Testing A Vaccine Against COVID-19 On The Staff Of The Center. Gamalei Called "violation Of All Norms"

Testing a vaccine against COVID-19 on the staff of the center. Gamalei called "violation of all norms"

Today it became known that a group of employees of the Moscow Research Institute of Epidemiology and Microbiology. Gamalei injected herself with a drug developed at their institution.

Photo: Karolina "This is a violation of all norms: both Russian legislation and international norms, in particular, the Declaration of Helsinki," Svetlana Zavidova, executive director of the Association of Clinical Research Organizations (ACOI), told MedPortal. She recalled that in accordance with Part 1 of Article 39 of the Law “On 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 examination of documents and ethical examination. permits to conduct clinical trials. "The fact that the experiment was attended by employees of the NITsEM named after N. F. Gamalei is not a mitigating circumstance,on the contrary, it only aggravates the guilt of the leadership of the center. The point is that we are talking about attracting a vulnerable group of participants to the experiment. According to the ICH GCP (International Standard for Clinical Trials) and similar documents adopted both in Russia and at the level of the EAEU, vulnerable research subjects are persons whose participation in the research may be influenced, including by the sanctions of those higher in the official hierarchy of persons 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,”Zavidova said. The Association suggested that such initiatives are due to the instruction of the country's supreme leadership to reduce the duration of clinical trials of vaccines against coronavirus.“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 clinical research, to which medical science went on its own mistakes. Unfortunately, the modern rules of clinical research were not invented for nothing, they are written in blood and are based on the tragedies that mankind had to face in the past,”recalled in AOKI. The test of the vaccine was reported today by the Interfax agency with reference to the head of the Gamaleya Center Alexander Gintsburg. "As for the developers, yes, they are not so much testing on themselves as they are protecting themselves, so that in a pandemic they can continue to develop (…) Everyone who is engaged in development, respectively, is all protected",- said Gunzburg in an interview with the agency. He added that all those who received the vaccines are “alive, healthy and happy”.

The exact number of employees who decided on the experiment is not named, but it is known that we are talking about both the developers of the drug and the organizers of preclinical studies and technologists.

We are talking about the so-called. a vector vaccine based on adenovirus DNA, into which the SARS-CoV-2 coronavirus gene is inserted.