Researchers develop COVID-19 vaccination recommendations for people with autoimmune rheumatic diseases

When the COVID-19 vaccine rollout started in December 2020, many Canadians eagerly anticipated when they would have the opportunity to be immunized. But Canadians with autoimmune rheumatic diseases such as rheumatoid arthritis and lupus faced uncertainty and barriers in vaccine access.

Initially, the National Advisory Committee on Immunizations (NACI) made a recommendation against offering COVID-19 vaccines to patients with autoimmune rheumatic diseases due to limited evidence for this population in clinical trials, although the group indicated that the vaccine may be offered if the benefits outweigh the risks for an individual patient.

“The initial recommendation created barriers in vaccine access for a patient population who already face many inequities,” explains Dr. Cheryl Barnabe, MD, a rheumatologist and associate professor in the Cumming School of Medicine (CSM). “There was a call from the rheumatology community stating the need to be a part of the discussion of weighing the benefits and risks of vaccines for this population.”

To develop COVID-19 vaccination recommendations for patients with autoimmune rheumatic disease, the Canadian Rheumatology Association (CRA) formed a multi-disciplinary panel of rheumatologists, methodologists, infectious disease physicians with expertise in vaccines and patients. The panel included McCaig Institute researchers Dr. Glen Hazlewood, MD, PhD; Dr.  Cheryl Barnabe; and Dr. Claire Barber, MD, PhD.

Hazlewood led the formal process of developing the vaccination recommendations by summarizing the evidence from the clinical trials and working through a decision to evidence framework as outlined in the study published in the Journal of Rheumatology.

After completing the evidence review process, the panel determined that the benefits of the vaccine outweigh the risk for most patients, so they made a conditional recommendation for the vaccine while acknowledging the limited data on vaccine effects for this population. The document continues to be updated with the approval of new vaccines.

“The rationale for making the recommendation is even though our patients weren’t included in the trials, we don’t have a reason to be concerned about the COVID-19 vaccine from a safety perspective,” explains Dr. Glen Hazlewood, rheumatologist and professor in the CSM. “Given the magnitude of the benefits, patients are willing to accept the theoretical risk for the benefits of the vaccine.” 

In acknowledging the need for more evidence, the panel developed future research priorities focusing on the COVID-19 vaccine effects and patient preferences with the hope of incorporating findings to strengthen the recommendations.

Patient decision tool for the COVID-19 vaccine

With questions arising on the COVID-19 vaccination recommendations, there was a need for consistent messaging. To help standardize communications surrounding the COVID-19 vaccine, Hazlewood helped lead the development of the CRA COVID-19 Vaccine Decision Tool with input from the Canadian Arthritis Patient Alliance (CAPA).

“How do you communicate to thousands of your patients within a month? Physicians were getting overwhelmed, patients couldn’t get hold of their rheumatologists, so the decision tool was a way to provide accessible information to patients and care providers,” says Hazlewood.

By gathering insights from patients through CAPA, the research team could identify and highlight key patient concerns and considerations. The decision tool includes information on how the COVID-19 vaccines work, benefits and risks, and potential effects of medications.

“The decision tool helps patients make informed decisions without being influenced by their providers’ or their family’s beliefs,” explains Barnabe.

The decision tool is being used in clinics across Canada to facilitate shared decision-making by providing clear information on the risks and benefits of the COVID-19 vaccine.