26.01.2022

Vector vaccine against coronavirus raises questions from doctors and scientists

Scientists talked about the features of the EpiVacCorona vaccine from Vector. In the Novosibirsk region, “EpiVacKoronoy ” began to be vaccinated in December, but mainly Sputnik V is installed in polyclinics.

The vaccine against coronavirus “EpiVacCorona” from the Novosibirsk center “Vector” has become the second vaccine registered in Russia after “Sputnik V”. The authors present it as “a simple, elegant and versatile solution” for building immunity against COVID-19.

Already at the first stages, the development of the vaccine was classified – any communication with “Vector” was carried out only through the federal Rospotrebnadzor. Over time, questions about the vaccine appeared among volunteers who took part in the trials, and among scientists who began to doubt the effectiveness of the drug. We tried to figure out why the new drug raises doubts among specialists and who supplies the materials for the vaccine.

Last week, the director of the private clinic “Sanitas”, surgeon Mikhail Andrushkevich, in an interview with “Precedent” spoke about “EpiVacCoron”:

– The vaccine “Vector” – “EpiVacCorona” – most likely does not work. The development of this vaccine was based on a beautiful hypothesis, but, unfortunately, we do not see antibodies, the doctor told the publication.

Andrushkevich’s statement caused a violent reaction – it was reprinted by several Novosibirsk media outlets. In a conversation with the NGS, Mikhail Andrushkevich clarified that he had made such a conclusion based on the analyzes of their clinic. He said that antibodies were not detected in patients vaccinated with EpiVacCorona.

Participants in clinical trials of the vaccine also announced the absence of antibodies after vaccination with EpiVacCorona. The vaccinated volunteers united in a chat on Telegram, where they published an open letter to the Ministry of Health, Rospotrebnadzor and Vektor. At the time of writing the letter, 80 members of the group confirmed their participation in the tests with documents. The letter was signed by 59 study participants.

– We independently and at our own expense check the level of antibodies, but all the results obtained are below the reference value. “Vector” claims that it is possible to determine the required antibodies only by their test system, but keeps it secret. You cannot order such a test yourself in a laboratory. In such a situation, doubts arise about the effectiveness of the vaccine among many study participants and among those who have already received the vaccine as part of civil vaccination. 33% of those who documented their participation in the study passed such tests, and all of them received negative tests for antibodies (against coronavirus), the letter says.

In this case, only 25% of volunteers should have a placebo. According to the data published in the unofficial telegram channel “EpiVacCorona Novosti”, on February 5, out of 77 participants in clinical trials, 39 (50.6%) did not find antibodies, 36 (46.8%) did not find antibodies, and 2 more people had the result borderline.

In January, Rospotrebnadzor announced 100% immunological effectiveness of the vaccine:

– The effectiveness of a vaccine is the sum of its immunological effectiveness and prophylactic effectiveness. According to the results of the first and second phases of clinical trials, the immunological effectiveness of the EpiVacCorona vaccine is 100%, the press service of Rospotrebnadzor quoted TASS.

Vektor acknowledged that antibodies after EpiVacCorona are not fixed by conventional test systems, and stated that they have developed their own for this – SARS-CoV-2-IgG-Vector.

– The new technological platform of peptide vaccines used to create the EpiVacCorona vaccine requires the development of new approaches to the determination of post-vaccination immunity. <…> Most commercial test kits are aimed at detecting a wide range of antibodies to different regions of the S envelope protein of the new coronavirus, and their sensitivity may not be sufficient to detect a small pool of key antibodies formed after vaccination with the EpiVacCorona vaccine. Such test systems with a high probability will not detect antibodies in persons vaccinated with EpiVacKorona, the Rospotrebnadzor reported.

What does all this mean

The “EpiVacCorona” vaccine belongs to the peptide vaccine – this is a fairly new type of vaccine design, which has a number of features.

As explained by the doctor of biological sciences, professor of virology Alexander Chepurnov, there are several ways to design a vaccine – they are also called platforms for vaccines.

The first option is an inactivated vaccine. In this case, the virus is propagated in a cell culture and purified from impurities – as a result, a pure virus suspension is obtained. Then it is deprived of the opportunity to reproduce:

– It turns out a complete portrait of the virus, but it is not able to cause disease, – explains Alexander Chepurnov. Such vaccines include “KoviVak”, which was developed at the Chumakov Federal Scientific Center.

Another option is a recombinant vaccine, when some part of the genome of the virus is removed so that it cannot constantly multiply.

– Then they add fragments of the coronavirus to the genome – in our case. Moreover, the part that is relevant for some function. In our case, for the coronavirus, “thorns” were used, with the help of which this virus attaches to cells. This is protein S. After being introduced into the body, this virus enters the cells once and, multiplying, creates proteins that are an exact copy of this surface protein (“spike”). The immune system, seeing all this, recognizes it as a foreign antigen and begins to create immune defense against it, – said Alexander Chepurnov. This platform was used to create the Sputnik V vaccine.

“Spikes” are the outgrowths on the surface of the coronavirus, from which it gets its name.

The third option is peptide vaccines, to which EpiVacCorona belongs. The peculiarity of peptide vaccines is that when they are created, specialists produce the smallest fragments of proteins – peptides. Alexander Chepurnov explains that peptides should create something like a “portrait” of a virus against which the immune system should be activated.

– The problem here is that you need to calculate very accurately and get into that fragment of the genome that will be relevant for the immune response. That is, in which the immune bodies can neutralize the virus. The presence of neutralizing antibodies is what makes a normal vaccine effective. The second point is that these peptides are very small. Small biological objects are not recognized by the immune system, it does not see them. Therefore, in order for the immune system to begin to see this, these peptides must be somehow precisely sewn to another protein. Together they become more recognizable by the immune system, and then it can see them and do something about it. In the case of “Vector”, they took as such a protein the central protein of the coronavirus – N-protein, – said the scientist.

According to Chepurnov, initially “Vector” stated that it would develop a vaccine on 6 different platforms, including a recombinant one, but in the end, all designs, except for “EpiVacCorona”, disappeared at the research stage.

What’s wrong with EpiVacCorona

Alexander Chepurnov suggests that when developing the drug, the authors miscalculated and chose the wrong peptides – they turned out to be weakly immunogenic and irrelevant for neutralizing the virus. That is, there are two main disadvantages of the vaccine, which the scientist highlights: the fact that it is a peptide and the immune system does not recognize it well, and the fact that the wrong peptides were chosen in the development.

– It turns out that we ourselves have developed a vaccine and a test to test its effectiveness. They themselves control the whole thing, since this is Rospotrebnadzor, and no one is allowed to approach this. They themselves take these proteins, and where they are produced is not clear. Naturally, all this begins to grow overgrown with gossip. This always happens if there is not enough transparency, – said Alexander Chepurnov.

Vektor reported that the three peptides that make up the EpiVacCorona vaccine are computer simulated and chemically synthesized fragments of the S protein of the new coronavirus, which were combined with a carrier protein (protein N of the new coronavirus).

According to Chepurnov, the only advantage of EpiVacCorona is that it does not cause side effects. For example, after Sputnik, 50% of patients experience fever and unpleasant symptoms.

– In fact, the side effects are okay, but people have different attitudes towards it. And the vaccine “Vector” is not reactogenic, but what is there with its properties in fact, no one knows. And if there are such doubts, then it should be investigated by someone independent. Otherwise, we may face the fact that a large percentage of vaccinated people will not be protected, the professor concluded.

Olga Matveeva, a molecular biologist and researcher at the University of Utah, also says that when creating a vaccine, Vector’s specialists made a mistake with a set of peptides.

– The SARS-CoV ‑ 2 virus is designed so that only antibodies to the spike protein can neutralize it. Antibodies to the nucleocapsid (N-protein) protein cannot do this: this protein is located inside the viral particle, and antibodies cannot interact with it, and therefore, it is not available for antibodies in an intact virus. Nevertheless, the nucleocapsid protein as an antigen (foreign substance) can help the immune response, writes Olga Matveeva in her article for the scientific journal Trinity Variant.

In an interview with the NHS, Olga Matveeva said that, according to recent scientific articles, the peptides used in EpiVacCoron are not visible to the immune system. Olga suggests that during the development of the vaccine, the authors assumed that they would work, but this did not happen:

– These peptides were chosen in March, when there was nothing but a show. There are objective difficulties here: indeed, how could they guess which peptides are needed. The problem is that the system is completely opaque. Nowhere do they demonstrate whether there is an antibody or a cellular response. But, probably, the biggest complaint is that they implemented it without having carried out the 1st and 2nd phases of testing, – explains Olga Matveeva.

The biologist says that during the 1st and 2nd phases of testing, the vaccine is tested for safety and the ability to elicit antibodies. According to the government of the Novosibirsk region, civil vaccination with EpiVacKorona began on December 16, when the drug began to be supplied to medical workers and representatives of the social sphere. The Ministry of Health sent the vaccine to areas where there are no conditions for low-temperature storage of the Sputnik V vaccine: Bolotninsky, Suzunsky and Toguchinsky. At the same time, in January this year, RIA Novosti, citing Vector, reported that the 1st and 2nd phases of testing should be completed by mid-February.

– There are no antibodies, the testing phases have not been completed, and the vaccine is being introduced into civilian circulation. Everything is so opaque that anything can be there, – says Olga Matveeva.

Olga Matveeva emphasizes that it is the hasty introduction of EpiVacCorona into widespread use that raises the main questions. The specialist says that it is in principle difficult to create a peptide vaccine, and the scientists of Vector, despite all the shortcomings, “took up an interesting task,” and EpiVacCoron could be improved:

– Now everyone is talking about mutations in the coronavirus. Mutations can indeed alter the immune system’s recognition of the virus, and vaccines may be less protective. In theory, it is possible to find such peptides that do not change, and the virus cannot afford to change them. If it is possible to make cellular immunity on it, then, indeed, it can be a long-term vaccine, since both peptides and N-protein change less, and this vaccine can protect longer, despite mutations, says Olga Matveeva.

Patent, contract and Anna Popova

Several experts, speaking with the NHS, mentioned that it is difficult to evaluate a new vaccine due to the lack of scientific publications about it. The only document available about EpiVacCoron is Vector’s vaccine patent. Among the authors of the invention are employees and the general director of “Vector” and its branches, as well as a woman named Anna Yuryevna Popova – the full namesake of the head of Rospotrebnadzor.

The first two lines in the list of authors are Alexander Ryzhikov – head of the department of zoonotic infections and influenza “Vector” – and Evgeny Alexandrovich Ryzhikov – together they are co-founders of the company “Epitek”. Evgeny Ryzhikov also owns Epivak LLC, registered at the same address as the Ryzhikovs’ joint company. Epivac filed an application for registration of the EpiVacCorona trademark, but later withdrew it.

Epivak was featured in the media as a developer of a vaccine for animals.

In 2021, Epivak LLC became a supplier of peptide antigens and test systems for Vector. According to the government procurement website, on February 3, Evgeny Ryzhikov, director of Epivak LLC, signed a contract with Vector for the supply of peptide antigens and test systems for the production of EpiVacCorona, as well as services for the purification and activation of the carrier protein. The contract price was 707 350 000 rubles, 30% have already been paid in advance. The source of funding was the federal budget. From June 2020 to today, this is the only purchase of “Vector” more expensive than 50 million rubles, associated with drugs.

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