https://orcid.org/0000-0002-3103-2342
ABSTRACT
Vaccination is a key protective factor against COVID-19. Some vaccines have already received emergency authorization from Health Agencies, but growing skepticism and vaccine hesitancy will probably affect COVID-19 vaccination campaigns. In the attempt to shed light on this issue, we conducted an online survey in a population of parents referring to 4 pediatric practices in Naples, Italy in whom we evaluated potential vaccine acceptability in relation to socio-demographic characteristics, perception of personal health and of the impact of COVID-19, and attitudes toward general vaccination practices. Vaccination rates were analyzed also in the corresponding pediatric population.
Almost 27% of participants declared they were in favor of vaccinations, and in fact real life vaccination rates in children exceeded the national mean. Only 26.5% of respondents declared they would receive COVID-19 vaccine. Vaccine refusal was attributed to safety concerns in 76% of parents. Specific vaccine attributes further reduced the acceptance rate. Female gender, younger age and lower education level were associated with non-adherence to vaccination. Among extrinsic factors of COVID-19 vaccination, only information from National Health Authorities was significantly associated to vaccine acceptance.
The rate of potential COVID-19 vaccine acceptability was very poor in our population of parents. Vaccine hesitancy was mainly due to safety concerns. Demographic and educational factors were correlated to vaccine acceptability. Health education and communication strategies are needed to achieve large-scale vaccine acceptability and finally herd immunity.
Introduction
Vaccines are a major tool in the development of global health, and an indisputable human right.Citation1 Their role has gained importance over the last decades in disease prevention and in controlling infectious disease outbreaks.Citation1,Citation2 Moreover, immunization implementation is one of the best investments for health.Citation1 COVID-19 pandemics are heavily stressing national health systems around the world and pushing toward new therapies and preventive strategies.Citation3,Citation4 The race to find a COVID-19 vaccine started in January 2020 after Chinese researchers shared the Coronavirus genomic sequence.Citation5 Several prophylactic vaccines against COVID-19 are currently under development in multiple countries,Citation6,Citation7 and some candidate vaccines have already received emergency authorization from the US Food and Drug Administration and the European Medicines Agency. Notably, this has led to the striking achievement of multiple vaccines for a single infectious disease in less than a year.
A safe and effective vaccine is only the starting point of a successful campaign against an infectious disease. Once a vaccine is developed and approved, a sufficient portion of the population should be vaccinated to reach herd immunity and prevent a wider spread of the infection in the community.Citation8 Recently, various studies have addressed the issue of the acceptance of potential COVID-19 vaccine candidates in different settings.Citation9 The impact of COVID-19 pandemics may favor very high acceptancy rates in a few countriesCitation10–13 but it is not clear whether the severity of the disease will overcome vaccine skepticism. In Italy, for instance, a very low number of people were willing to receive the new vaccine.Citation14 Vaccine hesitancy is defined a “delay in acceptance or refusal of vaccination despite availability of vaccination services” and is considered context-specific.Citation15 It is crucial to identify COVID-19-vaccine hesitancy in order to plan specific actions to achieve immunization rates able to halt disease propagation.
A few weeks before any emergency authorization, we evaluated the acceptability of a potential COVID-19 vaccine and the major factors limiting its implementation in a selected population of parents. This approach enabled us to focus on a population highly aware of childhood vaccinations. Moreover, by analyzing vaccination rates in children we were able to interpret the real rate of their parents’ hesitancy.
Patients and methods
Study design
We investigated a population of parents attending 4 pediatric practices in the metropolitan area of Naples, Italy. Family pediatricians in Italy see children up to 14 years of age. All children receive programmed visits at specific filter ages (1, 2, 5, 10, 15 months and 2, 4, 5, 7, 8, 12 years of age), during which the national vaccine program is explained in detail, information on each mandatory and non-mandatory vaccination is provided and adherence is strongly reinforced. Therefore, by surveying people with children we were able to observe a population well informed about vaccines in general and about the Italian National Vaccination Program, and who actually face the decision of vaccinating their children.
Parents were the target of our survey on COVID-19 vaccine hesitancy. Concurrently, we analyzed vaccination rates in the pediatric population as a direct measure of vaccine hesitancy of parents. At survey onset, our population comprised 2,260 families with 3,518 children (2,233 siblings). We enrolled all parents who provided their e-mail address and gave explicit informed consent (1 person per family, n. 1,590). The protocol complied with Italian national data privacy laws. This cross-sectional survey was conducted between November 14 and 28, 2020. An invitation letter was sent to enrolled parents in which we introduced the survey and provided information about anonymity and the analysis of results. The questionnaire was administered as a structured Google form linked to the invitation letter.
Measures
The Survey consists of three sections: i) socio-demographic characteristics; ii) attitudes toward general vaccination practices (including willingness to vaccinate children); and iii) perception of the personal health of the participant and of the impact of COVID-19. In the Survey, parents were asked whether they intended to be vaccinated for SARS-CoV-2, with the response options “yes”, “no”, “not sure”. Participants who responded “no” and “not sure” were asked to give their motivations. All responders were also asked about specific vaccine attributes that may characterize the candidate vaccines: duration of protection, efficacy, and incidence of minor adverse effects. Arbitrary attribute levels were assigned according to previous studiesCitation16 (6–12 months for duration of protection, 75–90% for efficacy, > 1:10 for the incidence of minor side effects). Finally, using a 5-point scale, we investigated the importance that responders placed on receiving information from the family physician, social media or national authorities.
Analysis of vaccination rates in children
Pediatricians can access their patients’ vaccination records on a regional vaccination database (GEVA, https://vaccinazioni.soresa.it). A query was completed by the pediatricians in charge of the four pediatric practices (VE, MM, GC, and GDM) at the end of the survey (30 November 2020) on mandatory and non-mandatory vaccinations of all children attending the pediatric practices evaluated in this study. Vaccination rates were obtained directly from GEVA and were expressed as percentages. According to the Italian National Vaccination Program for mandatory vaccines, we analyzed the first complete cycle of Polio vaccination as a proxy for hexavalent vaccination and the first dose for Measles as a proxy for Measles-Mumps-Rubella (MMR) in children aged 2 or older. The fourth dose of the anti-Diphtheria vaccine and the second dose of the MMR vaccine in children aged 7 or older were also examined. For non-mandatory vaccinations, we investigated a complete three-dose cycle of the anti-Rotavirus vaccine in two-year old children.
Data analysis
Statistical analyses were performed using IBM SPSS version 26 (IBM corp.). Descriptive statistics including frequencies, percentages, means, and standard deviations, were used to analyze the demographic and health-related characteristics of participants and scales about vaccine-related features. We used bivariate relative risks to correlate demographic and health-related characteristics with non-acceptance of COVID-19 vaccine and to compare vaccine-related features in participants who declared to be not willing or willing to receive the vaccine. Lastly, in the attempt to identify features that were significantly correlated to vaccine acceptability features, we performed a multivariate regression analysis with robust standard errors, including all demographic and COVID-19 vaccine acceptability variables with a p < .20 in bivariate analysis. The regression model returned adjusted relative risks (RRs) and 95% confidence intervals (CIs).
Results
Population characteristics
A total of 1590 parents received the survey, and 640 completed it (40.2%). shows the demographic features of participants and other health-related data. Almost 74% of respondents were female. More than 95% were younger than 50 years which was not surprising given that we were investigating the parents of children up to 14 years of age. Household sizes were quite large with more than 50% of respondents living with at least 4 cohabitants. When asked about their health status, most patients reported to be in the top 2 grades of a 1-to-5 scale in which 1 was “very bad” and 5 “optimal”. The impact of pandemics on everyday life and work was “high” or “very high” in more than 50% of cases. When questioned about their perception regarding the chance of contracting SARS-CoV-2, more than 60% of respondents thought that they could contract COVID-19 in a mild form ().
Table 1. Demographic and health-related characteristics of participants (n = 640)
Attitude toward vaccinations and toward the COVID-19 vaccine
The vast majority of participants declared to be generally in favor of vaccines (494, 77%) and almost all (619, 97%) reported that their children had received mandatory vaccinations. Similarly, when we asked about optional vaccinations, 450 respondents (70%) had previously agreed to them for their children. Regarding the COVID-19 vaccine, only 170 (26.5%) expressed their willingness to receive it, while 150 (23.4%) were not and 320 (50%) were “not sure” (of a total of 470 respondents, 73.4% declared they were not willing) (). Replies to the question about a potential COVID-19 vaccine for their children reinforced the afore-mentioned negative attitude. In fact, 221 participants (34.5%) were not willing, 309 (48.3%) were not sure and only 110 (17.2%) declared they were willing. Participants who were not willing or not sure were asked about their motivation and the results are shown in . Major concerns were for safety, and there were no significant differences between those responding “no” and “not sure” (). The reasons for not accepting COVID-19 vaccine did not differ in terms of gender or age group (data not shown).
Table 2. Reasons for answering “no” or “not sure” to the COVID-19 vaccine
Correlates of COVID-19 vaccine acceptability
We analyzed the demographic characteristics of respondents and the relative risk being not willing to receive the COVID-19 vaccine (). Non-adherence to vaccination was strongly associated with female gender and age below 35 years (). A high educational level and a working condition reduced the relative risk of being not willing. No positive effect was associated with the presence in the household of elderly or fragile subjects (). In addition, self-reported health status did not modify the probability of accepting the vaccine. Not surprisingly, the perception of a higher impact of COVID-19 on everyday life and working activity reduced the relative risk of being not willing to be vaccinated ().
Table 3. Bivariate correlates for demographic and health-related characteristics of non-acceptance of COVID-19 vaccine
shows the impact of vaccine features on vaccine acceptability. The introduction of specific vaccine attributes lowered the vaccine acceptancy rate, also in participants who previously declared they were willing to receive the vaccine. Consequently, while 73.6% of respondents agreed to 2 or more doses, only 55.2% would accept time-limited protection, but only 22.4% of participants were willing to accept a relatively high incidence of side effects (). The number of respondents still willing to receive the COVID-19 vaccine once all the above-mentioned vaccine attributes were applied, decreased to 47 (7.4% of all participants).
Table 4. Bivariate correlates of COVID-19 vaccine acceptability for vaccine-related features in participants declaring to be not willing or willing to receive the vaccine
Using a 5-point scale, we tested the impact of extrinsic factors of COVID-19 vaccination that could affect its acceptability (). The mean score of each factor did not differ between participants who were willing and those not willing to receive the vaccine (). When we grouped respondents who declared a factor to be important or very important (4 + 5 points on the scale), we found an association between the National Health Authorities as a source of information and acceptance of the vaccine (). On the contrary, no impact could be ascribed to social media or to the family physician ().
Multivariate analysis of correlates of vaccine acceptability
Lastly, we performed a multivariate analysis of all the features significantly associated with non-acceptability of the COVID-19 vaccine (). Demographic factors were confirmed to be crucial. Indeed, female gender and age below 35 remained significantly associated with non-acceptability of the vaccine (). A higher educational level was confirmed to be associated to vaccine adherence. Interestingly, we observed a lack of vaccine acceptability in relation to a greater impact of COVID-19 on life and working activities ().
Table 5. Multivariate analysis of correlates for COVID-19 vaccine acceptability
Vaccine coverage in children
In our survey, we targeted the parents of a population of 3,518 children. Vaccine coverage was very high in these children. In fact, vaccination rates for the first polio cycle (98%) and measles (98%) exceeded the mean Italian national rates (95% and 94.4% respectively).Citation17 Vaccination rate declined with the fourth dose of the anti-Diphtheria vaccine (89.8%) and the second dose of the MMR vaccine (88.5%), however vaccination rates still exceeded the current national rates (85% and 86.1%, respectively). In addition, the non-mandatory Rotavirus vaccination rate was low but, again, higher than the Italian national rate (36.3% vs 26%, respectively in 2 year old children).
Discussion
Herein, we report the results of a survey on the acceptability of a COVID-19 vaccine conducted at the end of November 2020 in Naples, Italy. In our sample, constituted by the parents of a known pediatric population, the rate of vaccine acceptance was very low, just above 26%, which to our knowledge, is the worst result reported so far. Indeed, in the United States, it was estimated that about two-thirds of a sample population would be willing to undergo COVID-19 vaccination,Citation11,Citation12 In a study conducted in China, over 91% of people interviewed would accept COVID-19 vaccination, and 52% of them wanted to be vaccinated as soon as possible.Citation18 In France, around 75% of interviewed people would agree to vaccination,Citation10 whereas in England less than 4% of surveyed subjects declared that they would definitely not accept a COVID-19 vaccine.Citation19 In a previous Italian study, the percentage of respondents willing to receive the vaccine was lower than in other countries, although it accounted for almost 60% of the population.Citation14 However, as the COVID immunization campaign in Italy entered first phase, which targets health care personnel, reports of growing skepticism and vaccine refusal are beginning to appear in many areas of the country and sectors of the population. The main determinants of hesitancy are reported to be fear of potential side effects, vaccine safety in general, and concern that vaccines are being introduced to serve economic and political interests rather than for medical needs.Citation20
Most of our survey respondents declared they were vaccine-hesitant because they feared the side effects of the vaccine. Female gender, younger age and lower educational level were the factors most frequently related to non-acceptability of the vaccine. Women constituted the vast majority of our study respondents since mothers are more frequently in charge of their children’s care. Such a low percentage of vaccine acceptance as that observed in our study (26.5%), could be also associated with the low risk perception of severe COVID-19 in people below the age of 50. Indeed, willingness to be vaccinated was lower in subjects under the age of 35 years than in older subjects probably due to an invulnerability bias.Citation21 However, our multivariate analysis reinforced the importance of age and sex for vaccine acceptability but failed to confirm that a greater impact of pandemics on everyday life and working activity would increase vaccination rates. Not even the presence of elderly or fragile subjects in the household seems to influence the decision to vaccinate against COVID-19.
It is noteworthy that in our survey, questions regarding specific vaccine attributes induced a further reduction in the acceptability rate. The vaccine attributes associated with vaccine acceptability are efficacy, protection duration, major and minor adverse effects, approval processes, the national origin of the vaccine and endorsement.Citation16 In our population, the need for multiple doses, a limited protection over time, and an efficacy below 90% all had discouraging effects, whereas it was a high rate of side effects, albeit mild, that had the greatest impact. The combination of all these characteristics reduced vaccine acceptance to 22.4% in subjects who had previously declared willing to receive the COVID-19 vaccine.
A common public concern seems to be that a COVID-19 vaccine might be “experimental”, that side effects have not been studied, and that the vaccine may not be safe for specific groups, such as pregnant women or people with preexisting conditions.Citation22 In fact, the probability of choosing a vaccine that has emergency use authorization is lower than that of choosing a fully approved vaccine.Citation16 Information about vaccine safety should be made public on a regular basis once the vaccine is applied. Moreover, timely health education and communication provided by authoritative sources such as healthcare professionals will be critical in alleviating public concerns. The risk of losing public trust in the COVID-19 vaccination could compromise the optimal target of reaching herd immunity,Citation18,Citation23
Vaccine hesitancy, which in Italy, is a well-known phenomenon, led to such a dramatic decrease in vaccine rates that national authorities had to reintroduce the obligation for some vaccinations in 2017. A general lack of knowledge and misconceptions play a role in vaccine hesitancy in Italian parents.Citation24 On the other hand, institutional sources of information such as GPs positively affect vaccine acceptance.Citation25 Interestingly, in our survey, being vaccinated by a GP did not seem to affect vaccination decision making. Nevertheless, we found that information about the vaccine supplied by the Ministry of Health was one of the strongest correlates of vaccine acceptability. Indeed, people are more willing to undergo vaccinations that have been endorsed by such authoritative organisms as the WHO.Citation16
Caution should be exercised in extrapolating the results of our survey to the general population. Our study was carried out in a population of a limited age range living in a restricted geographical area. However, all participants have children, and had received systematic information about vaccinations. Moreover, they had already faced the decision whether or not to vaccinate their children. We found that not only were parents favorable to vaccines in general, but their children had very high rates of both mandatory and optional vaccinations, higher than the Italian national mean rates. Thus, our results are of great relevance because the population we surveyed was highly aware of vaccinations. Moreover, the age ranges most represented in our study constitute almost 45% of the Italian population (33.6% in the case of the age group <35, and 21% in the case of the age group 35–49 years of age) according to the 2020 data of the Italian National Institute of Statistics.Citation26
Only when a sufficiently high proportion of the population is vaccinated, will the overall reduction of disease transmission in the community prevent outbreaks and thus protect unvaccinated individuals,Citation8,Citation27 Sufficient vaccine coverage to achieve herd immunity is the key to eliminating vaccine-preventable diseases. However, the thresholds needed for herd immunity to eradicate or control diseases differ among diseases. In the case of Measles, a vaccination coverage of at least 95% is required to prevent outbreaks.Citation28 In the case of a COVID-19 vaccine with a claimed efficacy of 95%, the required herd immunity level would be from 63% to 76%.Citation29 However, the immunization battle against COVID-19 is just starting, and in a real-world situation, epidemiological and immunological factors such as population structure, variation in transmission dynamics between populations, and waning immunity are only a few of the elements that will lead to variations in the extent of indirect protection conferred by herd immunity.Citation30 We know that explaining the social benefits of herd immunity can increase the intent to be vaccinated.Citation31 In the United States, vaccination intent increased approximately 10 percentage points within a few monthsCitation32 so it is important to monitor people’s willingness to be vaccinated because it can change within a short time. Initiatives should be undertaken to identify the causes of vaccine hesitancy and strategies to overcome it.
Disclosure of potential conflicts of interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Acknowledgments
The authors wish to thank Lucia Laurano and Marilena Terracciano for their precious help and collaboration.
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QUESTIONNAIRE
Your age (years): <35, 35–50, 51–65, >65
Gender: male/female
Your educational degree: less than high school/high school degree/college graduation
Your actual working status: employed/unemployed
Number of cohabitants:
Presence of cohabitants aged over 65 or suffering from chronic diseases: Yes/No
(If yes) Did your over 65 or chronically ill cohabitants get flu vaccination last year? Yes/No
How good is your health state? Scale from 1 to 5
What is the impact of COVID 19 pandemic on your everyday life? Scale from 1 to 5
What is the impact of COVID 19 pandemic on your job? Scale from 1 to 5
About vaccines in general: how safe do you think the available vaccines are? Scale from 1 to 5
How effective do you think the available vaccines are? Scale from 1 to 5
Are you generally favorable of vaccinations? Yes/No
Have your children received vaccinations? Yes/No
(If yes) Did they also get optional vaccinations? Yes/No
Do you think that COVID-19 vaccine is an effective way to prevent and control the pandemic? Yes/No/I don’t know
Would you agree to get the COVID-19 vaccination once it is available? Yes/No/Not sure
(If yes) Would you like to receive the vaccination as soon as possible? Yes/No, I‘d expect a large number of people to be vaccinated
(If no or doubtful) For what reason?
I think it’s not safe
I don’t think it’s useful
I already got covid-19
I am against vaccinations in general
Fear of side effects
Other
Would you accept your child to receive the COVID-19 vaccine? Yes/No/I don’t know
Talking about the COVID-19 vaccine, would you accept a vaccine that requires 2 or more doses? Yes/No/I don’t know
Would you accept a vaccine that gives limited protection over time (6–12 months)? Yes/No/I don’t know
Would you accept a vaccine with efficacy below 90% (say 70–90)? Yes/No/I don’t know
Would you accept a vaccine with a risk of mild side effects greater than 1 in every 10 vaccinated? Yes/no/I don’t know
Would you be willing to pay the cost of producing and distributing the vaccine (around 10 euros)? Yes/No/I don’t know
How important is the COVID-19 vaccine to be administered by your physician? Scale from 1 to 5
How important is it that the vaccine is produced in Europe? Scale from 1 to 5
How important is it to have information about the vaccine through social media? Scale from 1 to 5
How important is it to have information about the vaccine from the Ministry of Health? Scale from 1 to 5
Do you think the COVID 19 vaccine should be obligatory? Yes/No/I don’t know
What is your guess that you will get COVID-19 in the next 6 months?
I have already contracted it
I will not contract it
I will be able to contract it mildly
I will be able to contract it in severe form