Enhanced Consent for Special Populations
The province has published an extensive clinical practice guideline to support enhanced consent for the COVID-19 vaccine among special populations. This includes a consent process for pregnant and breastfeeding women as well as patients with autoimmune conditions or those who are immunosuppressed due to disease or treatment.
This has been a significant concern to many physicians who are already facing questions from health care providers who would otherwise be eligible but fall into a special population group.
The National Advisory Committee on Immunization (NACI) recommends the vaccine once a risk assessment determines the benefits outweigh the potential risks, considering the limited evidence about the use of COVID vaccines in these groups.
Enhanced consent for these individuals can be completed by the immunizer, or in advance by a physician or other health care provider. We have a summary of these guidelines below, as well as a link to the full document.
How to complete enhanced consent in advance
While individuals can complete the enhanced consent with the immunizer, many will prefer to discuss their specific situation with a physician who knows their medical history.
If you have a patient requiring enhanced consent, use the following process to complete and submit the consent form.
Provide the patient with the appropriate Public Health Factsheet about the vaccine.
- Version for immunosuppressed individuals or those with autoimmune condition
- Version for pregnant and/or breastfeeding individuals
Following the risk benefit discussion, complete both of the following documents
Submit the enhanced Consent Form using one of the following options, with fax-in-advance preferred.
- FAX the signed/completed form the same day you complete it to 204−948−3044. This must be done at least 48 hours before the scheduled immunization appointment. Also provide the patient with a hard copy of the form as a back up.
- Provide a hard copy of the signed/completed form to the patient and instruct them to bring it with them to their scheduled appointment. If the patient is not present (e.g. virtual visit), they should pick up the hard copy from your office or, if there is time, you can mail it to them.
The immunization will not proceed unless the immunizer can view the form, which was either faxed at least 48 hours in advance or is present in hard copy with the patient.
Complete instructions on completing the process can be viewed on pages 4 to 6 of the provincial guideline.
Clinic-based or virtual billing tariffs should be used for services provided to patients in relation to vaccine hesitancy, vaccine education, or enhanced consent. If you have any questions about this, please contact Doctors Manitoba.
Discussing the risks and benefits with your patient
The provincial guidelines provide a summary of the current evidence of potential harm from COVID-19 in the special populations and what is known about the risks of being immunized. This information can be used by health care providers to help individual patients make an informed decision about receiving the vaccine.
Pregnant and breastfeeding women
Use pages 7 – 8 of the provincial guidelines to discuss the risks and benefits with your patient. Even with the absence of evidence about the use of vaccine in this population, it should be considered for individuals at high risk of infection or morbidity due to COVID because the risk of not getting the vaccine outweighs the potential risk of being immunized:
“The potential risks of vaccination to a pregnant individual and fetus remain unknown. What is known, however, is that an unvaccinated pregnant individual remains at risk of COVID-19 infection and remains at heightened risk of severe morbidity if infected compared to non-pregnant counterparts. Severe infection with COVID-19 carries risks to both maternal and fetal health. While pregnancy itself does not appear to increase the risk of becoming infected with SARS-CoV‑2, pregnant individuals may be in work-related (e.g., health care worker, front line workers etc.) or community situations (e.g., caregiver, Indigenous communities, outbreak setting, etc.) where the risk of exposure is considerable…
With respect to breastfeeding specifically, there is no data on the safety of COVID-19 vaccines in lactating women or the effects of mRNA vaccines on the breastfed infant or on milk production. Because mRNA vaccines are not considered live virus vaccines, they are not hypothesized to be a risk to the breastfeeding infant.” (Page 7)
Immunosuppressed individuals and those with autoimmune condition
Use pages 9 – 10 of the provincial guidelines to discuss the risks and benefits with your patient. Your patient should know there is limited evidence on the use of the COVID vaccine in this population and understand the risks and benefits of immunization.
“There is limited evidence to demonstrate that individuals who are immunosuppressed due to disease or treatment or who have an autoimmune condition will benefit from vaccination, or the duration of benefit,” but these individuals “are known to benefit from other vaccinations, such as the annual seasonal influenza vaccine.”
“There is no evidence to suggest that people who are immunosuppressed have increased adverse events associated with mRNA vaccines for COVID-19 (unlike live vaccines). It is possible that the COVID-19 vaccine could make an autoimmune condition worse although there is limited information on this. Fever is a possible side effect of vaccination and this could make symptoms of an autoimmune disease temporarily worse.” (Page 9 – 10)
The guidelines list categories of individuals unlikely to mount an acceptable immune response and should not be immunized at this time, including recent organ transplant recipients, individuals on specific medications, or individuals with specific allergies (see page 10).
The clinical guidance may be updated as new evidence is available. The updated version will be maintained on the provincial vaccine web site.