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Incidence and severity of SARS-CoV-2 virus post COVID-19 vaccination: A cross-sectional study in India

  • Preethi Selvaraj
    Affiliations
    Research Associate, Orthopaedic Research Group, Coimbatore, Tamil Nadu, India

    Department of Community Medicine, SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Chengalpattu, Tamil Nadu, India
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  • Sathish Muthu
    Affiliations
    Research Associate, Orthopaedic Research Group, Coimbatore, Tamil Nadu, India

    Department of Orthopaedics, Government Medical College and Hospital, Dindigul, Tamil Nadu, India
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  • Naveen Jeyaraman
    Affiliations
    Research Associate, Orthopaedic Research Group, Coimbatore, Tamil Nadu, India

    Fellow in Arthroplasty, Department of Orthopaedics, Atlas Hospitals, Tiruchirappalli, Tamil Nadu, India
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  • Gollahalli Shivashankar Prajwal
    Affiliations
    Research Associate, Orthopaedic Research Group, Coimbatore, Tamil Nadu, India

    Fellow in Spine Surgery, Department of Orthopaedics, Mallika Spine Centre, Guntur, Andhra Pradesh, India
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  • Madhan Jeyaraman
    Correspondence
    ACorresponding author. Department of Orthopaedics, Faculty of Medicine - Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu, India.
    Affiliations
    Research Associate, Orthopaedic Research Group, Coimbatore, Tamil Nadu, India

    Department of Orthopaedics, Faculty of Medicine - Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu, India
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Open AccessPublished:February 08, 2022DOI:https://doi.org/10.1016/j.cegh.2022.100983

      Abstract

      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.

      Keywords

      1. Introduction

      COVID-19 was declared a pandemic by the World Health Organization (WHO) in March 2020.
      Weekly epidemiological update on COVID-19 - 30 March 2021.
      ,
      • Cucinotta D.
      • Vanelli M.
      WHO declares COVID-19 a pandemic.
      By December 5, 2021, 265 million cases had been documented globally, with 5.26 million deaths.
      WHO coronavirus (COVID-19) dashboard.
      COVID-19 preventive measures were practiced ineffectively in 2020,
      • Girum T.
      • Lentiro K.
      • Geremew M.
      • Migora B.
      • Shewamare S.
      Global strategies and effectiveness for COVID-19 prevention through contact tracing, screening, quarantine, and isolation: a systematic review.
      and India was hit by a second wave of the epidemic in mid-2021.
      • Asrani P.
      • Eapen M.S.
      • Hassan M.I.
      • Sohal S.S.
      Implications of the second wave of COVID-19 in India.
      In these conditions, mass vaccination is the most effective way to combat the pandemic.
      • Kumar S.
      Second wave of COVID-19: emergency situation in India.
      Most coastal states have achieved >50% adult vaccination since the introduction of COVID-19 vaccines, thanks to pro-immunization initiatives. The average number of daily dosages delivered declined after peaking at 6.44 million on June 26. Vaccine reluctance remained high in certain locations, with more than 60% of the adult population remaining unvaccinated (as of June 2021). Several sociodemographic variables, including ethnic inequality, have been identified as potentially influencing the uptake of COVID-19 vaccinations.
      • Chakraborty C.
      • Sharma A.R.
      • Bhattacharya M.
      • Agoramoorthy G.
      • Lee S.S.
      The current second wave and COVID-19 vaccination status in India.
      Vaccine apprehension may be trending, and the WHO has listed it as one of the biggest dangers to world health.
      • Bendau A.
      • Plag J.
      • Petzold M.B.
      • Ströhle A.
      COVID-19 vaccine hesitancy and related fears and anxiety.
      ,
      • Nossier S.A.
      Vaccine hesitancy: the greatest threat to COVID-19 vaccination programs.
      When compared to people of other races, African Americans had a lesser acceptance of influenza and COVID-19 vaccinations. However, a larger perceived risk of COVID-19 is a novel notion that has been shown to boost COVID-19 vaccination uptake despite individual preferences.
      • Karlsson L.C.
      • Soveri A.
      • Lewandowsky S.
      • et al.
      Fearing the disease or the vaccine: the case of COVID-19.
      • Caserotti M.
      • Girardi P.
      • Rubaltelli E.
      • Tasso A.
      • Lotto L.
      • Gavaruzzi T.
      Associations of COVID-19 risk perception with vaccine hesitancy over time for Italian residents.
      • Motta M.
      • Sylvester S.
      • Callaghan T.
      • Lunz-Trujillo K.
      Encouraging COVID-19 vaccine uptake through effective health communication.
      To develop herd immunity against COVID-19, at least 70–85% of the population must be vaccinated.
      • Anderson R.M.
      • Vegvari C.
      • Truscott J.
      • Collyer B.S.
      Challenges in creating herd immunity to SARS-CoV-2 infection by mass vaccination.
      • Kaplan R.M.
      • Milstein A.
      Influence of a COVID-19 vaccine's effectiveness and safety profile on vaccination acceptance.
      • Anand P.
      • Stahel V.P.
      Review the safety of Covid-19 mRNA vaccines: a review.
      As the situation with COVID-19 changes, the public's perception keeps fluctuating. Pfizer revealed in November 2020 that its COVID-19 vaccine was 95% effective in illness prevention, and the vaccine was thereafter released.
      • Jr B.L.
      Pfizer says final data analysis shows Covid vaccine is 95% effective, plans to submit to FDA in days. CNBC.
      Soon after, tales of negative impacts inundated social media channels.
      • Alfatease A.
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      • Alshahrani S.M.
      The impact of social media on the acceptance of the COVID-19 vaccine: a cross-sectional study from Saudi arabia.
      As a result, individuals have become increasingly skeptical of the COVID-19 vaccination.
      • Alfatease A.
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      • Orayj K.
      • Alshahrani S.M.
      The impact of social media on the acceptance of the COVID-19 vaccine: a cross-sectional study from Saudi arabia.
      ,

      Rosenberg H, Syed S, Rezaie S. The Twitter pandemic: the critical role of Twitter in the dissemination of medical information and misinformation during the COVID-19 pandemic. Cjem.:1-4. doi:10.1017/cem.2020.361.

      We designed a survey study with the primary aim to determine the prevalence of vaccinated individuals and the rate of infectivity post-vaccination. Secondary objectives were to study the clinical manifestations and infectivity of the SARS-CoV-2 virus post-vaccination.

      2. 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 estimate the prevalence of vaccinated individuals and the rate of infectivity post-vaccination. 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.
      • Nilima N.
      • Kaushik S.
      • Tiwary B.
      • Pandey P.K.
      Psycho-social factors associated with the nationwide lockdown in India during COVID-19 pandemic.
      General demographic data, followed by their lifestyle and comorbid conditions, and data on their vaccination, infectivity, and side effects were collected. Informed consent was taken from the respondents before the study and an option to terminate their participation was made available anytime they desired in the form by default. The target sample size of participants was determined using the epi info sample size calculator, the vaccine acceptance rate was estimated at 21%
      • Joshi A.
      • Kaur M.
      • Kaur R.
      • Grover A.
      • Nash D.
      • El-Mohandes A.
      Predictors of COVID-19 vaccine acceptance, intention, and hesitancy: a scoping review.
      and with a 3.3% confidence limit, 99.99 confidence level, the calculated sample size is 2334, adding 2% non-response rate the final sample size is 2382. The Institutional Ethics Committee approval was obtained for the conduction of the study.
      Statistical software used to analyze data were MS Excel, SPSS for Windows Inc. Version 25. Chicago, Illinois. Descriptive statistics were reported as mean and standard deviation for continuous variables, frequencies (percentage) for categorical variables. Proportions were compared using the chi-square test. Multiple logistic regression was used to find the risk of disease positivity with demographic variables. For all comparisons, the p-value of <0.05 was considered statistically significant.

      3. Results

      There were 2382 responses out of which 48 declined participation, hence the final sample size was 2334. Table 1 gives the demographic characteristics of the study participants. The majority of the study participants were in the age group of 25–34 years (38.6%) followed 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% 65 years and above. There was a male preponderance with 52.9% were males. The majority of them had Bachelor's degrees (51.4%) followed by master's degrees 25.5%. The majority of the respondents were South Indians (39.8%) followed by North Indians (34.1%).
      Table 1Demographic characteristics of the study participants (N = 2334).
      VariableFrequencyPercentage
      Age (years)
      18–2486036.8
      25–3490138.6
      35–4424010.3
      45–541667.1
      55–641084.6
      65 and above592.6
      Gender
      Male123452.9
      Female110047.1
      Education
      Bachelor's degree119951.4
      Doctorate2229.5
      High school graduate27011.6
      Master's degree59525.5
      None of the above482.0
      Region
      Central India2008.6
      East India1385.9
      North India79634.1
      North-Eastern India672.9
      North-Western India291.2
      South India92939.8
      Western India1757.5
      In our analysis, women (1243) felt the need to vaccinate more often than men (318) (p = 0.043). They were more satisfied with the decision to vaccinate (women = 1251, men = 337; p = 0.043). People with higher education were more motivated to vaccinate themselves, having known the rationale behind vaccination (p = 0.002) and they would choose a vaccine based on the viral mRNA technology Pfizer (911) and Moderna (39).
      • Meo S.A.
      • Bukhari I.A.
      • Akram J.
      • Meo A.S.
      • Klonoff D.C.
      COVID-19 vaccines: comparison of biological, pharmacological characteristics and adverse effects of Pfizer/BioNTech and Moderna Vaccines.
      Lifestyle risk factors were tabulated in Table 2. There were about 17.8% smokers, 35.2% alcoholics, 37.7% of the participants who exercise daily, 16.8% having one or the other co-morbidities, 10.9% had a history of surgical intervention for any bone, joint, muscle, soft tissue, or nerve-related conditions. Overall, 74.1% were vaccinated with a minimum of one dose of vaccine (Fig. 1) (see Fig. 2).
      Table 2Distribution of lifestyle risk factors among the study participants (N = 2334).
      VariableFrequencyPercentage
      History of smoking
      Yes, Regular active smoker994.2
      Yes. occasional active smoker2159.2
      Yes, passive smoker1024.4
      No history of smoking191882.2
      History of alcohol consumption
      Yes, consume regularly421.8
      Yes, consume occasionally77933.4
      No history of alcohol consumption151364.8
      Exercise daily
      Yes88137.7
      No145362.3
      Co-morbidity
      Yes39116.8
      No194383.2
      Listed co-morbidities
      Asthma572.4
      CVD150.6
      CKD110.5
      COPD130.6
      DM451.9
      DM & HTN321.4
      HTN1114.8
      Thyroid1074.6
      Any history of surgical intervention for any bone, joint, muscle, soft tissue or nerve related conditions
      Yes25510.9
      No207989.1
      How recently were u been operated
      <1 month ago170.7
      >1 year ago27411.7
      1–6 months ago170.7
      6–12 months ago110.5
      Vaccinated
      Yes172974.1
      No60525.9
      Fig. 1
      Fig. 1Distribution of percentage of vaccinated individuals among the study participants (N = 2334).
      Fig. 2
      Fig. 2Distribution of infectivity and severity among vaccinated individuals (n=1729).
      In our study among 1729 vaccinated individuals, 80.7% had received Covishield and 17.8% have 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%) (Table 3). Post-vaccination 50.8% had experienced muscle pain, 46% had experienced fatigue, 36.5% weakness, and 12.3% back pain. On the second dose, 55.9% didn't experience any side effects followed by 15% muscle pain, 14% fatigue, 10.3% weakness, 3.4% joint pain, and 3.1% back pain.
      Table 3Distribution of parameters on vaccine among the study participants (n = 1729).
      VariableFrequencyPercentage
      Type of vaccine
      AstraZeneca10.06
      Coronavac30.2
      Covaxin30817.8
      Covishield139580.7
      Moderna50.3
      Pfizer 13130.75
      Sputnik V40.23
      Are you full vaccinated (both dosages of covishield, covaxin, sputnik V)
      Yes105661.1
      No67338.9
      What was the period of difference for taking the second dosage of the COVID-19 vaccine?
      4–5 weeks64237.1
      5–6 weeks19611.3
      6–7 weeks1408.1
      7–8 weeks1307.5
      8–12 weeks1669.6
      More than 12 weeks915.3
      Did you experience any musculoskeletal pain after the first dose of the COVID-19 vaccination?
      Backpain21312.3
      Weakness63136.5
      Fatigue79646.0
      Joint pain23213.4
      Muscle pain87850.8
      None42124.3
      Did you experience any musculoskeletal pain after the second dose of the COVID-19 vaccination?
      Backpain533.1
      Weakness17810.3
      Fatigue24314.1
      Joint pain593.4
      Muscle pain26015.0
      None96855.9
      Among vaccinated 26% turned out to be COVID-19 positive whereas 44.5% among non-vaccinated participants got infected. The odds of infection among non-vaccinated individuals were 2.27 times higher than vaccinated individuals (Table 4).
      Table 4Association of vaccine and severity of the disease (N = 2334).
      VariableVaccinated

      (n = 1729)
      Non-vaccinated

      (n = 605)
      Chi-square (df) pOR (95% CI)
      COVID-19 positive
      Yes450 (26%)269 (44.5%)71.45 (1)1
      No1279 (74%)336 (55.5%)<0.0012.27 (1.87–2.76)
      Severity of infection
      Mild309 (17.9%)166 (27.4%)80.640 (3)

      <0.001
      2.045 (1.635–2.557)
      Moderate126 (7.3%)83 (13.7%)2.507 (1.854–3.392
      Severe15 (0.9%)20 (3.3%)5.075 (2.571–10.020)
      No infection1279 (74%)336 (55.5%)1
      Table 5 shows the association of clinical parameters and disease infectivity among vaccinated individuals. The IL-6 count (pg/ml) during the active infective phase including home-based care, ferritin level (ng/ml), and LDH level (U/L) were clinically raised among vaccinated individuals compared to non-vaccinated individuals.
      Table 5Association of clinical parameters and disease infectivity among vaccinated individuals (n=719).
      VariableVaccinated

      (n = 450)
      Non-vaccinated

      (n = 269)
      Chi-square (df) p
      What was your treatment plan?
      Both home-based + ICU35 (7.8)24 (8.9)
      Home isolation352 (78.2)204(75.8)0.81
      Hospital-based care with ICU26 (5.8)15 (5.6)(3)
      Hospital-based care with oxygen support37 (8.2)26 (9.7)0.84
      If hospital-based care what was the duration for the same?
      >6 weeks37 (8.2)23 (8.6)
      1–2 weeks47 (10.4)26 (9.7)3.69
      2–4 weeks11 (2.4)14 (5.2)(3)
      4–6 weeks5 (1.1)2 (0.7)0.29
      Maximum CRP count (mg/dl) during the active infective phase including home-based care
      0-6 (normal)101 (22.4)60 (22.3)
      <26 (mild)106 (23.6)56 (20.8)2.378
      26-100 (moderate)56 (12.4)33(12.3)(4)
      >100 (severe)13 (2.9)13 (4.8)0.67
      Not aware174 (38.7)107 (39.8)
      What was the maximum reported range of IL-6 count (pg/ml) during the active infective phase including home-based care
      0-7 (normal)106 (23.6)48 (17.8)
      <15 (mild)52 (11.6)21 (7.8)8.88 (5)
      15-100 (moderate)42 (9.3)27 (10)0.07
      100-500 (severe)6 (1.3)3 (1.1)
      >500 (critical)01 (0.4)
      Not aware244 (54.2)169 (62.8)
      Maximum reported range of D-dimer level (mcg/ml) during the active infective phase including home-based care
      <0.5 (normal)144 (32)78 (29)4.478 (3)
      <1 (mild)61 (13.6)32 (11.9)0.21
      >1 (moderate-severe)43 (9.6)18 (6.7)
      Not aware202 (44.9)141 (52.4)
      Maximum reported range of ferritin level (ng/ml) during the active infective phase including home-based care
      <1355 (12.2)30 (11.2)9.768 (3)
      13–15056 (12.4)24 (8.9)0.02
      >15073 (16.2)27 (10)
      Not aware266 (59.1)188 (69.9)
      Maximum reported range of your LDH level (U/L) during the active infective phase including home-based care
      0–25061 (13.6)25 (9.3)12.434 (2)
      >25095 (21.1)35 (13)0.002
      Not aware294 (65.3)209 (77.7)
      Maximum reported range of your ESR count (mm/hr) during the active infective phase including home-based care
      0–2295 (21.1)48 (17.8)1.934 (2)
      >2270 (15.6)37 (13.8)0.38
      Not aware285 (63.3)184 (68.4)

      4. Discussion

      The obtained research results indicate, the lack of reporting of side effects after the administration of the COVID-19 vaccine by people. The COVID-19 vaccines can induce moderate side effects after the first or second dose such as pain, redness, or swelling at the site of vaccination along with fever, exhaustion, headache, nausea, vomiting, itching, chills, and can infrequently cause anaphylactic shock.
      • Khan M.A.
      • Nilima N.
      • Prathibha J.
      • Tiwary B.
      • Singh M.
      Documentation compliance of in-patient files: a cross sectional study from an east India state.
      Quality documentation of the side effects of vaccine is essential as it encourages healthcare providers to communicate in a systematic, consistent, and effective manner.
      • Jeon M.
      • Kim J.
      • Oh C.E.
      • Lee J.Y.
      Adverse events following immunization associated with coronavirus disease 2019 vaccination reported in the mobile vaccine adverse events reporting system.
      In a study by Jęśkowiak et al.
      • Jęśkowiak I.
      • Wiatrak B.
      • Grosman-Dziewiszek P.
      • Szeląg A.
      The incidence and severity of post-vaccination reactions after vaccination against COVID-19.
      statistically significant side effects after receiving the vaccine were noted which include pain at the injection site (1275; p < 0.0001), redness at the injection site (696; p < 0.0001), and pain in the limb (766; p < 0.0001) after the first dose of the vaccine, and after the second dose of the vaccine, a temperature above 38 °C (226; p = 0.04).
      There was significant correlation between first dose of vaccine shot and side effects of the vaccine along with occurrence of covid 19 infection. Among those non infected with covid 19, stronger side effects were reported after the second dose of the vaccine (p < 0.001). In our study, post-second dose of vaccine, although around 55.9% didn't experience any side effects, 15% experienced muscle pain, 14% had fatigue, 10.3% with weakness, 3.4% had joint pain, and 3.1% with back pain which is significantly high (p < 0.001) compared to the reported side effects after the first dose of the vaccine in non-infected individuals.
      In our study, association of clinical parameters and disease infectivity among vaccinated individuals were assessed. The IL-6 count (pg/ml) during the active infective phase including home-based care, ferritin level (ng/ml), and LDH level (U/L) were clinically raised among vaccinated individuals significantly (p < 0.001) compared to non-vaccinated individuals.
      In a study by Jęśkowiak et al.,
      • Jęśkowiak I.
      • Wiatrak B.
      • Grosman-Dziewiszek P.
      • Szeląg A.
      The incidence and severity of post-vaccination reactions after vaccination against COVID-19.
      T-cell and antibody responses correlate with the severity of COVID-19 clinical disease. Among those previously infected with covid 19, the adverse effects reported after the first dose of vaccine may be because of antibody-dependent enhancement (ADE). ADE refers to a situation in which antibodies that would normally lessen the consequences of a viral infection end up doing the opposite: they fail to control the virus' pathogenicity, or even enhance its virulence by facilitating its entry into the cell, or by triggering an extensive reaction, causing damage to the host organs through hyper-inflammation (cytokine storm).
      • Danchin A.
      • Turinici G.
      Immunity after COVID-19: protection or sensitization?.
      In comparison to patients with severe disease, patients with milder disease have more clonal expansion and less active proliferation in CD8 T-cells in the bronchial fluid, as well as lower blood cytokine levels.
      • Hellerstein M.
      What are the roles of antibodies versus a durable, high quality T-cell response in protective immunity against SARS-CoV-2?.
      Our study has certain limitations. We could not achieve an overall representative data across all the age groups subjected for vaccination. Secondly, the cross-sectional observational nature of our study and the chosen sampling method may limit the validity of the results obtained. On the other hand, the strengths of our work include the novelty of the topic, the large sample size, and identification of the under-reported problem pertinent to the population subjected to vaccination. It also clearly exposes the lack of awareness of the people to report side effects for any health-related intervention being administered on large scale. In addition, the study identified the most frequent side effects associated with vaccination, such as fatigue and weakness.

      5. Conclusion

      Although more than 50% of the vaccinated individuals experienced some form of musculoskeletal side effects such as muscle pain, and fatigue following first dose of vaccination, we noted a high acceptance rate (74%) of vaccination among the participants. We did not note such high prevalence of adverse events following second dose of vaccination. The vaccinated individuals were 2.27 times safer from infection compared to the non-vaccinated individuals.

      Funding sources

      Nil.

      Declaration of competing interest

      Nil.

      Acknowledgements

      Nil.

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