|Ahead of print publication
COVID-19 vaccine hesitancy: A telephonic survey in patients with systemic lupus erythematosusxs
Reuben Praharsh Kumar1, Sandra Manuel2, D Elizabeth2, Vineeta Shobha2
1 MBBS, St. John's Medical College, Bengaluru, Karnataka, India
2 Department of Clinical Immunology and Rheumatology, St. John's Medical College Hospital, Bengaluru, Karnataka, India
|Date of Submission||01-Feb-2022|
|Date of Acceptance||21-Apr-2022|
|Date of Web Publication||27-Aug-2022|
Department of Clinical Immunology and Rheumatology, St. John's Medical College Hospital, Sarjapur Road, Bengaluru - 560 034, Karnataka
Source of Support: None, Conflict of Interest: None
Background: Vaccine against COVID-19 is an effective preventive measure; however, systemic lupus erythematosus (SLE) patients were excluded from the vaccine trials, which leads to questions regarding vaccine safety and efficacy, giving rise to vaccine hesitancy. We aim to study the prevalence of vaccine hesitancy among SLE patients and study the factors affecting it.
Methods: The study is a cross-sectional telephone-based survey done on SLE patients. The questionnaire included a series of 15 questions pertaining to their baseline characteristics, COVID-19 infection and vaccination details, and their perceptions regarding the COVID-19 vaccine. Nonvaccinated individuals were defined as “willing” and “hesitant” based on their intent to get vaccinated.
Results: Among 418 (93% women) participants, about 8% had contracted COVID-19 infection in the past. Nearly half had been vaccinated against COVID-19, and 83% had experienced one or more side effects which were largely mild. Out of the 215 nonvaccinated participants, 84% were “willing” and 16% were “hesitant.” Among the reasons for hesitancy, hasty vaccine production, fear of SLE flares, general vaccine refusal and limited transport facilities were significant. On the whole, 65.1% had a positive attitude toward the vaccine.
Conclusion: Despite a low-hesitancy rate, the number of SLE patients with a negative attitude toward the COVID-19 vaccine is reasonably high, with more than half of the patients yet to be vaccinated. This highlights that the mistrust and negative perceptions of the vaccine still persists. The role of health-care providers in vaccine acceptance in SLE patients is crucial.
Keywords: Autoimmune rheumatic diseases, COVID-19, COVID-19 vaccine, systemic lupus erythematosus, vaccine hesitancy
| Introduction|| |
The spread of coronavirus 19 (COVID-19) has resulted in a worldwide pandemic leading to a heavy burden of disease and deaths worldwide., The best hope for ending this pandemic is a mass vaccination against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. The enormous need for prevention of infection spread led to the vaccine development at an unprecedented pace which culminated in several uncertainties both regarding vaccine efficacy as well as their side effects. This has led to the emergence of vaccine hesitancy, which is amongst the top ten risks of public health as declared by the WHO. Vaccine hesitancy is the delay in acceptance or refusal of vaccines despite the availability of vaccine services. Multiple beliefs and apprehensions among different sectors of population affect the acceptance of vaccines, thus impairing its ability to reach herd immunity status.,
Patients with chronic diseases, especially those on immunomodulatory therapies, might be hesitant to accept the vaccine due to fear of lack of efficacy as well as unexpected adverse effects of the vaccine as this group was excluded from the clinical trials. However, it is well established that vaccination is effective in reducing mortality and the need for hospitalization not only in the general population but also in patients with autoimmune rheumatic diseases (AIRD). The rheumatology fraternity has unanimously recommended vaccination for all categories of patients with AIRD undertaking any modality of immunosuppressive therapy for all types of COVID-19 vaccines.,,
The AIRD patients on immunomodulatory therapy appear to have a higher risk of developing infections as reported in the Global Rheumatology Alliance network and our own data. Further, intense immunosuppression in patients with systemic lupus erythematosus (SLE) may result in suboptimal antiviral immune response to SARS-CoV-2 infection resulting in a longer disease course and progression to a severe respiratory phase. Further, these patients may serve as a reservoir for SARS-CoV-2, with prolonged shedding of virus and an increased opportunity for the development of viral variants.
Prime reasons for vaccine hesitancy include the concerns regarding the new technology used for the production of the vaccines, fear of adverse effects, and flare of the underlying autoimmune disease.,, This study aims to understand the mindset of the SLE patients regarding COVID-19 vaccination and identify factors influencing their choice. This would help the clinicians and policymakers to impart specific guidance to the patients regarding vaccination.
| Methods|| |
The study is a cross-sectional, telephone-based survey.
A tertiary care referral teaching hospital.
All vaccine eligible (≥18 years of age) patients diagnosed with SLE as per Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) 2012 criteria in our database.
Data were collected from July 13, 2021, to October 28, 2021.
The study included vaccine eligible (>18 years) patients diagnosed with SLE as per SLICC 2012 criteria in our database which is a tertiary care referral teaching hospital. This study was approved by the Institutional Ethics Committee (IEC No 194/2021). Patients were telephonically contacted and invited to participate in the interview. After verbal consent, the interview was conducted in their local language (Supplementary 1). The participants were informed that they were free to stop the interview at any time if they felt discomfort of any kind. Each interview lasted approximately 15 min, and the data were entered into a spreadsheet. Data collection was done from July 13, 2021, to October 28, 2021.
The interview questions were framed based on the understanding of vaccine hesitancy in our country and were reviewed and fine-tuned by two specialist clinicians based on a study which studies behavior toward COVID-19 vaccines in patients with AIRD. The Checklist for Reporting Results of Internet E-Surveys (CHERRIES) was used to devise the questionnaire.
The interview was divided into three sections.
The first section comprised the socio-demographic details about the participant, including name, age, gender, marital status, address, education, and occupation details.
The second section consisted of the details about their illness and COVID-19 infection. This included duration of illness, history, and outcome of COVID-19 infection, and behavioral changes to prevent COVID-19 infection.
The third section included details about vaccination against COVID-19, side effects, and a set of 15 questions which assessed the various reasons for vaccine hesitancy. Willingness to vaccinate in non-vaccinated patients was assessed using a single question, “Do you intend to get vaccinated against COVID-19 disease?”. Participants who responded “Yes” were labeled as “Willing” and those who responded “No” and “Not sure” were labeled as “Hesitant”. Subsequently, the set of 15 questions assessed perceptions, limitations, willingness, and attitude toward COVID-19 vaccine. Each question was answered on a 5-point Likert Scale (1-Strongly Agree to 5-Strongly Disagree). The responses were stored on a spreadsheet, and the 5-point Likert Scale responses were reduced to zero and one, with one being a positive response (i.e., Likert score of >3) and zero being a negative response and a neutral response to a particular question (i.e., Likert score of ≤3). A positive response is one which includes the truth regarding the COVID-19 vaccine and vice versa. Each positive response added a point toward the final score and a score of ≥70% was determined as the cut-off for positive attitude toward the vaccine. Proportion of participants who gave a negative response to each question, according to “Willing” and “Hesitant” status were compared to evaluate the association of each statement to hesitancy to get vaccinated.
Continuous variables are presented as mean and standard deviation, and categorical variables as frequency and percentage. Chi-square test was used for checking the association of vaccine hesitancy with predictor variables. Univariate and multivariate logistic regression models were built using a backward stepwise approach to identify variables associated independently with COVID-19 vaccine hesitancy. Questions with P < 0.15 in the univariate analysis were considered in the multivariate analysis and a P < 0.05 was considered significant in all analyses. The questions with wider confidence intervals for odds ratio were removed from the multivariate analysis, and the odds ratio of #3 was obtained after adjusting #5, #9, #10, and #13. All statistical analyses were performed using IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, New York: IBM Corp.United States.
| Results|| |
A total of 486 eligible SLE patients were invited to participate in the telephonic interview, of whom 432 (88.88%) responded. Among those who responded, 426 consented to take part in the study. Another 8 interviews were removed from the data set either due to missing data or duplicity of the data, leaving a total of 418 completed interviews which was considered the final data set for the study.
Of 418 participants, 389 (93.1%) were female, mean age being 34.85 years (+10.93). Nearly three-fourth, 317 (75.8%) of the participants were married and 319 (76.3%) were at least high school qualified. The baseline characteristics are described in [Table 1].
|Table 1: Baseline characteristics and COVID-19 infection details (n=418)|
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Prior COVID-19 was reported in 34 (8.1%) and 53 (12.7%) of participants and family members, respectively. Out of the 34 infected patients, majority had mild illness, the most common symptoms being, fever 21 (61.8%), sore throat 5 (14.7%), dry cough and anosmia 10 (29.4%) each, fatigue 11 (32.4%), diarrhea and chest pain 2 (5.9%) each. Five (14.7%) participants were hospitalized for breathing difficulty; two required noninvasive oxygen administration. All participants recovered from COVID-19, however, five participants reported residual nonspecific symptoms. None experienced lupus flare following COVID-19.
The remaining 384 (91.9%) participants who did not get infected by COVID-19 disease were enquired about the reasons why they think they did not get the infection. Large majority of 309 (80.5%) participants believed that adequate safety precautions such as face masks, frequent hand washing, and social distancing protected them. Further, 316 (82.3%) participants reported that they were largely confined to their residence. Seventeen participants (4.4%) believed that their natural immunity protected them and 61 (15.9%) took home remedies. Only two participants attributed the protective effect of COVID-19 vaccine. About one-third 11 (32.9%) believed that medications such as hydroxychloroquine and Vitamin C and multivitamins protected them.
A total of 203 (48.6%) participants had received at least one dose of COVID-19 vaccine at the time of participation, 64 (31.5%) had completed both doses as per recommended schedule. 67% of participants accepted vaccination due to the information provided by their health-care provider and 95% of the unvaccinated patients were willing to accept the vaccine after doctor's recommendation. Large majority, 173 (85.2%) received COVISHIELD vaccine (AZD1222-ChAdOx1 nCoV-19 CoronaVirus Vaccine (Recombinant); ChAdOx1 vector encoding the S glycoprotein of SARS-CoV-2) and 30 (14.8%) received COVAXIN (COVAXINTM (BBV152); an inactivated vaccine obtained from the SARS-CoV-2 strain obtained at the NIV, Pune). Majority 168 (82.8%) reported one or more side effects after vaccination. Fever was reported in 75 (44.6%) participants and almost three-fourth, i.e., 123 (73.2%) had pain at the injection site. The various side-effects are elaborated in [Figure 1].
|Figure 1: Vaccination details, side-effects and intention of getting vaccinated|
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On asking about the reasons why these participants chose to accept the vaccine, 136 (67%) reported that their doctor/nurse advised them to and 69 (34%) reported that the fear of getting COVID-19 drove them to get vaccinated. Family and media played a role in 10.3% and 5.4% of the population, respectively, whereas four participants were afraid of dying due to COVID-19 disease.
Vaccine hesitancy and associated factors
Out of 215 (51.4%) nonvaccinated participants, 34 (15.8%) were “Hesitant” and 181 (84.2%) were “Willing.” Through the 15 questions that were used to assess reasons of vaccine hesitancy, 272 (65.1%) had a total score of more than 70%, thus signifying that they had a positive attitude toward the vaccine and 146 (34.9%) had a negative attitude.
Out of the 15 questions, the major reasons for vaccine hesitancy could be grouped as follows: Perceptions – 60% believed that vaccine has decreased efficacy in SLE, 57.2% believed that vaccine can cause flare of SLE, and 44.7% believed that vaccine was produced in a hurry and did not undergo adequate trials. Limitations – 47% reported that they had inadequate information on vaccines due to the language barrier. Attitude – 56.3% reported fear of side effects, 40.9% raised concerns regarding crowding at vaccination centers. Willingness – 5.6% refuse to take the vaccine even if recommended by their treating doctor. The various reasons for vaccine hesitancy are described in [Table 2]. Out of the 15 statements, five (#3, #5, #9, #10, #13) were independently associated with unwillingness to get vaccinated out of which only two were significant (#3, #13). Participants who gave a negative response to statements #3, #5, #10, and #13 were at higher odds of rejecting vaccination, and similarly, odds were lower for statement #9. Therefore, participants with the perception of vaccine being produced in a hurry and not having undergone adequate trials; perception that vaccine can cause flare of symptoms of SLE; with inaccessibility due to limited transport facilities; refusal to take any other vaccine in general, were at higher odds of rejecting COVID-19 vaccine. Participants among the “willing” group were more concerned about crowding at the vaccination centers than the “hesitant” group, thus, the odds to reject the vaccine were lower [Table 2].
|Table 2: Association between the likelihood of rejecting COVID-19 vaccination and perceptions regarding the vaccine|
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| Discussion|| |
This study measures the magnitude of hesitancy toward COVID-19 vaccines in a cohort of adult SLE patients. Our study was conducted during the early phase of vaccination drive in India. More than half of our patients were unvaccinated at the time of participation in our study; however, the vaccine hesitancy rate was low (15.8%).
A study from Gujarat, India, reported a significantly lower vaccine acceptance rate of 54% (152/280) among the AIRD patients compared to the control healthy population (67% [68/102] [P = 0.03]). The COVAD study, done on AIRD patients from 29 countries, is a long-term patient self-report e-survey and reports that approximately half of the participants who had not received the vaccine were unwilling to get vaccinated against COVID-19. The ARCOVAX study conducted in 19 Arab countries reports a vaccine hesitancy rate of 37% in patients with chronic rheumatic diseases and 19% in health-care professionals. This signifies that AIRD patients may be more predisposed to such behavior toward the COVID-19 vaccine than others. Another survey-based study involving 1638 participants from 27 states/union territories in India, 37% were hesitant to accept the COVID-19 vaccine and 71% had one or more concerns regarding the vaccines. A single-center study from Uttarakhand, India, reported a hesitancy rate of 46.6% among general population. People living with HIV had a hesitancy rate of 38.4% in a study conducted in South India. In contrast, the hesitancy among the medical students from India was reported to be quite low (10.6%). Various studies on other chronic illness cohorts such as coeliac disease, HIV, and epilepsy have reported a wide range of hesitancy rate (11.4%–28.7%).,,, Largely, the reasons for COVID-19 vaccine hesitancy in these studies centered around the concerns regarding vaccine safety and efficacy among various others.
Our study was conducted in January 2021, when people in India were apprehensive about the COVID-19 vaccine, and trial results were awaited. Our study demonstrates a significant association between patients with a negative attitude toward COVID-19 vaccine and vaccine hesitancy. In our study, hesitancy was not associated with any specific demographic variables. In a study done on AIRD patients in Greece and the general public in the USA, younger age and education less than a college degree were associated with vaccine hesitancy., AIRD patients older than 45 years of age were associated with higher acceptance of the vaccine in the study from Gujarat, India, which could possibly be attributed to India's phased vaccination program. A higher level of education was also a predictor of higher acceptance of vaccines as reported by three different studies.,, The level of education might be related to a better understanding of the need for vaccines to combat this pandemic. Patients who had received flu vaccines in the past were also associated with a higher acceptance of COVID-19 vaccine. Our study did not collect this data, thus fails to comment on this.
Our study identified the reasons for rejection of COVID-19 vaccine to be as follows: perception of hurried vaccine production and inadequate trials; fear of flare of SLE symptoms; inaccessibility due to limited transport facilities; refusal to take any vaccine in general. The first two reasons are supported by studies done in Italy, France, and Pakistan.,,, General vaccine refusal was also associated with hesitancy in French people living with HIV. Although our study did not show any significant association between vaccine hesitancy and fears regarding adverse effects, more than half of the participants reported their concerns for the same. This is supported by various other studies as well.,,,,,, Nearly 60% of participants believed that vaccines have lower efficacy in SLE patients, and this was also reported in other studies.,, This again highlights the mistrust in the development of the COVID-19 vaccines. Although the magnitude of vaccine hesitancy and negative attitude poses a significant barrier in achieving a substantial vaccination rate, 95% of the unvaccinated individuals said that they would follow their doctor's recommendation about taking the vaccine. This points out the positive doctor's role in influencing vaccination acceptance patients with AIRD. Health-care providers play a vital role in vaccine acceptance in SLE patients. Willingness to get vaccinated on doctor's recommendation is supported by a number of studies.,,,,,
This calls for targeted educational strategies and counseling of patients by their treating doctors regarding pros and cons of the COVID-19 vaccine to overcome the problem of vaccine hesitancy. This can be done during follow-up visits and dedicated online patient meetings. Furthermore, public health campaigns and educational programs which are currently being conducted positively influence people's perceptions and beliefs regarding COVID 19 vaccination. Irrespective of vaccination status, patients with SLE should continue to be highly vigilant regarding social distancing, face masks, and unnecessary contact with other people. A study done in France developed an interactive web tool which provides information on the benefits and risks of the COVID-19 vaccines. The study showed that amongst those hesitant, 8% were willing to accept vaccination after consulting the tool. Moreover, the authors reported that anti-vaccination attitudes may be overcome by incentivizing vaccination and complex combined strategies could be beneficial too.
We report mild vaccine-related side effects in nearly 83% of participants. The side effects were mild such as fever, pain at the injection site, and muscle pain. Whereas another study done in India reported side effects to be 35%. Another study reported a flare of AIRDs in 0.23% and 1.8% of participants after the 1st and 2nd dose of the vaccine. Our study reported zero cases of SLE flare after COVID-19 vaccination, thus adding to the safety of the vaccines.
Our study has few limitations. First, it is a telephonic survey. Efforts were made to include all relevant core questions based on public perceptions, medical knowledge, and expertise available in this domain, however, pilot testing was not done. Second, it was conducted only in patients with SLE from the database of a single medical hospital, and the controls were not interviewed. This may have an impact on the generalizability of the findings of this study. Third, we could not evaluate the impact of vaccine requirements for vocational purposes, the impact of comorbidities, and immunosuppressants on vaccine hesitancy. Finally, the perceptions and information for COVID-19 vaccine have evolved as the pandemic has progressed.
The strengths of our study include that it has a directed interview design which reduces self-reporting bias. To the best of our knowledge, this is the first prospective study done in India that explains vaccine hesitancy in SLE patients.
| Conclusion|| |
We identified the magnitude of the burden of vaccine hesitancy in SLE patients and the reasons regarding the same. Further, we demonstrate that a negative attitude toward the vaccine still persists in nearly a third of the population. We also address the possible solutions and actions that can be taken to increase the vaccination rates in these patients, the most important of which being recommendations by the treating doctors. The role of health-care providers in vaccine acceptance in SLE patients is pivotal. Our study did not report any flare of SLE post-COVID-19 vaccination and the side effects were fairly mild with no significant health risks.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]