In Russia, scientists illegally tested the COVID-19 vaccine in humans

Employees of the National Research Center for Epidemiology and Microbiology named after. N.F. Gamaleya, who is developing a vector vaccine for COVID-19, tested it on themselves and several of their employees. The center considers this a success, and the Association of Clinical Research Organizations (AOKI) considers it a violation. Scientists have entered into a “mad race to please the supreme power,” the association said. Writes about this with the BBC.

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“In this case, we are talking about a gross violation of the fundamentals of conducting clinical trials, Russian legislation and generally accepted international standards,” says the AOKI letter addressed to Health Minister Mikhail Murashko. A copy of the document was sent to the Prime Minister and the President.

AOKI is a non-profit organization that unites participants in the Russian clinical research market. It includes the world's largest pharmaceutical companies Pfizer, AstraZeneca, Bayer, etc.

According to her, before the tests on the employees of the center, the Ministry of Health did not give permission to conduct a clinical trial, there were no results of document examination and ethical examination.

Those on whom the vaccine was studied should be informed about the nature of the study and the risks, and these risks should be insured, the letter says. “None of this, as we understand, was done in this case,” the authors write.

What did they do in the center of Gamalea

The center’s employees themselves introduced an experimental drug in order to continue development without a risk of infection in a pandemic, said the director of the center, academician of the Russian Academy of Sciences Alexander Gunzburg.

The vaccine is still at the stage of preclinical trials, which involve testing on animals, in particular primates. Its results are not yet. Scientists have introduced a vaccine for protection rather than research, Gunzburg said.

After the introduction of the vaccine, scientists had no side effects, he clarified, saying that “everyone is alive, healthy and happy.”

The academician did not specify the number of employees who received the vaccine, but said that they were developers, organizers of preclinical studies and technologists.

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As Gunzburg said, we are talking about a vector vaccine based on adenovirus DNA, into which the SARS-CoV-2 coronavirus gene is embedded. The adenovirus acts as a “container” to deliver the coronavirus gene into cells, trigger the synthesis of coronavirus shell proteins there, and thus “introduce” the immune system to it. Such vaccines are called vector vaccines.

“The fact that the experiment involved employees of the National Research Center for Experimental Mathematics named after. N.F. Gamaleya, is not a mitigating circumstance; on the contrary, it only aggravates the guilt of the center’s leadership,” AOKI said in turn.

According to the association, employees of the Gamaleya Center are a “vulnerable group of participants” in the experiment, since they could be influenced by management if they refuse to participate.

“We believe that the roots of such gross violations committed during the novel coronavirus pandemic lie primarily in the wrong message on the part of the country’s leadership,” write the authors of the letter, recalling that in April, President Vladimir Putin instructed the government to reduce the time frame for clinical trials of COVID vaccines -19.

“Many scientists understand this, but they are involved in a mad race, wanting to please the supreme power,” the letter says.

How did scientists and doctors react to this: the pros and cons

“In the US, all employees and their smug bosses would be fired immediately. This is called unapproved experiments on people, and they are prohibited by law,” pediatrician Fyodor Katasonov, author of a telegram channel about medicine, wrote on Facebook.

Katasonov condemned the experiment, saying that now “there is not a single vaccine approved and used in practice made using this technology on adenoviral vectors.”

The epidemiologist and president of DiaPrep System Inc. agrees with Katasonov. Mikhail Favorov. “An experiment in the future may cast doubt on the use of this vaccine, even if it is good,” the expert said.

This practice, according to Favorov, who previously worked as deputy director of the UN International Vaccine Institute, is not accepted or recognized by international standards. In addition, it “encourages amateurs to commit such acts, which is absolutely unacceptable,” the scientist said.

“This is considered unethical because it is conceivable that vaccine products, especially in a disease as complex as COVID-19, may increase the severity of the disease, and there is a chance that those vaccinated with an untested drug may become more severely ill.” form and even die,” Favorov explained.

Usually, vaccines are tested in humans at the stage of clinical trials, said the head of the molecular biotechnology laboratory of the Research Institute of Vaccines and Serums named after Mechnikov Vitaly Zverev. But this situation, he said, cannot be called any special: all drug developers in Russia are first of all trying development on their own.

Self-tests can be carried out if the vaccine is produced using already known technology, for example, influenza, explained academician Zverev. But in this case, the tests should also be formalized in protocols, approved by ethical committees and by higher organizations.

“Everything, of course, is possible, but in the beginning it is better to test on animals if possible,” Zverev added. He is also against accelerating testing, as he considers it important to fully complete all stages. In addition, according to Zverev, “the infection is not so terrible.”

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“We must not forget that we will administer the vaccine to healthy people. You can give medicine and take a risk when it comes to life and death, but here the situation is different,” the scientist believes.

Zverev’s colleague, Doctor of Sciences Mikhail Kostinov, who heads the laboratory of vaccine prevention and immunotherapy of allergic diseases at the same institute, believes that the vaccine could have been produced based on a model of an existing one, therefore he does not see “anything criminal” in this. In his opinion, this is correct, and many scientists tested their developments in this way.

Self-testing means that the scientist is confident in his development, Kostinov told the BBC: “In our institute, when the first phase of research is underway, we take our friends and relatives. I persuade you: I know the drug, there is nothing to be afraid of! Come and help us get through the first phase! And this is how it is always done.”

Zoya Skorpileva, immunologist, European Center for Vaccination, agrees that this is common practice. This can be dangerous for someone who agreed to such tests, but they are voluntary for him, and in medical practice there are even cases where the doctor himself infected himself with a dangerous infection and kept a diary of his condition, Skorpileva recalled.

Was this before

In April, the Vector Virology Center announced the start of testing a coronavirus vaccine on volunteers. 60 people were selected, including one of the vaccine developers, Ilnaz Imatdinov.

Virologist Alexander Chepurnov, who previously headed the Vector laboratory of especially dangerous infections, said that “every scientist tests the vaccine that he came up with on himself.”

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“I myself was vaccinated five times against Marburg fever, which I worked with: however, at that time the vaccine was still “dirty.” Then it turned out that in case of infection, the effect of the vaccine would be reversed and harm health. And they decided to stop vaccination,” Chepurnov said.

In the middle of the last century there were epidemics of polio. By 1955, the United States created two different vaccines against the disease, three Soviet scientists went to study it: Mikhail Chumakov, his wife and colleague Marina Voroshilova, and virologist Anatoly Smorodintsev. The first vaccinations in the USSR they brought in a suitcase.

Chumakov and Smorodintsev first conducted experiments on themselves, then on relatives and friends.

“The vaccine trials were carried out primarily on us - Chumakov’s children, Smorodintsev’s granddaughters, relatives, colleagues,” said Chumakov’s son Peter, a molecular biologist and professor. “It couldn’t be otherwise—developers always test inventions on themselves and their children.” There was no danger in this, the parents were sure. And none of the relatives was against it: everyone understood the danger of polio and believed that the vaccine would protect children from the disease.”

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