Originally published January 2017 / Updated December 2020
For more information specific to issues related to COVID-19 vaccines, see the CMPA COVID-19 Hub.
Vaccines are considered one of the most valuable methods of preventing and controlling infectious diseases1 and have saved countless lives.2 They are readily available in most parts of the world and are generally accepted as safe and effective in preventing disease. In the context of the COVID-19 pandemic, vaccines are considered an essential component for the long-term containment of the disease. Yet, some people still debate their necessity, efficacy, and safety. This may present challenges for physicians who know a particular vaccine is indicated and appropriate, but the patient or the patient’s legal guardian is hesitant about or refuses the vaccine.
Physicians who provide vaccinations should be appropriately aware of their obligations, including providing patients (or patients’ legal guardians) with sufficient information about recommended vaccines so that they can make an informed decision. The National Advisory Committee on Immunization is a helpful resource for information about recommended vaccines, including COVID-19 vaccines.3
Trends and attitudes toward vaccinations
The National Advisory Committee on Immunization4 and the Canadian Paediatric Society5 recommend routine immunizations to prevent certain infectious diseases and their consequences. However, some individuals refuse or delay routine vaccination for themselves or their children. A 2015 national survey of attitudes toward vaccines indicated more than one in four Canadians are hesitant or misinformed about vaccines.6 The 2013 Childhood National Immunization Coverage Survey found high vaccination coverage rates for Canadian toddlers, ranging from 73% for chicken pox to 91% for polio, but experts said that these rates fall below the rates needed for community immunity to keep vaccine-preventable diseases at bay.7 While the rollout of COVID-19 vaccines is still in early days, the latest data from the non-profit Angus Reid Institute indicates that 21% of Canadians are either hesitant or will refuse to be vaccinated.8
Public health officials and studies in recent years expressed concern about vaccine hesitancy and refusal increasing the risk of epidemics of vaccine-preventable illnesses.6, 9 The factors that influence hesitancy and refusal can be placed into one of three categories: complacency, confidence, and convenience.10 They are also diverse, ranging from a lack of knowledge and information, to past negative experience with vaccinations, to risk perceptions, to lack of trust in health professionals, to moral or religious convictions on disease and vaccines.11
Discussing vaccines with patients
When physicians determine that it is in the best interests of a patient to recommend a specific vaccination, they must obtain the informed consent of the patient (or legal guardian) before administering the vaccination. In most cases, the informed consent discussion might include:
- benefits of the vaccine
- risks of the vaccine (including material risks and uncommon risks with serious consequences, such as paralysis or death)
- risks of the disease including complications
- possible consequences of refusing the vaccine
- relevant recommendations from authoritative groups, governments, provincial medical regulatory authorities (Colleges), and medical specialty associations and federations
- need for follow up, for example if immunization requires a series of doses
- any cost of the vaccine if it is not covered by the provincial or territorial health plan
Because COVID-19 vaccines may be novel in the manner in which they have been developed and approved, special care should be taken when obtaining informed consent to disclose all of the known risks, side effects and discomfort that might be encountered (regardless of how remote the risk might be). In addition, it is generally expected that the patient will be informed if there may be other risks not yet known and the anticipated benefits may not be achieved.
When the patient (or the patient’s legal guardian) chooses to have the vaccine administered, physicians should also inform them about signs or symptoms of common side effects and complications, and what to do if these symptoms occur.
The details of the informed consent discussion and the patient’s (or legal guardian’s) consent to the vaccine should be documented in the patient’s medical record and/or a designated provincial/territorial record. Any consent form that is relied upon should also be retained in the medical record and/or a designated provincial/territorial record. The Public Health Agency of Canada’s Canadian Immunization Guide recommends that healthcare providers record vaccinations in the following documents: the immunization record held by the vaccine recipient (or legal guardian); the patient’s personal health record maintained by the healthcare provider who administered the vaccine; and the local provincial or territorial immunization registry, if it has been established.12
To help patients (or their guardians) manage their vaccinations, including keeping a record of those they’ve received, physicians may want to make them aware of available resources, such as those on the websites of Health Canada, the Public Health Agency of Canada, and ImmunizeCA.
Patients (or legal guardians) may have questions and concerns on the safety and efficacy of new vaccines. And some may wonder about alternatives to routine vaccines, such as unproven homeopathic therapies.13 To respond appropriately to these concerns, primary care physicians and those practising in related areas should remain up to date on relevant or common vaccines, their effectiveness, any significant risks, and the risks of the diseases being prevented. Physicians should be prepared to communicate clearly and professionally with patients or legal guardians on the matter. The healthcare provider’s advice generally has significant influence on decision-making for vaccines.14
When the patient or legal guardian is hesitant or refuses vaccination
If patients (or legal guardians) are reluctant about a vaccine, physicians should explore and address the reasons for their concern, answer any questions to the best of their ability and consider referring patients or guardians to other relevant resources for additional information.15 Physicians should be empathetic and respectful throughout these discussions and remind patients or guardians that their best interests (or those of their child) are the primary concern.15 The 2018 Practice Point from the Canadian Paediatric Society, "Working with vaccine-hesitant parents," provides useful evidence-based approaches on how to communicate effectively.14
Physicians should make every effort to continue to care for patients in the existing doctor-patient relationship in accordance with current standards of care.16 For assistance and advice on caring for patients who are reluctant about a vaccine, physicians should consult with the expectations and guidance of their College, other organizations such as the Canadian Paediatric Society, and contact the CMPA.
Despite good explanations, parents and/or legal guardians may still have a variety of reasons for refusing to consent to the vaccination of their children. Except in Québec, physicians should generally respect an informed decision by a child who they consider to be a mature minor and capable of understanding the risks of refusing the vaccination. In Québec, the law generally only permits children 14 years of age and older to consent to care.17 Physicians should document the wishes of the minor and the parent, if known, on the medical record along with the physician’s assessment of the child’s capacity to consent and understanding of the risks.17
If a vaccine is recommended but refused, a detailed note of both the consent discussion and the refusal should be made in the medical record. The physician should also keep the lines of communication open for future discussions about immunization and consider directing the patient or legal guardian to a trusted source of reliable information.15
Physicians with unvaccinated patients will want to consider how to arrange their office processes to address any risks associated with these patients coming into contact with vulnerable patients, such as those with suppressed immune systems or those who have not yet received vaccinations. Scheduling appointments at different times of the day or week to treat each type of patient could be one approach. Physicians should encourage unvaccinated patients or their legal guardians to inform the healthcare providers they come in contact with that they are not fully immunized. These steps are especially important in the context of the COVID-19 pandemic.
Physicians may be troubled if a patient refuses a vaccine solely for reasons of cost. The patient or legal guardian can be informed to contact their provincial health ministry on programs and assistance available for vaccinations.
In exceptional circumstances where a patient (or a patient’s legal guardian) has refused immunization, but the vaccine is medically appropriate and necessary to preserve the life or health of the child, it may be necessary for physicians to contact child protection agencies. For information on child protection agencies across Canada, physicians can refer to the Canadian Child Welfare Research Portal.18 Physicians may also wish to contact the CMPA for advice in these circumstances.
The necessity for follow-up
In situations where adequate immunization will require a series of doses (such as certain COVID-19 vaccines), physicians should remind patients or legal guardians of the importance of obtaining all doses on schedule. Physicians should be aware of the immunization schedules in their province or territory. This schedule should be discussed before the first dose is administered. Physicians should discuss any risks associated with dosing delays and the importance of staying on the recommended immunization schedule.15 It may be appropriate to have a system in place to follow up with any patients who do not return for their subsequent doses and to document the steps taken and the response.
The bottom line
- Provide information to patients or their legal guardians about the benefits and any significant risks associated with recommended vaccines, as well as the risks of the disease being prevented.
- Be familiar with the provincial or territorial immunization schedule, legislation, and College policies in your jurisdiction regarding vaccination.
- Engage in a more robust informed consent discussion when recommending new vaccines, such as COVID-19 vaccines.
- Carefully document the information given to patients and their responses in the medical record and/or designated provincial/territorial record (including their reasons for refusing the vaccine, if that is the case).
- Accurately document vaccines discussed with, refused by, or administered to a patient.
- Patients or legal guardians have the right to accept or refuse the vaccine. Be patient and empathetic to their needs and beliefs on vaccines and keep lines of communication open.
- Arrange follow up for patients to complete the course of immunization, if required, and document the steps taken.
- Taylor G. Message from the deputy chief public health officer, Canadian Immunization Guide. Ottawa (ON): Public Health Agency of Canada:2014 Apr 15 [cited 2016 May 31].
- Worboys M. Vaccines: Conquering untreatable diseases. Brit Med J [Internet]. 2007 Jan [cited 2016 May 31];334 (suppl 1):s19. Available at: http://www.bmj.com/content/334/suppl_1/s19 doi: 10.1136/bmj.39045.558889.94.
- National Advisory Committee on Immunization (NACI): Statements and publications, Public Health Agency of Canada,
- National Advisory Committee on Immunization (NACI). Ottawa (ON): Public Health Agency of Canada; 2015 May 10 [cited 2016 April 20]. Available from: http://www.phac-aspc.gc.ca/naci-ccni/index-eng.php
- Canadian Paediatric Society. Immunization [Internet]. Ottawa (ON): Canadian Paediatric Society; 2016 Apr 26 [cited 2016 Apr 20]. Available from: http://www.cps.ca/en/status-report/immunization-2016-report
- Payne E. Survey raises concern about vaccine ‘hesitancy’ among Canadian parents, shows some harbour misinformation. National Post [Internet]. 2015 Dec 18[cited 2016 Apr 20];Health:[about 3 screens]. Available from: http://news.nationalpost.com/health/survey-raises-concern-about-vaccine-hesitancy-among-canadian-parents-shows-some-harbour-misinformation
- Public Health Agency of Canada. Vaccine coverage in Canadian children : results from the 2013 Childhood National Immunization Coverage Survey (CNICS) [Internet]. Ottawa (ON):Public Health Agency of Canada; 2016 May [cited 2016 Dec 12]. http://publications.gc.ca/site/eng/9.816369/publication.html
- Angus Reid Institute, More Canadians willing to roll up their sleeves right away as national COVID-19 vaccine rollout begins, December 14, 2020.
- Li J. Vaccine refusal linked to recent U.S. measles outbreak, study suggests. CBC News [Internet]. 2016 March 30 [cited 2016 Apr 25];Health:[about 5 screens]. Available from: http://www.cbc.ca/news/health/vaccination-refusal-measles-outbreak-study-1.3490506
- MacDonald NE. SAGE Working Group on Vaccine Hesitancy. Vaccine hesitancy: Definition, scope, and determinants [Internet]. Vaccine. 2015 Aug 14;33(34):4161-4. Available from: http://www.sciencedirect.com/science/article/pii/S0264410X15005009
- Dubé E, Laberge C, Guay M, Bramadat P, Roy R, Bettinger J. Vaccine hesitancy [Internet]. Human Vaccines & Immunotherapeutics. 2013;9(8):1763-1773. Available from: http://www.tandfonline.com/doi/abs/10.4161/hv.24657
- Canadian Immunization Guide [Internet]. Ottawa (ON):Public Health Agency of Canada; 2016 Feb 2[cited 2016 Apr 25]. Available from: http://www.phac-aspc.gc.ca/publicat/cig-gci/p01-11-eng.php
- Rieder MJ, Robinson JL. Canadian Paediatric Society , Drug Therapy and Hazardous Substances Committee, Infectious Diseases and Immunization Committee. ‘Nosodes’ are no substitute for vaccines [Internet]. Ottawa (ON): Canadian Paediatric Society. 2015 May 11. Updated: Feb 23 2016. Paediatr Child Health. 2015 [cited 2016 Apr 25]; 20(4):221-22. Available from: http://www.cps.ca/en/documents/position/nosodes-are-no-substitute-for-vaccines
- MacDonald NE, Desai S, Gerstein B. Canadian Paediatric Society. Infectious Diseases and Immunization Committee. Working with vaccine-hesitant parents - An update. Paediatr Child Health [Internet]. 2018 [cited 2020 Dec 21];23(8)562. Available from: https://www.cps.ca/documents/position/working-with-vaccine-hesitant-parents
- Talking with parents about vaccines for children: Strategies for healthcare professionals [Internet]. Copenhagen (DK):World Health Organization, Regional Office for Europe. 2012 [cited 2016 Apr 25]. Available from: http://www.euro.who.int/__data/assets/pdf_file/0006/160755/Talking-with-Parents.pdf?ua=1
- Shen S, Dubey V. Addressing vaccine hesitancy. Clinical guidelines for primary care physicians working with parents. Can Fam Physician [Internet]. 2019 Mar [cited 2020 Dec 21];65(3)175-181. Available from: http://www.cfp.ca/content/65/3/175?rss=1.full.pdf+html
- Canadian Medical Protective Association. Can a child provide consent? [Internet]. Ottawa (ON):Canadian Medical Protective Association; 2014 May [cited 2016 Apr 25]. Available from: https://www.cmpa-acpm.ca/en/legal-and-regulatory-proceedings/-/asset_publisher/a9unChEc2NP9/content/can-a-child-provide-consent-
- Provincial and Territorial Assistance [Internet]. Montreal (QC): Canadian Child Welfare Research Portal; 2011 [cited 2016 May 20]. Available from: http://cwrp.ca/help