key: cord-0867244-xt12zs31
authors: Selvaraj, Preethi; Muthu, Sathish; Jeyaraman, Naveen; Prajwal, Gollahalli Shivashankar; Jeyaraman, Madhan
title: Incidence and severity of SARS-CoV-2 virus post COVID-19 vaccination: A cross-sectional study in India
date: 2022-02-09
journal: Clin Epidemiol Glob Health
DOI: 10.1016/j.cegh.2022.100983
sha: fbc807dfae9bb2f7fe2233ca13766661469c2ed6
doc_id: 867244
cord_uid: xt12zs31

INTRODUCTION: Several sociodemographic variables, including ethnic inequality, have been identified as potentially influencing the uptake of COVID-19 vaccinations. To develop herd immunity against COVID-19, at least 70–85% of the population must be vaccinated. As the situation with COVID-19 changes, the public's perception keeps fluctuating. We designed a survey to determine the prevalence of vaccinated individuals and the rate of infectivity post-vaccination. We also aimed to study the clinical manifestations and infectivity of the SARS-CoV-2 virus post-vaccination. MATERIALS AND METHODS: A cross-sectional study was conducted from May 10, 2021 to July 10, 2021 across India through a pre-tested validated semi-structured self-administered electronic questionnaire, to the study subjects with objectives explained and the confidentiality of the data and results had been assured. The questionnaires were prepared using Google forms and the link was sent across social media platforms such as WhatsApp, Facebook, and various social platforms where people are actively engaged following the restrictions and protocols of social distancing. General demographic data, followed by their lifestyle and comorbid conditions, and data on their vaccination, infectivity, and side effects were collected. RESULTS: We included 2334 participants in the study, of which the majority of the study participants were in the age group of 25–34 years (38.6%). 1729 were vaccinated individuals of which 80.7% had received Covishield and 17.8% had received Covaxin. Around 61.1% have received both doses among 1729 vaccinated individuals and 38.9% had received only one dose of vaccine. The majority of the fully vaccinated individuals had a gap of 4–5 weeks for the second dose (37.1%) followed by 5–6 weeks (11.2%). Post-vaccination 50.8% had experienced muscle pain, 46% had experienced fatigue, 36.5% weakness, and 12.3% back pain. Among vaccinated 26% turned out to be COVID-19 positive and 44.5% non-vaccinated got infected. The odds of infection among non -vaccinated individuals was 2.27 times higher than vaccinated individuals. Individuals who encountered the viral antigen for the second time experienced either through vaccination or infection demonstrated exaggerated inflammatory response which is explained by the antibody-dependent enhancement phenomenon without life-threatening complications. CONCLUSION: Although more than 50% of the vaccinated individuals experienced some form of musculoskeletal side effects, we noted a high acceptance rate (74%) of vaccination among the participants. The vaccinated individuals were two times safer from infection compared to the non-vaccinated individuals.

March 2020. 1,2 By 5 th December 2021, 265 million cases had been documented globally, with 39 5.26 million deaths. 3 COVID-19 preventive measures were practiced ineffectively in 2020, 4 40 and India was hit by a second wave of the epidemic in mid-2021. 5 In these conditions, mass 41 vaccination is the most effective way to combat the pandemic. 6 Vaccine apprehension may be trending, and the WHO has listed it as one of the biggest 49 dangers to world health. 8, 9 When compared to people of other races, African Americans had a 50 J o u r n a l P r e -p r o o f lesser acceptance of influenza and COVID-19 vaccinations. However, a larger perceived risk 51 of COVID-19 is a novel notion that has been shown to boost COVID-19 vaccination uptake 52 despite individual preferences. 10,11,12 53

To develop herd immunity against COVID-19, at least 70-85% of the population must 54 be vaccinated. [13] [14] [15] As the situation with COVID-19 changes, the public's perception keeps 55 fluctuating. Pfizer revealed in November 2020 that its COVID-19 vaccine was 95% effective 56 in illness prevention, and the vaccine was thereafter released. 16 Soon after, tales of negative 57 impacts inundated social media channels. 17 As a result, individuals have become increasingly 58 skeptical of the COVID-19 vaccination. 17,18 59

We designed a survey study with the primary aim to determine the prevalence of 60 vaccinated individuals and the rate of infectivity post-vaccination. Secondary objectives were 61

to study the clinical manifestations and infectivity of the SARS-CoV-2 virus post-vaccination. 62

A cross-sectional study was conducted from 10/05/2021 to 10/07/2021 across India 64 through a pre-tested validated semi-structured self-administered electronic questionnaire, to 65 estimate the prevalence of vaccinated individuals and the rate of infectivity post-vaccination. 66

The questionnaires were prepared using Google forms and the link was sent across social media 67 platforms such as WhatsApp, Facebook, and various social platforms where people are actively 68 engaged following the restrictions and protocols of social distancing. 19 General demographic 69 data, followed by their lifestyle and comorbid conditions, and data on their vaccination, 70 infectivity, and side effects were collected. Informed consent was taken from the respondents 71 before the study and an option to terminate their participation was made available anytime they 72 desired in the form by default. The target sample size of participants was determined using the 73 epi info sample size calculator, the vaccine acceptance rate was estimated at 21% 20 and with a 74 3.3% confidence limit, 99.99 confidence level, the calculated sample size is 2334, adding 2% 75 J o u r n a l P r e -p r o o f non-response rate the final sample size is 2382. The Institutional Ethics Committee approval 76 was obtained for the conduction of the study. 77

Statistical software used to analyze data were MS Excel, SPSS for Windows Inc. 78

Version 25. Chicago, Illinois. Descriptive statistics were reported as mean and standard 79 deviation for continuous variables, frequencies (percentage) for categorical variables. 80

Proportions were compared using the chi-square test. Multiple logistic regression was used to 81 find the risk of disease positivity with demographic variables. For all comparisons, the p-value 82 of <0.05 was considered statistically significant. 83

There were 2382 responses out of which 48 declined participation, hence the final 85 sample size was 2334. Table 1 gives the demographic characteristics of the study participants. 86

The majority of the study participants were in the age group of 25-34 years (38.6%) followed 87 by 18-24 years (36.8%), 10.3% in 35-44 years, 7.1% 45-54 years, 4.6% 55-64 years and 2.6% 88 65 years and above. There was a male preponderance with 52.9% were males. The majority of 89 them had Bachelor's degrees (51.4%) followed by master's degrees 25.5%. The majority of the 90 respondents were South Indians (39.8%) followed by North Indians (34.1%). 91

In our analysis, women (1243) felt the need to vaccinate more often than men (318) 92 (p = 0.043). They were more satisfied with the decision to vaccinate (women = 1251, men = 93 337; p = 0.043). People with higher education were more motivated to vaccinate themselves, 94 having known the rationale behind vaccination (p = 0.002) and they would choose a vaccine 95 based on the viral mRNA technology Pfizer (911) and Moderna (39). 21 96

Lifestyle risk factors were tabulated in Table 2 . There were about 17.8% smokers, fully vaccinated individuals had a gap of 4-5 weeks for the second dose (37.1%) followed by 105 5-6 weeks (11.2%) ( Table 3) . Post-vaccination 50.8% had experienced muscle pain, 46% had 106 experienced fatigue, 36.5% weakness, and 12.3% back pain. On the second dose, 55.9% didn't 107 experience any side effects followed by 15% muscle pain, 14% fatigue, 10.3% weakness, 3.4% 108 joint pain, and 3.1% back pain. 109

Among vaccinated 26% turned out to be COVID-19 positive whereas 44.5% among 110 non-vaccinated participants got infected. The odds of infection among non-vaccinated 111 individuals were 2.27 times higher than vaccinated individuals (Table 4 ). 112 Table 5 shows the association of clinical parameters and disease infectivity among Our study has certain limitations. We could not achieve an overall representative data 150 across all the age groups subjected for vaccination. Secondly, the cross-sectional observational 151 nature of our study and the chosen sampling method may limit the validity of the results 152 obtained. On the other hand, the strengths of our work include the novelty of the topic, the large 153 sample size, and identification of the under-reported problem pertinent to the population 154 subjected to vaccination. It also clearly exposes the lack of awareness of the people to report 155 side effects for any health-related intervention being administered on large scale. In addition, 156 the study identified the most frequent side effects associated with vaccination, such as fatigue 157 and weakness. 158

Although more than 50% of the vaccinated individuals experienced some form of 160 musculoskeletal side effects such as muscle pain, and fatigue following first dose of 161 vaccination, we noted a high acceptance rate (74%) of vaccination among the participants. We J o u r n a l P r e -p r o o f 

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