At what stage is the first Russian vaccine now?
The first batch of Russian vaccine against COVID-19
The first batch of vaccine to prevent newcoronavirus infection “Gam-COVID-Vac” (“Sputnik V”), developed by the N. F. Gamaleya Research Center for Epidemiology and Microbiology of the Russian Ministry of Health, passed the necessary quality tests in the laboratories of Roszdravnadzor and was released into civilian circulation.
Ministry of Health message
As noted in the department, the vaccine has passed all the necessary laboratory tests.
What are the complaints about the drug?
Even during clinical trials on patients, claims began to be made against the Russian vaccine, which was being developed by the Gamaleya Center.
- Request from AOKI
For the first time about not rushing to registervaccines, said the Association of Clinical Research Organizations (ACRO), which unites pharmaceutical companies and research organizations. Its representatives called on the Russian Ministry of Health to postpone the registration of the vaccine. The appeal stated that the creators of the vaccine had not completed its testing with the participation of “even hundreds of people.” In addition, it is based on another MERS vaccine, the trials of which are still ongoing, so “there are no grounds yet to draw conclusions about its effectiveness.”
Vaccine development at the Gamaleya Centeris not the first time it has been accompanied by a scandal. The developers began by testing it on themselves, even before permission to conduct the study was received from the Ministry of Health. And in other countries, before giving the drug to a person, you must first obtain permission from a government agency.
The authors of the appeal called on the Ministry of Health “not to speed up the development” of the vaccine, since there are 26 candidate vaccines in the world, and six of them are being tested with the participation of thousands and tens of thousands of people.
Accelerated registration will no longer make Russia a leader in this race; it will only expose the final consumers of the vaccine, citizens of the Russian Federation, to unnecessary danger.
Appeal by the Association of Clinical Research Organizations (ACOI)
- Questions about scientific vaccine test results
After a while, the developers of the Russian vaccine againstcoronavirus "Sputnik V" from the Gamaleya Center for the first time published the results of its initial tests in a scientific journal. This is an important stage for the development of any vaccine. Firstly, any such publication is peer-reviewed by other scientists, and this, to some extent, allows us to guarantee the correctness of the conclusions and the completeness of the experiments. Secondly, now all the specific technical details of the tests are available to the whole world, from which everyone can draw their own conclusions.
- As a result, it became known that unexpectedand/or serious side effects were not identified in this small sample, the administration of the vaccine does induce an immune response in all volunteers at least on the 28th day after immunization.
- Those who received two components of the vaccine, rather than just one, had a stronger immune response. We are talking about antibodies and the reaction of cells of the immune system.
- The vaccinated not only form antibodies to the "thorn" of the coronavirus, but the population of the so-called T-cells - lymphocytes that fight the virus - begins to increase.
- Among the general pool of antibodies in vaccinated people, there are neutralizing ones - those that not only bind to the virus, but also reliably block its penetration into the cell.
- The researchers compared the level of antibodies in vaccinated people with similar indicators in those who had recovered from the disease - in total, they analyzed samples from 4,817 people from Moscow.
- Average level of antibodies in vaccinated peopleturned out to be even higher than in those who had recovered from the disease, but the proportion of those neutralizing was lower. In terms of the level of neutralizing antibodies, which is much more important for predicting the effectiveness of the vaccine, the groups of those who had been ill and those who were vaccinated did not differ significantly.
The authors themselves admit that one of the most importantrestrictions on their work - the volunteers are too young. Although the study card stated that it would involve people between the ages of 18 and 60, their actual average age was small — in most groups around 25, with very little variation. Since the vaccine, of course, is most needed by people of the older generation, then tests on an older group would be much more informative.
However, even at the time of publication,a few questions to the finished product: the actual effectiveness of the vaccine. That is, how much immunization with it reduces the risk of infection and severe disease. The study, which should find out this, will include not 76, but 40,000 people, some of whom will receive a placebo. At the same time, mass vaccination with a drug with unclear efficacy should begin as early as October this year.
The results of the preclinical tests of "Sputnik V" - that is, studies on animals, have not yet been published.
- Open letter from an international group of scientists
A group of scientists from different countries approachedto the editor of the medical journal The Lancet and the authors of an article on the Russian coronavirus vaccine, asking to explain the duplication of some experimental values in the graphs. The open letter, which was signed by 19 researchers, was published by the Italian website Cattivi Scienziati, which specializes in the fight against pseudoscience.
An article in which Russian vaccine developersfrom the coronavirus from the Gamaleya Research Center for Epidemiology and Microbiology first spoke about the first two phases of clinical trials of the substance, released last week. The vaccine's makers said they tested its safety and the ability to trigger an immune response in a sample of 76 volunteers. The authors of the article indicated that after two weeks, 100% of the subjects developed antibodies and T cells. However, no serious side effects were found, and in August, the researchers began the third phase of clinical trials.
A group of international scientists drew attention tothat the results of several experiments show the same data patterns, even when it comes to different volunteers. For example, volunteers from different groups on days 21 and 28 after immunization had the same antibody level, although they were injected with different components of the vaccine, the authors of the open letter indicate.
It still seems to us that, based on simple probability estimates, the fact that such a large number of data fragments coincide in different experiments is unlikely.
Open letter from an international group of scientists
The scientists who signed the letter urge the creators of the Russian vaccine to publish the "raw" data of the instruments obtained during the measurements and to clarify some other details of the study.
Meduza requested comment on the accusations from Denis Logunov from the N. F. Gamaleya Research Center for Epidemiology and Microbiology.
If The Lancet's editors ask for clarification, we are ready to respond. There are no errors in the publication, and the data on the credits is exactly the same [as they are presented in the illustrations in the article].
Denis Logunov, employee of the N. F. Gamaleya Center for Epidemiology and Microbiology
How critical are possible violations?
There are vulnerable groups of patients - employeespharmaceutical companies, military personnel, prisoners, minors. Those whose decision can be influenced by persons higher in the hierarchy, explains the executive director of AOKI Svetlana Zavidova. There is no prohibition on the participation of such groups in research, you can participate. But the norm says that research with the participation of such persons is allowed only if it is impossible to attract other categories and if it is known that participation in the research will benefit specifically these participants.
State by government decreemade it possible to register drugs without the required amount of clinical data. But the question of how much to take a risk and release an incompletely researched drug to the market is up to the experts. We see that all over the world the requirements are still met: the third phase must be carried out. On the other hand, we understand that experts must evaluate, and experts are now clearly under pressure.
When the car is released from the assembly line, there isa set of necessary tests: you need to check the brake system, pass the crash test, and so on. And here, in fact, we are talking about a drug that is planned to be used in large quantities. Moreover, the car can still be checked visually in some way - well, the nuts are tightened, but here something gets inside. Moreover, we do not know what the effect will be.
The characteristics of any drug consist ofthree components: safety, efficiency and quality. Humanity has not yet come up with any other scheme of how to launch a drug on the market, first studying it in preclinical studies, then sequentially in studies of the first clinical phase, the second and the third. And in the first, safety is checked. Then the dosage is selected, the effectiveness is studied. And only the third phase allows you to collect data on how the drug affects specific diseases. What have you done with us? The first and second phases were combined, the report on it was not published, and it is already talking about mass vaccination. We understand that it is impossible to talk about any evidence from the point of view of clinical medicine.
What's the bottom line?
Results of combined phase I/II trials, onon which the temporary registration was issued were published in The Lancet on September 4. Before this, details about the development of the vaccine were known only from an interview with Denis Logunov.
Expert opinion, on the basis of whichThe Ministry of Health made a decision on the registration of the vaccine, and has not been published in the public domain until now. In accordance with Article 37 of the Federal Law "On Circulation of Medicines", the results of the examination of drugs registered in Russia must be published within five days after receiving these documents.
The vaccine has not yet undergone large-scale clinical trials.
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