A sentinel surveillance of adverse events and breakthrough infections following COVID-19 precautionary dose among south Indian healthcare workers

Merrin Mathew, Juny Sebastian, Chetak Kadabasal Basavaraja, Devayani Josh, Deleena Varughese, Sidharth Soman, Madhu Sreeja Mahalekshmi

Article ID: 2216
Vol 7, Issue 2, 2023

VIEWS - 183 (Abstract) 60 (PDF)


Background: Adverse events following immunization (AEFI) is defined as any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. Break-through infections are referred to as antigen or SARS-CoV-2 RNA positivity of respiratory specimens more than 14 days after receiving all recommended doses. Aim: The study was conducted to identify adverse events and breakthrough infections following the precautionary dose of the COVID-19 vaccine among healthcare workers. Methodology: The study was designed as a cohort event monitoring; all healthcare professionals who received COVID-19 precautionary dose from the study site were included in the study. The study population was actively followed for any adverse event following immunization (AEFI) through telephonic contact (within 30 days of postvaccination). Reported adverse events were carefully scrutinized and evaluated by the AEFI investigation team of the study site. Results: Out of 1232 vaccine beneficiaries, a total of 359 (29.14%) individuals were reported with 385 AEFIs. Of which 138 (38.44%) individuals were laboratory-confirmed (RTPCR positive) breakthrough cases. Less severity and low morbidity were observed among all the breakthrough cases. According to the WHO’s new causality assessment algorithm, 183 (47.53%) events were vaccine product-related and 202 (52.46%) were co-incidental events. Conclusion: There was a prevailing outbreak of COVID-19 infection in the study site, which resulted in many breakthrough infections soon after immunization. Initially, all breakthrough infections were misleading as vaccinerelated events, where this study helped to break the concerns among the study population.


adverse events following immunization (AEFI); breakthrough infection; causality assessment; COVID-19 vaccine; precautionary dose

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1. Chakraborty C, Bhattacharya M, Sharma AR. Present variants of concern and variants of interest of severe acute respiratory syndrome coronavirus 2: Their significant mutations in S-glycoprotein, infectivity, re‐infectivity, immune escape and vaccines activity. Reviews in Medical Virology 2022; 32(2): e2270. doi: 10.1002/rmv.2270

2. Koller CN, Schwerzmann CJ, Lang ASA, et al. Addressing different needs: The challenges faced by India as the largest vaccine manufacturer while conducting the world’s biggest COVID-19 vaccination campaign. Epidemiologia 2021; 2(3): 454–470. doi: 10.3390/epidemiologia2030032

3. 86% of India’s adult population fully vaccinated against COVID-19: Mandaviya. Available online: https://economictimes.indiatimes.com/news/india/86-of-indias-adult-population-fully-vaccinated-against-covid-19-mandaviya/articleshow/91107827.cms (accessed on 28 April 2023).

4. COWIN. Ministry of Health and Family welfare, Government of India. Available online: https://dashboard.cowin.gov.in (accessed on 28 April 2023).

5. Ghosh S, Shankar S, Chatterjee K, et al. COVISHIELD (AZD1222) Vaccine effectiveness among healthcare and frontline workers of Indian Armed Forces: Interim results of VIN-WIN cohort study. Medical Journal Armed Forces India 2021; 77(2): 264–270. doi: 10.1016/j.mjafi.2021.06.032

6. Desai D, Khan AR, Soneja M, et al. Effectiveness of an inactivated virus-based SARS-Cov-2 vaccine, BBV152, in India: A test-negative, case control study. The Lancet Infectious Diseases 2021; 22(3): 674–675. doi: 10.1016/S1473-3099(21)00674-5

7. Jain VK, Iyengar KP, Ish P. Elucidating causes of COVID-19 infection and related deaths after vaccination. Diabetes & Metabolic Syndrome: Clinical Research & Reviews 2021; 15(5): 102212. doi: 10.1016/j.dsx.2021.102212

8. Gupta N, Kaur H, Yadav PD, et al. Clinical characterization and genomic analysis of samples from COVID-19 breakthrough infections during the second wave among the various states of India. Viruses 2021; 13(9): 1782. doi: 10.3390/v13091782

9. Shah J, Samson P, Pradhan N, et al. Breakthrough infection after COVID-19 vaccination: A threat for Nepal due to SARS-CoV-2 variants circulating in 2nd wave ravaging India. Journal of Patan Academy of Health Sciences 2021; 8(2): 38–48. doi: 10.3126/jpahs.v8i2.37287

10. World Health Organization. VigiAccess. Available online: https://www.vigiaccess.org/ (accessed on 21 April 2023).

11. Jayadevan R, Shenoy R, Anithadevi TS. COVID-19 third wave experience in India, a survey of 5971 adults. medRxiv 2022. doi: 10.1101/2022.04.26.22274273

12. Sebastian J, Gurumurthy P, Ravi MD, Ramesh M. Active surveillance of adverse events following immunization (AEFI): A prospective 3-year vaccine safety study. Therapeutic Advances in Vaccines and Immunotherapy 2019; 7. doi: 10.1177/2515135519889000

13. World Health Organization. Causality assessment of adverse events following immunization (AEFI): User manual for the revised WHO classification, 2nd ed., 2019 update. Available online: https://www.who.int/publications/i/item/9789241516990 (accessed on 27 April 2023).

14. Parida SP, Sahu DP, Singh AK, et al. Adverse events following immunization of COVID-19 (Covaxin) vaccine at a tertiary care center of India. Journal of Medical Virology 2022; 94(6): 2453–2459. doi: 10.1002/jmv.27655

15. Gautam A, Patiyal N, Kansal D, et al. Pattern of adverse effects following ChAdOx1 nCoV-19 COVISHIELD vaccination in adults tertiary healthcare institution in North India: A retrospective observational study. International Journal of Comprehensive and Advanced Pharmacology 2022; 7(2): 91–95. doi: 10.18231/j.ijcaap.2022.017

16. Mer RJ, Kakasaniya GG, Acharya TA, Mehta DS. A participant centered surveillance of adverse events following coronavirus disease immunization phase 1 at a tertiary care teaching hospital. National Journal of Physiology, Pharmacy and Pharmacology 2022; 12(3): 312–316. doi: 10.5455/njppp.2022.12.08308202106092021

17. Kaur S, Singh A, Saini S, et al. Reporting adverse events of ChAdOx1 nCoV-19 coronavirus vaccine (Recombinant) among the vaccinated healthcare professionals: A cross-sectional survey. Indian Journal of Medical Research 2022; 155(1): 123–128. doi: 10.4103/ijmr.ijmr_1221_21

18. Mathew M, Sebastian J, Doddaiah N, et al. Clinico-epidemiological profile and outcome of infected health care workers during the three consecutive waves of COVID-19 pandemic: A longitudinal cohort study. Therapeutic Advances in Vaccines and Immunotherapy 2023; 11: 25151355231181744. doi: 10.1177/25151355231181744

19. Singh UB, Rophina M, Chaudhry R, et al. Variants of concern responsible for SARS-CoV-2 vaccine breakthrough infections from India. Journal of Medical Virology 2022; 94(4): 1696–1700. doi: 10.1002/jmv.27461

20. Arora G, Taneja J, Bhardwaj P, et al. Adverse events and breakthrough infections associated with COVID‐19 vaccination in the Indian population. Journal of Medical Virology 2022; 94(7): 3147–3154. doi: 10.1002/jmv.27708

21. Bergwerk M, Gonen T, Lustig Y, et al. COVID-19 breakthrough infections in vaccinated health care workers. New England Journal of Medicine 2021; 385(16): 1474–1484. doi: 10.1056/NEJMoa2109072

22. Glampson B, Brittain J, Kaura A, et al. Assessing COVID-19 vaccine uptake and effectiveness through the North West London Vaccination Program: Retrospective cohort study. JMIR Public Health and Surveillance 2021; 7(9): e30010. doi: 10.2196/30010

23. Saadat S, Tehrani ZR, Logue J, et al. Binding and neutralization antibody titers after a single vaccine dose in health care workers previously infected with SARS-CoV-2. Jama 2021; 325(14): 1467–1469. doi: 10.1001/jama.2021.3341

24. Zhuang C, Liu X, Chen Q, et al. Protection duration of COVID-19 vaccines: Waning effectiveness and future perspective. Frontiers in Microbiology 2022; 13: 828806. doi: 10.3389/fmicb.2022.828806

25. Ministry of Health and Family Welfare, Government of India. The world’s largest vaccination drive. Available online: https://www.mohfw.gov.in/pdf/COVIDVaccinationBooklet14SEP.pdf (accessed on 29 April 2023).

26. Singh AK, Phatak SR, Singh R, et al. Humoral antibody kinetics with ChAdOx1-nCOV (Covishield™) and BBV-152 (Covaxin™) vaccine among Indian Healthcare workers: A 6-month longitudinal cross-sectional coronavirus vaccine-induced antibody titre (COVAT) study. Diabetes & Metabolic Syndrome: Clinical Research & Reviews 2022; 16(2): 102424. doi: 10.1016/j.dsx.2022.102424

27. Paolo B, Cécile TK, Alessio A, et al. Impact of booster vaccination on the control of COVID-19 Delta wave in the context of waning immunity: Application to France in the winter 2021/22. Eurosurveillance 2022; 27(1): 2101125. doi: 10.2807/1560-7917.ES.2022.27.1.2101125

28. Tart SY, Slezak JM, Fischer H, et al. Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: A retrospective cohort study. The Lancet 2021; 398(10309): 1407–1416. doi: 10.1016/S0140-6736(21)02183-8

29. Niyas VKM, Arjun R. Breakthrough COVID-19 infections among health care workers after two doses of ChAdOx1 nCoV-19 vaccine. QJM: An International Journal of Medicine 2021; 114(10): 757–758. doi: 10.1093/qjmed/hcab167

30. Christensen PA, Olsen RJ, Long SW, et al. Signals of significantly increased vaccine breakthrough, decreased hospitalization rates, and less severe disease in patients with coronavirus disease 2019 caused by the Omicron variant of severe acute respiratory syndrome coronavirus 2 in Houston, Texas. The American Journal of Pathology 2022; 192(4): 642–652. doi: 10.1016/j.ajpath.2022.01.007

31. Lin L, Zhao Y, Chen B, Daihai H. Multiple COVID-19 waves and vaccination effectiveness in the United States. International Journal of Environmental Research and Public Health 2022; 19(4): 2282. doi: 10.3390/ijerph19042282

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

33. Chen Y, Xu Z, Wang P, et al. New-onset autoimmune phenomena post-COVID-19 vaccination. Immunology 2021; 165(4): 386–401. doi: 10.1111/imm.13443

34. Watanabe T, Minaga K, Hara A, et al. Case report: New-onset rheumatoid arthritis following COVID-19 vaccination. Frontiers in Immunology 2022; 13: 859926. doi: 10.3389/fimmu.2022.859926

35. Ferri C, Ursini F, Gragnani L, et al. Impaired immunogenicity to COVID-19 vaccines in autoimmune systemic diseases. High prevalence of non-response in different patients’ subgroups. Journal of Autoimmunity 2021; 125: 102744. doi: 10.1016/j.jaut.2021.102744

36. Mathew M, John SB, Sebastian J, Ravi MD. COVID-19 vaccine triggered autoimmune hepatitis: Case report. European Journal of Hospital Pharmacy 2022; 0: 1–4. doi: 10.1136/ejhpharm-2022-003485

DOI: https://doi.org/10.24294/ti.v7.i2.2216


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