'Not everyone knows why they came': how the Russian vaccine against COVID-19 is tested in humans

Russian authorities call the development of Sputnik-V by the Gamaleya Center the first registered coronavirus vaccine in the world. The daughter of Russian President Vladimir Putin and dozens of high-ranking officials and businessmen have already tested the vaccine, but its effectiveness has not yet been officially confirmed - first the drug must undergo the 3rd stage of clinical trials. 40 thousand Russians will participate in them on a voluntary basis. Bi-bi-si watched the progress of this study, who is participating in it and why not all of them can be called volunteers.

Photo: Shutterstock

- Hello! Are you from the organization or did you come yourself?

With this question, the reception staff at one of the Moscow polyclinics meet those who have come to participate in the third phase of the coronavirus vaccine trial.

The drug “Gam-COVID-Vac”, better known under the brand name “Sputnik-V” and developed by the N.F. Gamaleya Center for Epidemiology and Microbiology, is being tested.

In mid-August, Russian President Vladimir Putin announced it as the world's first registered vaccine against coronavirus infection.

“I know that it works quite effectively, forms a stable immune system and, I repeat, has passed all the necessary tests,” the president announced then.

True, Putin did not mention that the vector two-component vaccine based on adenoviruses received only limited registration - until January 1 of next year, since Sputnik-V passed only two stages of testing out of the three required. The study “Gam-COVID-Vac” was tested on animals and only 38 volunteers (only 20 of whom received both components of the drug). The third phase of testing, which began in September, should involve 40 thousand people.

“The main thing is to check in”

At noon, the corridor reserved for volunteers is quite crowded - at least ten people are waiting in line. Some are just preparing for the mandatory screening before vaccination, others have come to receive the first or second dose of the drug.

Among all the volunteers sitting outside the office, the BBC correspondent is one of the few who came to the study after learning about it from the media. Most were referred to voluntary testing by the very “organizations” that participants are asked about at the entrance.

Three of the volunteers who came for tests before vaccination are colleagues who work in one of the organizations in the housing and communal services sector. Their bosses asked them to sign up for the study “without fail” because of “working with people.” They decide whether it is dangerous to test a vaccine on themselves that has not passed all the necessary stages of the study “after the examination.”

Clinic staff keep a list of everyone who is participating in the trials from the “organizations.” Several state employees, whom the BBC found, came to the clinic only to refuse the vaccine. Their names, surnames and places of work are written down at the reception desk with the note “refusal” - “in case they call to check.”

One of them, a young man, explains to the doctors that he came for vaccination from one of the Moscow district administrations, but has doubts - together with his wife, he and his wife are preparing to have a child.

“This could have some effect,” he says hesitantly.

“So it’s not for you to give birth,” the employees object.

As stated in one of the chapters of the informed consent that is given to volunteers (available from the BBC), the effect of Sputnik V on sperm “has not been studied,” so volunteers are not recommended to try to have a child during the study. The doubtful man writes a refusal and leaves.

— Are you from Lukoil? — the employee switches to the woman who approached the counter.

- No... I only returned recently. At work they told me to just take the tests.

- Here they vaccinate, you go back and down the stairs.

Soon several more state employees arrive - one in a jacket with the words “Highways” written on it. Two men are already receiving the second dose, two more are writing a refusal to be vaccinated.

— You won’t have any consequences in the organization? — the clinic staff carefully ask, copying down the data.

- No, the main thing is to check in!

Already in the courtyard, those who refused to meet their colleagues, who are also sent to the clinic. They are discussing who and when managed to get vaccinated against the coronavirus.

During half an hour of waiting for an appointment, the BBC correspondent noticed at least two more women who were sent for the study from budgetary organizations subordinate to the Moscow mayor's office - one of them was waiting for the examination before vaccination and carefully read the informed consent, the other wrote a refusal to participate.

The BBC correspondent does not name the number of the clinic, as well as the names of the doctors and the specific places of work of the volunteers, so as not to harm their interests.

On the subject: Russian vaccine against COVID-19 went into circulation: scientists doubt the authenticity of the data about it

Six months for the third phase

It is usually during the third stage of vaccine testing that scientists determine how effective the vaccine is - sometimes the final phase lasts several years.

Competitors of the Russian drug - for example, a vector vaccine with a similar operating principle, which is being developed by Oxford University and AstraZeneca - began the third phase of research back in July, but have not yet announced “registration” like the Russian authorities.

In recent months, high-ranking officials and businessmen have tried Sputnik-V for themselves, Bloomberg wrote.

Vladimir Putin said that among the volunteers was one of his daughters, who developed antibodies and had only a slight fever after vaccination. Moscow Mayor Sergei Sobyanin recently announced that he had also been vaccinated against coronavirus infection. Defense Minister Sergei Shoigu also managed to get vaccinated.

As TASS reported, in early September, Sputnik-V actually went into civilian use.

“People from risk groups, in particular teachers and doctors, began to receive the drug,” the agency wrote. The BBC correspondent did not meet representatives of these professions at the clinic where the screening took place.

TASS clarified that mass vaccination of specialists from risk groups, which includes schoolchildren, students, conscripts, social security employees, trade workers, etc. - will begin at the end of October-November 2020.

At the same time, according to a study by United Russia, 73% of Russians are not yet ready for vaccination.

Two top managers of large state-owned companies told the BBC that, against the backdrop of the second wave of the virus, it is now difficult even for influential people to get a vaccine outside of trials due to high demand. Therefore, now the easiest way to get vaccinated is to sign up for the tests that started in September at the Moscow Gamaleya Center.

Of the 40 thousand volunteers who will participate in the Sputnik V study, 30 thousand will be given two doses of the real drug, and another 10 thousand will be given a placebo.

Officially, the study lasts six months. You can sign up for vaccinations through the form on the mos.ru website. The compilers of the questionnaire ask potential participants whether they have had time to recover from COVID-19 (they only take those who have not developed specific antibodies) and whether they have allergies or serious diseases.

You can come to the research, which is carried out on the basis of several Moscow clinics, from the street, confirmed the BBC at the reception. One of the potential volunteers told the doctors in front of the correspondent that he just saw the signs in the yard and decided to find out if it was possible to get vaccinated against the coronavirus.

Those who register on mos.ru are invited for an examination 7-10 days after the application is submitted. At the screening, those who wish are examined, tested for COVID-19, HIV and drugs; women are additionally tested for pregnancy. After that, the volunteers are explained the possible risks, they are offered to sign an informed consent, and an insurance policy is issued.

Those who are invited for vaccination based on the results of the tests are recommended to download the “electronic volunteer diary” application on their smartphone to report on their well-being. Those who cannot or do not want to install the program will be contacted by telemedicine center specialists by telephone. The second dose of the drug is administered 21 days after the first vaccination. You can refuse to participate in the study at any time.

Out of curiosity and fear of getting sick

Other media outlets have also written about the fact that state employees are being involved in vaccine research, for example, “Proekt” and “Meduza”. But in recent weeks, the BBC correspondent also spoke with those volunteers who decided to test Sputnik-V independently and voluntarily: some out of fear of getting sick, others out of curiosity

MBH Media correspondent Anastasia Olshanskaya told the BBC that she decided to try the vaccine on herself out of “banal curiosity and a thirst for adventure.”

“I’m a journalist, I constantly communicate with people and I can easily get infected. A vaccine is just a possible way to avoid this. Also, most likely, I’ll write a column a little later about my feelings - this is also one of the reasons,” she explains.

Lawyer Sergei Manegin tells the BBC that the spread of coronavirus has "kept and continues to keep him in constant tension" and the vaccine could give him the opportunity to "return to pre-quarantine times."

“You need to be constantly on guard: wear gloves, masks, and regularly use antiseptic. But even if you follow all the recommendations, there is still a risk of infection, so you feel uncomfortable on public transport, in the office, or at public events,” says Sergei. He has not yet been able to test the drug on himself - Sergei successfully passed the screening, but fell ill just before the vaccination, and the doctors asked him to wait two weeks.

“Coronavirus is a new reality that we all have to live with. There are two options for now. The first is to get sick at some point and get antibodies. But this is also a lottery: how will the disease progress, how severe will it be, how long will the antibodies last, is there a high risk of re-infection?.. The second approach is closer to me - action, vaccination, that is, an attempt to make the virus controllable,” journalist Armina Baghdasaryan says about her motivation .

In addition, the very appearance of an effective and safe vaccine is important for her. As an example, she cites the famous Soviet virologists Mikhail Chumakov and Anatoly Smorodintsev, who worked in conditions of lack of time and resources and tested the polio vaccine on themselves.

“I participate because it doesn’t always have to be done by “someone else.” Of course, it would be stupid to think that there are no risks... That is why the third stage of testing is needed, in which I am participating,” says Armina. She did not see any government employees in her clinic.

On the subject: 'We won't even test on monkeys': why the United States refused the Russian vaccine against COVID-19

“Take care of your health and show civic responsibility”

The doctor who screened the BBC correspondent (the journalist was eventually not allowed to test the vaccine for medical reasons) said that more than a thousand people had already passed through the testing center at the base of her clinic. She confirmed that not all of them were volunteers who learned about the vaccine from the media.

“A lot of them come from organizations. We even started recording them, because their employers then ask for lists, these are some of their procedures. But we are trying to convey that this is a voluntary study, that we are not going to force anyone. And why they are sent is no longer our problem. Some people hear for the first time where they came from,” she sighs.

The Gamaleya center did not answer a BBC question about how many people have already been included in the study.

As an employee of an organization subordinate to the city property department of the Moscow City Hall told the BBC, his superiors obliged him and his colleagues to get vaccinated against coronavirus. Those who agreed were promised a bonus - a total payment of about 20 thousand rubles (according to the rules, volunteers participate in the Sputnik-V study free of charge). Those who refuse, in the absence of contraindications to vaccination, are threatened with deprivation of bonuses, the BBC’s interlocutor clarified.

The BBC's staff memo describes the vaccination schedule (registration on mos.ru and subsequent screenings) and lists the rules for participating in the study.

“Vaccination is voluntary, and we strongly recommend that you take care of your health and the health of your loved ones, as well as show civic responsibility and help prevent the spread of coronavirus infection in our country. In addition, now is the period of colds and ARVI. Lack of vaccination against coronavirus increases the risk of a simultaneous attack on the body by two viruses that have a devastating effect on the functioning of the respiratory system. It has been scientifically proven that this can aggravate the situation, even leading to death,” warn the authors of the memo. There is no reference to scientific evidence of this fact in the document.

“The labor law does not give employers the authority to force employees to get vaccinated. There are cases provided for by law when an employer can interfere with some things related to an employee’s health (for example, the employer’s obligation to provide compulsory social insurance for employees). But forcing budget employees to get vaccinated - and manipulating bonuses and bonuses, of course, is coercion - these are not such cases. This is absolutely illegal,” Elizaveta Moskovkina, a leading researcher in medical law at the National School of Integrative Studies, explains to the BBC.

“As for ethics, the standards here are more vague. But if you look at the experience of other countries, this, of course, does not happen,” adds Moskovkina.

The BBC sent questions about attracting state employees to research to the Moscow Mayor's Office and the Gamaleya Center. There was no response from the mayor's office at the time of publication. The BBC's Gamaleya Center said it was not authorized to make contact with the media without the approval of the Ministry of Health.

The BBC sent a request to the Ministry of Health. The press service of the ministry redirected him to the Moscow government.

The HRC assumed back in the summer that the category of public sector employees could be forced to get vaccinated, and promised to consider every complaint about this. Vladimir Putin, at a meeting with the government in August, ordered that vaccination against coronavirus be “exclusively voluntary.”

There is no talk of forcing public sector employees to get vaccinated, but rather of “active campaigning,” says the BBC’s interlocutor at the Moscow City Hall, who asked for anonymity because he is not authorized to communicate with the media. He confirmed that brochures were being distributed to employees encouraging them to participate in the study.

“I think that [the facts of coercion] are excesses on the ground where the authorities are trying to curry favor,” the source suggested. He noted that he is familiar with employees of a budget institution, where two-thirds of the employees refused to participate in the Gamaleya Center study without any consequences for themselves.

“The authorities are interested in general statistics on those vaccinated to show its effectiveness and popularity,” says another BBC interlocutor close to the mayor’s office (also not authorized to communicate with the media). “Well, then at different levels they include administrative resources, as best they can,” he adds.

A top manager of a large state-owned company, who by the nature of his work is well acquainted with the progress of Sputnik-V research, also explains the attraction of public sector employees by “the inertial reaction of our administrative and management system.”

“State employees are attracted because they are the most organized cohort of the population. Administrative commands are received and that’s it. In fact, in their case we are no longer talking about research, but about vaccination,” the top manager added.

Undesirable effects

The operating principle of Gam-COVID-Vaka is based on recombinant vectors. The informed consent that volunteers fill out states that these are “special structures created in the laboratory that help deliver the active substance of the drug into the body.” In response to the introduction of vectors, the body produces a protein to which the immune system reacts - this is how “specific immunity” is produced against COVID-19.

Those same “special structures” - vectors - are modified human adenoviruses that cause respiratory diseases. One of the vaccine creators, Denis Logunov, explained to Meduza that scientists partially “edit” the genome of the adenovirus, making it non-dangerous.

When creating Sputnik V, neither the “active” nor the inactivated coronavirus SARS-Cov-2 is used - that is, you cannot get COVID-19 from a vaccination.

The informed consent does not say much about the specific negative consequences of Sputnik V. Volunteers are told that the vaccine was tested on “mice, rabbits, guinea pigs, Syrian hamsters and monkeys.”

“The drug does not have a negative effect on the body of animals in doses many times higher than doses for clinical use; protective activity is shown in monkeys and hamsters: the drug forms an immune response and protects against COVID-19,” the document says.

The authors of the document report that volunteers who participated in studies of other vector vaccines at the Gamaleya Center (including influenza and MERS syndrome) developed side effects “often” and “very often.” Their severity was most often low, according to the informed consent.

During the second phase, there were no serious “adverse effects” in any of the 38 volunteers. For comparison: to participate in the first/second phase of trials, the University of Oxford (this vaccine is also based on an adenovirus, but not a human, but a chimpanzee) recruited more than a thousand volunteers - the larger the sample, the higher the chance of catching serious side effects.

Among the most common reactions to Sputnik-V, scientists call a flu-like syndrome (fever, chills, joint pain, weakness) and pain at the injection site. Several volunteers had slight changes in blood counts (this did not require treatment), one had an allergic reaction - it was stopped with antihistamines, the authors of the informed consent report.

Because of possible allergic complications, people with a severe allergic reaction are not included in the study, and after the vaccine is administered, volunteers are asked to remain in the office for a while. In rare cases, a blood clot or an infectious complication may develop after the needle is inserted - but the authors promise volunteers to reduce these risks through the use of "highly qualified medical personnel."

Volunteer Anastasia Olshanskaya told the BBC that after the first injection of the drug (theoretically, it could be a placebo), her temperature rose to 37,5 degrees. Doctors ask to stop such phenomena with simple paracetamol.

Armina Baghdasaryan “on the first day, in the evening, her head ached very badly and her body ached, for some reason, mainly in the area of ​​​​the hip joints.” “During the first three days, doctors called me: once a therapist, the other two from a pediatrician. My health is now under control,” she is sure.

Now both test participants are doing well, they have not yet received the second dose of the drug.

Volunteers can report any complaints to telemedicine doctors, who are regularly contacted via video link. Individual volunteers, including those with symptoms of a cold, may be invited for additional blood tests.

Volunteers have few restrictions - on the day before and after vaccination they are advised not to exercise or drink. Throughout the study, volunteers are asked to limit smoking and avoid “excessive” alcohol consumption.

Women are specifically advised not to become pregnant, breastfeed or donate eggs for three months after vaccination. By signing the informed consent, volunteers agree to use reliable methods of contraception “unless they completely avoid heterosexual sexual intercourse.”

If pregnancy does occur, volunteers should immediately contact a doctor - they will be suspended from the vaccination procedure if the second dose of the drug has not yet been received, and they will be monitored throughout the entire period.

“It’s unlikely that people would be vaccinated with something dangerous”

The possibility of serious complications in the consent is spelled out in a small paragraph headed “unknown risks.”

“In addition to the risks and discomfort listed above, previously unreported or atypical effects may occur. All adverse events that may occur while taking the study drug cannot be predicted in advance. Therefore, the possibility of the development of an unforeseen adverse event cannot be excluded,” the document says.

“Such a warning complies with legal requirements,” says lawyer Elizaveta Moskovkina. “Unlike other classes of drugs, the effects of which are better “predictable,” vaccines belong to a special category and require careful testing according to all criteria provided for by law in order to minimize risks. Therefore, the manufacturing company honestly states that it cannot foresee all risks.”

Russian volunteers participating in the tests are automatically insured by Evgeniy Giner’s Capital Life company. 300 thousand rubles will be paid for deterioration of health that does not lead to disability. Those who become disabled in group III will receive 599 thousand rubles, group II - 1 million, group I - 1,5 million. The families of deceased participants are promised to be paid 2 million rubles. But if the injured volunteer violated the terms of informed consent or did not follow the advice of the research physician, he or his family will not receive money.

It is not clear from the informed consent who, in the event of an injury, will conduct a medical investigation to determine whether it is related to the vaccination. The doctor who advised the BBC correspondent suggested that the issue would have to be resolved with the insurance company - “perhaps hiring a lawyer and going to court.”

Serious cases, such as deaths, are, in principle, very rare at the stage of clinical trials, says the BBC Moskovkina.

“The safety of a drug is usually confirmed at the stage of preclinical studies - that is, without the participation of people. If there are indications that a drug may cause death or disability, it is usually not allowed into clinical trials. Another question is that at this stage of clinical trials it may turn out that it is ineffective.”

According to Moskovkina, in the event that the research participant does suffer, it will be the court that will bring medical experts to investigate who is to blame.

The safety of the Russian vaccine has been actively discussed in the world media in recent months. Concerns were aroused by the fact that the first publications about her appeared in the authoritative medical journal The Lancet only in September, after the announcement of her registration in August.

Foreign scientists have a number of questions for the article. Some drew attention to the coincidence of indicators in different experimental groups and the rapid speed of preparation of the publication. The Gamaleya Center did not agree with the criticism of the scientific work.

The Informed Consent Model for British volunteers testing the coronavirus vaccine describes serious complications in much more detail than its Russian counterpart.

Participants are warned that with any vaccination, in rare cases, serious neurological symptoms may occur, such as Guillain-Barré syndrome. This disease causes damage to peripheral nerves and can be fatal. True, as the authors of the Oxford study note, similar symptoms were not previously observed during trials of similar vector vaccines.

But due to the development of severe symptoms in volunteers, the third phase of trials of the Oxford University/AstraZeneca drug has already been suspended twice, although they have resumed in the UK. And in the USA it is still on pause. The previously healthy 37-year-old woman developed transverse myelitis, an inflammation of the spinal cord that is usually caused by infections, after receiving the second dose of the drug, according to an internal report obtained by CNN.

Russian volunteers who spoke to the BBC have different views on the possibility of serious complications. “I am quite an oppositional person, I work in the opposition media. But still, it seems to me that it is unlikely that so many people would be vaccinated with something too dangerous and untested,” says journalist Olshanskaya. “What a blow it will be to the image of the country, to the image of Russian scientists, if one of the volunteers dies!”

Sergei admits that he has “some concerns” about the vaccine - but Covid-19, in his opinion, is still more dangerous: “Given that at the previous stages all the subjects received an immune response, I am ready to take this risk associated with possible complications."

Armina Baghdasaryan draws attention to the fact that those who are thinking about vaccination should remember that for now we are not talking about mass vaccination, but about trials. She herself closely follows the research of other drugs, including the Oxford University vaccine: “In principle, the Russian vaccine is showing good results so far. But, of course, there is tension and questions.”

Read also on ForumDaily:

Isolated from everyone: Russia has invented a unique way to protect Putin from coronavirus

Coronavirus took 7 relatives from him: the story of the first American to test the COVID-19 vaccine

Freemasons, Reptilians, and the Flat Earth: 10 Craziest Conspiracy Theories

Ex-US Special Forces soldier arrested on charges of espionage for Russia

Do you want more important and interesting news about life in the USA and immigration to America? — support us donate! Also subscribe to our page Facebook. Select the “Priority in display” option and read us first. Also, don't forget to subscribe to our РєР ° РЅР ° Р »РІ Telegram  and Instagram- there is a lot of interesting things there. And join thousands of readers ForumDaily New York — there you will find a lot of interesting and positive information about life in the metropolis.