’s working-age population of just under 72 million.
