The EpiVacCorona-N vaccine, registered recently by the Russian Ministry of Health, has proven its effectiveness against circulating strains. Tatiana Nepomnyashchikh, Deputy Director General of the Vector Center of Rospotrebnadzor, announced this in an exclusive interview with RT. According to her, the new drug is easily tolerated and safe to use. At the same time, Nepomnyashchikh noted the high export potential of the EpiVacCorona-N vaccine, the production of which is “easily scalable”. In addition, the drug can be stored in a conventional refrigerator and use modern logistics chains to transport it.
– Please tell us what is the fundamental difference between EpiVacKorona-N and EpiVacKorona?
– For a person who will go to be vaccinated, there are no differences. The vaccine consists of the same carrier protein, excipients and three peptides. The only thing, in the “EpiVacCorona” vaccine, all three peptides were synthesized separately. And if we look at the vaccine, it looks like an ear of corn – it is a carrier protein covered with grains of three colors. These are our three peptides. In “EpiVacCoron-N” these grains, two of them, are combined into one. This was done for production convenience. The demand for the vaccine is very high, and in this format it will be much easier and easier to scale up.
– Can we say that the changes that were made to the vaccine formulation, its structure, were caused precisely by the need for scaling, and not by the shortcomings of the vaccine itself?
– Of course. In fact, the vaccine contains the same active ingredients. Only in this form is it easier to produce in large volumes.
– The new vaccine “EpiVacCorona-N” was registered in the Ministry of Health, it also passed clinical trials, like “EpiVacCorona”? What are the performance indicators for the new drug, according to research?
– According to Russian legislation, since we have changed the technological process, then, of course, the vaccine must undergo clinical trials anew. Our vaccine has now undergone clinical trials of the first – second phases on 225 volunteers. The vaccine has shown the same efficacy and safety as EpiVacCorona. Such studies are carried out to ensure the safety of the vaccine, the absence of serious consequences and side effects after its use, as well as to determine its immunological efficacy, which shows that antibodies are formed upon the administration of the vaccine. As for the epidemiological safety, this is precisely why the following extended post-registration clinical studies of the third – fourth phase are being carried out.
– What strains does EpiVacCorona-N protect against?
– The vaccine is effective against circulating strains: both those that are rare, and those that now occupy a leading position in prevalence, such as the delta strain. We are checking it out. Both theoretically, by studying what mutations there are in the virus, and making sure in theory that they do not fall into the regions of the peptides we have chosen, and in practice, by conducting an extensive cycle of virological studies against some strains. In both cases, we see that the vaccine is effective.
- Tatiana Nepomnyashchikh – on the export potential of the EpiVacCorona-N vaccine
– Some people were skeptical about EpiVacCorona due to the fact that the immune response to it was determined only by a specific test of the Vector itself. What can you say about EpiVacCoron-N in this context?
– The main thing is not what test system determines post-vaccination immunity, but what kind of protection the vaccine provides against coronavirus infection. Currently in Russia, about a million citizens have completed a full course of vaccination (“EpiVacKoronoy”. – RT). And we can assess the effectiveness of Russian vaccines. They are all roughly equal here and protect against a new coronavirus infection. On average, about 0.6% of those vaccinated who have completed a full course of vaccination get sick. Determination of antibodies after vaccination is optional, but it is possible. Our vaccine is based on a new technology platform. And there is its own test system for it, since conventional test systems may not have sufficient sensitivity to detect antibodies that appear after vaccination.
– How do you assess the export prospects of the new Russian drug EpiVacCorona-N?
– We highly appreciate the export potential of our vaccine. And we are ready to transfer the technology of its production to potential partners not only in Russia, but also abroad. The vaccine has a number of undeniable advantages: it is effective against various strains, its production is relatively cheap, and it is easily scalable. The vaccine is stably stored at a temperature of +2 … + 8 ° C – that is, it can be stored in an ordinary refrigerator. Modern logistics chains are applicable for transportation. In addition, EpiVacCorona-N is easy to carry and safe to use.
– Is there any difference between EpiVacCorona-N vaccination?
– Now the scheme is the same. A person comes to the clinic, gets vaccinated. After two to three weeks, according to the instructions, you can deliver the second dose of the vaccine. Both vaccinations, the first and the second, are the same in composition.
– How is the EpiVacCorona-N vaccination tolerated?
– According to our observations, it is very easy to carry. There is a slight increase in temperature. But according to the experience of my colleagues who were vaccinated with this vaccine, and my own, there was no rise in temperature. If it is observed, then it goes away on its own in one or two days, as well as possible pain at the injection site.
- Tatiana Nepomnyashchikh – on clinical trials of the EpiVacCorona-N vaccine
– What about the revaccination of EpiVacKorona-N?
– As well as “EpiVacCorona” and “EpiVacCorona-N” are completely suitable for revaccination. You can revaccinate an unlimited number of times. Currently, revaccination will also be performed with two doses of the vaccine, as written in the instructions.
– What age categories of citizens can use EpiVacKoronu-N? What about pregnant women, the elderly and children?
– Vaccines are registered for use first in the adult population. This is 18-60 years old. After that, the vaccines undergo additional clinical trials. As for the use in children, these are six studies with decreasing age, starting with the group of 14-17 years and up to the category of 0-6 months. Separate clinical trials are also being conducted for the use of the vaccine in the elderly over 60 years of age. The same applies to the use of the vaccine for use by pregnant women. That is, in order for the vaccine to receive permission for use in these categories of citizens, it must undergo additional research. If such a task is set, we are ready to carry out them.
- Vaccination point in Moscow
- RIA News
- © Alexey Maishev
– Do you plan to publish in international medical journals about EpiVacCoron-N?
– We plan to publish in scientific journals included in international databases. In fact, if a journal is included in an international database such as Scopus or Web of Science, it makes no difference in which country it is published. In order to enter this international database, journals from any country must meet certain requirements. Such publications are available to readers from anywhere in the world. We plan to continue the series of publications dedicated to our vaccine.