Russian vaccine against COVID-19 entered civilian circulation, but there are many complaints about it

At what stage is the first Russian vaccine now?

The first batch of Russian vaccine against COVID-19

"Sputnik V" has been released into civil circulation, deliveries to the regions are expected in the near future. This was reported by the press service of the Ministry of Health.

The first batch of vaccine to prevent newcoronavirus infection "Gam-COVID-Vac" ("Sputnik V"), developed by the Research Center for Epidemiology and Microbiology named after N.F. Gamaleya of the Ministry of Health of Russia, passed the necessary quality tests in the laboratories of Roszdravnadzor and was released into civil 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 (ACOI), which brings together pharmaceutical companies and research organizations. Its representatives called on the Russian Ministry of Health to postpone the registration of the vaccine. The appeal said 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 vaccine from MERS, the trials of which are still ongoing, so "there is still no reason to conclude on its effectiveness."

Vaccine development at the Gamaleya Centeraccompanied by not the first scandal. The developers began by testing it on themselves, even before permission was obtained to conduct the study from the Ministry of Health. And in other countries, before giving a 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 end users of the vaccine, the 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 againstSputnik V coronavirus from the Gamalea Center published the results of its initial tests for the first time in a scientific journal. This is an important milestone in the development of any vaccine. First, any such publication is reviewed by other scientists, and this, to some extent, allows us to guarantee the correctness of the conclusions and the completeness of experiments. Secondly, all the specific technical details of the tests are now 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 introduction of the vaccine does indeed induce an immune response in all volunteers at least 28 days after immunization.
  • Those who received two components of the vaccine, and not just one, the brightness of the immune response is higher. We are talking about antibodies and about 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 total pool of antibodies in the vaccinated, there are neutralizing antibodies - those that not only bind to the virus, but also reliably block its entry into the cell.
  • The researchers compared the level of antibodies in vaccinated people with similar indicators in those who had been ill - in total, they analyzed samples of 4,817 people from Moscow.
  • Average level of antibodies in vaccinatedturned out to be even higher than in those who had recovered, but the proportion of those who neutralized was lower. In terms of the level of neutralizing antibodies, which is much more important for predicting the effectiveness of a vaccine, the groups of the recovered and 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 seems to us, however, that based on simple probabilistic 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 has requested comment on the allegations from Denis Logunov of the N.F. Gamaleya Research Center for Epidemiology and Microbiology.

If The Lancet asks for clarification, we are ready to respond. There are no errors in the publication, and the data on titles 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 decreeallowed to register drugs without the required amount of clinical data. But the question of how much you need to risk and release on the market an incompletely researched drug is up to the experts. We see that the requirements are still met all over the world: the third phase is necessarily carried out. On the other hand, we understand that experts should 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 tests, onthe basis of which the temporary registration was issued was published in The Lancet on September 4. Prior to that, details about the development of a 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.

Read also

It turned out that made the Mayan civilization leave their cities

On day 3 of illness, most COVID-19 patients lose their sense of smell and often suffer from a runny nose

Scientists have found out why children are the most dangerous carriers of COVID-19