Are we ready to abrogate compulsory vaccinations for children?

Abstract

In Italy, vaccination against diphtheria, tetanus, polio and hepatitis B is compulsory for infants countrywide, except in Veneto region where since 2007 Health Authorities have experimented the suspension of mandatory vaccination. In light of the recent discussion on the potential abrogation in other regions, we explored the opinion of family pediatricians who play a crucial role in promoting immunization programmes in Italy. In November 2009, we interviewed by phone the family pediatricians working in Puglia region using a standardised, ad hoc and piloted questionnaire. Of the 596 contacted, 502 (84.2%) completed the questionnaire (54% female, median age = 52 y). Among the respondents, 72 (14.3%) would agree on the hypothesis of abrogation. This judgment was associated with having a good opinion on the level of awareness of the importance of vaccinations in the general public (OR = 6.6; 95% CI: 3.6–12.1) and having the perception of adequate organization of Vaccination Services in supporting the abrogation (OR = 3.6; 95% CI: 1.7–5.9). Family pediatricians appeared really sceptical about the abrogation of compulsory vaccination that could be hypothesized only increasing public awareness, communication skills and capability of Vaccination Services personnel in offering vaccinations.

Keywords: :

• compulsory immunization
• vaccination
• family pediatricians
• ethics

Background

Childhood vaccinations are globally considered one of the most effective prevention tools, even though the success of immunization programmes largely depends on high rates of acceptance and coverage.¹

Mandatory vaccination, introduced for the first time in UK in 1853, has strongly contributed to the rapid achievement of high vaccines intake. Although, benefits of compulsory vaccination are not universally recognized and several physicians and scientists postulated that voluntary vaccination allow people to be responsible for their own health. Both policies are under debate inside and outside the international scientific community. Compulsory immunization might not be acceptable in some countries where high coverage has been achieved through other approaches or efforts.^2-5

Up to 2010, an overview of recommended and mandatory vaccinations in the EU countries performed by the Vaccine European New Integrated Collaboration Effort (VENICE) network, reported that 15 countries had not included any compulsory vaccination and the remaining 14 had included at least one mandatory in their national immunization plans. Many programmes in Europe are effective even though voluntary and recommended.⁶

In Italy, vaccinations are offered on a mixed system: four are mandatory (diphtheria, tetanus, poliomyelitis and hepatitis B), others (pertussis, Haemophilus Influenzae type b, 13-valent pneumococcal conjugate vaccine, measles, mumps, rubella, serogroup C meningococcal conjugate vaccine, HPV) are strongly recommended to infants, children and adolescents. Both mandatory and non-mandatory vaccinations are included in the list of Essential Health Interventions which must be actively provided by law free of charge to all subjects targeted by vaccination strategies.⁷

Since 2001, the National Health Service (NHS) has been decentralized and all the 21 Italian regions have the responsibility for allocating budget, organizing and delivering health care, including vaccinations.⁸ Since 2007, the suspension of mandatory vaccination has been experimented in Veneto region due to some specially favorable conditions: high coverage for all actively offered vaccinations, region-wide computerised immunization register, Vaccination Services well distributed across the region and easily reachable by the public, sensitive infectious diseases and vaccine adverse events surveillance systems, and strengthened training of health care workers.⁹ Following this experience, recently, other Italian regions are debating on the potential abrogation.¹⁰

In Italy, Public Health Departments deliver immunization through Vaccination Services (VSs) while family pediatricians assure primary health care of children aged 0–14 y. Thereby, they have the potential to strongly influence parental acceptance of vaccinations.^11,12

Since 2006, Puglia region (South-Italy) actively offers vaccinations not yet provided in the list of Essential Health Interventions, such as 13-valent pneumococcal conjugate vaccine, serogroup C meningococcal conjugate vaccine, varicella vaccine, achieving coverage rates higher than other Italian regions.⁸ Furthermore, a region-wide computerised immunization register has been implemented and electronic-based infectious diseases surveillance works since 1996. Thus, a debate on the possibility to abrogate mandatory vaccination has started in Puglia though local health authorities have not yet adopted any formal action.

The aim of this study was to explore the opinion of family pediatricians on mandatory vaccinations and their potential abrogation in Puglia region.

Results

Of the 596 family pediatricians working in Puglia and invited to the survey, 502 (84.2%) returned the questionnaire. The median age of respondents was 52 y (range 42–72), the median duration of their professional career was 25 y (range 12–53), the mean number of children cared by each physician was of 811 ± 157, 271 (54%) were female.

Among the interviewed pediatricians, 72 (14.3%) would agree with the hypothesis of abrogation of mandatory vaccination. Gender, age, duration of professional career and number of children cared did not modify this judgement (P > 0.05; Table 1).

Table 1. Family pediatricians’ opinion on abrogation of mandatory vaccination; Puglia, Italy, 2009

	Disagree (n = 430)		Agree (n = 72)		Total (n = 502)		OR (95% CI)	Chi-square ; p
	N	%	N	%	N	%
Gender (Male)	191	45.1	40	55.6	231	46.6	1.5 (0.9–2.6)	2.73; > 0.05
Age (≥ median)	267	62.1	40	55.6	307	61.2	0.8 (0.4–1.3)	1.11; > 0.05
Duration of professional career (≥ median)	217	50.4	34	47.2	251	57.8	9 (0.5–1.5)	0.26; > 0.05
Number of children cared (≥ average)	216	50.2	39	54.2	255	50.8	1.2 (0.7–2)	0.38 ; > 0.05

Mandatory vaccinations were considered more valuables than those recommended by 46.6% (n = 234) of the respondents and 53.4% (n = 268) thought that the general public has a similar perception. The opinion of 21.5% (n = 108) of the sample was that the level of awareness of the importance of vaccination in the public is sufficient to abrogate the obligation. An amount of 34.1% (n = 171) deemed that the organization of Apulian Vaccination Services is adequate to support the abrogation.

In the univariate analysis, “agreeing with the abrogation” was associated with: (1) perceiving the level of awareness of the importance of vaccination in the community as sufficient in order to support the abolition (OR = 10; 95% CI: 5.6–18.1; chi-square = 85.03, P < 0.001); (2) being confident that the organization of VSs is adequate to support the abrogation (OR = 6; 95% CI: 3.3–10.9; chi-square = 47.4, P < 0.001; Table 2).

Table 2. Family pediatricians’ opinion on mandatory vaccination and their potential abrogation; Puglia, Italy, 2009

	Disagree (n = 430)		Agree (n = 72)		Total (n = 502)		OR (95% CI)	Chi-square; p
	N	%	N	%	N	%
Mandatory vaccinations are more important than those recommended (Yes)	204	47.8	30	42.9	234	47.1	0.8 (0.5–1.4)	0.58; > 0.05
Level of awareness of the importance of vaccinations in the public is sufficient in order to abrogate obligation (Yes)	63	14.7	45	63.4	108	21.6	10 (5.6–18.1)	85.03; < 0.001
The public perceives mandatory vaccinations as more important than those recommended (Yes)	234	54.7	34	47.2	268	53.6	0.7 (0.4–1.3)	1.38; > 0.05
Organization of vaccination services is adequate to support the abrogation (Yes)	121	28.5	50	70.4	171	34.5	6 (3.3–10.9)	47.4; < 0.001

Providing parents with complete information on vaccinations is a common habit of 98.2% (n = 493) of the interviewed pediatricians. The 28.9% (n = 145) declared that they usually give support to VSs in the management of vaccination refusal (Table 3).

Table 3. Family pediatricians’ attitude in counselling vaccination and managing vaccine refusal; Puglia, Italy, 2009

	Disagree (n = 430)		Agree (n = 72)		Total (n = 502)		OR (95% CI)	Chi-square; p
	N	%	N	%	N	%
To give information on vaccinations is a common habit (Yes)	422	98.8	71	98.6	493	98.8	0.8 (0.1–40.3)	0.02; > 0.05
To support vaccination services in the management of vaccine refusal (Yes)	131	30.5	14	19.4	145	28.9	0.5 (0.2–1)	3.65; 0.06

The logistic model confirmed the association between agreeing with the abrogation of mandatory vaccination in Puglia and a good opinion on both the level of awareness of the importance of vaccination in the public (OR = 6.6; 95% CI: 3.6–12.1; P < 0.001) and an adequate organization of VSs (OR = 3.6; 95% CI: 1.7–5.9; P < 0.001).

Discussion

This study has documented that the majority (> 80%) of Apulian family pediatricians was sceptical about the abolition of compulsory immunization by law. Good judgements on the awareness of the importance of vaccination in the public and on the organization of Vaccination Services appear as main determinants of potential abrogation.

The debate on mandatory vaccination represents a major Public Health concern, since vaccination compulsory by law is often considered the more workable measure to ensure high coverage for the protection of vulnerable people against infections.^13,14 Apulian family pediatricians appeared conscious that the debate involves the public opinion, often struggled between the principle of delegating responsibility for children health to parents and the need to guarantee the public interest, that cannot be put at risk from parental ignorance, neglect or abuse.¹⁵

Our study was focused only in a region, which could be not representative of the entire country. Furthermore, it was conducted by a quantitative approach and, probably, a qualitative analysis should better contribute to evaluate the point of view of family pediatricians.

Our findings are consistent with the results of a similar survey performed in 2008 among Apulian Vaccination Services employees, of which 75% was not favorable with the abrogation of compulsory vaccination. A survey performed in 2008 in France showed that only 8.1% of general practitioners and 20.7% of pediatricians opposed to mandatory vaccinations.^16,17

The national and international scenario on compulsory immunization is changing in recent years. In 2006, the American Academy of Paediatrics stated “continued (vaccine) refusal after adequate discussion should be respected unless the child is put at significant risk of serious harm (as, for example, might be the case during an epidemic). Only then should state agencies be involved to override parental discretion on the basis of medical neglect.”¹⁸ Recently, some evidences showed an increasing vaccine refusal in clustered geographic areas where the risk of outbreaks appeared larger.¹⁹ In 2009, UK faced a large outbreak of measles on a scale never seen since vaccination was available, consequently, health authorities explored the hypothesis of introducing mandatory vaccination.²⁰ Nevertheless, compulsion would fall when parents are unfavorably to an imposition on their freedom of choice and compulsory vaccination laws would fan the anti-vaccination lobbies, recently increasing.^21,22

The abolishment of mandatory vaccinations requires a series of both cultural and organizational prerequisites that must be achieved before the abrogation. Several studies investigating the determinants of vaccine refusal showed that parents claim more information on childhood vaccination and health care providers are cited as the most frequent source of information also by parents who refused vaccination.^19,23,24 This appears consistent with the opinion of Apulian pediatricians who, even though declared scepticism about the abolition of compulsion, hypothesized that law could be overridden increasing public awareness, communication skills and capability of Vaccination Services in offering vaccinations.

Further studies are needed to investigate what are the most effective tools for improving scientific communication, management with the media and information to parents to support the process of compulsory law abolition.

Methods

In November 2009, a survey was conducted among family pediatricians working in Puglia, interviewed by phone using a standardised, ad hoc and piloted questionnaire. The list of pediatricians was obtained from the regional physicians registry. Collected data were anonymized after data-entry.

The questionnaire included demographic and job information (gender, age, duration of professional career, number of children cared) and opinion on mandatory vaccinations with respect to:

1. The value given to compulsory vaccinations in comparison to those recommended

2. The perception of the level of awareness of the importance of vaccination in the public

3. The judgment on the organization of the Vaccination Services

Attitudes in counselling vaccinations and managing vaccine refusal were also assessed.

An univariate analysis was performed to assess association between the opinion on abrogation and other investigated variables, by using double-entry contingency tables, computing chi-square (or Fisher’s exact test when appropriated) and Odds Ratio (OR) with 95% Confidence Intervals (95% CIs), considering as significant p values < 0.05. Variables significantly associated with a favorable opinion on the abolition were included in a multivariate logistic model to calculate adjusted ORs with 95% CIs. Data were analyzed with Stata V.12 for Mac OS software.

Abbreviation:
CIs	=	Confidence Intervals
HPV	=	Human Papilloma Virus
LEA	=	Livelli essenziali di assistenza (Essential Health Interventions)
NHS	=	National Health Service
ORs	=	Odds Ratios
UK	=	United Kingdom
VSs	=	Vaccination Services
VENICE network	=	Vaccine European New Integrated Collaboration Effort network

Disclosure of Potential Conflicts of Interest

No potential conflicts of interest were disclosed.

Acknowledgments

We thank all the Apulian family pediatricians participating in the survey whose results have been returned to them and to health authorities. We also acknowledge Biagio Pedalino for his suggestions for the manuscript.