Legal Considerations Regarding the Administration of COVID-19 Vaccines

This article was published in November 2021 and reflects information current at the time of publication.  

The rollout of COVID-19 vaccinations is well underway across Canada with nurses at the forefront of COVID-19 vaccine administration. The following information highlights some legal considerations that nurses may wish to keep in mind when they are involved with vaccine administration.

Authorizing Mechanisms

Before administering a vaccine, it is important to be aware of the source of authority ordering the vaccine, and any relevant nursing practice guidelines, and health institution policy and procedures. There is more than one possible legal mechanism that can authorize an order for vaccination. There may be a patient-specific order or a directive e.g. from the Medical Officer of Health, and these mechanisms may vary with circumstances and between provinces and territories.

Prior to the pandemic, Registered Nurses, Registered Psychiatric Nurses, and Licensed Practical Nurses (or Registered Practical Nurses in Ontario) could not, in the majority of cases, administer vaccines without an order or a directive from a Nurse Practitioner or physician as administering a substance by injection is considered a controlled act.1

To meet the unprecedented challenge of vaccinating a large population within a short timeframe, many provinces have created exemptions2 that allow nurses to administer the COVID-19 vaccines without an order.3 Even within these general exemptions, nurses are still accountable for complying with any applicable requirements and standards.

In order to increase the human health resources needed to effectively immunize millions of Canadians as quickly as the COVID-19 vaccines are available, many jurisdictions are enabling a wider range of regulated healthcare professionals, retired health professionals, students and others to administer COVID-19 vaccines by other authorizing mechanisms such as ministerial orders, or new regulations. These include Ontario, Manitoba, British Columbia and Québec. These individuals do not typically administer vaccines, so nurses may be called upon to supervise them for the otherwise controlled or reserved act of injection. Nurses know that proper professional practice goes beyond the completion of tasks, and encompasses principles and knowledge such as infection prevention and control and sufficient assessment before an intervention and evaluation afterwards. This knowledge and training makes them ideal to supervise others who are recruited to meet the challenges of the pandemic. It is important to note that ministerial orders and new regulations are dynamic and their authority will come to an end when COVID-19 is no longer a serious and immediate threat to public health.

Knowledge, Skills, and Training

Nurses learn about medication administration and injection as part of their basic competencies, and yet ongoing education is a hallmark of professionalism. Vaccines are designed to affect the immune system and patient reactions can vary, with anaphylaxis being an uncommon but life-threatening possibility. Consequently, nurses may seek, or be required to complete, a course in vaccine competency. Some examples are the British Columbia Centre for Disease Control’s COVID-19 Immunization Course for Nurses and New Brunswick’s Office of the Chief Medical Officer of Health’s COVID-19 Basic Vaccine Immunization Training.

Before becoming involved with vaccination, nurses can inquire about the resources available in case of an adverse reaction. If an adverse reaction occurs, the patient must be assessed and treated as soon as possible. Administration must be made aware of critical incidents as soon as possible. While the person authorized to make decisions and take action may be a risk manager, quality assurance officer or facility manager, nurses are responsible for reporting critical incidents by using the internal reporting procedure, typically a written incident report. The next step is internal investigation or tracking, depending on the nature and seriousness of the event. It is helpful for an organization to know what worked well during the incident as well as what did not. Recommendations for improvement may follow once the incident is analyzed.

Redeployment of Nursing Staff

To assist in staffing pandemic measures, nurses may be redeployed by their employers to areas in which they do not regularly practice or to newly created units such as COVID-19 vaccination centres. There are legitimate expectations of all nurses, which are to adhere to the standards of their profession, act ethically, and to practice reasonably in the circumstances to avoid foreseeable harm. When redeployed, nurses can use their core competencies, such as critical thinking and professional judgment, as they practice in an unfamiliar venue. Awareness of relevant nursing standards and employer policies and procedures will be key, as well as any needs for on-the-job training.4

The pandemic has motivated all levels of government to take extraordinary measures. For instance, the Ontario government had issued a temporary order, now revoked, that permits health care professionals that have a licence, registration or certificate from another province or territory to come work in Ontario health institutions pursuant to the authority granted in their home province or territory.5 Nurses subject to this temporary order could practice without obtaining licensure in Ontario, and were “authorized to engage outside of their regular scope of practice provided that doing so is necessary in order for the health care professional to respond to, prevent, or alleviate the effects of the COVID-19 outbreak”.6

Mature Minor Consent

Health Canada has approved certain COVID-19 vaccines for minors aged 12-17, which means the question of consent by mature minors may be raised.

Nurses must adhere to the law of consent in their jurisdiction. Québec’s Civil Code, states that a child aged 14 years or older can generally provide consent to treatment, and New Brunswick’s Medical Consent of Minors Act permits those who are aged 16 years and older to consent to treatment, with a recent amendment that permits those younger than 16 years of age to consent in certain circumstances. Elsewhere in Canada, it is typical that the law of the mature minor is used to determine if a person younger than the age of majority in that province or territory has the capacity to consent to treatment.

The healthcare professional ascertains whether the patient understands the nature of the decision to be made and the consequences of consenting to a proposed plan of treatment or refusing consent. If the young person has this capacity, they are considered a mature minor for the purposes of that decision.  It would be prudent for nurses to document their assessment thoroughly, including the reasoning behind their decision as to whether to proceed with vaccination.

Where there is a disagreement between parents regarding vaccination of children, some courts have generally granted decision-making authority to the parent who wishes to have a child vaccinated, deeming it to be in the child’s best interest.7 The issue may also need to be resolved on the basis of the parental rights assigned to each parent in the context of a divorce or separation.

Vaccination of Children

Nurses must adhere to the law of consent in their jurisdiction when treating children. As a reminder, some jurisdictions mandate a minimum age to consent, while most require an assessment of the minor’s capacity to do so. A case-by-case assessment will be required and should consider the child’s maturity (physical, mental and emotional development) and their ability to appreciate the risks and benefits of receiving treatment, as well as the risks and benefits of declining. Generally, this exercise may be more straightforward with very young children. In such cases where the child is incapable of providing consent because they do not understand the nature and consequences of proceeding or declining treatment, parents or legal guardians are authorized to provide consent on the minor’s behalf.8

It is important to note that with respect to COVID-19 vaccinations for children aged 5-11, some jurisdictions require consent by a parent or guardian despite the minor’s capacity to consent. Further, some public health authorities have stated that they will not vaccinate children without a parent or guardian present.9 

As discussed above, there may be disagreements between parents regarding the vaccination of their children. The court will generally endorse the position of the party that acted in the best interests of the child.10

What if a patient expresses vaccine hesitancy?

Prior to administering a vaccine, the patient must provide their informed consent and the nurse should consider documenting their discussion with the patient concerning the vaccine. For more information regarding documentation, please consult our InfoLAW on the subject. Also note that patients or their substitute decision makers generally have the legal right to refuse a vaccine.

What if a patient requests a vaccine exemption?

With the mandating of vaccination in certain professions11 and vaccine passports in most jurisdictions, nurses may now be more likely to receive vaccine exemption requests from patients.  

Generally speaking, certain grounds may exempt a person from receiving a COVID-19 vaccine, such as a medical exemption if there is a risk of substantive injury or disability. For instance, a medical exemption may apply if the individual has an allergy to a preservative in the vaccine, or if they have an underlying medical condition that could be worsened by receiving the vaccine.  

When completing or signing a form, it is important to offer accurate and objective information. Further, it is a good practice to ascertain that the information relied upon is documented or readily available in the records so that the content of the report can be further explained and supported, if necessary. It is generally advisable to also document that a discussion about the risks and benefits from not receiving the vaccine has occurred, and that the patient has understood the potential consequences of the decision.    

CNPS beneficiaries can contact CNPS at 1-800-267-3390 with specific questions related to their practice to speak with a member of CNPS legal counsel. All calls are confidential.

1. There are varying definitions of what constitutes a controlled act in the legislation across the provinces and territories. For example, in Ontario, the Regulated Health Professions Act, 1991, defines a controlled act as an activity that can cause harm if an unqualified person completes it.[1]In this case, the controlled acts would be administering a substance by injection, and “performing a prescribed procedure below the dermis”.
2. These exemptions typically stem from the medical officer of health or a similar provincial or territorial authority.
3. Office of the Chief Medical Officer of Health (NB), COVID-19 Basic Vaccine Immunization Training, 2022, online: https://www.nanb.nb.ca/wp-content/uploads/2022/08/MEMO_COVID-19_Basic_Vaccine_Immunization_Training_-_NOTE_Formation_de_base_sur_limmunisation_contre_la_COVID-19_.pdf
4. For more information on nursing in a pandemic, you may also wish to consult: CNPS, Legal Considerations when Nursing in a Pandemic: https://cnps.ca/article/legal-considerations-nursing-pandemic/
5. Ontario Legislature, Emergency Management and Civil Protection Act: O. Reg 305/21: Regulated Health Professionals
6. College of Nurses of Ontario, IMPORTANT UPDATE: New provincial orders – change to scope of practice in hospitals, April 23^rd 2021.
7. For instance, see Tarkowski v. Lemieux, 2020 ONCJ 280 (CanLII).; https://globalnews.ca/news/7881765/bc-covid-19-vaccine-youth-consent-infants-act/
8.  Canadian Medical Protective Association, Can a child provide consent?, May 2021.
9. For example, Ottawa Public Health has the following information; https://www.ctvnews.ca/health/coronavirus/covid-19-vaccines-and-minors-where-does-canadian-law-stand-on-consent-1.5623287
10. For example, Droit de la famille — 211637, 2021 QCCS 3582 (CanLII), https://canlii.ca/t/jhvzz 
11. For example, the Government of Canada to require vaccination of federal workforce and federally regulated transportation sector . The Government of Ontario has also implemented mandatory vaccination policies for high risk settings such as long-term care homes and healthcare settings.  

August 2021, last modified in November 2021.

THIS PUBLICATION IS FOR INFORMATION PURPOSES ONLY. NOTHING IN THIS PUBLICATION SHOULD BE CONSTRUED AS LEGAL ADVICE FROM ANY LAWYER, CONTRIBUTOR OR THE CNPS. READERS SHOULD CONSULT LEGAL COUNSEL FOR SPECIFIC ADVICE