Today it became known that a group of employees of the Moscow Research Institute of Epidemiology and Microbiology. The Gamaleis introduced a drug developed at their institution.
“This is a violation of all norms: both Russian legislation and international norms, in particular, the Helsinki Declaration,” said MedPortal Executive Director of the Association of Clinical Research Organizations (AOKI) Svetlana Zavidova.
She recalled that in accordance with Part 1 of Article 39 of the Law on the Circulation of Medicines, a clinical trial of a medicinal product for medical use is carried out on the basis of an appropriate permit issued by the Ministry of Health of Russia based on the results of document examination and ethical examination. In this case, the drug developed by the center. Gamalei is not even listed in the open registry of permits for clinical trials.
“The fact that employees of the NF Gamalei Research Center for Chemical Technology participated in the experiment is not a mitigating circumstance, on the contrary, it only aggravates the guilt of the center’s leadership. The fact is that it involves attracting a vulnerable group of participants to the experiment. According to ICH GCP (international standard for conducting clinical trials) and similar documents adopted both in Russia and at the EAEU, vulnerable individuals are identified as individuals whose participation in the study may be affected, including sanctions by those higher in the service hierarchy in case of refusal to participate, in this sense, vulnerable groups include students of medical and pharmaceutical educational institutions, junior staff of clinics and laboratories, employees of pharmaceutical companies, ”said Zavidova.
The Association suggested that such initiatives were driven by an order from the country's top leadership to shorten the timelines for clinical trials of coronavirus vaccines.
“Haste in this case will not help to get a positive result. More precisely, it is dangerous. It is dangerous when it comes to violating the fundamental principles of conducting clinical trials, to which medical science went on its own mistakes. Unfortunately, the modern rules of clinical trials were not just invented, they are written in blood and are based on the tragedies that humanity has had to face in the past, ”the AOKI recalled.
The vaccine test was reported today by Interfax with reference to the head of the Gamaleya center Alexander Gunzburg.
"As for the developers, yes, they are not so much testing themselves as defending themselves, so that in the event of a pandemic they could continue to develop (...) Everyone involved in the development, respectively, is all protected," Gunzburg said interview with the agency. He added that all vaccine recipients are “alive, healthy, and happy.”
The exact number of employees who decided to experiment is not known, but it is known that we are talking about both the developers of the drug and the organizers of preclinical studies and technologists.
It's about the so-called Adenovirus DNA vector vaccine into which the SARS-CoV-2 coronavirus gene is integrated.