PEOPLE WITH INFLAMMATORY BOWEL DISEASE SHOULD NOT BE EXCLUDED FROM VACCINATION AGAINST COVID-19.
Last updated: January 21, 2021
In December 2020, Health Canada authorized the use and distribution of two mRNA vaccines against SARS-CoV-2, the virus responsible for the novel coronavirus disease-2019 (COVID-19). These vaccines have been shown in clinical trials to be highly effective in preventing infection with SARS-CoV-2, reducing the risk of infection by up to 95%, and severe infection by up to 100%. People with inflammatory bowel disease (IBD), as well as those using immunosuppressive medications, were excluded from the clinical trials. As a result, there is uncertainty about the effectiveness and safety of these vaccines in people with IBD.
On January 12, 2021, the National Advisory Committee on Immunization (NACI) issued an update to their December 23, 2020 recommendations guiding the use of mRNA vaccines against COVID-19, stating that people with autoimmune or immune mediated conditions and people who are immunosuppressed may receive the COVID-19 vaccine through a shared decision-making process where the risks and benefits associated with vaccination are discussed.
Despite NACI’s recommendation, many health care systems have withheld access to vaccines for people with autoimmune or immune mediated disorders, including those with IBD. These decisions place people with IBD at an unnecessary disadvantage compared with other Canadians in being protected against COVID-19.
WE RECOMMEND THAT PEOPLE WITH INFLAMMATORY BOWEL DISEASE ARE NOT EXCLUDED FROM BEING ELIGIBLE TO RECEIVE COVID-19 VACCINES.
Our recommendations are informed by the following core principles:
There is no evidence on mRNA vaccines in people with IBD.
Excluding people with IBD from receiving COVID-19 vaccines does not uphold the principles of equity inherent in our health care system and Canadian society.
The benefits of receiving the currently available vaccines against SARS-CoV-2 may outweigh both the known and unknown risks in some people with IBD.
A theoretical decreased immune response to vaccination should not be the only deciding factor to being vaccinated in otherwise eligible individuals, and people at-risk for COVID-19.
The impact of not having access to vaccinations may further add to the emotional and psychological hardships that people with IBD experience.
Our recommendations are as follows:
A diagnosis of IBD should not be a reason to exclude any person from receiving any of the current available vaccines against SARS-CoV-2.
People with IBD who would otherwise be prioritized for earlier access to the current available vaccines against SARS-CoV-2 (such as frontline health care workers or long-term care residents) should not be deprioritized as a consequence of their IBD diagnosis or immunosuppressive therapy.
People with IBD should be offered the opportunity to discuss the risks and benefits of vaccination with their health care providers, and make a decision on vaccination based on their individual risk factors, as well as their risk for acquisition of COVID-19. Informed consent should balance the lack of evidence regarding safety and effectiveness of COVID-19 vaccines in the IBD population, as well as the underlying risk of contracting COVID-19, accounting for occupational and personal risk factors, and prevalence of COVID-19 in the local population.
These recommendations are made based on the best available current information, and are consistent with other professional organizations including the Canadian Association of Gastroenterology, and the International Organization for the Study of Inflammatory Bowel Disease (IOIBD).
These recommendations apply only to the currently available mRNA vaccines, and not necessarily for vaccines that may be approved in the future. The distribution of the vaccine is under the control of provincial governments and local health authorities. Your health care provider does not have direct access to the vaccine and is not responsible for prioritizing when the vaccine is available to different populations.
These recommendations are subject to change as new data and information are generated. As new scientific evidence becomes available, these recommendations may be revised by Crohn’s and Colitis Canada.
frequently asked questions about vaccines and IBD
What are the vaccines for COVID-19?
Currently, Health Canada has approved two vaccines: the Pfizer and BioNTech mRNA vaccine and the Moderna mRNA vaccine. The mRNA vaccines have a novel “mechanism of action” compared to traditional vaccines that inject either a diluted virus or proteins of a virus. Both mRNA vaccines target the spike protein that sits on the surface of the virus (SARS-CoV-2), which is the part of the virus that allows it to attach to human cells and begin replicating.
Scientists have isolated the genetic sequence for the spike protein and recreated its genetic (mRNA) sequence. By familiarizing the immune system with the mRNA of the virus’ spike protein it triggers the body to make antibodies against the spike protein, which allows the body to quickly and effectively fight off future infections of the intact virus.
How effective are the mRNA vaccines to SARS-CoV-2 that are approved by Health Canada?
The Pfizer and BioNTech mRNA vaccine and the Moderna mRNA vaccine have been shown in large, randomized controlled trials to be roughly 95% effective. What does 95% effective vaccine mean? The mRNA vaccine was given to ~15,000 people and only five developed COVID-19, but none were seriously ill. Another ~15,000 people were given a placebo shot, and 90 developed COVID-19, with several becoming severely ill. By comparing the vaccinated group and the placebo group, we can see that these vaccines are highly likely to prevent getting COVID-19 and to reduce the severity of the disease if a vaccinated person does contract COVID-19.
Have the vaccines for COVID-19 been studied in people with IBD?
Vaccines to SARS-CoV-2—the virus that causes COVID-19—hold the promise of protecting individuals who are immunocompromised, such as people on immunosuppressive medications for their IBD. However, the effectiveness and safety of the COVID-19 vaccines in people with immune-mediated diseases or immunocompromised populations are currently unknown.
The current vaccines approved by Health Canada, have not been studied in people with IBD. In fact, this is the first time an mRNA vaccine has been approved for use in humans in Canada. Initial randomized controlled vaccine trials excluded people with immune-mediated conditions, autoimmune diseases, and those on immunosuppressive therapy. Currently, vaccines are being given to people with IBD in Canada, Europe and in the USA, and so data on safety and effectiveness of the vaccines in this population will be coming soon.
What is the impact of IBD on vaccine effectiveness?
Many individuals with IBD are prescribed medications that may reduce the immune response (lower antibody titers) following vaccination as compared to the general population. This means people with IBD may not be as protected against COVID-19 from the vaccine as others, or they may require booster doses of the vaccines due to decreasing antibodies over time. However, a reduced immune response to a vaccine does not mean a vaccine is ineffective.
Overall, non-live vaccines (e.g., influenza, zoster, Hepatitis B) are widely recommended for immunocompromised individuals, including people with IBD on immunosuppressing medications. Reduced effectiveness due to immune suppression is NOT a reason to avoid these COVID-19 vaccines.
Are COVID-19 vaccines safe for people with IBD?
Prior vaccine studies (i.e., non-COVID-19 vaccines) have not shown the risk of side effects from vaccines is different for people with IBD compared to the general population. The novel mRNA vaccines have not been studied in those with IBD. Unlike other vaccine types, there is little information in the general population either, as this is a new type of vaccine, however that is rapidly changing as large numbers of vaccine are given around the world.
There is no reason to believe they would be more risky or unsafe for people with IBD. There is no evidence to date that non-live vaccines cause disease or IBD flare-ups when given to people with IBD, but we do not have that data for mRNA vaccines yet.
Can vaccines trigger an IBD flare?
While the mRNA vaccines have not been studied in those with IBD, there is no evidence to date that other non-live vaccines cause an IBD flare-ups. We do not have data on the use of mRNA vaccines in people with IBD at this point, but the risk is likely low. We do know individuals with IBD who contract COVID-19 often pause their immunosuppressing medication while recovering from infection, which in turn may cause a flare of their IBD.
What are the Canadian recommendations for COVID-19 vaccines for people with IBD?
The National Advisory Committee on Immunization (NACI) has made the following recommendation to the Public Health Agency of Canada:
“NACI recommends that a complete COVID-19 vaccine series may be offered to individuals who are immunosuppressed due to disease or treatment in the authorized age group in this population, if a risk assessment deems that the benefits outweigh the potential risks for the individual, and if informed consent includes discussion about the absence of evidence on the use of COVID-19 vaccine in this population.”
The Canadian Association of Gastroenterology has provided the following guidelines:
“Specifically, in patients with IBD not on immunosuppressive therapy, we recommend the COVID-19 vaccine be given (strong recommendation, moderate-certainty of evidence). In patients with IBD on immunosuppressive therapy, we suggest the COVID-19 vaccine be given (conditional recommendation, low-certainty of evidence).”
What are Crohn’s and Colitis Canada’s recommendations for COVID-19 vaccines for people with IBD?
People with IBD, whether on immunosuppressive medications or not, should be offered the COVID-19 vaccine after informed consent. Informed consent should be based on a discussion between the patient and healthcare provider, and should balance the safety of the vaccine, the lack of evidence in IBD patients, the risk factors that could result in severe COVID-19 in the IBD patient, and the underlying prevalence of COVID-19 in the patient’s community. After these factors are discussed with the patient, and if the patient wishes to receive the COVID-19 vaccine, it should be provided to them.
These recommendations are aligned with the Canadian Association of Gastroenterology and the International Organization for the study of IBD (IOIBD).
If I decide to delay getting a vaccine for a few months, does that mean I should never get a COVID-19 vaccine?
No! New information is becoming available all the time. If you and your healthcare provider think your risk of COVID-19 infection is low, and you want to wait until there is more information on COVID-19 vaccines for people with IBD, that is an option. With more information, you can assess your risks and benefits again in a few months and reconsider the vaccine at that time. Saying you want to delay until there is more information does NOT mean you should never get the vaccine.
Where can I receive more information about COVID-19 and vaccines for those with IBD?
In March 2020, Crohn’s and Colitis Canada created the National COVID-IBD Taskforce. The COVID-IBD Taskforce has met regularly since March 12, establishing recommendations for people with IBD during the pandemic.21 The Taskforce recommendations are communicated directly with the IBD community through Crohn’s and Colitis Canada’s COVID-19 and IBD Webinars that started on March 19th 2020.
The webinars (~1.5 hours) are co-moderated by Dr. Gil Kaplan and Dr. Eric Benchimol, who provide regular updates and lead a Q&A segment with guest panelists. A recording of each webinar is available on Crohn’s and Colitis Canada’s website and YouTube channel. The webinar series has discussed COVID-19 vaccines in people with IBD. These webinars will continue throughout the pandemic as a source of communication to the IBD community.
Watch our latest webinar below to hear directly from members of the COVID-19 Task Force:
Last updated: January 19, 2021