Adverse events and breakthrough infections associated with COVID‐19 vaccination in the Indian population

Abstract

Vaccines against COVID‐19 provide immunity to deter severe morbidities associated with the infection. However, it does not prevent infection altogether in all exposed individuals. Furthermore, emerging variants of SARS‐CoV‐2 impose a threat concerning the competency of the vaccines in combating the infection. This study aims to determine the variability in adverse events and the extent of breakthrough infections in the Indian population. A retrospective study was conducted using a pre‐validated questionnaire encompassing social, demographic, general health, the status of SARS‐CoV‐2 infection, vaccination, associated adverse events, and breakthrough infections in the Indian population. Informed consent and ethical approval were obtained as per Indian Council of Medical Research (ICMR) guidelines. Participants, who provided the complete information, were Indian citizens, above 18 years, and if vaccinated, administered with either Covishield or Covaxin, were considered for the study. Data have been compiled in Microsoft Excel and analyzed for statistical differences using STATA 11. The responses from 2051 individuals fulfilling the inclusion criteria were analyzed. Among 2051, 1119 respondents were vaccinated and 932 respondents were non‐vaccinated. Among 1119 vaccinated respondents, 7 were excluded because of missing data. Therefore, out of 1112 vaccinated, 413 experienced adverse events with a major fraction of younger individuals, age 18–40 years, getting affected (74.82%; 309/413). Furthermore, considerably more females than males encountered adverse consequences to vaccination ( p < 0.05). Among vaccinated participants, breakthrough infections were observed in 7.91% (88/1112; 57.96% males and 42.04% females) with the older age group, 61 years and above (odds ratio, 3.25 [1.32–8.03]; p = 0.011), and males were found to be at higher risk. Further research is needed to find the age and sex‐related factors in determining vaccine effectiveness and adverse events.

COVID-19 breakthrough infection among vaccinated individuals: A cross-sectional study

“…more exposed to infected individuals, there was not much difference in the prevalence.Arora et al, in her study also reported prevalence of breakthrough infection as 7.91% 17. Furthermore, similar to our study, the prevalence was higher among males than females.…”

Clinical manifestations of COVID‐19 breakthrough infections: A systematic review and meta‐analysis

“…Another study reported that vaccine breakthrough infections with the Alpha and Delta variants were associated with comorbidities such as hypertension, immunosuppression, cancer, and coronary heart disease 36 . Further, the rate of severe or critical disease has been found to be higher among older individuals with comorbidities in previous studies alluding to the importance of underlying patient health and well‐being when concerned with COVID‐19 infection 37 . In a recently published study, the role of gender was stressed as a predictor for breakthrough infection 37 and there were several plausible explanation describing gender‐related difference in angiotensin‐converting‐enzyme‐2 expression, 38,39 estrogen, X‐chromosome, 40,41 and behavioral patterns in precautionary measures for COVID‐19 prevention 42,43 .…”

“… 36 Further, the rate of severe or critical disease has been found to be higher among older individuals with comorbidities in previous studies alluding to the importance of underlying patient health and well‐being when concerned with COVID‐19 infection. 37 In a recently published study, the role of gender was stressed as a predictor for breakthrough infection 37 and there were several plausible explanation describing gender‐related difference in angiotensin‐converting‐enzyme‐2 expression, 38 , 39 estrogen, X‐chromosome, 40 , 41 and behavioral patterns in precautionary measures for COVID‐19 prevention. 42 , 43 As the virus continues to mutate, it is important to monitor, understand and further analyze the respective clinical outcomes of both vaccinated and unvaccinated groups for future variants to come.…”

Analysis of Side Effects Following Vaccination Against COVID-19 Among Individuals With Multiple Sclerosis Treated With DMTs in Poland

“…The same observations were made on a smaller cohort of people with SM by Achiron et al ( 10 ). In several other studies, based on the general population, also younger patients reported any adverse events more often ( 11 , 12 ). Therefore, the shift toward younger patients may not be related to the coexistence of autoimmune diseases.…”