SERIES CANVax - www.canvax.

ca

Considerations for mandatory childhood

immunization programs
Noni E MacDonald1*, Eve Dubé2, Daniel Grandt3
This work is licensed under a Creative
Commons Attribution 4.0 International
Abstract License.

Outbreaks of vaccine preventable diseases occur even in countries that have unrestricted
and relatively equitable accesses to immunizations because vaccine uptake rates are lower
Affiliations
than necessary for effective disease control. Vaccine hesitancy is seen in many countries,
including Canada, and has led to enacting or strengthening legislation requiring mandatory 1
Department of Pediatrics,
childhood immunization in some provinces. Although mandatory immunization may seem Dalhousie University, IWK Health
Centre, Halifax, NS
to be the simplest solution to this issue, it is not always as effective as anticipated. Different
countries/states/provinces/territories have used different strategies to encourage parents to
2
Quebec National Institute of
Public Health, Department of
fully immunize their children. Definition, scope, flexibility (such as exemptions for medical, Anthropology, Laval University,
religious and philosophical reasons) and framework factors (such as strictness of application Québec, QC
and levels of enforcement of the mandate) vary widely between jurisdictions. Surprisingly, no 3
Department of Internal
marked differences were seen in vaccination rates between countries that recommended versus Medicine, Klinikum Saarbruecken,
mandated them. Unintended consequences of mandatory immunization programs—both good Germany
(increased availability of data) and bad (“gaming” of the system and disproportionate impacts
on families of lower socioeconomic status) have been reported. Addressing lower vaccine
uptake rates is a complex problem that needs a multipronged, more nuanced and tailored *Correspondence:
approach. [email protected]

Suggested citation: MacDonald NE, Dubé E, Grandt D. Considerations for mandatory childhood immunization
programs. Can Commun Dis Rep 2020;46(7/8):247–51. https://doi.org/10.14745/ccdr.v46i78a06
Keywords: childhood immunization, mandatory, CANVax

Introduction
Outbreaks of vaccine preventable diseases occur even in high- this Canadian Vaccination Evidence Resource and Exchange
income countries that have unrestricted and equitable access to Centre (CANVax) Brief provides an overview and brief discussion
immunizations. The reason for these outbreaks is that vaccine of what mandatory childhood vaccination means followed by
uptake rates are not where they need to be for adequate control discussions of scope and framework factors to consider. Also
of vaccine preventable diseases. Parents in many jurisdictions, discussed are the reported outcomes, including reports of
including Canada, have been hesitant about immunizing unintended consequences.
their infants and children on time and on schedule (1). As a
consequence, several countries have discussed, enacted or This is the sixth in a series of articles, produced by CANVax, an
strengthened mandatory childhood immunization legislation online database supporting immunization program planning and
to address this vaccine hesitancy problem (2–4). Mandatory delivery. This series includes both the identification of existing
immunization is seen as a “simple” solution to the problem. resources and the description of the new resources developed by
Historically, three factors appear to act as triggers for the a multidisciplinary group of professionals (6). The article is one of
implementation of mandatory childhood immunizations: failure of a series and shows how the various aspects of vaccine hesitancy
incentives to achieve desired vaccine uptake rates; response to that have been considered to date can be applied to fostering
a vaccine preventable disease outbreak that is difficult to control vaccine acceptance.
because of lower than desired vaccine uptake rates; and the
push to achieve a vaccine preventable disease elimination goal,
such as for polio (5). Definition, scope and frameworks of
mandatory immunization programs
Given that queries have also been raised in the press about
whether coronavirus disease 2019 (COVID-19) vaccine(s), when In 2010, an expert group proposed the definition that a
available, should be made mandatory for some or all in Canada, “mandatory” vaccine is one that every child in the country/state/

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CANVax - www.canvax.ca SERIES

province/territory must receive by law without the option for the • Laws requiring immunization with serious financial penalties
parent to accept or refuse it, independent of whether a legal or social restrictions; only allowing medical exemptions;
or economical implication or sanction exists for the refusal (7). strict enforcement (e.g. California, US after 2016 (4,15) and
Mandatory immunization programs vary widely. There is neither Australia after 2016 (11))
a uniform approach for establishing mandatory immunization
programs nor a common scope for such programs. Hence, it is
critical when discussing any mandatory program for childhood Outcomes of mandatory immunization
vaccinations (and/or for other age groups) to understand what
programs
that program entailed and what it was hoped that program
would achieve. There are surprisingly few systematic reviews, and very little
comparative evidence on the outcomes of mandatory infant
With respect to childhood immunizations, the scope of the and childhood immunization programs. A 2006 report noted no
mandate may apply to the entire country (Italy (3) and France strong difference in vaccination rates between countries that
(3)) or to specific constituent states, territories or provinces only recommend certain vaccinations and countries that mandate
(California, United States (US) (3) and Ontario, Canada (8)), or them (16). A 2016 systematic review of outcomes of mandates
it may apply more narrowly to a defined subset of the child found only 11 before and after studies, and 10 studies comparing
population (9). Some programs cover most but not all of the immunization rates in similar populations with and without
World Health Organization (WHO) recommended childhood mandates. Overall, the authors concluded that mandatory
vaccines (e.g. Italy (3)), another may identify a limited range of immunization was generally helpful to increase vaccine uptake
vaccines (e.g. France, a specific list (3)) and another only one rates, albeit 18 of the included studies originated from one
vaccine (Belgium, polio vaccine (10)). Some may specify an age country, the US, with only two from Canada and one from
group or milestone such as on school entry (Italy on enrolment France (17). This review did not assess the impact of mandatory
in kindergarten) (3) and California, US, on school entry). With immunization on attitudes toward immunization.
respect to flexibilities, some contain exemptions for medical
contraindications only, while others include or previously In 2018, a landscape review of the legislative environment
included exemptions for religious and philosophical reasons for childhood immunization was conducted in 53 countries
(California, US (4) and Australia (11) prior to 2016). of the European region (18). Findings of this review showed
a diversity of legislative frameworks for immunization (from
Framework factors, such as strictness of application and levels recommendations to strong mandatory policies) with no clear
of enforcement of the mandate, also vary, as can the body evidence for the “best approach” to enhance vaccine uptake
responsible for enforcement of the mandatory requirements and acceptance (i.e. uptake rates did not correlate with presence
(California, US) (4). Other programs may not enforce the or absence or type of legislation). To interpret the results
mandate at all (Serbia). The program may focus on financial correctly it is necessary to understand the differences that exist
incentives to encourage compliance (11) or impose penalties that between mandatory immunization programs in a historical and
maybe financial or social (e.g. children can be precluded from geographical context. The 15 ethnic Republics that composed
daycare (Ontario, Canada (12) and Australia (11)) or school entry the former United Soviet Socialists Republic and its communist
(California, US). Individuals may be precluded from access to neighbours all had very strong centralized public health
theme parks (California, (12)) or they may be fined (Slovenia (10)) systems with mandatory vaccination that enabled enforcement
or even imprisoned (Uganda (13)). without question and was associated with high uptake rates. By
2018, however, much had changed with respect to childhood
There is a wide diversity of approaches to mandatory childhood immunization in many of these countries. By 2018, Ukraine had
immunization required by law: the lowest childhood vaccine uptake rate in the WHO European
• No enforcement, anyone can opt out without penalty (e.g. Region, and Serbia and Poland had experienced protests against
France before changes in 2018 (2)) mandatory immunizations.
• Opt out due to personal or philosophical objection without
penalty (e.g. Ontario before changes in 2016 (14)) There have not been studies of mandates in high-income
• Laws requiring parental education about immunization countries in jurisdictions with relatively high baseline rates or
(rather than immunization itself); opt out with personal or with mandates for child-care centers. In Belgium and Italy, for
philosophical objection but requires specific forms and example, some vaccines were mandatory for historical reasons
notarization but no penalty for noncompliance (e.g. Ontario and others were not. Non-mandatory vaccines may have been
(8)) perceived by the public and health care professionals as being
• Laws requiring immunization but opt out with personal or less important and less necessary. In Italy, this divergence in
philosophical objection that requires specific forms and the program led to high coverage (all greater than 93%) of
added effort. There is a penalty for noncompliance and strict the mandatory vaccines (e.g. diphtheria, tetanus, poliomyelitis
enforcement (e.g. Australia before changes in 2016 (11)) and hepatitis B) but lower than needed coverage of other

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recommended but not mandated vaccines (e.g. measles COVID-19 vaccines and consideration for a
coverage was 87%) (3). Measles outbreaks led Italy to move to mandatory approach
broader mandatory immunization (3).
While a poll in Canada in late April 2020 reported strong support
In Australia, in 2015, due to concerns about uptake rates, amongst the general public for making COVID-19 vaccination
the No Jab No Pay amendment bill removed the vaccination mandatory (21), this strategy can only be considered when
“conscientious objection” exemption to vaccination these vaccines become widely available in Canada. Given that a
requirements (11). By March 2017, these changes were mandatory program has costs both in terms of implementation
associated with an increase in vaccine uptake among five-year and monitoring (5), decisions need to rest on what additional
olds from 92.59% to 94.34% (10) but, as noted below, the impact benefit is hoped to be achieved. If vaccine uptake is already
of the change was not uniform across socioeconomic classes. expected to be high amongst groups deemed necessary for
the control of the spread of COVID-19, then the added costs
In Ontario, tightening of the mandatory process required of a mandatory program are likely not justified. In contrast, if
to obtain a philosophical exemption has revealed valuable the rates of uptake are low and the ease of access and other
information, as this newly available record-level data has strategies known to improve uptake have been addressed, then
permitted more detailed analysis (19). In 2016–2017, 2.4% of a mandatory approach may be worth pursuing. Careful attention
students had a non-medical exemption to at least one antigen; must be paid to whether this will be an incentive or penalty
however, there were also students who were not yet immunized program, how it will be monitored and by whom (5).
but who had not requested an exemption. Furthermore, having
a signed non-medical exemption did not always correlate with
non-immunization. The likelihood of having a non-medical Conclusion
exemption and not being immunized was higher for private or
other non-government funded schools and specific geographic There is no standard global approach to mandatory
areas. In addition, older and/or disadvantaged students were less immunizations. Which vaccines are included, which age
likely to have a non-medical exemption. groups are covered, program flexibility and rigidity (e.g.
opportunities for opting out, penalties or incentives and
Unintended consequences of mandatory degree of enforcement) all have to be considered. Mandatory
immunization programs immunization for childhood vaccines is no guarantor that the
problem of lower‑than-desired vaccine uptake rates will be
Mandatory immunization programs have the potential for overcome, although it can lead to increased uptake. There were
unintended consequences. The removal of non-medical no strong differences in vaccination rates between countries
exemptions (i.e. personal belief exemptions) has led to an that only recommend certain vaccinations and countries that
increase in medical exemptions in California, US (20) and mandate them. Context matters; different countries have
Australia (11). Regions with high previous rates of personal implemented or not implemented mandatory immunization for
exemptions before the instigation of more restrictive laws appear different reasons, different circumstances and used different
to develop higher rates of medical exemptions. This suggests a approaches. Furthermore, unintended consequences like a
“gaming” of the system. Disappointingly, the target population reduced acceptance rate of non-mandatory immunizations needs
response has been to seek medical exemption rather than to to be anticipated as well as the possibility of vaccine‑hesitant
accept immunization. individuals gaming the system. Rigid mandatory vaccination
requirements may appear, at the first sight, to be the simple
In Australia, the No Jab No Pay mandatory childhood solution to improving vaccine uptake rates; however, evidence
immunization program did increase immunizations as noted does not strongly support this conclusion. Mandatory
above; but disproportionately children and families living in immunization is but one strategy to consider. Addressing
poverty were most negatively affected, leading to equity and lower vaccine uptake rates is a complex problem that needs a
justice concerns (11). multipronged, more nuanced and tailored approach (22).

An unintended benefit of mandatory programs is the

requirement for greater attention to data collection on who is Authors’ statement
immunized. This was notable in Ontario where time, attention NEM — Writing original draft
and funds were paid to make the childhood immunization ED — Writing, review & editing
registry functional. DG — Writing, review & editing

Competing interests
Dr. MacDonald reports grants from the Public Health Agency
of Canada, the Canadian Institutes of Health Research, Nova
Scotia Health Authority, IWK Health Authority and the Canadian

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CANVax - www.canvax.ca SERIES

Immunization Research Network. Dr. Dubé reports grants from 10. Walkinshaw E. Mandatory vaccinations: the international
the Public Health Agency of Canada, the Quebec Ministry of landscape. CMAJ 2011 Nov;183(16):E1167–8. DOI PubMed
Health and Social Services, le Fonds de la recherche en Santé
11. Leask J, Danchin M. Imposing penalties for vaccine rejection
du Québec, the Canadian Institutes of Health Research, the
requires strong scrutiny. J Paediatr Child Health 2017
Canadian Immunization Research Network, and the Social May;53(5):439–44. DOI PubMed
Sciences and Humanities Research Council of Canada.
12. Government of Ontario. Child Care and Early Years Act,
2014, S.O. 2014, c. 11, Sched. 1. Immunization.
Acknowledgements https://www.ontario.ca/laws/regulation/150137#BK46

13. Uganda Legal Information Institute. Immunisation Act, 2017.

Contributions to Canadian Vaccination Evidence Resource https://ulii.org/node/27644
and Exchange Centre (CANVax) come from a very wide range
of authors, committees, immunization partners, reviewers and 14. Wilson SE, Seo CY, Lim GH, Fediurek J, Crowcroft NS,
especially the CANVax secretariat at Canadian Public Health Deeks SL. Trends in medical and nonmedical immunization
Association. exemptions to measles-containing vaccine in Ontario: an
annual cross-sectional assessment of students from school
years 2002/03 to 2012/13. CMAJ Open 2015;3(3):E317–23.
DOI PubMed
References
15. Zipprich J, Winter K, Hacker J, Xia D, Watt J, Harriman K;
1. Lane S, MacDonald NE, Marti M, Dumolard L. Vaccine Centers for Disease Control and Prevention (CDC). Measles
hesitancy around the globe: analysis of three years of WHO/ outbreak--California, December 2014-February 2015.
UNICEF Joint Reporting Form data-2015-2017. Vaccine MMWR Morb Mortal Wkly Rep 2015;64(6):153–4. PubMed
2018;36(26):3861–7. DOI PubMed
16. Salmon DA, Teret SP, MacIntyre CR, Salisbury D, Burgess
2. Ward JK, Colgrove J, Verger P. Why France is making eight MA, Halsey NA. Compulsory vaccination and conscientious
new vaccines mandatory. Vaccine 2018;36(14):1801–3. or philosophical exemptions: past, present, and future.
DOI PubMed Lancet 2006;367(9508):436–42. DOI PubMed

3. Ricciardi W, Boccia S, Siliquini R. Moving towards 17. Lee C, Robinson JL. Systematic review of the effect of
compulsory vaccination: the Italian experience. Eur J Public immunization mandates on uptake of routine childhood
Health 2018;28(1):2–3. DOI PubMed immunizations. J Infect 2016;72(6):659–66. DOI PubMed

4. Delamater PL, Leslie TF, Yang YT. Change in medical 18. Sabin Vaccine Institute. Legislative Landscape Review:
exemptions from immunization in California after elimination Legislative Approaches to Immunization Across the
of personal belief exemptions. JAMA 2017;318(9):863–4. European Region. Washington (DC): Sabin Institute; 2018.
DOI PubMed https://www.sabin.org/sites/sabin.org/files/legislative_
approaches_to_immunization_europe_sabin_0.pdf
5. MacDonald NE, Harmon S, Dube E, Steenbeek A, Crowcroft
N, Opel DJ, Faour D, Leask J, Butler R. Mandatory infant & 19. Wilson SE, Murray J, Bunko A, Johnson S, Buchan SA,
childhood immunization: Rationales, issues and knowledge Crowcroft NS, Dubey V, Loh LC, MacLeod M, Taylor C,
gaps. Vaccine 2018;36(39):5811–8. DOI PubMed Deeks SL. Characteristics of immunized and un-immunized
students, including non-medical exemptions, in Ontario,
6. Canadian Public Health Association. The Canadian Canada: 2016-2017 school year. Vaccine 2019;37(23):3123–
Vaccination Evidence Resource and Exchange Centre. 32. DOI PubMed
Ottawa (ON): CANVax (accessed 2019-12-15).
https://www.canvax.ca 20. Delamater PL, Pingali SC, Buttenheim AM, Salmon DA,
Klein NP, Omer SB. Elimination of nonmedical immunization
7. Haverkate M, D’Ancona F, Giambi C, Johansen K, Lopalco exemptions in California and school-entry vaccine status.
PL, Cozza V, Appelgren E; VENICE project gatekeepers and Pediatrics 2019;143(6):e20183301. DOI PubMed
contact points. Mandatory and recommended vaccination
in the EU, Iceland and Norway: results of the VENICE 2010 21. Leger. Concerns about COVID-19 – April 28, 2020.
survey on the ways of implementing national vaccination https://leger360.com/surveys/concerns-about-covid-19-
programmes. Euro Surveill 2012;17(22):20183. DOI PubMed april-28-2020/

8. Dyer O. Ontario suspends unvaccinated children from 22. Dubé E, Bettinger JA, Fisher WA, Naus M, Mahmud SM,
school and proposes mandatory classes for parents. BMJ Hilderman T. Vaccine acceptance, hesitancy and refusal in
2015;351:h6821. DOI PubMed Canada: challenges and potential approaches. Can Commun
Dis Rep 2016;42(12):246–51. DOI PubMed
9. Yezli S. The threat of meningococcal disease during the Hajj
and Umrah mass gatherings: A comprehensive review. Travel
Med Infect Dis Jul – Aug 2018;24:51–8. DOI PubMed

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CANVax is the first online resource of its kind in Canada to equip public health professionals with
access to a centralized resource centre focused on vaccine acceptance and uptake.

https://www.canvax.ca/

ALREADY PUBLISHED IN CCDR

A new resource to summarize evidence on immunization from the Canadian Vaccination Evidence Resource and Exchange Centre
(CANVax) – CCDR Vol. 46 No. 1 (January 2, 2020)
Promoting immunization resiliency in the digital information age – CCDR Vol. 46 No. 1 (January 2, 2020)
Optimizing communication material to address vaccine hesitancy – CCDR Vol. 46 No. 2/3 (February 6, 2020)
Motivational interviewing: A powerful tool to address vaccine hesitancy – CCDR Vol. 46 No. 4 (April 2, 2020)
Vaccine acceptance: How to build and maintain trust in immunization – CCDR Vol. 46 No. 5 (May 7, 2020)
Managing immunization stress-related response: A contributor to sustaining trust in vaccines – CCDR Vol. 46 No. 6 (June 4, 2020)

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