The drug “EpiVacCorona” began to arrive in the Russian regions to vaccinate the population against coronavirus. This was announced in early April by the Minister of Health. Mikhail Murashko.
According to Rospotrebnadzor, about 250 thousand EpiVacKorona sets were delivered to the constituent entities of the Russian Federation. It became the second, after Sputnik V, a domestic vaccine against coronavirus registered and released into civilian circulation.
What does the EpiVacCorona vaccine consist of?
The drug “EpiVacCorona” was developed by the Federal Budgetary Scientific Institution “State Scientific Center for Virology and Biotechnology” Vector “of Rospotrebnadzor. There is no live virus in it. The vaccine is chemically synthesized on a peptide platform. Earlier, “Vector” in the same way created a peptide vaccine “EpiVacEbola” against Ebola.
EpiVacCorona contains three peptides – small artificially synthesized proteins that copy fragments of the S-protein of the SARS-CoV-2 coronavirus. They are deposited on a large carrier protein.
How does EpiVacCorona work?
Three peptides of “EpiVacCorona” stimulate the formation of only antibodies necessary to fight the virus. The body does not need to burden itself with the production of all antibodies that are formed in response to natural infection.
According to the deputy head of “Vector” Tatiana Nepomniachtchi, EpiVacCorona provides three lines of defense. At the first level, the vaccine prevents the virus from entering the cell. If he does get into the cage, the second line of defense comes into play. These are antibodies produced against the fusion peptide of the coronavirus. If this does not stop the virus and it penetrates further into the cell, the third line of defense is triggered. The vaccine activates humoral (antibody) immunity, as well as cellular immunity. As a result, the infected cell dies, along with it viruses are destroyed, and this stops the damage to neighboring cells.
How is the EpiVacCorona vaccine administered?
EpiVacCorona is a one-component vaccine, but it is given twice. Vektor explains that in the national vaccination calendar there were previously vaccines requiring multiple administrations.
The drug is administered intramuscularly. The interval between stages is 14-21 days.
What are the advantages of EpiVacCorona?
The results of two phases of clinical trials of the vaccine among volunteers aged 18-60 years showed that it caused the production of antibodies specific to the antigens that make up the vaccine in 100% of participants in the trials 21 days after receiving the second dose of the drug.
According to Nepomniachtchi, EpiVacCorona produces only specific, necessary antibodies, which reduces the burden on the immune system.
In addition, the developers deliberately did not use the immunodominant regions of viral proteins – they cause a violent immune response, but at the same time they are subject to rapid evolution. They used conserved viral protein fragments. Thanks to this, as the developers assure, the vaccine does not lose activity against the modified strains of the virus. Vektor claims that EpiVacCorona has been effective against British, South African, Brazilian and Californian strains of coronavirus.
The center also declares the safety of the vaccine, that it is non-reactive (does not cause any side effects) and practically does not cause allergic reactions. The drug is suitable for multiple revaccinations.
According to Nepomniachtchi, EpiVacCoron is easy to store and transport. The required temperature is + 2 … + 8 °, as in a conventional refrigerator.
How to check the level of antibodies after vaccination with EpiVacCorona?
Due to the fact that EpiVacCorona is designed to produce specific antibodies, standard tests may not always detect the presence of antibodies after using this drug. Center “Vector” has developed a special test system for the determination of antibodies specific for this vaccine. It has great sensitivity and is “tuned” to detect the “desired” antibodies. Such test systems are supplied to all regions where the population is vaccinated by EpiVacKorona.
How long can immunity last after EpiVacCorona?
The developers assume that EpiVacCorona will defend during the year. According to Nepomniachtchi, the monkeys, who were injected with the drug last spring, “are alive, healthy and cheerful, periodically donate blood, and they retain antibodies.” It will be possible to say exactly how much immunity will remain in people only a year after the vaccine tests.
Who can be vaccinated with EpiVacCorona?
Vaccination “EpiVacKorona” is carried out to adult citizens. The drug is prohibited for use by children under 18 years of age, since clinical studies on children have not yet been conducted. The vaccine has undergone successful clinical trials in people aged 60 and over. As a result, EpiVacCorona was approved for use among people over 60 years of age.
Rospotrebnadzor emphasizes that vaccination with EpiVacKorona is free for Russian citizens. It will be carried out on a purely voluntary basis.
Who is contraindicated for EpiVacCorona vaccination?
According to Rospotrebnadzor, EpiVacCorona has contraindications, so a doctor’s examination is required before using it. Contraindications to the use of the drug are as follows:
- hypersensitivity to vaccine components;
- severe forms of allergic diseases;
- primary immunodeficiency;
- malignant blood diseases and neoplasms;
- pregnancy and the period of breastfeeding;
- reaction or post-vaccination complication to a previous vaccine administration.
In acute infectious and non-infectious diseases, chronic diseases in the acute stage, vaccination can be done only a month after recovery or remission. If a person is sick with mild ARVI or acute infectious diseases of the gastrointestinal tract, vaccination is possible after the temperature has returned to normal.
Women planning post-vaccination pregnancy should consult with their doctor.
At what stage are clinical trials of the vaccine now?
EpiVacCoron was registered on October 13, 2020 based on the results of the first and second phases of clinical trials. Subsequently, the drug has successfully passed the phase II-IV open clinical trial among persons aged 60 years and older and received permission for use in elderly patients.
According to Rospotrebnadzor, clinical trials of the EpiVacCorona vaccine have been completed. Also, a post-marketing clinical trial of the vaccine was completed with the participation of 150 volunteers over 60 years old. A post-marketing clinical study is currently underway, involving 3000 volunteers over 18 years of age. It will last six months after the last participant was vaccinated.
In the future, clinical trials of the vaccine are planned among the child population aged 14 to 17 years. This will be possible after obtaining the appropriate permission from the Ministry of Health of Russia. It is assumed that 100-150 teenage volunteers in the Novosibirsk region will take part in the tests.
What symptoms did the volunteers have after administration of the drug?
Rospotrebnadzor reports that after the introduction of the vaccine, all volunteers felt well. Several participants in the trials, a day after the vaccination, developed a slight soreness at the injection site, it persisted for 1-2 days. No other undesirable phenomena were recorded.
There are contraindications, it is necessary to consult a doctor.