Problems associated with new coronavirus infection vaccination in patients with rheumatic diseases

Abstract

BACKGROUND: Decreasing new coronavirus infection-associated morbidity and mortality among patients with rheumatic diseases is one of the main goals of current rheumatology. Vaccination may be one of the ways to limit the incidence of new coronavirus infection in patients with rheumatic diseases.

AIM: To evaluate the results of vaccination in the patients with rheumatic diseases against the new coronavirus infection according to the data from real clinical practice and a review of the literature.

MATERIALS AND METHODS: 68 out of 556 literary medical sources and data from the St. Petersburg register of patients with rheumatic diseases as of September 1, 2021 (n = 16,263) have been analyzed. The data from the register have been compared with the population data on morbidity and mortality from a new coronavirus infection (data of the Ministry of Health of the Russian Federation).

RESULTS: Despite the matched incidence rates of new coronavirus infection associated mortality and morbidity in rheumatological patients and population (morbidity 26.2 and 34.1% mortality 3.47 and 2.8%, respectively), the patients with rheumatic diseases demonstrate three times lower frequency of vaccination against new coronavirus infection (13.2% of patients versus 31.8% in the population, respectively). Vaccination is prescribed by rheumatologists in 8.2%; 75% of patients are self-vaccinated. Data analysis from 2,134 rheumatological patients vaccinated in 2021 have shown a decrease in the incidence of the new coronavirus infection to 0.25% compared to the incidence of unvaccinated patients (25.6%) in the absence of deaths among the vaccinated. There were no serious adverse reactions to vaccination among the vaccinated rheumatological patients; in 12% of the cases, pyrogenic post-vaccination reactions, arthralgias and myalgias have been noted. A prolonged pyrogenic reaction, myalgia, arthralgia, hypercreatinophosphataemia have been revealed in 11 patients, who recovered within 6 months. Exacerbations of the underlying rheumatic disease after vaccination has been revealed in 12% of the cases, all the exacerbations have been resolved with the use of standard tactics recommended by the Association of Russian Rheumatologists.

The question of the timing and the necessity of revaccination, as well as the long-term efficacy and safety of vaccination, has not yet been resolved. Determining the level of antibodies to coronavirus infection can be a useful option in the formation of an individual vaccination plan for rheumatological patients in the present conditions.

CONCLUSIONS: The register data show the efficacy and safety of vaccination against COVID-19 in rheumatological patients in the short term, including in relation to exacerbation of rheumatic disease, and justify the need to comply with epidemiological safety measures after vaccination.

Keywords

new coronavirus infection / COVID-19 / vaccination / rheumatic diseases / infection / autoimmune diseases

References

[1] Nasonov EL, Lila AM, Mazurov VI, et al. Coronavirus disease 2019 (COVID-19) and immunoinflammatory rheumatic diseases. Recommendations of the Association of Rheumatologists of Russia. Rheumatology Science and Practice. 2021;59(3):239–254. (In Russ.). DOI: 10.47360/1995-4484-2021-239-254

[2] Насонов Е.Л., Лила А.М., Мазуров В.И. и др. Коронавирусная болезнь 2019 (COVID-19) и иммуновоспалительные ревматические заболевания. Рекомендации общероссийской общественной организации «Ассоциация ревматологов России» // Научно-практическая ревматология. 2021. Т. 59, № 3. С. 239–254. DOI: 10.47360/1995-4484-2021-239-254

[3] Avdeev SN, Adamyan LV, Alekseeva EI, et al. Prevention, diagnosis and treatment of new coronavirus infection (COVID-19). Version 12 (09.21.2021). Moscow; 2021. (In Russ.)

[4] Авдеев С.Н., Адамян Л.В., Алексеева Е.И. и др. Профилактика, диагностика и лечение новой коронавирусной инфекции (COVID-19). Версия 12 от 21.09.2021 г. Москва, 2021.

[5] Belov BS, Tarasova GM, Muravyova NV. Modern approaches to vaccination of patients with rheumatic diseases. Therapeutic Archive. 2021;93(5):622–627. (In Russ.). DOI: 10.26442/00403660.2021.05.200794

[6] Белов Б.С., Тарасова Г.М., Муравьева Н.В. Современные подходы к вакцинации больных с ревматическими заболеваниями // Терапевтический архив. 2021. Т. 93, № 5. С. 622–627. DOI: 10.26442/00403660.2021.05.200794

[7] Bugatti S, Balduzzi S, De Stefano L, et al. Correspondence on ’EULAR December 2020 viewpoints on SARS-CoV-2 vaccination in patients with RMDs’. Ann Rheum Dis. 2021;80(10):e156. DOI: 10.1136/annrheumdis-2021-220541

[8] Bugatti S., Balduzzi S., De Stefano L. et al. Correspondence on ’EULAR December 2020 viewpoints on SARS-CoV-2 vaccination in patients with RMDs’ // Ann. Rheum. Dis. 2021. Vol. 80, No. 10. P. e156. DOI: 10.1136/annrheumdis-2021-220541

[9] Hyrich KL, Machado PM. Rheumatic disease and COVID-19: epidemiology and outcomes. Nat Rev Rheumatol. 2021;17(2):71–72. DOI: 10.1038/s41584-020-00562-2

[10] Hyrich K.L., Machado P.M. Rheumatic disease and COVID-19: epidemiology and outcomes // Nat. Rev. Rheumatol. 2021. Vol. 17, No. 2. P. 71–72. DOI: 10.1038/s41584-020-00562-2

[11] Gianfrancesco M, Hyrich KL, Al-Adely S, et al. Characteristics associated with hospitalisation for COVID-19 in people with rheumatic disease: data from the COVID-19 Global Rheumatology Alliance physician-reported registry. Ann Rheum Dis. 2020;79(7):859–866. DOI: 10.1136/annrheumdis-2020-217871

[12] Gianfrancesco M., Hyrich K.L., Al-Adely S. et al. Characteristics associated with hospitalisation for COVID-19 in people with rheumatic disease: data from the COVID-19 Global Rheumatology Alliance physician-reported registry // Ann. Rheum. Dis. 2020. Vol. 79, No. 7. P. 859–866. DOI: 10.1136/annrheumdis-2020-217871

[13] Kocyigit BF, Akyol A. YouTube as a source of information on COVID-19 vaccination in rheumatic diseases. Rheumatol Int. 2021;41(12):2109–2115. DOI: 10.1007/s00296-021-05010-2

[14] Kocyigit B.F., Akyol A. YouTube as a source of information on COVID-19 vaccination in rheumatic diseases // Rheumatol. Int. 2021. Vol. 41, No. 12. P. 2109–2115. DOI: 10.1007/s00296-021-05010-2

[15] Park JK, Lee EB, Shin K, et al. COVID-19 Vaccination in patients with autoimmune inflammatory rheumatic diseases: Clinical Guidance of the Korean College of Rheumatology. J Korean Med Sci. 2021;36(12):e95. DOI: 10.3346/jkms.2021.36.e95

[16] Park J.K., Lee E.B., Shin K. et al. COVID-19 Vaccination in patients with autoimmune inflammatory rheumatic diseases: Clinical Guidance of the Korean College of Rheumatology // J. Korean Med. Sci. 2021. Vol. 36, No. 12. P. e95. DOI: 10.3346/jkms.2021.36.e95

[17] Furer V, Rondaan C, Agmon-Levin N, et al. Point of view on the vaccination against COVID-19 in patients with autoimmune inflammatory rheumatic diseases. RMD Open. 2021;7(1):e001594. DOI: 10.1136/rmdopen-2021-001594

[18] Furer V., Rondaan C., Agmon-Levin N. et al. Point of view on the vaccination against COVID-19 in patients with autoimmune inflammatory rheumatic diseases // RMD Open. 2021. Vol. 7, No. 1. P. e001594. DOI: 10.1136/rmdopen-2021-001594

[19] Li X, Tong X, Yeung WWY, et al. Two-dose COVID-19 vaccination and possible arthritis flare among patients with rheumatoid arthritis in Hong Kong. Ann Rheum Dis. 2022;81(4):564–568. DOI: 10.1136/annrheumdis-2021-221571

[20] Li X., Tong X., Yeung W.W.Y. et al. Two-dose COVID-19 vaccination and possible arthritis flare among patients with rheumatoid arthritis in Hong Kong // Ann. Rheum. Dis. 2022. Vol. 81, No. 4. P. 564–568. DOI: 10.1136/annrheumdis-2021-221571

[21] Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603–2615. DOI: 10.1056/NEJMoa2034577

[22] Polack F.P., Thomas S.J., Kitchin N. et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine // N. Engl. J. Med. 2020. Vol. 383, No. 27. P. 2603–2615. DOI: 10.1056/NEJMoa2034577

[23] Monti S, Balduzzi S, Delvino P, et al. Clinical course of COVID-19 in a series of patients with chronic arthritis treated with immunosuppressive targeted therapies. Ann Rheum Dis. 2020;79(5):667–668. DOI: 10.1136/annrheumdis-2020-217424

[24] Monti S., Balduzzi S., Delvino P. et al. Clinical course of COVID-19 in a series of patients with chronic arthritis treated with immunosuppressive targeted therapies // Ann. Rheum. Dis. 2020. Vol. 79, No. 5. P. 667–668. DOI: 10.1136/annrheumdis-2020-217424

[25] Pablos JL, Abasolo L, Alvaro-Gracia JM, et al. Prevalence of hospital PCR-confirmed COVID-19 cases in patients with chronic inflammatory and autoimmune rheumatic diseases. Ann Rheum Dis. 2020;79(9):1170–1173. DOI: 10.1136/annrheumdis-2020-217763

[26] Pablos J.L., Abasolo L., Alvaro-Gracia J.M. et al. Prevalence of hospital PCR-confirmed COVID-19 cases in patients with chronic inflammatory and autoimmune rheumatic diseases // Ann. Rheum. Dis. 2020. Vol. 79, No. 9. P. 1170–1173. DOI: 10.1136/annrheumdis-2020-217763

[27] Zhong J, Shen G, Yang H, et al. COVID-19 in patients with rheumatic disease in Hubei Province, China: a multicentre retrospective observational study. Lancet Rheumatol. 2020;2(9):e557–564. DOI: 10.1016/S2665-9913(20)30227-7

[28] Zhong J., Shen G., Yang H. et al. COVID-19 in patients with rheumatic disease in Hubei Province, China: a multicentre retrospective observational study // Lancet Rheumatol. 2020. Vol. 2, No. 9. P. e557–564. DOI: 10.1016/S2665-9913(20)30227-7

[29] Strangfeld A, Schäfer M, Gianfrancesco MA, et al. Factors associated with COVID-19-related death in people with rheumatic diseases: results from the COVID-19 global rheumatology alliance physician-reported registry. Ann Rheum Dis. 2021;80(7):930–942. DOI: 10.1136/annrheumdis-2020-219498

[30] Strangfeld A., Schäfer M., Gianfrancesco M.A. et al. Factors associated with COVID-19-related death in people with rheumatic diseases: results from the COVID-19 global rheumatology alliance physician-reported registry // Ann. Rheum. Dis. 2021. Vol. 80, No. 7. P. 930–942. DOI: 10.1136/annrheumdis-2020-219498

[31] Ferri C, Giuggioli D, Raimondo V, et al. COVID-19 and rheumatic autoimmune systemic diseases: report of a large Italian patients series. Clin Rheumatol. 2020;39(11):3195–3204. DOI: 10.1007/s10067-020-05334-7

[32] Ferri C., Giuggioli D., Raimondo V. et al. COVID-19 and rheumatic autoimmune systemic diseases: report of a large Italian patients series // Clin. Rheumatol. 2020. Vol. 39, No. 11. P. 3195–3204. DOI: 10.1007/s10067-020-05334-7

[33] Mazurov VI, Gaydukova IZ, Bakulin IG, et al. Features of the course and factors of unfavorable prognosis of coronavirus infection COVID-19 in patients with immuno-inflammatory diseases. RMJ. 2020;28(11):4–8. (In Russ.)

[34] Мазуров В.И., Гайдукова И.З., Бакулин И.Г. и др. Особенности течения и факторы неблагоприятного прогноза коронавирусной инфекции COVID-19 у пациентов с иммуновоспалительными заболеваниями // РМЖ. 2020. Т. 28, № 11. С. 4–8.

[35] Reshetnyak TM, Cheldieva FA, Lila AM, Nasonov EL. Disorders of hemostasis, thrombosis, antiphospholipid antibodies in patients with COVID-19. Consilium Medicum. 2021;23(1):35–42. DOI: 10.26442/20751753.2021.1.200607

[36] Решетняк Т.М., Чельдиева Ф.А., Лила А.М., Насонов Е.Л. Нарушения гемостаза, тромбозы, антифосфолипидные антитела у пациентов с COVID-19 // Consilium Medicum. 2021. Т. 23, № 1. С. 35–42. DOI: 10.26442/20751753.2021.1.200607

[37] Tomelleri A, Sartorelli S, Campochiaro C, et al. Impact of COVID-19 pandemic on patients with large-vessel vasculitis in Italy: a monocentric survey. Ann Rheum Dis. 2020;79(9):1252–1253. DOI: 10.1136/annrheumdis-2020-217600

[38] Tomelleri A., Sartorelli S., Campochiaro C. et al. Impact of COVID-19 pandemic on patients with large-vessel vasculitis in Italy: a monocentric survey // Ann. Rheum. Dis. 2020. Vol. 79, No. 9. P. 1252–1253. DOI: 10.1136/annrheumdis-2020-217600

[39] Ramirez GA, Gerosa M, Beretta L, et al. COVID-19 in systemic lupus erythematosus: data from a survey on 417 patients. Semin Arthritis Rheum. 2020;50(5):1150–1157. DOI: 10.1016/j.semarthrit.2020.06.012

[40] Ramirez G.A., Gerosa M., Beretta L. et al. COVID-19 in systemic lupus erythematosus: data from a survey on 417 patients // Semin. Arthritis Rheum. 2020. Vol. 50, No. 5. P. 1150–1157. DOI: 10.1016/j.semarthrit.2020.06.012

[41] Terracina KA, Tan FK. Flare of rheumatoid arthritis after COVID-19 vaccination. Lancet Rheumatol. 2021;3(7):e469–e470. DOI: 10.1016/S2665-9913(21)00108-9

[42] Terracina K.A., Tan F.K. Flare of rheumatoid arthritis after COVID-19 vaccination // Lancet Rheumatol. 2021. Vol. 3, No. 7. P. e469–e470. DOI: 10.1016/S2665-9913(21)00108-9

[43] Wan EYF, Chui CSL, Lai FTT, et al. Bell’s palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case- control study. Lancet Infect Dis. 2022;22(1):64–72. DOI: 10.1016/S1473-3099(21)00451-5

[44] Wan E.Y.F., Chui C.S.L., Lai F.T.T. et al. Bell’s palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study // Lancet Infect. Dis. 2022. Vol. 22, No. 1. P. 64–72. DOI: 10.1016/S1473-3099(21)00451-5

[45] Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403–416. DOI: 10.1056/NEJMoa2035389

[46] Baden L.R., El Sahly H.M., Essink B. et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine // N. Engl. J. Med. 2021. Vol. 384, No. 5. P. 403–416. DOI: 10.1056/NEJMoa2035389

[47] Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021;397(10269):99–111. DOI: 10.1016/S0140-6736(20)32661-1

[48] Voysey M., Clemens S.A.C., Madhi S.A. et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK // Lancet. 2021. Vol. 397, No. 10269. P. 99–111. DOI: 10.1016/S0140-6736(20)32661-1

[49] Logunov DY, Dolzhikova IV, Shcheblyakov DV, et al. Safety and efficacy of an rAd26 and rAd5 vector-based 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)00234-8

[50] Logunov D.Y., Dolzhikova I.V., Shcheblyakov D.V. et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia // Lancet. 2021. Vol. 397, No. 10275. P. 671–681. DOI: 10.1016/S0140-6736(21)00234-8

[51] Vaccines and related biological products advisory committee meeting [Internet]. Available from: https://www.fda.gov/media/146219/download. Accessed: Feb.13, 2021.

[52] Vaccines and related biological products advisory committee meeting [Электронный ресурс]. Режим доступа: https://www.fda.gov/media/146219/download. Дата обращения: 13.02.2021.

[53] Novavax creating tomorrow’s vaccine today: announcement of UK and South Africa trial results [Internet]. Available from: https://www.novavax.com/sites/default/files/2021-01/UK-SouthAfrica-Trial-Results--FINAL.pdf. Accessed: Feb.13, 2021.

[54] Novavax creating tomorrow’s vaccine today: announcement of UK and South Africa trial results [Электронный ресурс]. Режим доступа: https://www.novavax.com/sites/default/files/2021-01/UK-SouthAfrica-Trial-Results--FINAL.pdf. Дата обращения: 13.02.2021.

[55] Sinovac announces phase III results of its COVID-19 vaccine [Internet]. Available from: http://www.sinovac.com/?optionid=754&auto_id=922. Accessed: Feb 13, 2021.

[56] Sinovac announces phase III results of its COVID-19 vaccine [Электронный ресурс]. Режим доступа: http://www.sinovac.com/?optionid=754&auto_id=922. Дата обращения: 13.02.2021.

[57] Dan JM, Mateus J, Kato Y, et al. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science. 2021;371(6529):eabf4063. DOI: 10.1126/science.abf4063

[58] Dan J.M., Mateus J., Kato Y. et al. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection // Science. 2021. Vol. 371, No. 6529. P. eabf4063. DOI: 10.1126/science.abf4063

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Mazurov V., Nasonov E., Lila A., Gaydukova I., Inamova O., Leonchenkova N.