INTRODUCTION

The World Health Organization (WHO) declared the coronavirus disease 2019 (COVID-19) outbreak a public health emergency of international concern on January 30, 2020 and subsequently classified it as a pandemic on March 11, 2020 [1,2]. By mid-May 2021, COVID-19 had infected approximately 163 179 059 people worldwide, resulting in 3 383 608 deaths [3]. In India, the first case of COVID-19 was reported in Kerala on January 30, 2020 [2], and by May 16, 2020, the outbreak had impacted 24 684 077 people nationwide [4].

Primary preventive measures such as masks, social distancing, frequent hand sanitization, and surface disinfection [5] proved insufficient, leading to rising case numbers [6]. Therefore, the development of a safe and effective vaccine became essential [6]. Public acceptance and uptake are critical determinants for vaccine success [7,8]. Acceptance of vaccination is influenced by multiple factors, including perceived susceptibility to the disease, vaccine availability and cost, social media and cultural influences, individual age, literacy levels, attitudes, perceptions regarding vaccination, and recommendations from healthcare professionals [9,10].

Vaccine hesitancy refers to delays in acceptance or refusal of vaccines despite the availability of vaccination services [7]. The WHO identified vaccine hesitancy as one of the ten threats to global health [11]. According to the Strategic Advisory Group of Experts (SAGE) on vaccine hesitancy [7], attitudes towards vaccination span a spectrum from complete acceptance to outright refusal. Vaccine-hesitant individuals occupy an intermediate position, accepting some vaccines while rejecting others [7]. Vaccine hesitancy hinders achieving community immunity and contributes to the resurgence of infectious diseases [11–13]. Additionally, unvaccinated individuals contribute to viral mutations that lead to emerging diseases. Therefore, identifying vaccine-hesitant groups and understanding their reasons for hesitancy is crucial. Globally, COVID-19 vaccine acceptance rates have varied widely, ranging from 23% to 97% [9,10,14]. In India, vaccine acceptance among the general population has ranged from 79% to 86% [15–17].

Kerala, distinct from other Indian states with a population of 33.4 million and the highest literacy rate of 94.0% [18], experienced a high rate of COVID-19 infection during the second wave of the pandemic, in stark contrast to its low infection rate during the initial wave. By May 15, 2021, Kerala had reported 2 147 967 COVID-19 cases, with 440 652 active cases, a test positivity rate of 28.61%, and 6428 deaths—higher than in other parts of India [19]. The COVID-19 vaccination drive was implemented in a phased manner by the Ministry of Health and Family Welfare, Government of India, under the guidance of the National Expert Group (NEGVAC), beginning January 2021. The drive followed a risk-based prioritization strategy, initially targeting healthcare and frontline workers [20]. Vaccination became available to individuals above 60 years and those aged 45–59 years with comorbidities in March 2021; vaccination for all adults began on May 24, 2021 [20].

All previous studies assessing COVID-19 vaccine acceptance globally [9,10,14] and nationally [15–17] have primarily focused on willingness to receive the vaccine when it became publicly available. Real intent to be vaccinated can differ significantly after the vaccine is accessible [8], potentially limiting the validity of hesitancy determinants assessed before vaccine availability. Despite Kerala’s higher COVID-19 burden relative to other Indian states, studies exploring COVID-19 vaccine acceptance and hesitancy among its general population remain limited [21–23]. Moreover, these studies primarily occurred during early vaccination stages when only healthcare workers, frontline workers, senior citizens, and those above 45 with comorbidities were eligible. No study has evaluated acceptance after vaccine availability expanded to the general adult population. Thus, this study aimed to assess vaccine acceptance and hesitancy among the general population of Kerala following its widespread availability, specifically identifying determinants of vaccine hesitancy among those who remained unvaccinated.

METHODS

Study Design

A cross-sectional descriptive online questionnaire study was conducted from June to December 2021 following approval from the Institutional Ethics Committee of an educational institution in Kerala, where the study originated. A sample size of 1075 was calculated considering a 13.7% prevalence of vaccine hesitancy (N=Z²_α/2×p×(1−p)×D/E²; Z_α=1.96, margin of error d=15%) [15]. Participants aged 18 years and older, residing in the Indian state of Kerala, were recruited using a snowball sampling technique. The questionnaire, distributed via Google Forms, was shared through email and WhatsApp groups of faculty and students affiliated with various professional and non-professional educational institutions under a prominent educational trust in the North Malabar region of Kerala, as well as with patients visiting their medical, dental, and Ayurveda college hospitals.

This group of educational institutions served as the initial distribution point, given their extensive network of over 7000 faculty members and students from various regions of Kerala. Primary recipients were encouraged to further distribute the survey link to family and friends from their native regions. To ensure broad representation, the 14 districts of Kerala were categorized geographically, culturally, and historically into North, Central, and South regions, and care was taken to distribute the survey link across these regions. The initial section of the questionnaire documented informed consent, after which consenting participants proceeded to the main questionnaire. Participation was voluntary, and participants could withdraw from the study at any time.

Questionnaire

The self-administered, anonymous, structured, closed-ended electronic questionnaire was developed in English and translated into the local language, Malayalam. It was based on the determinants of vaccine hesitancy matrix proposed by SAGE [7] and the study by Magadmi and Kamel [9]. The questionnaire contained 38 items, focusing on contextual, individual, and group influences; COVID-19 vaccine/vaccination-specific factors; and attitudes toward the vaccine. Contextual influences assessed included sources of COVID-19 information, the impact of religion, socioeconomic status, sex, education, occupation, and vaccination processes. Individual and group influences evaluated beliefs about immunization, susceptibility to COVID-19 infection, trust in the government, and perceived benefits of the COVID-19 vaccine. Vaccine-specific issues examined perceptions regarding vaccine safety, efficacy, side effects, preference for vaccine types, cost, availability of vaccine-related information, and attitudes toward vaccination. Scenarios were provided to assess willingness to be vaccinated among those not yet vaccinated.

Response options included multiple-choice or dichotomous types, except for questions assessing attitudes toward the COVID-19 vaccine, which used a 5-point Likert scale (“strongly agree” to “strongly disagree”). Multiple selections were permitted for items addressing primary sources of information concerning the COVID-19 vaccine and circumstances that would encourage hesitant individuals to be vaccinated for COVID-19. The questionnaire underwent content validation (Aiken’s V=0.78) and internal consistency testing (Cronbach’s alpha=0.80). Translation into Malayalam was completed using forward and backward translation methods.

Statistical Analysis

The primary outcome measure was acceptance of the COVID-19 vaccine. Participants responding “yes” to “have you been vaccinated for COVID-19?” were categorized as the “vaccine acceptance” group, while those responding “no” formed the “vaccine hesitant” group. Socioeconomic status was classified using the Modified Kuppuswamy’s Socioeconomic Scale, 2019 [24]. Educational categories in the education index of this scale —“primary school certificate,” “middle school certificate,” and “high school certificate”—were merged into a single category termed “school level” of education. For analytical convenience, Likert scale responses for attitude-related questions were collapsed into 3 categories: “agree,” “neither agree nor disagree,” and “disagree.”

Statistical analysis was performed using the SPSS version 20.0 (IBM Corp., Armonk, NY, USA). Categorical variables were summarized as frequencies and percentages. Associations were evaluated using the chi-square test, followed by binary logistic regression to identify determinants of COVID-19 vaccine hesitancy. Socio-demographic variables were controlled in regression analysis to evaluate the effects of vaccine-specific determinants, contextual and individual factors, and attitudes. Tests for multicollinearity were conducted; none of the predictor variables showed tolerance statistics below 0.1 or variance inflation factor values above 10, indicating no significant multicollinearity concerns. Results are presented as odds ratios (ORs) with 95% confidence intervals (CIs). Statistical significance was set at p-value <0.05.

Ethics Statement

The study received approval from the institutional ethics committee of the educational institution in Kerala, India (approval No. KMCTDC/IEC/2021/01 dated 19/01/2021). Informed consent was obtained from all participants. The study adhered to the Declaration of Helsinki and the Indian Council of Medical Research’s National Ethical Guidelines for Biomedical and Health Research involving Human Participants (2017).

RESULTS

Study Population

A total of 1078 individuals representing 13 of the 14 districts of Kerala participated in the study (Supplemental Material 1). The participants were predominantly female (n=650, 60.3%), and more than half belonged to the 18–29-year age group (53.3%) (Table 1). Most respondents were highly educated, with a majority having completed either graduation (n=521, 48.3%) or professional/honors education (n=268, 24.9%), and over half earned a monthly income exceeding 19 795 Indian rupees. Regarding vaccination, 85.0% (n=916) of respondents had accepted the COVID-19 vaccine, while 15.0% (n=162) were hesitant (Table 1).

Socio-demographic Determinants of Vaccine Hesitancy

Significant predictors of COVID-19 vaccine hesitancy included younger age, male sex, educational attainment limited to school-level, employment in the private sector/self-employment, students in non-health-related fields, being unmarried, not having children, and no prior history of immunizations (Table 2). Conversely, higher income and a history of medical conditions (OR, 0.38; 95% CI, 0.21 to 0.69) were associated with reduced odds of vaccine hesitancy.

Coronavirus Disease 2019 Vaccine Specific Factors and Vaccine Hesitancy

Respondents who expressed uncertainty regarding the effectiveness (OR, 1.99; 95% CI, 1.41 to 2.81) or safety (OR, 2.98; 95% CI, 1.46 to 6.11) of the COVID-19 vaccine, as well as those who felt that the government’s vaccination program lacked adequate information to address their concerns (OR, 1.88; 95% CI, 1.33 to 2.68), exhibited significantly higher odds of vaccine hesitancy (Table 3).

Individual Influences and Coronavirus Disease 2019 Vaccine Hesitancy

Table 4 illustrates the influences of contextual factors, personal health and preventive perceptions (individual influences), and attitudes toward COVID-19 vaccination. Respondents who believed that COVID-19 vaccination was unnecessary if other preventive measures were followed (OR, 1.69; 95% CI, 1.00 to 2.85) or if they considered themselves healthy (OR, 3.55; 95% CI, 1.93 to 6.51) had increased odds of vaccine hesitancy. Those who perceived no community risk from delaying or refusing COVID-19 vaccination also had higher odds of hesitancy (no vs. yes: OR, 2.10; 95% CI, 1.12 to 3.96; not sure vs. yes: OR, 1.84; 95% CI, 1.16 to 2.93). Additionally, individuals lacking trust in the government’s vaccination program (OR, 2.36; 95% CI, 1.46 to 3.82) and those who believed immunization does not prevent serious illnesses (OR, 2.15; 95% CI, 1.06 to 4.38) were more likely to hesitate. Conversely, respondents unsure whether COVID-19 infection was life-threatening exhibited lower odds of vaccine hesitancy (OR, 0.56; 95% CI, 0.33 to 0.94).

Contextual Influences and Coronavirus Disease 2019 Vaccine Hesitancy

Among contextual factors, respondents who perceived the vaccination process as complex or inconvenient had higher odds of hesitancy (“no”: OR, 2.41; 95% CI, 1.65 to 3.53; “not sure”: OR, 2.26; 95% CI, 1.44 to 3.54) (Table 4). The primary sources of COVID-19 vaccine information reported were social media (n=730), local television news (n=647), and newspapers/radio (n=534) (Supplemental Material 2).

Attitudes Towards Coronavirus Disease 2019 (COVID-19) Vaccine and COVID-19 Vaccine Hesitancy

Respondents who were uncertain about the vaccine’s importance in ending the COVID-19 pandemic (OR, 1.71; 95% CI, 1.12 to 2.61) or unsure whether they would recommend the vaccine to others showed greater odds of vaccine hesitancy (no vs. yes: OR, 5.64; 95% CI, 2.25 to 14.13; not sure vs. yes: OR, 1.88; 95% CI, 1.08 to 3.28) (Table 4). The most commonly reported circumstances that would encourage vaccine-hesitant individuals to accept vaccination included: “If made compulsory by the Government of India” (n=184), “If more research on vaccine effectiveness and safety was conducted by the government and health agencies” (n=143), and “If my family physician/doctor advised me to get vaccinated” (n=116) (Figure 1).

DISCUSSION

Studies assessing COVID-19 vaccine acceptance have predominantly focused on willingness to receive the vaccine when it became publicly available [10,14–17,21–23,25]. To date, this is the only study conducted within a timeframe allowing an accurate reflection of actual vaccine acceptance, as true vaccination intent often changes following vaccine availability [8].

High vaccine acceptance (85.0%) was observed, aligning with previous Indian studies [15,16,21–23] and other Asian research [26] conducted prior to vaccine availability, which reported an average acceptance rate of 80.3%. However, 15.0% remained vaccine hesitant. Low vaccine hesitancy at a single time point may fluctuate based on influencing factors [7,8], making the identification of determinants of vaccine hesitancy essential.

Males, younger age, school-level education, low income, being unmarried, and not having children characterized vaccine-hesitant individuals in this study. Although these findings align with other Indian studies [16,25], they differ from global assessments indicating that younger individuals and male typically exhibit higher vaccine acceptance [14,26].

Consistent with observations from other populations [26], uncertainty regarding vaccine effectiveness and safety emerged as significant determinants of COVID-19 vaccine hesitancy. Additionally, hesitant respondents perceived the vaccination process as neither simple nor convenient. India’s vaccination drive utilized the Co-Win digital platform, which required online pre-registration and beneficiary verification [27]. The digital nature of the vaccination process likely contributed to its perceived complexity and inconvenience, particularly among hesitant individuals from lower educational and income groups.

Trust in government significantly influences public vaccine acceptance [10,14]. Studies conducted in Kerala prior to vaccine availability found acceptance positively influenced by trust in the government’s vaccination campaign [21,22]. Contrastingly, our study revealed hesitant individuals lacked trust in the government’s vaccination program and perceived available information as inadequate for addressing their concerns.

Conventionally, individuals compliant with government-recommended preventive measures against COVID-19 tend to accept vaccination strongly [9]. However, our study indicated that although hesitant individuals prioritized preventive measures such as hand sanitizing and social distancing, they considered these measures more effective than vaccination. Remarkably, hesitant respondents did not perceive refusal of vaccination as a risk to community health, suggesting they do not view COVID-19 vaccination as a social responsibility. Vaccine-hesitant individuals were unlikely to recommend the COVID-19 vaccine to others and doubted vaccination’s role in ending the pandemic. Such negative attitudes potentially influence others similarly [9,11], undermining vaccination program effectiveness.

Various hypothetical scenarios were explored to identify whether hesitant individuals could be persuaded to be vaccinated. Most respondents indicated they would receive the vaccination only if mandated by the government, implying vaccination acceptance only under compulsory conditions. Others stated willingness if more research validated vaccine safety and effectiveness or if advised by their family physician. Healthcare providers are trusted sources of vaccination information and influence vaccine decision-making processes [26,28]. Thus, enhanced involvement of healthcare providers in vaccine counseling could improve vaccine acceptance significantly.

Vaccine-hesitant individuals are not fundamentally anti-vaccine and can potentially be persuaded to vaccinate. However, providing additional information on safety and effectiveness alone is insufficient to reduce hesitancy [28]. Results suggest a targeted approach by government and healthcare workers is necessary in identifying and addressing specific areas of concern. Educational efforts should emphasize the safety and efficacy of vaccines, highlight vaccination as a social responsibility, and establish support systems for individuals from lower socioeconomic backgrounds to assist with digital health technologies and direct them toward assisted registration services [27]. India’s primary healthcare system, being the first point of individual healthcare contact, focuses on addressing social determinants of health and ensuring equitable access. Policy initiatives within the primary care structure that train grassroots-level health workers to identify and address vaccine hesitancy can empower communities, enhance vaccination rates, and improve overall public health outcomes.

Strengths and Limitations

Several aspects require cautious interpretation, as the study included only individuals who use the internet. Nevertheless, the sample can be considered representative due to several factors. Kerala has India’s highest literacy rate (94.0%) [18] and a tech-savvy population [29,30]. High mobile network penetration ensures widespread internet accessibility [29,30]. Additionally, increased internet use and social media dependency were noted during lockdown periods [29,30]. Kerala comprises of 14 revenue districts, geographically, culturally, and historically categorized into North (Kasaragod, Kannur, Wayanad, Kozhikode, Malappuram), Central (Palakkad, Thrissur, Ernakulam, Idukki), and South (Thiruvananthapuram, Kollam, Alappuzha, Pathanamthitta, Kottayam) regions. Although the large sample size from a single state included respondents from all 3 regions, the use of snowball sampling constitutes a notable limitation. However, conducting the study in a relevant timeframe, immediately following vaccine availability, significantly enhances the validity and practical applicability of the findings.

The present study identified new areas of focus that can assist government and healthcare workers in effectively educating vaccine-hesitant individuals, particularly those from lower socioeconomic backgrounds. Correcting misconceptions and regularly monitoring vaccine hesitancy is essential to preventing future COVID-19 outbreaks. Nonetheless, larger and more representative population-level studies, combined with focused qualitative investigations, are needed for a comprehensive understanding of the complex phenomenon of COVID-19 vaccine hesitancy.

Supplemental Materials

Notes

Data Availability

Data will be available on request from the corresponding author.

Conflict of Interest

The authors have no conflicts of interest associated with the material presented in this paper.

Funding

None.

Acknowledgements

This research study was presented by author Muralidharan D at the scientific session of the 26th National Conference of the Indian Association of Public Health Dentistry held from 23rd to 25th September 2022 at Maquinez Palace, Panaji, Goa, India and was awarded the ‘Best Paper Award’ for the session. We would like to thank the Indian Association of Public Health Dentistry, the largest public health organization working towards improvement of Dental Public Health specialty in India, for giving us an opportunity to present the findings of this research work at the National Conference.

Author Contributions

Conceptualization: Muralidharan D, Paul A, Nandakumar ST, Poothotill SS. Data curation: Muralidharan D, Panangadanakath S, Nandakumar ST, MoiduKunhi RA, Ameen Z. Formal analysis: Muralidharan D. Funding acquisition: None. Methodology: Muralidharan D, Paul A, Panangadanakath S, Nandakumar ST, Poothotill SS, MoiduKunhi RA. Visualization: Muralidharan D. Writing – original draft: Muralidharan D, Panangadanakath S. Writing – review & editing: Muralidharan D, Paul A, Nandakumar ST, MoiduKunhi RA, Poothotill SS, Ameen Z.

Figure 1

Circumstances in which vaccine-hesitant individuals would be encouraged to receive the coronavirus disease 2019 (COVID-19) vaccine. The values are mutually inclusive as respondents could select more than one option.

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