Employees of the Gamaleya National Research Center for Epidemiology and Microbiology, which is developing a vector vaccine against Covid-19, tested it on themselves. The center considers this a success, while the Association of Clinical Research Organizations (ACRO) considers it a violation. Scientists have joined the “mad race to please the highest authority,” the association said.
“In this case, we are talking about a gross violation of the basic principles of conducting clinical trials, Russian legislation and universally accepted international standards,” said the letter from AOKI (obtained by the BBC), 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. Its members include major global pharmaceutical companies such as Pfizer, AstraZeneca, Bayer and others.
According to their data, before conducting tests on the Center’s employees, there was no permission from the Ministry of Health to conduct a clinical study, there were no results of document examination and ethical expert evaluation. Those who were studied the vaccine must receive information about the nature of the study and the risks, these risks must be insured, the letter says. “None of this, as we understand it, was done in this case,” the authors write.
“The center’s staff independently took an experimental drug to continue their development work without risking infection during the pandemic,” said Alexander Gintsburg, the center’s director, an academician of the Russian Academy of Sciences. The vaccine is currently in preclinical testing, which involves testing on animals – primates. Results are not yet available. Scientists have introduced the vaccine primarily for protection rather than research purposes, Gintsburg said.
After the introduction of the vaccine, there were 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 he said that they are developers, organizers of preclinical trials and technologists. The vaccine, Gintsburg explained, is a DNA-based vector vaccine in which the SARS-CoV-2 coronavirus gene is embedded. The adenovirus serves as a “container” to deliver the coronavirus gene into cells, where it initiates the synthesis of coronavirus envelope proteins and “introduces” them to the immune system. Such vaccines are called vector vaccines.
In turn, AOKI stated that “the fact that employees of the NIIDEM named after N.F. Gamalei were involved in the experiment is not a mitigating circumstance, on the contrary, it only aggravates the guilt of the center’s management”. According to the association, the employees of the Gamaleya Center are considered a “vulnerable group of participants” in the experiment, as they can be influenced by the management if they refuse to participate.
“We believe that the roots of such gross violations committed during the COVID-19 pandemic lie primarily in the wrong approach of the country’s leadership,” the authors of the letter write, recalling that in April President Vladimir Putin ordered the government to shorten the timeline for clinical trials of COVID-19 vaccines. “Many scientists understand this, but they have joined the mad race, wanting to please the highest authority,” – the letter says. “In the USA, all of them and their smug bosses would be fired immediately. This is called unethical experimentation on people, and it is prohibited by law there,” pediatrician Fyodor Katasonov, the author of a Telegram channel on medicine, wrote on Facebook.
Katasanov criticized the experiment, saying that currently “there is not a single approved and used vaccine made with this technology [adenoviral vectors]. Epidemiologist and president of DiaPrep System Inc. Mikhail Favorov agrees with Katasonov. “The experiment in the future may cast doubt on the use of this vaccine, even if it is good,” the expert believes. Such a practice, according to Favorsky, who previously worked as deputy director of the United Nations Institute of Vaccines, is not accepted and not recognized by international standards. Moreover, it “encourages amateurs to engage in such actions, which is absolutely unacceptable,” said the BBC scientist.
“This is considered unethical because one can imagine cases in which vaccine drugs, especially in such a complex disease as Covid-19, can exacerbate the severity of the disease, and there is a possibility that those who are vaccinated with an untested drug could get a more severe form of the disease and even die,” Favorov explained.
Usually, vaccines are tested on humans at the stage of clinical trials, said Vitaly Zverev, the head of the laboratory of molecular biotechnology at the Mechnikov National Research Institute of Vaccines and Serums, according to the BBC. However, according to him, this situation cannot be called particularly peculiar: all drug developers in Russia first try their development on themselves. Self-testing can be done if the vaccine is produced using a known technology, such as the flu vaccine, said BBC academician Zverev. But even in this case, the tests should follow protocols and be approved by ethics committees and higher authorities. “Of course, everything is possible, but in the beginning it is better to test on animals if possible,” Zverev added.
He is also against speeding up the trials, as he believes it is important to complete all stages. Besides, according to Zverev, “the [Covid-19] infection is not that scary. “We must not forget that we will be administering the vaccine to healthy people. Drugs can be given and taken at the risk of life and death, but the situation here is different,” the scientist believes.
Zvereva’s colleague, Doctor of Science 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 on the basis of the existing prototype, so he does not see anything criminal in it. In his opinion, this is correct, and many scientists have tested their developments in this way. Testing on themselves means that the scientist is confident in their development, said Kostinov to the BBC: “In our institute, when the first phase of research is underway, we take our friends, relatives. I convince them: I know the drug, there is nothing to fear! Come and help us in the first phase! And that’s how it’s always done.
Immunologist Zoya Skorpileva of the European Vaccination Center agrees that this is a common practice. It can be dangerous for those who have agreed to such trials, but they are voluntary for them, and there are even cases in medical practice when a doctor infected himself with a dangerous infection and kept a diary of his condition, Skorpileva reminded.
Vaccines have been tested on themselves since Soviet times. In April, the Vector Virology Center announced the start of the vaccine testing phase against coronavirus in volunteers. 60 people were selected, including one of the vaccine developers, Ilnaz Imatdinov. Virologist Alexander Chepurnov, who previously headed Vector’s Laboratory for Highly Dangerous Infections, revealed that “every scientist tests the vaccine he develops on himself. “I myself was vaccinated five times against Marburg fever, with which I worked: true, 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 cause damage to health. And it was decided to stop vaccination,” Chepurnov said.
In the middle of the last century, there were polio epidemics. By 1955, two different vaccines against the disease had been developed in the United States. Three Soviet scientists, Mikhail Chumakov, his wife and colleague Marina Voroshilova, and virologist Anatoly Smorodintsev, were sent to study them. They brought the first vaccines back to the USSR in a suitcase. Chumakov and Smorodintsev first conducted experiments on themselves, then on their relatives and friends. “The vaccine trials were conducted primarily on us – Chumakov’s children, Smorodintsev’s grandchildren, relatives, colleagues,” said Peter, Chumakov’s son, a molecular biologist and professor. “It couldn’t have been otherwise – developers always test their inventions on themselves and their children. There was no danger, the parents were sure. And none of the relatives objected: everyone understood the danger of polio and believed that the vaccine would protect the children from the disease.”