Alla M. Sokurova, PhD in Biological sciences, Associate Professor, Associate Professor of the Department of microbiology, virology and immunology of the St. Petersburg State Pediatric Medical University, 2 Litovskaya Street, 194100 St. Petersburg, Russian Federation; e-mail: email@example.com
In the heading: Rewiews
Year: 2022 Volume: 4 Journal number: 1
Article type: scientific and practical
Introduction. The article presents current information on the developed domestic and foreign vaccines against a potentially severe acute respiratory infection caused by the SARS-CoV-2 coronavirus (2019-nCoV). Since March 11, 2020, the spread of this disease has been recognized by the World Health Organization as a pandemic. As of early November 2021, more than 250 million human infections and more than 5 million deaths have already been registered. The action of all vaccines against COVID-19 is aimed at the formation of antibodies to the S-protein of the virus, which prevents its penetration into cells.
Aim. Characterization of different types of vaccines against COVID-19, as well as the study of differences in the number of doses, interval and method of administration.
Materials and methods. A content analysis of the regulatory framework, scientific publications and an analysis of the information contained on the official websites of the World Health Organization, the Russian Ministry of Health, and vaccine manufacturers for 2020-2021 was carried out.
Results. According to WHO data (early November 2021), 317 vaccines are in development, 123 of which are being tested in the clinical phase and 194 in the preclinical phase. There are 10 types of vaccines in total. Vaccines also differ in the number of doses, interval and route of administration. There are 10 Russian vaccines undergoing clinical and preclinical trials. Seven of them are undergoing preclinical trials. In the Russian Federation, four domestic vaccines are approved for use.
Discussion. In the world at the beginning of November 2021, 251,200,167 cases of the disease were detected, 5,074,052 patients died (2 %). In the Russian Federation, these figures were 8,873,655 and 249,215 (about 3 %), respectively. 35.7 % of the world’s population have been fully vaccinated, in the Russian Federation — about 34 %.
Vaccine development is a long and expensive process. It includes baseline studies, preclinical studies, clinical trials (consisting of three phases), state control and registration, further regular studies to assess the safety, efficacy of the drug and identify other side effects.
With COVID-19, scientists have not fully figured out what exactly constitutes an effective immune response. Without this, it is difficult to unambiguously assess the effectiveness of the vaccine.
In preclinical studies, it was found that antibodies that are able to bind to the S-protein of the SARS-CoV-2 virus block the penetration of the virus into the cell. It is for this reason that the action of all COVID-19 vaccines is aimed at the formation of antibodies to the S-protein of the virus, which prevents its penetration into cells.
Conclusion. Over the past two years, new information has been obtained on the mechanisms of both humoral and cellular immune responses to SARS-CoV-2, more than 300 vaccines have been developed and are being studied, and highly sensitive and specific test systems are used for diagnostics. But it has not been finally established which classes of immunoglobulins to the S-protein and in what titers provide protection against infection. It is already clear that the very presence of IgG to the virus is not an absolute protection against infection.
It is also relevant to assess the role of cellular immunity in protection against SARS-CoV-2.
1. Beeching NJ, Fletcher TE, Beadsworth MBJ. Covid-19: testing times. British Medical Journal. 2020; 369: m1403. doi:10.1136/bmj.m1403.
2. Pravitel’stvo Rossiyskoy Federatsii [Government of the Russian Federation]. Available at: http://government.ru/ dep_news/38904/. (accessed 01.03.2022). (In Russian).
3. Profilaktika, diagnostika i lecheniye novoy koronavirusnoy infektsii (COVID-19). Vremennyye metodicheskiye rekomendatsii. Minzdrav Rossii (3 marta 2020) [Prevention, diagnosis and treatment of novel coronavirus infection (COVID-19). Temporary guidelines. Ministry of Health of Russia (March 3, 2020)]. Available at: https://static-0.rosminzdrav.ru/
system/attachments/attaches/000/049/629/original/ BpeMeHHbie_MP_C0VID-19_03.03.2020_%28eepc iiii3%29 6 6.|)(lf?1583255386. (accessed 01.12.2021). (In Russian).
4. David L Heymann, Nahoko Shindo. COVID-19: what is next for public health? The Lancet Journal. 2020; 395(10224):542-5. doi:10.1016/S0140-6736(20)30374-3.
5. Klinicheskoye vedeniye tyazheloy ostroy respiratornoy infektsiipripodozreniinanovuyukoronavirusnuyu(2019-nCoV) infektsiyu. Vremennyye rekomendatsii. VOZ. 28 yanvarya 2020 g. [Clinical management of severe acute respiratory infection for suspected novel coronavirus (2019-nCoV) infection. Temporary recommendations. WHO. January 28, 2020]. Available at: https://apps.who. int/iris/bitstream/handle/10665/330893/WHO-nCoV-Clinical-2020.3-rus.pdf?sequence=5&isAllowed=y/. (accessed 01.12.2021). (In Russian).
6. World Health Organization. Media briefing on COVID19 with DrTedros. Available at: https://twitter.com/WHO/ status/1237777021742338049/. (accessed 01.12.2021).
7. Gam-KOVID-Vak — instruktsiya po primeneniyu [Gam-COVID-Vak — instructions for use]. Available at: https:// medi.ru/instrukciya/gam-kovid-vak_17105/. (accessed 01.03.2022). (In Russian).
8. EpiVakKorona — instruktsiya po primeneniyu [EpiVacCorona — instructions for use]. Available at: https://medi.ru/instrukciya/epivakkorona_26307/. (accessed 01.03.2022). (In Russian).
9. KoviVak — instruktsiya po primeneniyu [KoviVak — instructions for use]. Available at: https://medi.ru/ instrukciya/kovivak_26476/. (accessed 01.03.2022). (In Russian).
10. Sputnik Layt — instruktsiya po primeneniyu [Sputnik Light — instructions for use]. Available at: https:// medi.ru/instrukciya/sputnik-layt_26611/. (accessed 01.03.2022). (In Russian).
11. COVID-19 vaccine tracker and landscape) Available at: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines. (accessed 01.12.2021).
12. EpiVakKorona. Vaktsina na osnove peptidnykh antigenov dlya profilaktiki COVID-19 [EpiVacCorona. Vaccine based on peptide antigens for the prevention of COVID-19]. Available at: http://www.vector.nsc.ru/ page/878/. (accessed 01.03.2022). (In Russian).
13. Registratsionnoye udostovereniye KoviVak (Vaktsiny koronavirusnoy inaktivirovannoy tsel’novirionnoy kontsentrirovannoy ochishchennoy) [Registration certificate of CoviVac (Coronavirus vaccine inactivated whole virus concentrated purified)]. Available at: https://grls.rosminzdrav.ru/Grls_View_ v2.aspx?routingGuid=099fb38b-271f-4a80-93d1-9b1c1611c509&t=. (accessed 01.03.2022). (In Russian).
14. Coronavirus (COVID-19) Vaccinations. Available at: https://ourworldindata.org/covid-vaccinations/. (accessed 01.12.2021).
15. Resheniye Soveta Yevraziyskoy ekonomicheskoy komissii ot 03.11.2016 № 78 (redaktsiya ot 23.04.2021) «O Pravilakh registratsii i ekspertizy lekarstvennykh sredstv dlya meditsinskogo primeneniya» (s izmeneniyami i dopolneniyami, vstupil v silu s 06.10.2021) [Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 78 (as amended on April 23, 2021) “On the Rules for the Registration and Examination of Medicinal Products for Medical Use” (as amended and supplemented, entered into force on October 6, 2021)]. Available et: https://legalacts.ru/doc/reshenie-soveta-evraziiskoi-ekonomicheskoi-komissii-ot-03112016-n-78/. (accessed: 25.02.2022). (In Russian).
16. Resheniye Soveta Yevraziyskoy ekonomicheskoy komissii ot 03.11.2016 № 77 (redaktsiya ot 14.07.2021) «Ob utverzhdenii Pravil nadlezhashchey proizvodstvennoy praktiki Yevraziyskogo ekonomicheskogo soyuza» [Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 77 (as amended on July 14, 2021) “On Approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union”]. Available et: https://www.vgnki.ru/assets/files/reshenie-soveta-evrazijskoj-ekonomicheskoj-komissii-ot-03_11_2.pdf. (accessed: 25.02.2022). (In Russian).
17. Resheniye Soveta Yevraziyskoy ekonomicheskoy komissii ot 03.11.2016 № 89 «Ob utverzhdenii Pravil provedeniya issledovaniy biologicheskikh lekarstvennykh sredstv Yevraziyskogo ekonomicheskogo soyuza» [Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 89 “On Approval of the Rules for Conducting Research on Biological Medicinal Products of the Eurasian Economic Union”]. Available et: https://docs.eaeunion.org/docs/ru-ru/01411954/cncd_21112016_89. (accessed: 25.02.2022). (In Russian).
18. Yaqinuddin A, Kashir J. Innate immunity in COVID-19 patients mediated by NKG2A receptors, and potential treatment using Monalizumab, Cholroquine, and antiviral agents. Med. Hypotheses. 2020; 140: 109777. DOI: 10.1016/j. mehy.2020.109777.
19. Cao W, Li T. COVID-19: towards understanding of pathogenesis. Cell Res. 2020; 30 (5): 367-9. DOI: 10.1038/ s41422-020-0327-4.
20. Tay MZ, Poh CM, Renia L. et al. The trinity of COVID19: immunity, inflammation and intervention. Nat. Rev. Immunol. 2020; 20 (6): 363-74.
DOI: 10.1038/s41577-020- 0311-8.
21. Kostinov MP, Markelova EV, Svitich OA, Polishchuk VB. Immunnyye mekhanizmy SARS-CoV-2 i potentsial’nyye preparaty dlya profilaktiki i lecheniya COVID-19. Pul’monologiya [Immune mechanisms of SARS-CoV-2 and potential drugs for the prevention and treatment of COVID-19]. Pulmonology [Pulmonology]. 2020; 30 (5): 700-8. DOI: 10.18093/0869-0189-2020-30-5-700-708. (In Russian).
22. He Z, Ren L, Yang J, et al. Seroprevalence and humoral im-mune durability of anti-SARS-CoV-2 antibodies in
Wuhan, China: a longitudinal, population-level, crosssectional study. Lancet.2021;397(10279):1075-84. doi: 10.1016/S0140-6736(21)00238-552.
23. Minervina AA, Komech EA, Titov A, et al. Longitudinal high-throughput TCR repertoire profiling reveals the dynamics of T-cell memory formation after mild COVID-19 infection. Elife.2021;10:e63502. doi: 10.7554/eLife.6350254.
24. Tan AT, Linster M, Tan CW, et al. Early induction of functional SARS-CoV-2 specific T cells associates with rapid viral clearance and mild disease in COVID-19 patients. Cell Reports.2021 Feb 9;34(6):108728. doi: 10.1016/j.celrep.2021.108728.
25. Dan JM, Mateus J, Kato Y, et al. Immunologi-cal memory to SARS-CoV-2 assessed for up to 8 months after infection. Science.2021;371(6529):eabf4063. doi:10.1126/science. abf406358.
26. Kang CK, Kim M, Lee S, et al. Longitudinal analysis of human memory T-Cell Response according to the severity of illness up to 8 months after SARS-CoV-2 infection. J Infect Dis. 2021;jiab159. doi: 10.1093/infdis/jiab15959.
27. Shomuradova AS, Vagida MS, Sheetikov SA, et al. SARS-CoV-2 Epitopes Are Recognized by a Public and Diverse Repertoire of Human T Cell Receptors. Immunity. 2020;53(6):1245-1257 e1245. doi: 10.1016/j.immuni.2020.11.00460.
28. Lampasona V, Secchi M, Scavini M, et al. Antibody response to multiple antigens of SARS-CoV-2 in patients with diabetes: an observational cohort study. Diabetologia. 2020;63(12):2548-2558. doi: 10.1007/s00125-020-05284-440.
29. Noval MG, Kaczmarek ME, Koide A, et al. Antibody isotype diversity against SARS-CoV-2 is associated with differential serum neutralization capacities. Sci Rep. 2021;11(1):5538. doi: 10.1038/s41598-021-84913-3.
30. Logunov DY, Dolzhikova IV, Shcheblyakov DV, et al. Safety and efficacy of an rAd26 and rAd5 vectorbased heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021;397(10275):671-681. doi: 10.1016/S0140-6736(21)00234-870.
31. Selhorst P, Van Ierssel S, Michiels J, et al. Symp-tomatic SARS-CoV-2 reinfection of a health care worker in a Belgian nosocomial outbreak despite primary neutralizing antibody response. Clin Infect Dis. 2020;ciaa1850. doi: 10.1093/cid/ciaa1850.