In Russia, scientists illegally tested the COVID-19 vaccine in humans
Employees of the National Research Center for Epidemiology and Microbiology. N.F. The Gamaleas, who are developing a vector vaccine against COVID-19, have tested it on themselves and several of their employees. The center considers this a success, and the Association of Clinical Research Organizations (AOKI) - a violation. Scientists have embarked on a "crazy race to please the supreme power," the association said. Writes about it with the BBC.
“In this case, we are talking about a gross violation of the foundations for conducting clinical trials, Russian legislation and generally recognized international norms,” the AOKI letter addressed to the Minister of Health Mikhail Murashko says. A copy of the document has been sent to the Prime Minister and the President.
AOKI is a non-profit organization that unites participants in the Russian market for clinical trials. 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 who tested the vaccine should be informed about the essence of the study and the risks, and these risks should be insured, the letter says. “None of this, as we understand it, 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, the scientists had no side effects, he said, 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.
According to Gunzburg, we are talking about a vector vaccine based on adenovirus DNA, into which the SARS-CoV-2 coronavirus gene is inserted. Adenovirus acts as a “container” to deliver the coronavirus gene into cells, start the synthesis of coronavirus envelope proteins there and thus “introduce” the immune system to it. Such vaccines are called vector vaccines.
“The fact that the experiment was attended by employees of the NITsEM them. N.F. Gamalei is not a mitigating circumstance, on the contrary, it only exacerbates the guilt of the center's leadership, ”AOKI said in turn.
According to the association, the staff of the Gamaleya Center are a “vulnerable group of participants” in the experiment, as they may be influenced by the management if they refuse to participate.
“We believe that the roots of such gross violations committed during the pandemic of the new coronavirus lie primarily in the wrong message from the country's leadership,” the authors of the letter write, recalling that in April, President Vladimir Putin instructed the government to shorten the time frame for clinical trials of COVID vaccines. -nineteen.
“Many scientists understand this, but they have entered 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 there, ”wrote on Facebook pediatrician Fyodor Katasonov, the author of the telegram channel about medicine.
Katasonov condemned the experiment, stating that now "there is not a single approved and used vaccine made using this technology on adenoviral vectors."
The epidemiologist and president of DiaPrep System Inc. agree with Katasonov. Mikhail Favorov. “An experiment in the future may call into question the use of this vaccine, even if it is good,” the expert said.
This practice, according to Favorov, who previously worked as the deputy director of the UN International Vaccine Institute, is not accepted and not recognized by international standards. In addition, it “pushes amateurs to commit such acts, which is absolutely unacceptable,” the scientist said.
“This is considered unethical because one can imagine cases where vaccine preparations, especially in a complex disease like COVID-19, can increase the severity of the disease, and there is a chance that those who are vaccinated with an untested drug could become ill in a more severe form and even die, ”said Favorov.
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.
“Of course, everything is possible, but in the beginning it is better to test on animals, if possible,” Zverev added. He, too, is against accelerating the tests, since he considers it important to complete all the stages. In addition, according to Zverev, "the infection is not so terrible."
“We must not forget that we will administer the vaccine to healthy people. The medicine can be given and risked 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 is in charge of the laboratory for vaccine prevention and immunotherapy of allergic diseases at the same institute, believes that the vaccine could have been produced using a model of an existing one, so he does not see “anything criminal” in this. In his opinion, this is correct, and many scientists have 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: I know the drug, there is nothing to be afraid of! Come, help me pass the first phase! And that's how it's 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 beginning of the stage of testing a vaccine against coronavirus on volunteers. Sixty people were selected, including one of the vaccine developers Ilnaz Imatdinov.
Virologist Alexander Chepurnov, who used to be in charge of the laboratory of especially dangerous infections at "Vector", said that "every scientist tests, among other things, the vaccine he invented."
“I myself have been vaccinated five times against the Marburg fever with which I worked: however, then the vaccine was still“ dirty ”. Then it turned out that in case of infection, the effect of the vaccine would be the opposite 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 performed experiments on themselves, then on relatives and friends.
“The vaccines were tested primarily on us - Chumakov’s children, Smorodintsev’s granddaughters, relatives, colleagues,” said Chumakov’s son Peter, a molecular biologist and professor. - It could not 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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