Review of vaccines against COVID-19 registered in Russia
Currently, three vaccines against COVID-19 have been approved for use in the Russian Federation:
- “Sputnik V” developed by the National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya;
- “EpiVacCorona” developed by Vector Institute;
- “CoviVak” developed by the state-run Chumakov Research Center.
The Sputnik V vaccine was released on the market first on August 8, 2020. According to the State Register of Medicines (GRLS), production of finished dosage form, as well as packaging in primary packaging of the Sputnik V vaccine can be done by several pharmaceutical companies: JSC “Binnofarm”, JSC “GENERUM”, JSC “R-Pharm”, CJSC “BIOKAD”, CJSC “LEKKO”, JSC “FarmStandard-UFAVita”, “Medgamal” Branch of the National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya, but only the Gamalea Research Institute of the Ministry of Health of Russia is responsible for the release quality control.
The vaccine itself is a biotechnology drug created from adenovirus particles containing the SARS-COV-2 virus gene S protein. The S protein produced in viral particles induces the formation of immunity against coronavirus infection.
Since the registration of the drug, 9 changes have been made to the instructions for medical use, including the addition of data on epidemiological efficacy of the vaccine (intermediate analysis – 91%), the category of people aged 60+ was added to the indications for use, several times the content of the section “posology and method of administration” has been changed.
As for the vaccine “EpiVacCorona”, it was registered on October 13, 2020. Two organizations are engaged in the production of the finished vaccine: Vector Institute belonging to Rospotrebnadzor and JSC “Vector-Bialgam”. Vector Institute is the only manufacturing site responsible for the release quality control.
The drug consists of peptide antigens of the SARS-COV-2 virus protein S, connected to the carrier protein and adsorbed on an aluminum-containing adjuvant (a substance that enhances the body’s immune response).
Currently, 3 changes have been approved to the instructions for medical use. Approval of Change No. 3 made it possible to use vaccine “EpiVacCorona” for people older than 60, but the protective titer of antibodies and duration of immunity remain unknown for all age groups.
It should be noted that participants of clinical studies doubt the effectiveness of the vaccine “EpiVacCorona” and asked the Ministry of Health of the Russian Federation to organize independent from Rospotrebnadzor study of the vaccine immunogenicity.
If we talk about the last approved vaccine “CoviVak”, it is the most classic of all three vaccines, since it is a suspension of the inactivated coronavirus SARS-COV-2 strain of “AYDAR-1”. The drug was reported on February 19, 2021. The state-run Chumakov Research Center is responsible for the whole production cycle.
The drug is intended for use in people between 18 and 60. As in the case of the vaccine “EpiVacCorona”, the protective titer of antibodies and the duration of immunity remain unknown.