Antonina Oblasova, a biologist and author of the vaccination blog, commented on MedPortal’s decision by employees of the Moscow Research Institute of Epidemiology and Microbiology named after Gamalei introduce themselves a vaccine against coronavirus.
The head of the Gamaleya center, Alexander Gunzburg, previously informed Interfax to the fact that the institute’s employees introduced the vaccine that the research institute is working on. This is the so-called vector vaccine based on adenovirus DNA, in which the SARS-CoV-2 coronavirus gene is integrated. According to Gunzburg, in this way the employees protected themselves from infection and are now “alive, healthy and happy.”
According to MedPortal Antonina Oblasova, clinical trials of any new pharmaceutical product and vaccines are conducted in accordance with the rules of GCP (Good Clinical Practice) - an international standard of ethical standards and quality of scientific research. The essence of these rules is based on the protection of human rights and dignity of the person formulated in the Helsinki Declaration, where, among other things, voluntary participation in research is fixed and the opportunity to refuse it at any time.
“Technically, such actions violate the established procedure for conducting trials, but if participation was voluntary and informed, then these people made an invaluable contribution to the work on a vaccine that can return our life back to normal. History knows many such examples when scientists conducted tests on themselves and thanks to their dedication, many breakthroughs were made, ”the biologist said.
Oblasova also noted that the new vaccine was created on the basis of previously successfully tested technology that was used, in particular, in the development of the Ebola vaccine. Therefore, specialists who were directly involved in the development know enough about it to make a decision to participate in the tests.
“We are now in a non-standard situation, which means that non-standard methods are being applied. I don’t think that this will somehow affect the rules of clinical trials of other drugs where there is no such pressure, such a short time and such damage that a new coronavirus is now causing to society. Perhaps if we again encounter some new virus with a similar profile, then this experience will be taken into account, but voluntariness and awareness will remain integral characteristics of the process, ”said Antonina Oblasova.
According to MedPortal, Clinical Pharmacology Doctor at the Chekhov Regional Hospital, Candidate of Medical Sciences Andrei Kondrakhin, administering the vaccine to employees cannot be considered a test and the results are unlikely to be entered into official data.
“The first tests of a new vaccine can give dizzying results, this is a known fact. But in order to confirm its effectiveness and safety, full-scale research is needed. The Gamalei Institute did not indicate the number of employees who introduced the vaccine, but in any case this is too small a sample for statistics and for some conclusions. A sample of at least 100 participants, separated by race, age, gender and weight, is required, and data on the immune status of each volunteer are also required. Only then will there be data on the effectiveness and safety of the new vaccine, ”said Kondrakhin.