Table of contents:
- Oblasova on the vaccine test at the Research Institute of Gamaleya: “if it is voluntary, then this is an invaluable contribution”
Video: Oblasova On The Vaccine Test At The Research Institute Of Gamaleya: “if It Is Voluntary, Then This Is An Invaluable Contribution”
Oblasova on the vaccine test at the Research Institute of Gamaleya: “if it is voluntary, then this is an invaluable contribution”
Biologist, author of the vaccination blog Antonina Oblasova commented to MedPortal on the decision of the Moscow Research Institute of Epidemiology and Microbiology. Gamalei to inject themselves with the coronavirus vaccine.
The fact that the employees of the institute had injected themselves with a vaccine, which the research institute is working on, was previously reported to the Interfax by the head of the Gamaleya Center, Alexander Gintsburg. This is a so-called vector vaccine based on adenovirus DNA, into which the SARS-CoV-2 coronavirus gene is inserted. According to Gunzburg, in this way the employees protected themselves from infection and are now "alive, healthy and happy."
As Antonina Oblasova told MedPortal, clinical trials of any new pharmaceutical product and vaccines are carried out in accordance with the rules of GCP (Good Clinical Practice) - the international standard of ethical norms and quality of scientific research. The essence of these rules is based on the protection of human rights and dignity, formulated in the Declaration of Helsinki, which, among other things, enshrines voluntary participation in research and the ability to refuse it at any time.
“Technically, such actions violate the established testing procedure, but if the participation was voluntary and informed, then these people made an invaluable contribution to the work on a vaccine that can return our lives to normal. History knows many such examples, when scientists conducted tests on themselves and thanks to their dedication many breakthroughs were made,”said the biologist.
Oblasova also noted that the new vaccine was created on the basis of a previously successfully tested technology, which was used, in particular, in the development of an Ebola vaccine. Therefore, the 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 used. I do not think that this will somehow affect the rules for clinical trials of other drugs, where there is no such pressure, such tight deadlines and such damage that the 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,”Antonina Oblasova emphasized.
Andrei Kondrakhin, a doctor of clinical pharmacology at the Chekhov Regional Hospital, Candidate of Medical Sciences, told MedPortal that the administration of the vaccine to employees cannot be considered a test and the results are unlikely to be included in the official data.
“The first trials of a new vaccine can give dizzying results, this is a well-known fact. But in order to confirm its effectiveness and safety, full-scale research is needed. The Gamaleya Institute did not indicate the number of employees who injected themselves with the vaccine, but in any case, this is too small a sample both for statistics and for any conclusions. A sample of at least 100 participants, divided by race, age, sex and weight, is required, and data on the immune status of each volunteer is required. Only then will there be data on the effectiveness and safety of the new vaccine,”said Kondrakhin.
Popular by topic
Next, the issue of state registration of the vaccine will be decided
Scientists suggest older people may need additional vaccinations
The vaccine successfully stimulated the production of antibodies and T cells, the scientists did not find any serious side effects
Whether it is capable of preventing COVID-19, the next phase of the study, which will begin on July 27, will show