The Canadian Association of Gastroenterology (CAG) has published a two-part clinical practice guideline for immunizing patients with inflammatory bowel disease (IBD) that covers both live and inactivated vaccines across pediatric and adult patients.
The guideline, which has been endorsed by the American Gastroenterological Association, is composed of recommendations drawn from a broader body of data than prior publications on the same topic, according to Eric I. Benchimol, MD, PhD, of the University of Ottawa and the University of Toronto, and colleagues.
“Previous guidelines on immunizations of patients with IBD considered only the limited available evidence of vaccine safety and effectiveness in IBD populations, and failed to consider the ample evidence available in the general population or in other immune-mediated inflammatory diseases when assessing the certainty of evidence or developing their recommendations,” they wrote in Gastroenterology.
Part 1: Live vaccine recommendations
The first part of the guideline includes seven recommendations for use of live vaccines in patients with IBD.
In this area, decision-making is largely dependent upon use of immunosuppressive therapy, which the investigators defined as “corticosteroids, thiopurines, biologics, small molecules such as JAK [Janus kinase] inhibitors, and combinations thereof,” with the caveat that “there is no standard definition of immunosuppression,” and “the degree to which immunosuppressive therapy causes clinically significant immunosuppression generally is dose related and varies by drug.”
Before offering specific recommendations, Dr. Benchimol and colleagues provided three general principles to abide by: 1. Clinicians should review each patient’s history of immunization and vaccine-preventable diseases at diagnosis and on a routine basis; 2. Appropriate vaccinations should ideally be given prior to starting immunosuppressive therapy; and 3. Immunosuppressive therapy (when urgently needed) should not be delayed so that immunizations can be given in advance.
“[Delaying therapy] could lead to more anticipated harms than benefits, due to the risk of progression of the inflammatory activity and resulting complications,” the investigators wrote.
Specific recommendations in the guideline address measles, mumps, and rubella (MMR); and varicella. Both vaccines are recommended for susceptible pediatric and adult patients not taking immunosuppressive therapy. In contrast, neither vaccine is recommended for immunosuppressed patients of any age. Certainty of evidence ranged from very low to moderate.
Concerning vaccination within the first 6 months of life for infants born of mothers taking biologics, the expert panel did not reach a consensus.
“[T]he group was unable to recommend for or against their routine use because the desirable and undesirable effects were closely balanced and the evidence on safety outcomes was insufficient to justify a recommendation,” wrote Dr. Benchimol and colleagues. “Health care providers should be cautious with the administration of live vaccines in the first year of life in the infants of mothers using biologics. These infants should be evaluated by clinicians with expertise in the impact of exposure to monoclonal antibody biologics in utero.”
Part 2: Inactivated vaccine recommendations
The second part of the guideline, by lead author Jennifer L. Jones, MD, of Dalhousie University, Queen Elizabeth II Health Sciences Center, Halifax, N.S., and colleagues, provides 15 recommendations for giving inactivated vaccines to patients with IBD.
The panel considered eight vaccines: Haemophilus influenzae type B (Hib); herpes zoster (HZ); hepatitis B; influenza; Streptococcus pneumoniae (pneumococcal vaccine); Neisseria meningitidis (meningococcal vaccine); human papillomavirus (HPV); and diphtheria, tetanus, and pertussis.
Generally, the above vaccines are recommended on an age-appropriate basis, regardless of immunosuppression status, albeit with varying levels of confidence. For example, the Hib vaccine is strongly recommended for pediatric patients 5 years and younger, whereas the same recommendation for older children and adults is conditional.
For several patient populations and vaccines, the guideline panel did not reach a consensus, including use of double-dose hepatitis B vaccine for immunosuppressed adults, timing seasonal flu shots with dosing of biologics, use of pneumococcal vaccines in nonimmunosuppressed patents without a risk factor for pneumococcal disease, use of meningococcal vaccines in adults not at risk for invasive meningococcal disease, and use of HPV vaccine in patients aged 27-45 years.
While immunosuppressive therapy is not a contraindication for giving inactivated vaccines, Dr. Jones and colleagues noted that immunosuppression may hinder vaccine responses.
“Given that patients with IBD on immunosuppressive therapy may have lower immune response to vaccine, further research will be needed to assess the safety and effectiveness of high-dose vs. standard-dose vaccination strategy,” they wrote, also noting that more work is needed to determine if accelerated vaccinations strategies may be feasible prior to initiation of immunosuppressive therapy.
Because of a lack of evidence, the guideline panel did not issue IBD-specific recommendations for vaccines against SARS-CoV-2; however, Dr. Jones and colleagues suggested that clinicians reference a CAG publication on the subject published earlier this year.
The guideline was supported by grants to the Canadian Association of Gastroenterology from the Canadian Institutes of Health Research’s Institute of Nutrition, Metabolism and Diabetes; and CANImmunize. Dr. Benchimol disclosed additional relationships with the Canadian Institutes of Health Research, Crohn’s and Colitis Canada; and the Canadian Child Health Clinician Scientist Program.