Vaccines

Last updated: May 7, 2021

PEOPLE WITH INFLAMMATORY BOWEL DISEASE SHOULD NOT BE EXCLUDED FROM VACCINATION AGAINST COVID-19 AND REQUIRE TIMELY ACCESS TO THE SECOND DOSE OF COVID-19 VACCINES

In December 2020, Health Canada authorized the use and distribution of two mRNA vaccines (manufactured by Pfizer/BioNTech and Moderna) against SARS-CoV-2, the virus responsible for the novel coronavirus disease-2019 (COVID-19). Since then, two additional vaccines have been approved, both non-replicating adenovirus vector based (manufactured by AstraZeneca and Johnson & Johnson). None of the approved vaccines for COVID-19 in Canada are ‘live’ vaccines.

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. However, the Crohn’s and Colitis Canada COVID-19 and IBD Task Force recommends all of these COVID-19 vaccines be administered to patients with IBD at the earliest available opportunity.

The National Advisory Committee on Immunization (NACI) recommends 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. The COVID-19 and IBD Task Force has developed an info sheet that summarizes key points from the recommendations on this page. Please click here to download a PDF copy of our COVID-19 Vaccination info sheet.

People on immunosuppression therapies require timely access to the second dose of COVID-19 vaccines. The COVID-19 & IBD Task Force calls on the National Advisory Committee on Immunization (NACI) to include IBD patients on immunosuppression therapies on the list of exceptions for extended dosing intervals. Please click here to read the letter. 

Recommendations

WE RECOMMEND THAT PEOPLE WITH INFLAMMATORY BOWEL DISEASE ARE ELIGIBLE TO RECEIVE COVID-19 VACCINES.

Our recommendations are informed by the following core principles:

  1. The COVID-19 vaccines are new vaccines, and have not been formally studied in people with IBD.

  2. 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.

  3. The benefits of receiving the currently available vaccines against SARS-CoV-2 likely outweigh both the known and unknown risks in the majority of people with IBD.

  4. A theoretically decreased immune response to vaccination should not be the only factor considered in a decision to vaccinate otherwise eligible people at-risk for COVID-19.

  5. The impact of not having access to vaccinations may further add to the emotional and psychological hardships that people with IBD experience, and may impair the ability of people with IBD to actively participate in society. 

Our recommendations are as follows:

  1. 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.

  2. People with IBD who would otherwise be prioritized for earlier access to the currently available vaccines against SARS-CoV-2 (such as frontline health care workers, older individuals, and people living/working in a high risk environment for COVID-19) should not be deprioritized as a consequence of their IBD diagnosis or immunosuppressive therapy.

  3. 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 and non-replicating adenovirus vector 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.

PEOPLE ON IMMUNOSUPRESSION THERAPIES REQUIRE TIMELY ACCESS TO THE SECOND DOSE OF COVID-19 VACCINES

The COVID-19 & IBD Task Force calls on the National Advisory Committee on Immunization (NACI) to include IBD patients on immunosuppression therapies on the list of exceptions for extended dosing intervals. Provincial Ministries of Health should allow IBD patients to have the second dose of their vaccine at the time indicated on vaccine labels (as indicated by the manufacturers). Click here to see a copy of the letter.

The Task Force cites the results of the CLARITY IBD study from the UK for people living with IBD. The study provides substantial biologic plausibility that individuals with IBD on immunosuppression therapies (such as azathioprine, methotrexate and biologics like infliximab) should receive their second vaccine dose as indicated in the manufacturer’s randomized clinical trials (3 weeks after the first dose for the Pfizer mRNA vaccine; 4 weeks after the first dose for the Moderna mRNA vaccine and Oxford-AstraZeneca adenovirus-vector vaccine).

The Crohn's and Colitis Canada COVID-19 & IBD Task Force recommends:

  • People with IBD who are using immunosuppression therapy should not delay the second dose of their COVID-19 vaccine beyond the time recommended by the manufacturers;

  • People with IBD who have received one dose of a COVID-19 vaccine (Pfizer, Moderna, or AstraZeneca) should consider themselves susceptible to COVID-19; and

  • While COVID-19 vaccines continue to be studied, those with IBD, regardless of vaccination, should practice physical distancing, wear a mask, use good hand hygiene, and follow the recommendations of the COVID-19 & IBD Task Force and local public health authorities.

COVID-19 Vaccine resources

COVID-19 Vaccine Recommendation Letter

Crohn's and Colitis Canada's Task Force has developed a vaccine recommendation and timely second-dosing letter that people with IBD can provide to pharmacies and other COVID-19 distribution sites. The letter can be signed by your primary healthcare provider or IBD specialist. While we recommend a second dose occur within the manufacturer’s timeframe, local health authorities retain the right to limit access to vaccines at their discretion. The QR codes on the letter can be scanned to view these vaccine recommendations and members of the COVID-19 Task Force. Please click here to download or print a PDF copy of the letter.

COVID-19 Vaccines and IBD Infosheet

The Task Force has also developed a single page info sheet (PDF) that can be downloaded and printed. It summarizes key points from the recommendations on this page. Please click here to download a copy of our COVID-19 Vaccination info sheet.

COVID-19 Vaccine Interval Letter (Advocacy)

Crohn's and Colitis Canada's Task Force has developed a vaccine interval letter to the National Advisory Committee on Immunization (NACI) that indicates IBD patients on immunosuppression therapies should be on the list of exceptions for extended dosing intervals. The letter can be used as a reference when speaking to your primary healthcare provider, pharmacist, or IBD specialist. Please click here to download a PDF copy of the letter

How to book a vaccine appointment

For information and contact details on how to register to get a COVID vaccine in your region, please click on your province of residence below:

frequently asked questions

What are the vaccines for COVID-19?

Currently, Health Canada has approved four vaccines: the Pfizer/BioNTech mRNA vaccine, the Moderna mRNA vaccine, the University of Oxford/AstraZeneca/COVISHIELD non-replicating adenovirus vector vaccine and the Johnson & Johnson’s (Janssen) non-replicating adenovirus vector 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.

Non-replicating adenovirus vector vaccines means the adenovirus is a ‘skeleton’ used to carry the COVID-19 spike genetic material. The adenovirus vector cannot replicate and therefore cannot cause disease. The vector virus uses the machinery of our cells to produce the spike component of the COVID-19 virus.

Our immune system naturally recognizes the spike protein as foreign and triggers our body to develop antibodies against the protein. This allows the body to quickly and effectively fight off future infections of the intact COVID-19 virus. 

None of these vaccines are considered “live virus vaccines”, and therefore they cannot cause disease in anyone, including people who are immunosuppressed. While the clinical trials did not include patients who were immunosuppressed, real-world experience in patients with cancer or who use medications which suppress the immune system has not demonstrated that receiving any COVID-19 vaccine increased the risk of adverse events in this population.

How effective are the vaccines to SARS-CoV-2 that are approved by Health Canada?

The Pfizer/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.

In similar large, randomized clinical trials, the AstraZeneca vaccine has been shown to be roughly 62% effective whereas the Janssen vaccine has been shown to be 66% effective. However, these trials were conducted later in 2020 and in parts of the world where “genetic variants of concern” were more prevalent (e.g. South Africa and Brazil). Therefore, the rates of effectiveness should not be compared to earlier trials. In addition, all of these vaccines are nearly 100% effective at preventing severe COVID-19 disease (hospitalization and death).

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, were not studied in people with IBD in the clinical trials. Initial randomized controlled vaccine trials excluded people with immune-mediated conditions, autoimmune diseases, and those on immunosuppressive therapy. 

Since then, many people with IBD around the world have received these vaccines. To date, increased risk of adverse events or safety concerns have not been reported. Additionally, international studies like CLARITY IBD and ICARUS-IBD are recruiting and monitoring IBD patients before and after they are vaccinated. 

What is the impact of IBD on vaccine effectiveness?

Many individuals with IBD are prescribed medications that may reduce the immune response (due to lower antibody titres and other immune system changes) 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 immunosuppressive medications. Reduced effectiveness due to immune suppression is NOT a reason to avoid these COVID-19 vaccines. Even partial protection against COVID-19 is preferable to not having protection at all.

Results of CLARITY IBD and ICARUS-IBD:

Both the CLARITY IBD study and ICARUS-IBD study found that people with IBD who are immunosuppressed responded less effectively to the first dose of the vaccine, measured by levels of antibodies to the SARS-CoV-2 virus. However, both studies reported excellent response after two vaccine doses, or after one vaccine dose in people who previously had COVID-19. 

Antibody levels give an indication but not the full picture of the strength of our immune system to fight viruses. Therefore, we recommend getting the first dose of the COVID-19 vaccine as soon as it is available. Also, if possible, we recommend that people with IBD on immunosuppressants receive the second dose of vaccine according to manufacturer recommendations (3 to 4 weeks after the first dose).

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. The use of adenovirus vectors has been well studied by scientists.

There are currently several clinical trials using the adenovirus vectors for protection against infections such as the Ebola virus, HIV, and tuberculosis. However, patients with IBD were not included in the trials of the COVID-19 adenovirus vector vaccines, and therefore no data are available for safety in IBD patients.

There is no reason to believe the COVID-19 vaccines 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. The CLARITY IBD and ICARUS-IBD studies, which examine immunity after vaccination in IBD patients, have not reported any unexpected problems with safety of the vaccines.

Can vaccines trigger an IBD flare?

While the mRNA and non-replicating adenovirus vector vaccines have not been studied in those with IBD, there is no evidence to date that other non-live vaccines cause IBD flare-ups. We do not have data on the use of mRNA and adenovirus vector 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. The CLARITY IBD and ICARUS-IBD studies, which examine immunity after vaccination in IBD patients, have not reported any unexpected flares of IBD in patients who get the vaccines.

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).

When should I get the COVID-19 vaccine?

People with IBD should get a COVID-19 vaccine at the first available opportunity, as determined by the rules in each province. There is no research to support “timing” the vaccine at a certain point in the cycle of biologic medication infusions/injections. People with IBD who are taking steroids should discuss with their doctor whether to get the vaccine while on steroids, or whether to wait until the steroids are tapered off.

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.

Since the mRNA vaccines seem to have higher efficacy than the non-replicating adenovirus vector vaccines, should I try to get the mRNA vaccine?

You should get the first vaccine that is offered to you, no matter which brand or type. The effectiveness of the non-replicating adenovirus vector vaccines are just as high at preventing hospitalization and death as other successful vaccines, and will contribute to herd immunity. The trials for the non-replicating adenovirus vector vaccines run by Oxford/AstraZeneca and Janssen took place later in 2020 and in parts of the world where “genetic variants of concern” were more prevalent (South Africa and Brazil).

In addition, the criteria needed to test people in the trials for the adenovirus vector vaccines were less stringent, so more mild cases were probably diagnosed in the Oxford/AstraZeneca and Janssen trials. These would all result in the appearance of lower vaccine effectiveness in those trials. Therefore, the rates of effectiveness should not be compared to earlier trials. In addition, all of these vaccines are nearly 100% effective and preventing severe COVID-19 disease (hospitalization and death). Therefore, all of these vaccines will protect you from hospitalization and death, which are the most important outcomes to prevent.

I am pregnant. Should I get a COVID-19 vaccine?

Yes. Research studies have found that pregnant women are at increased risk for severe COVID-19 if they are infected with the SARS-CoV-2 virus. This includes an increased risk of ICU admission, needing mechanical ventilation and death. There are also increased risks to the baby, such as stillbirth and preterm birth. The Society of Obstetricians and Gynaecologists of Canada recommend the COVID-19 vaccine be offered to all pregnant and breastfeeding women.Some provinces, such as Ontario, are prioritizing pregnant women to receive the vaccine earlier than other groups because their risk of severe COVID-19 is higher.

There is news that the AstraZeneca vaccine may cause blot clots. Should I avoid the AstraZeneca vaccine?

No. The non-replicating adenovirus vector vaccines (from AstraZeneca and Johnson & Johnson) may be associated with a rare, serious immune disorder called Vaccine-Induced Immune Thrombocytopenia (VIIT). This condition results in antibodies to a molecule on platelets (one of the clotting factors in blood) called PF4, resulting in their activation and potentially serious blood clots.
 
The risk of this condition is approximately 1 in 250,000 people who receive the vaccine in Canada. Because it is so rare, researchers have been able to identify risk factors in people who get this condition. Based on current information, it does not occur with increased frequency in people who have hypertension (high blood pressure), previous blood clots, bleeding disorders, HELLP Syndrome (in pregnancy), or a family history of clots.
 
As of April 2021, the risk of contracting COVID-19 and dying in Canada far outweighs the risk of developing a blood clot from these vaccines. For this reason, on April 23, 2021, NACI recommended that the AstraZeneca vaccine could be offered to anyone 30+ years old because the benefits outweigh the risks. If you have questions about the safety of the COVID-19 vaccines, speak to your doctor and read the Public Health Agency of Canada page on immunizations.

Where can I receive more information about COVID-19 and vaccines for those with IBD?

The Public Health Agency of Canada has extensive information on the vaccines available for COVID-19, their safety and effectiveness.

In March 2020, Crohn’s and Colitis Canada created the National COVID-19 and IBD Taskforce. The Taskforce has met regularly since March 12, establishing recommendations for people with IBD during the pandemic. 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 19 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:

If you require more information or support, please click here

Dr Benchimol and Dr Kaplan photos

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READ MORE

  • Canada has among the highest incidence rates of Crohn's and colitis in the world.
  • 1 in 140 Canadians lives with Crohn’s or colitis.
  • Families new to Canada are developing these diseases for the first time.
  • Incidence of Crohn’s in Canadian kids under 10 has doubled since 1995.
  • People are most commonly diagnosed before age 30.