Placebo Effect: Russian EpiVac scam could cost thousands of lives

«Both of our vaccines are good, modern, and the Vektor vaccine is synthetic, it is quite advanced. <...> EpiVacCorona by Vektor does not even cause fever», - said Vladimir Putin while promoting the vaccine during his recent Direct Line TV show. He himself, however, was given a shot of a different vaccine. But there are those who are not lucky enough to put their trust in Vektor.

«Another 6 days have passed, during which time my husband was hospitalized, and today he was transferred to intensive care,” writes Irina S. in a private Telegram chat set up by volunteers who participated in the clinical trials of the Vektor vaccine. - He got the vaccine during the CTs <clinical trials - The Insider>, his plasma is <shown> in all color graphs related to our experiments as the plasma of one of those subjects who had fake «high» antibody count during the CTs, he completed the CTs with flying colors, showing a good antibody count 3 weeks ago, on the 180th day. We did not have time to re-vaccinate ... Say a big hello to Vektor! I would like to write to them in Koltsovo, but what can I say? Thank you for the sham vaccine? Demand that my husband be given monoclonal antibodies to treat the disease? Let them sort it out and rescue the man now? All because he was treated with their EpiVacCorona, which was supposed to protect him for at least a year...».

Peptide vaccines are an experiment on living people.

EpiVacCorona is made on a special peptide platform; the world has yet to see a working vaccine of this type. The development of peptide vaccines began in the 1980s, but initially they were only intended for use in veterinary medicine. The principle on which they are based is quite simple: the immune system is shown some small but very characteristic (immunogenic) fragments of the pathogen's protein, which produce neutralizing antibodies. The protein itself is made up of many amino acid residues, of which there can be thousands. Of those thousands, only a small fragment is taken and worked on.

«A sequence of amino acids can be compared to a long string, and the protein itself to a knitted sweater, which has a certain spatial structure, and if it is deprived of that structure, we end up with only a pile of thread that no one needs,» explains a molecular biologist, speaking on condition of anonymity to avoid potential problems with the Ministry of Health. «And if a specialist chooses only one small region (a fragment of a protein) from the entire structure - a peptide or several peptides, there can be no guarantee that special cells of the body - B cells – can recognize those peptides and produce an immunity response in the form of antibodies.

To create EpiVacCorona, they used three scraps of the coronavirus S-protein, which the Vektor specialists considered immunogenic. But not every protein fragment (or, in other words, every scrap in the form of a peptide) will retain the desired structure if you separate it from the whole. To find the appropriate one, you need to do a lot of research, which no one did, and neither did Vektor, because at this point in time no method exists in molecular biology for conducting such research.»

Moreover, as practice has shown, even if it were possible to find a way to preserve the structure of the protein, this would not guarantee protection from the virus:

«When scientists were working on veterinary vaccines, in particular, on a vaccine against foot and mouth disease, they managed to find the right protein fragment that could retain its structure. When animals were immunized, neutralizing antibodies were produced (the ones that were able to neutralize the virus on their own), and it was considered a success. But later, when conducting tests on animals, it turned out that the vaccine had a very low effectiveness, and the animals eventually began to get sick. The idea of ​​creating peptide vaccines was later abandoned. Now, such a platform can only be used in research, but not in the context of mass vaccination of the population,» the biologist explains.

However, the specialists from Vektor decided to take a risk, believing they would be able to create a vaccine developed according to this method. They selected several sections of the coronavirus S-protein, synthesized the corresponding peptides, attached those peptides to the virus's internal N-protein obtained artificially, and created a vaccine that theoretically should be able to protect against coronavirus. At the same time, none of the developers can guarantee it is those peptides that will cause the production of the necessary antibodies which can play a protective role.

«I looked at the peptides they used, and I realized that many independent laboratories had also been trying to understand which peptides could be visible to the human immune system. And I found that the peptides found in independent laboratories were often the same, but they are not the same as the peptides that Vektor used in the development of its vaccine. I have data from several laboratories – in China, America and so on, and they all differ from what Vektor chose,» says molecular biologist Olga Matveeva, founder of the biotechnological company Sendai Viralytics (USA).

Mythical antibodies

When EpiVacCorona was presented as a special scientific development, Vektor specialists began to emphasize its pseudo-mildness - the ability to cause fewer side effects and, accordingly, to harm fewer people with contraindications for vaccination. But what is the basis for such a conclusion by the developers? It is primarily the statements of Natalia Pshenichnaya, deputy director of the Central Research Institute for Epidemiology of Rospotrebnadzor, and Alexander Semenov, head of the Research Institute of Viral Infections of the State Research Center Vektor:

«The vaccination is very easily tolerated, with practically no side effects. Therefore, by the way, EpiVacCorona is recommended for the elderly as well - it has no upper age limit. It is also suitable for people with chronic ailments - it is no secret that health problems accumulate with age. No one had any unpleasant consequences.»

But those claims have yet to be confirmed by testing. Moreover, all those who participated in clinical trials were young people, there were no elderly subjects or subjects with chronic diseases. On what basis did Semenov and Pshenichnaya make such statements?

The volunteers who participated in the clinical trials of the vaccine really felt nothing. They had nothing to discuss with each other, unlike, for example, the participants in the Sputnik study, who did experience side effects, to a greater or lesser extent, and had a certain antibody count; the EpiVacCorona testers experienced nothing of the kind.

According to the volunteers who set up a Telegram chat, their antibody count was zero. The participants of the experiment were tested in various places and commercial laboratories, but the existing antibody test systems simply failed to detect any antibodies.

“At first, we had no doubts the vaccine worked,” says one of the subjects. “Personally, I was sure that EpiVacCorona is generally a subunit vaccine <Subunit vaccine is a vaccine, for whose development the entire protein is used, rather than its fragments - The Insider>. And only later, when more information became available, it became clear that this was not the case. People began taking tests for antibodies, and none were found in the first 15 to 20 subjects, so we decided we had been given a placebo, but when the number of those with zero antibody count exceeded 100, we realized something was wrong. We started asking questions.»

To this, Vektor and its parent organization Rospotrebnadzor initially responded by saying that antibodies can only be detected using a special test system produced by Vektor itself, since there are nearly 12 determinants in the S-protein, and only three have been included in the vaccine, so conventional methods for detecting antibodies are ineffective in this case.

“But this is complete nonsense,” a molecular biologist says, speaking on condition of anonymity. “The test system promoted by Vektor is, to put it mildly, incomprehensible. There is no evidence of what it contains as the antigen, and it is unknown which antibodies to which particular protein, nucleocapsid (N) or spike (S), it can detect. There is a kind of plastic substrate onto which proteins suitable for the detection of antibodies are «planted». During testing, some antibodies bind up with others, then antibodies of a third kind are poured onto them, for example, rabbit or mouse antibodies, and then a solution is poured on top, which provides visualization (for example, the color may change, or the substance may begin to glow). But in the Vektor test it is completely unclear what is used at the initial stage, i.e., what latches onto the substrate. It can be anything at all, but then the antibodies that will be produced will have nothing in common with the viral proteins”.

Vector told The Insider that their test system is aimed at the simultaneous detection of antibodies to spike protein peptides and to nucleocapsid protein, but independent observers claim the system is designed to detect antibodies to nucleocapsid protein that offer no protection against the virus.

“All vaccines have their own problems, and the problem of EpiVacCorona is that it has its own support structure which partly consists of viral proteins, and partly of bacterial proteins. And therefore, it may as well easily produce antibodies to bacterial protein. And we do not know whether the Vektor test distinguishes between one and the other, but what is important is that, among other things, it has a lot of other ballast (or extraneous) antibodies that offer no protection,” - Olga Matveeva explains.

«The Vektor test does not detect antibodies to the S-protein, more precisely, it does in rare cases, but very poorly, we tested it on those vaccinated by Sputnik,” says a microbiologist speaking on condition of anonymity.

Simply put, the Vektor vaccine may produce some antibodies, but that does not mean they offer protection, that is, help fight the virus. And if the Vektor test system detects only non-protective antibodies, it means there is no point in using it. The volunteers decided to clarify the matter with the representatives of Vektor, and hence of Rospotrebnadzor, since Vektor is an organization that is subordinate to the federal service and does not give any comments without permission. The online meeting took place on February 2. To most of the questions asked by the participants of the clinical trials (molecular biologists among them) they got answers from the head of the department of zoonotic infections at Vektor and one of the authors of the EpiVacCorona patent, Alexander Ryzhikov, that sounded either like “We didn’t think about it” or “I don’t know”. Rospotrebnadzor responded to all claims and letters of the volunteers that they sent to the agency itself, to Vektor, and even to the Ministry of Health by saying “we are open to dialogue, but we have not received any requests from individuals.”

The subjects subsequently sent serum samples to an independent laboratory along with control samples of people vaccinated with Sputnik V and those who had recovered from the coronavirus disease and found that none of the people vaccinated with EpiVacCorona had the virus neutralized by the vaccine. In other words, those people (more than 60 at the time) were not protected from the coronavirus infection and could get sick at any time.

If the vaccine really does not work, not tens, but thousands of people are currently under threat.

“In recent years, the medical community has developed clear protocols on how to develop and test medicines,” says science journalist and molecular biologist Irina Yakutenko. “If these protocols are not followed, it’s impossible to say that the drug can be used safely and that it has at least some kind of effect. Worst of all, when such drugs enter public circulation, people use them and think they are protected, although in fact there is no evidence of this, and the coronavirus continues to pose a real threat.”

Anna Popova: from helicopters to vaccines

Scientists are also alarmed by the fact that there were no international publications about the vaccine, and only two papers have been published in Russia. Vektor assured The Insider that this is enough: “The journals Bulletin of the Russian Academy of Medical Sciences and Infection and Immunity, which published the results of research on the EpiVacCorona vaccine, are indexed in the Scopus international citation database. The journal Infection and Immunity is also indexed in the Web of Science international database. Both articles are available to foreign readers in English, their total number of views exceeding 30,000.» However, firstly, 30,000 is a very small number (say, fewer views than this publication by The Insider will have), and secondly, both of these journals, which are in the lower quartile in the international databases and have an extremely low impact factor, are more suitable for papers describing the sanitary situation in the Ivanovo region, not a breakthrough coronavirus vaccine (for comparison, papers on Sputnik appeared in Lancet and Science, the most respected and cited scientific publications). Thirdly, by a strange coincidence, the journal Infection and Immunity, which is published by the Pasteur Research Institute of Epidemiology and Microbiology, is subordinate to Rospotrebnadzor, headed by Anna Popova, the patent holder.

The first paper published by Vektor on the results of phase 1 and 2 studies was published in the journal only on March 25 and caused indignation among Russian scientists over a huge number of typos, the lack of positive control (that is, a comparison with vaccines known to be effective), the lack of data on the safety of the vaccine for people with chronic diseases, the absence of a description of the test for detecting antibodies (which, ironically, were detected even in participants from the placebo group).

«There is an analogy with an airplane, when the developers say: «We conquered gravity with a completely new method, but we will only show you a photo of an airplane.» You say: «Show a photograph of how the plane is flying» - «No, we will show you a picture of the plane, but there will be no sky or earth there.» It is exactly the same thing that the specialists from Vektor wrote about the vaccine in the paper published by Infections and Immunity, Olga Matveeva says.

“In a normal journal, such an article would never pass peer review. There is a serious error in the experiment, because without positive control it is completely incomprehensible how to interpret the results,” says a molecular biologist speaking on condition of anonymity.

Vektor itself gave The Insider as vague an answer as possible: “The number of positive or negative controls in a given study and their feasibility are determined by the conditions necessary to obtain the required data. With this in mind, in some of the experiments positive controls were used, and in some, negative.» Vektor did not specify, where and how positive control was used.

It turns out that Rospotrebnadzor and Vektor have their own system of reviewing materials. One of the former employees of the organization, who spoke on condition of anonymity, told The Insider that from the very moment of his appointment the CEO of Vektor, Rinat Maksyutov, in some cases refused to sign off on expert documents required for sending papers to the journal for months without explaining the reasons, but at the same time, signed off on papers under the names of «proper» authors without delay. The «proper» authors included the head of Rospotrebnadzor Anna Popova, Rinat Maksyutov himself, his father Amir Maksyutov and many others who have a very cursory relationship to molecular biology but have repeatedly authored papers on coronavirus infection.

Popova, being a specialist in hygiene, sanitation, and epidemiology by education, at some point, without being a narrow specialist or even a molecular biologist, took it upon herself to choose peptides for the vaccine. The head of Rospotrebnadzor has a rather impressive list of publications from various fields of medicine: a study of the consequences of radiation accidents, patents for protein-containing products, models of response to the spread of coronavirus infection, assessments of population immunity, and even the study of male infertility caused by the pandemic. But the patents describing an airmobile-based anti-epidemic complex and a helicopter intended for the evacuation of patients with especially dangerous infections deserve special attention. 328 scientific papers, many of them devoted to scientific experiments.

However, Vektor insists that Popova is a great scientist and the actual author of the patent: “Head of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare Anna Yuryevna Popova is indeed one of the authors of the patent for the EpiVacCorona vaccine. This vaccine is based on the same platform as the Ebola vaccine EpiVacEbola. For this reason, the authorship of the patents for these vaccines is largely the same. As a Doctor of Medical Sciences, Anna Yuryevna Popova participated in the development of the drug with regard to the use of the vaccine in the population.»

Another research center employee noted in a conversation with The Insider that during the development of the vaccine, Anna Popova gathered all Vektor’s department heads for a meeting and asked: “Do you believe in the effectiveness of EpiVacCorona?” All those present, except one, answered this question in the affirmative, and a drug based on the belief of its developers that it really worked entered public circulation. One of the developers, Alexander Ryzhikov, recently announced that neutralizing bodies may well be absent in EpiVacCorona. Their presence, it turns out, was not what the developers of the vaccine wanted - they only wanted the vaccine to offer protection, and such protection, according to Ryzhikov, may be based on a principle unknown to us!

“We set the task, firstly, to protect the lungs from severe damage,” Ryzhikov explained, “and secondly, to limit the spread of the virus among the population. We’ve oriented the immune defense towards the lungs since we do not claim to have a completely sterilizing vaccine.»

But, unfortunately, even the statement about the possible protection of the lungs cannot be confirmed by any scientist or any of the participants in the study. Moreover, this statement only raises new questions related to the conduct of experiments on animals that led the developers of the vaccine to the conclusion that it offered «protection» against complications and pneumonia.

Experiments or falsifications?

Rospotrebnadzor was handed 1.4 billion rubles for the development of means for preventing and diagnosing the new coronavirus infection, and in particular for the development of EpiVacCorona. A source close to Vektor told The Insider that the research center was originally going to develop a vaccine in three months. With deadlines approaching and experience lacking, all the results of the studies of the first two phases got «slightly distorted,» he said.

“Vektor has a vivarium in Pavlovsky Posad, where experiments were carried out on animals. The exact data from those studies have not been published anywhere by Vektor. In their paper, published in the Bulletin of the Russian Academy of Medical Sciences, the authors themselves were confused about their own findings, saying they followed the reaction in the subjects, but at the same time they took sera from the animals.

In their publication in Infections and Immunity the authors presented X-rays of the animals, allegedly without pneumonia. According to one of the sources close to EpiVacCorona research, much of the experimental data was simply «manipulated and fabricated.»

Some experiments were carried out, but the animals were injected with relatively small doses of the virus, and therefore the course of the disease was not so severe, and there were no problems with the lungs. The weight of the lungs in animals that were vaccinated after being infected with the virus turned out to be significantly smaller, which meant less edema, hence the conclusion that the vaccine worked; but based on that alone, one cannot draw such serious conclusions. Again, it all boils down to the conclusion that the molecular mechanism of the vaccine’s action is incomprehensible, yet, mysteriously, the vaccine works and offers some sort of protection.

“All evidence indicates there were some falsifications during the study. It is possible that the neutralization experiment, where there was no positive control, was simply fabricated. This is even more likely than the assumption that there is some kind of artifact. The method in itself is erroneous. It sometimes happens in biology: you see some experimental result and think that you got what you wanted, and then you redo the experiment, and you either cannot reproduce the result, or you can reproduce it, but with some irregularities. And then there is a reason for these irregularities. You cannot simultaneously have antibodies in animals, and not have antibodies in humans,” the molecular biologist says.

Injected without warning.

With the advent of the third wave, people poured into the vaccination rooms, and many of them faced doctors strongly recommending the EpiVacCorona vaccine; some were injected with that vaccine instead of Sputnik without warning.

“Recently I told my mother about the vaccines, strongly recommending that she get a Sputnik, but when she went to the clinic, she was still given EpiVacCorona and told it was safer for the elderly,” says Ksenia from Moscow. “My mom is 74, she has had a heart attack, she has a lot of chronic diseases, but this does not change the fact that EpiVacCorona was simply imposed on her. I will now try to have her revaccinated with Sputnik, I am going to persuade her to go to the district shopping center, although she keeps refusing and saying that «the doctors should know better.»

As a rule, doctors advise choosing EpiVacCorona saying it has fewer side effects, and, most likely, the doctors themselves believe it.

“Today I received the first dose of Sputnik in the Park House shopping center, and the service leaves much to be desired: there was no computer, they use actual ledgers to record patients,” says Irina from Kazan, “they offer either Gam-COVID-Vac or EpiVacCorona. When asked by those who appear for vaccination about the difference between these vaccines, the doctors answer that EpiVac is milder, and you have to wait only two weeks instead of three to get the second dose. After such an explanation, many people give their consent to be injected with EpiVacCorona.

«We went to get our vaccine shots together with my parents,” says Svetlana from Moscow, “I had been mulling over the choice of what vaccine to use for a long time, read different articles, and in the end, I opted for Sputnik. We came to the clinic. First, they invited me, gave me my shot, recorded it in the certificate and let me go, then they invited my parents. When they left the office, I asked if everything was all right, they said yes, but they got a different vaccine. I asked what he meant by “different”. Dad said he got an EpiVac because the nurse said that vaccine produced antibodies faster and it was not necessary to wait three weeks for the next injection, and mom just followed his example. I tried to explain to them it was some kind of provocation, we needed to go to the head physician to clarify the whole situation, but my parents did not listen to me, saying it made no difference which vaccine was used and if the doctors said the other one also worked and was even faster than Sputnik, why shouldn’t they use it?”

But there are also instances when people chose Sputnik and then suddenly found out they had been injected with Vektor:

“I signed a consent for Gam-COVID-Vac,” says Albina from Vladivostok, “After the vaccination, I was given a memo about possible side effects, where it was also indicated that I had received a Sputnik. Information about the vaccination was recorded in a printed certificate, but I did not check it of course, the doctor did not show me the ampoule, but at that point in time I did not even think it was worth asking about it. When I was receiving the second dose the situation was the same, all the data was recorded, I did not even think about it. Two weeks later, I received a call from the clinic and was prescribed an antibody test; they said I would need my obligatory medical insurance policy and the printed vaccination certificate. The next day, I began to collect documents and for some reason decided to read what was written on my certificate. What I saw shocked me: the certificate listed two completely different vaccines - Sputnik and EpiVacCorona. I checked the State Services app, and it showed (and still shows) the absence of the second stage of vaccination. The next day I came to the clinic, gave a blood sample for detecting antibodies, gave the doctor my printed vaccination certificate and asked him to straighten it out and find out what happened. In the evening, the doctor called me back and said it was a mistake, and in fact they gave me two Sputnik vaccines, and the nurse wrote the word “EpiVacCorona” by accident. But apart from the doctor's words, I have no other confirmation. And they did not give me the result of the antibody test because I had made the appointment by phone while in fact, I needed a doctor’s prescription for the test. They only said that according to the test results, I have no antibodies. Now I want to do another test at a paid clinic, but, frankly, I still do not know what they gave me, and I’m not at all sure that the first dose was a Sputnik”.

Maria from Balashikha had a similar situation:

“I came in for the Sputnik vaccination, went into the office, signed my consent and waited for the injection. The nurse for some reason did not proceed with it right away, she hesitated for some reason. I thought she was new or something like that, I did not rush anyone, of course, I did not see what ampoule she was taking and did not ask her to show it to me, why would I? She gave me an injection, recorded the necessary information in the certificate, I was about to leave, when suddenly she told me she had injected me with EpiVacCorona, because they ran out of Sputnik, and, really, there was no significant difference between those vaccines, and EpiVac was even better – milder and practically without any side effects. I became angry with her, saying it was outrageous and I would go to the head physician to sort it out. But she stopped me and said that nothing terrible had happened, and if I wanted to be vaccinated with Sputnik, then my certificate said «Sputnik» anyway, if that piece of paper was so important to me. But the matter is not the certificate but the vaccine! Now I want to go to some shopping center and get a Sputnik for myself. I still cannot get over this, and it will cost me more to take the matter to the hospital management. How can I prove anything when all the documents say I was vaccinated with Sputnik?”

It is not known how many people have already received a dummy vaccine, but Vektor planned to launch the production of up to 5 million doses per month this year. Amid the new wave of coronavirus, the lives of thousands of people may be threatened and public trust in vaccines may be generally undermined. Perhaps the authorities have realized that, since rumor has it that the reason for the shortage of the vaccine is that it is being quietly withdrawn from circulation.