Russian state employees describe pressure to join vaccine trials

[December 04, 2020]  By Polina Ivanova, Rinat Sagdiev, Gleb Stolyarov and Kate Kelland

MOSCOW (Reuters) - In late September, Moscow municipal official Sergei Martyanov sent a series of text messages to his subordinates: "Colleagues!!!... What is this sabotage???"

Martyanov was expressing dismay at his staff's apparent reluctance to volunteer for the human trials of Russia's Sputnik V coronavirus vaccine, named after the Soviet-era satellite that triggered the space race. The official in the Moscow department of city property said many quota spots for his staff to join the trial remained unfilled.

He said he had heard some workers were signing up to receive flu vaccines, making them ineligible for the coronavirus trial.

"Who are you trying to trick???" Martyanov said in the texts. "The coronavirus vaccine is the absolute priority!!!"

Anyone who had received the flu jab, he said, must still sign up for the COVID trial, allowing a month's delay. He urged his colleagues to recruit friends and family into the trials. "At least two people per employee!"

Martyanov, the head of his department and Moscow's city administration did not respond to requests for comment. The Moscow health department said the vaccine has already successfully passed two stages of clinical trials and has shown its safety, and the decision to participate in the trial is made by residents only voluntarily and only after a medical examination.

But the messages, seen by Reuters, reveal how some Russian state employees are coming under heavy pressure to sign up for the trials, an effort that medical ethicists say may run afoul of ethical norms for voluntary participation in such tests.

A source close to Martyanov's department told Reuters that all departments in Moscow's city administration, which employs around 20,000 people, were set quotas for participation in the trials.

Russia's vaccine testing began in early September and is in its final phase in 29 clinics across Moscow. About 20,000 people have already taken part. The government says interim results show the vaccine is 92% effective. The country aims to produce more than a billion doses of the shots at home and abroad next year.

Even before the trials have been completed, Russians are already receiving the vaccine. The medicine received formal regulatory approval from Russian authorities in August; Russia, which has the world's fourth-highest number of recorded COVID-19 cases, says it has so far inoculated more than 100,000 people considered at high risk such as military personnel, doctors and teachers.

President Vladimir Putin has said the vaccine "passed all checks." Putin himself has yet to be vaccinated, however: His position means he cannot take something that is still being tested, the Kremlin says. In August, Putin said one of his daughters had been inoculated and was fine afterwards.

In conducting the trials, Moscow is helped by legions of Russian public sector workers who rely on the government for their pay. Over three days in November and six days in October, Reuters reporters visited 13 of the trial clinics and spoke to 32 trial participants. Thirty of the 32 said they had been told about the trial at work.

Of the 32, 23 people said they were genuine volunteers. Most expressed enthusiasm for participating in the trial.

Nine said they were not true volunteers. All nine were public sector workers who spoke on condition of anonymity. A few said they felt they could not refuse their employers' entreaties to seek the vaccinations, but that after they arrived, medical tests had shown them to be ineligible, or staff gave them reasons they could use to opt out.

Some said they got as far as the clinic and then simply refused to take part. None said they had been injected against their will.

Medical ethicists said the pressure being put on state employees may nonetheless be stretching the norms of ethical testing guidelines.

Generally speaking, if people feel there's a cost to them if they refuse to take part in a trial, that is coercion, which wouldn't be justified in the United States, the UK or other Western countries, Oxford University ethics professor Julian Savulescu told Reuters.

Jonathan Ives, a reader in empirical bioethics at Bristol University's Centre for Ethics in Medicine in Britain, said that what counts as coercive can depend on the relationship between those involved.

"Even if very light pressure is being put on an employee by an employer to take part in a trial, and that employee feels their job or wellbeing may be at risk if they do not accede to that pressure, I think this would be coercive, and I would be very concerned about that," he said.

The Russian Direct Investment Fund, which is backing the vaccine's development and responsible for its marketing abroad, declined to comment.

Alexei Kuznetsov, an aide at the health ministry, which oversees the Gamaleya Institute where the vaccine is being developed, said the participation of volunteers in clinical trials "is possible only on a voluntary basis."

"COMPULSORY"

With the vaccine already approved, some officials have outright ordered staff to receive the shots.

"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," Olga Tsvetkova, deputy chief medical officer at Moscow's Clinic Number 3, announced in a message to staff in October.

"If you refuse to get vaccinated, you could be suspended from work. There is a legislative basis for this," she wrote in the WhatsApp message seen by Reuters, without elaborating.

Asked to comment, Clinic Number 3 said Moscow is one of the few regions where healthcare workers are given the opportunity to be vaccinated against the coronavirus, and the order to vaccinate employees of the clinic shows the degree of care it takes.

"The decision on vaccination is made by employees voluntarily and only after passing a medical examination," it said in a statement.

Moscow's health department did not comment on that order.

Savulescu, the Oxford professor, said a vaccine can be ethically rolled out while clinical trials are still underway if there is enough evidence it is safe. "If you have reached that point, then, it is possible to justify a mandatory policy," he said.

He added that without knowing the safety data on Sputnik V, it was not possible to comment on Russia's decision. The trial organisers have said there were no unexpected adverse events so far and monitoring of the participants is ongoing, but detailed safety data has not been published.

A medic of the regional hospital receives Russia's "Sputnik-V" vaccine shot against the coronavirus disease (COVID-19) in Tver, Russia October 12, 2020. REUTERS/Tatyana Makeyeva

Mandatory vaccination is common in the U.S. healthcare industry; the U.S. Occupational Safety and Health Administration (OSHA) has said in the past that employers have the right to mandate vaccines. In Europe, there is a patchwork of national vaccine regulation. Some countries mandate childhood vaccinations, but experts say employers overall are unlikely to be able to do so for staff.

BUDZHETNIKI

The world community has established norms for ensuring ethical participation in clinical trials. According to guidelines in the World Medical Association Declaration of Helsinki, used by most countries globally, individuals taking part in clinical trials must be capable of giving consent, informed of all aspects of the trial that are relevant to them, and taking part voluntarily.

Russia has adopted a different set of internationally agreed guidelines - from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). These also say participation must be voluntary.

The process includes signing an informed consent form. In Moscow, participants sign a similar 16-page document which says participation is voluntary, unpaid, and that "it is impossible to exclude the possibility of the development of an unexpected undesired effect."

Staff in Martyanov's department, like others who work for institutions that are financed from the Russian state budget, are known as 'budzhetniki,' or 'budgetniks.' Their ranks are often described in Russia as a reliable tool for the Kremlin when it needs large numbers of people to participate in projects such as voting in elections or referendums.

Sociologist Denis Volkov, deputy director of the Levada-Center, an independent opinion and sociological research organization, said many Russians with government-funded jobs feel duty-bound to deliver what the government wants as part of a social contract between them and the state.

"You are asked by the state, and in exchange it takes care of you and provides you with financial prosperity," he said. "It is a delicate game. They won't force you but will persuade you, convince and give recommendations."

According to recent estimates from the Federal State Statistics Service, there are almost 19 million budzhetniki working in jobs in areas such as schools, hospitals, or municipal hygiene in Russia. That's 26% of Russia's working-age population of just under 72 million.

"HERDED IN"

At a clinic in Solntsevo, a neighbourhood of high-rise apartment blocks on Moscow's outer edge, five people turned up to join the trial over the course of an hour. All five, approached by Reuters, said they didn't actually want to take part but had felt they had to - they were among the nine public sector workers who said their bosses had pressured them to take part.

"They herded us in here," one middle-aged emergency services worker said. His whole team was told they had to sign up, he said. "It's impossible to say no, you just can't."

Moscow emergency services said participation in vaccination trials was "absolutely voluntary, there was no coercion against the personnel," and so far 101 volunteers have been vaccinated.

A teacher said that the school where he worked had been allocated a quota of trial spots, but it was more than simply an invitation to take part.

"If they say you have to come, you have to come," the teacher said, adding that 17 staff members signed up.

Two hospital workers said they had been sent by their employer. And a worker with a street-cleaning company said he and his colleagues had been told participation was compulsory because they come face-to-face with city residents in the street.

Asked if he could decline, he laughed: "No, we work for the public sector."

All five people at the clinic were ultimately deemed ineligible, so they wound up not receiving the shots.

But one woman aged around 50 at Polyclinic Number 68 in central Moscow took a different view. She said her employer had compelled her to attend, but she had only turned up to exercise her right to formally refuse a jab.

"I don't want to be a guinea pig," she said.

"NO DOWNSIDES"

Most Muscovites Reuters spoke to were keen to join the trials. Asked about side effects, some volunteers who had already had one of the two-jab doses variously described feeling drowsy and said their temperatures briefly rose at the start. None reported any serious impact.

At Clinic Number 68, a worker with state bank PJSC Sberbank, the largest lender in Russia, said he was offered the vaccine at work and that the first stage of the process - the medical exam - could be done in the company's office. Sberbank said it had actively supported the vaccine development and employees could volunteer for trials but no medical exams took place in its offices.

"You don't need to go around the different clinics. If you want (to be vaccinated) - go ahead. If you don't want to - so be it," he said. "I didn't see any downsides."

Anton Shirkin, a park worker, said he decided to participate because he frequently visits his elderly parents and because "ultimately, someone has to do it."

(Reporting by Polina Ivanova, Rinat Sagdiev, Gleb Stolyarov in Moscow and Kate Kelland in London; with additional reporting by Maria Tsvetkova, Vladimir Soldatkin, Polina Nikolskaya and Anton Zverev in Moscow and Marisa Taylor in Washington; Edited by Sara Ledwith)

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