Vaccination Guide for
Immunosuppressed Patients with IBD

Live Vaccines

  • Contraindicated in patients who are immunosuppressed due to the concern that vaccination may result in disease
  • Patients considered to be immunosuppressed include, but are not limited to:
    • Immunomodulators: Azathioprine, 6-mercaptopurine, methotrexate*
    • Steroids: Patients on ≥ 2 mg/kg/day (patients < 10 kg) or ≥ 20 mg/day (patients ≥ 10 kg) for at least 2 weeks§
    • Advanced therapies such as:
      • TNF antagonist (infliximab, adalimumab, golimumab)†
      • IL-12/23 antagonist (ustekinumab)
      • Integrin receptor antagonist (vedolizumab‡)
      • JAK inhibitor (tofacitinib, upadacitinib)
      • IL-23 antagonist (mirikizumab, risankizumab)
      • S1P inhibitor (ozanimod, etrazimod)­­
    • Significant protein-calorie malnutrition
  • Suggested time intervals to allow for immune system recovery:
    • Between last dose of live vaccine and initiation of immune suppression: at least 4 weeks
    • From discontinuation of immunosuppression and vaccination: 3 months (1 month for high-dose steroids)
  • Family members should be vaccinated to prevent transmission from family members to patients (see section on Vaccination of Family Members)
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VACCINE

Measles, mumps, rubella

SHOULD TITRES BE CHECKED?

Considered immune if 2 documented doses of vaccine or positive serology­

BEFORE INITIATION OF IMMUNE SUPPRESSION

Contraindicated if plan to start therapy in < 4 weeks. Contraindicated in pregnancy.
When rapid protection is required, a minimum interval of 4 weeks between the 2 doses is acceptable.

WHAT TO DO IF ALREADY IMMUNOSUPPRESSED
(ON ANTI-TNF OR IMMUNOMODULATOR)

Contraindicated.

           
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VACCINE

Varicella

SHOULD TITRES BE CHECKED?

Considered immune if the following:

  • History of varicella of herpes zoster diagnosed by health care provider
  • Received 2 doses of varicella-containing vaccine
  • Born before 1970

Serology testing can be considered if patients do not meet above criteria.

BEFORE INITIATION OF IMMUNE SUPPRESSION

Contraindicated if plan to start therapy in < 4 weeks. Contraindicated in pregnancy.
When rapid protection is required, a minimum interval of 4 weeks between the 2 doses is acceptable.

WHAT TO DO IF ALREADY IMMUNOSUPPRESSED
(ON ANTI-TNF OR IMMUNOMODULATOR)

Contraindicated.

           
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VACCINE

Herpes zoster (for > 50 years old)
ZOSTAVAX® II

SHOULD TITRES BE CHECKED?

Persons who have had shingles in the last year are considered immune.

This vaccine is no longer available and has been replaced by the non-live herpes zoster (Shingrix®) vaccine.

BEFORE INITIATION OF IMMUNE SUPPRESSION

Not recommended. Use inactivated vaccine.

WHAT TO DO IF ALREADY IMMUNOSUPPRESSED
(ON ANTI-TNF OR IMMUNOMODULATOR)

Not recommended. Use inactivated vaccine.  

Note: The non-live herpes zoster (Shingrix®) vaccine is suggested for all IBD patients who are immunosuppressed age 18 years and older, and strongly recommended for all IBD patients age 50 and older, whether immunosuppressed or not.

           
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VACCINE

Live attenuated influenza
(FluMist® intranasal form)

CHECK TITRE BEFORE VACCINATION?

Not applicable

RECCOMENDATIONS / COMMENTS

Contraindicated (use inactivated vaccine)

WHAT TO DO IF ALREADY IMMUNOSUPPRESSED
(ON ANTI-TNF OR IMMUNOMODULATOR)

Contraindicated.

           
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VACCINE

 Rotavirus

SHOULD TITRES BE CHECKED?

Not applicable

BEFORE INITIATION OF IMMUNE SUPPRESSION

Contraindicated

WHAT TO DO IF ALREADY IMMUNOSUPPRESSED
(ON ANTI-TNF OR IMMUNOMODULATOR)

Contraindicated.  Click here for more details on special populations.

           
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VACCINE

Mpox (monkeypox) Imvamune® 
(live-attenuated, non-replicating)

SHOULD TITRES BE CHECKED?

Not applicable. In the context of an active mpox outbreak, vaccination using Imvamune® should be offered to individuals/groups considered at high-risk of mpox.

BEFORE INITIATION OF IMMUNE SUPPRESSION

Note: Infectious Disease consultation is suggested for pediatric patients under age 18. The IMVAMUNE® formulation is live-attenuated but non-replicating, so this is a discretionary recommendation for immunocompromised individuals based on exposure. The freeze-dried and frozen liquid formulations are contraindicated.

Post-exposure vaccination using a single dose of Imvamune® may be offered to individuals with high-risk exposures to a probable or confirmed case of mpox or within a setting where transmission is happening. Post-exposure vaccination should be offered as soon as possible, ideally within 4 days (but up to 14 days) of last exposure. A second dose may be offered after 28 days from the first dose if an assessment indicates an ongoing risk of exposure or if the individual is in a high-risk group for whom pre-exposure vaccination is recommended.

During the 2022 outbreak, the following individuals/groups were considered for pre-exposure vaccination with Imvamune®:
  • Men who have sex with men (MSM)—and individuals who have sex with MSM—and who meet at least one of the following criteria:
    • Having two or more sexual partners or being in a relationship where at least one of the partners has other sexual partners
    • Having had a confirmed sexually transmitted infection acquired in the last year
    • Engaging in sexual contact in sex-on-premises venues
  • Individuals who self-identify as sex workers regardless of self-identified sex/gender
  • Staff or volunteers in sex-on-premises venues where workers may have contact with fomites potentially contaminated with monkeypox virus without the use of personal protective equipment

WHAT TO DO IF ALREADY IMMUNOSUPPRESSED
(ON ANTI-TNF OR IMMUNOMODULATOR)

Individuals receiving pre-exposure vaccination should be offered Imvamune® as a two-dose primary series, with at least 28 days between first and second 0.5 mL sub-cutaneous doses. Individuals considered moderately to severely immunocompromised and eligible for pre-exposure vaccination should be prioritized to receive two doses of Imvamune® administered at the authorized interval (28 days between doses).

           
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VACCINE

Smallpox
  • Lyophilized (freeze-dried) vaccine – Smallpox Vaccine (dried) (Sanofi Pasteur Ltd.)
  • Frozen liquid formulation vaccine – Smallpox Vaccine (frozen-liquid) (Sanofi Pasteur Ltd).

CHECK TITRE BEFORE VACCINATION?

Naturally occurring smallpox has been eradicated worldwide and smallpox vaccination is associated with the risk of significant morbidity and even mortality. The overall risk-benefit analysis supports the recommendation to not routinely immunize the general Canadian population against smallpox. As a result, smallpox vaccination is highly restricted.

BEFORE INITIATION OF IMMUNE SUPPRESSION

Not recommended in Canada.

WHAT TO DO IF ALREADY IMMUNOSUPPRESSED
(ON ANTI-TNF OR IMMUNOMODULATOR)

Not recommended

           
Live-virus vaccines not administered on the same day should be given at least 28 days (4 weeks) apart.6
TNF: tumour necrosis factor, IL: interleukin, JAK: Janus-activated kinase, NACI: National Advisory Committee on Immunization
*As per NACI, ≤ methotrexate 0.4 mg/kg/week; ≤ azathioprine 3.0 mg/kg/day; ≤ 6-mercaptopurine 1.5 mg/kg/day.
§For patients on high-dose steroids (≥ 2 mg/kg/day or ≥ 20 mg/day) for less than 2 weeks, some experts would consider having a two-week interval between discontinuing steroids and vaccination.
†Immunodeficiency that follows the use of recombinant human proteins, including tumor necrosis factor alpha antagonists (i.e. adalimumab, infliximab and etanercept) or anti-B-cell monoclonal antibodies (i.e. rituximab) may be prolonged. The interval until immune reconstitution varies with the specific treatment regimen and other factors. Recommendations may change as further data become available.
‡Patients receiving treatment with vedolizumab may continue to receive non-live vaccines. There are no data on the secondary transmission of infection by live vaccines in patients receiving vedolizumab. Live vaccines may be administered concurrently with ENTYVIO® only if the benefits outweigh the risks.

Travel Vaccines

  • The same principles apply as outlined above for inactivated and live vaccines, but timing of travel may also play role in optimal timing for vaccination
  • Ensure that all routine vaccinations are up to date (especially MMR, tetanus, and pertussis)
  • The following are vaccines that may be indicated for travel to specific areas*
  • CDC link for vaccination recommendations by country: click here
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Cholera/Traveller’s diarrhea (DUKORAL®)

Considered safe.

Hepatitis A and B

Considered safe.

Japanese encephalitis

Considered safe. Indicated for travel to certain parts of Asia.

Meningococcal vaccine

Considered safe. Indicated for travel to certain regions.

Rabies

Considered safe. Pre-exposure prophylaxis can be considered if travelling to high-risk areas. Given possible suboptimal response to vaccine if immunosuppressed, post-exposure prophylaxis with both vaccine and immunoglobulin should be considered in the event of exposure.

Typhoid (injectable)

Considered safe. Indicated for travel to certain regions.

           
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Bacillus Calmette-Guerin (BCG)

Contraindicated.

Dengue

Contraindicated. Not available in Canada.

Typhoid (oral)

Contraindicated if immunosuppressed. Consider injectable inactivated form if indicated.

Yellow Fever

Contraindicated if immunosuppressed. If travelling to a yellow fever area, consult infectious disease specialist.

           

RECENT BLOOD TRANSFUSION/IMMUNE GLOBULIN

  • Blood products of human origin can interfere with the immune response to live vaccines
  • If vaccination with MMR or varicella is indicated and there are no contraindications as previously outlined, the recommended minimal intervals between blood products or immune globulin and vaccination are:
    • Reconstituted RBCs: 3 months
    • Washed RBCs: No delay necessary
    • Intravenous immune globulin (400 mg/kg): 8 months†

For travel vaccinations, it is recommended that you consult a travel medicine specialist about immunization questions specific to your destination. Please notify the travel medicine clinic of current medications prescribed.

*This list is not comprehensive. Vaccination requirements vary depending on the location of travel. Consult an infectious disease specialist for specific recommendations.
†A longer interval is recommended for higher doses of immune globulin (see Red Book2).  

Inactivated Vaccines

  • Inactivated vaccines are safe in immunosuppressed patients, but patients on immunosuppressive therapy may have a suboptimal response to vaccination.
  • Optimize vaccination status prior to initiating immunosuppression whenever possible.
  • Antibody and T-cell response to vaccine requires 2 to 4 weeks.
  • Suggested time intervals to allow for best response to vaccine:
    • Between inactivated vaccine and initiation of immunosuppression: at least 2 weeks, and preferably 3-4 weeks.
    • Between discontinuing immunosuppression and vaccine: ≥ 3 months (this interval may vary with the type and intensity of treatment, underlying disease, or urgency of vaccination if vaccines are needed for post-exposure or outbreak management).
  • If vaccines are administered during immunosuppression, attempt to give them when the next 2 weeks represent the least immunosuppression.
  • Additional doses of inactivated vaccines may cause an increase in sore arm but are not associated with adverse effects. In patients whose immunosuppression may be temporary, it is acceptable to give a vaccine that is due during immunosuppression in order to provide some immediate protection and then give another dose when the patient is no longer immunocompromised and may respond more effectively.
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VACCINE

Respiratory syncytial virus (RSV)
[ABRYSVOâ„¢ and Arexvy]: Adults 60 years of age and older

CHECK TITRE BEFORE VACCINATION?

No

RECOMMENDATIONS / COMMENTS

ABRYSVOâ„¢ has been authorized for use in Canada for:

  • Active immunization of pregnant individuals from 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through 6 months of age
  • The prevention of LRTD caused by RSV in individuals 60 years of age and older by active immunization

NACI is reviewing the use of ABRYSVOâ„¢.

Arexvy has been authorized for use in Canada for the prevention of LRTD caused by RSV in adults 60 years of age and older.

NACI is reviewing the use of Arexvy.

NACI recommendations on RSV prophylaxis for infants are forthcoming, including further analysis of nirsevimab in relation to comparator interventions. Respiratory syncytial virus (RSV): Canadian Immunization Guide – Canada.ca
           
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VACCINE

Tetanus diphtheria (Td absorbed) / Tetanus diphtheria acellular pertussis / Tetanus diphtheria acellular pertussis and inactivated polio 
(Td/Tdap or DTaP/DTaP-IPV-Hib)

CHECK TITRE BEFORE VACCINATION?

No

RECOMMENDATIONS / COMMENTS

Give according to routine schedule.
Tdap booster every 10 years; with Tdap used instead of Td at 14 to 16 years of age.1
Pregnant women should be offered Tdap vaccine to be given at 27 to 32 weeks’ gestation during every pregnancy, irrespective of previous immunization history.

           
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VACCINE

Hemophilus influenza type B (Hib)

CHECK TITRE BEFORE VACCINATION?

No

RECOMMENDATIONS / COMMENTS

Give according to routine schedule, especially in case of added risk for invasive Hib.
           
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VACCINE

Human papillomavirus (HPV)

CHECK TITRE BEFORE VACCINATION?

No

RECOMMENDATIONS / COMMENTS

Intended for males and females age 9 to 26 years old.*
Two doses (0, then 6 to 12 months after).
Highly recommended for MSM.
           
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VACCINE

Influenza (inactivated/injectable form)

CHECK TITRE BEFORE VACCINATION?

No

RECOMMENDATIONS / COMMENTS

Annual vaccine. Timing of administration should balance nadir of immunosuppression and the need to deliver vaccine prior to the onset of influenza season (usually mid-December).

           
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VACCINE

Pneumococcal
(conjugate) [Pneu-C-13]
Or [Pneu-C-15]

CHECK TITRE BEFORE VACCINATION?

No

RECOMMENDATIONS / COMMENTS

Give according to routine schedule§
In adults, if no prior pneumococcal vaccine:

  • Give one dose Prevnar® 13 (or PCV 15), wait 8 weeks minimum, then give one dose Pneumovax® 23 (see below)
  • Alternatively, one dose of Prevnar® 20 can be given


*PCV-13, PCV-15 and PPSV-23 should not be routinely used in patients at increased risk of invasive pneumococcal disease (IPD) unless PCV-20 is not available (or not funded by the provincial/territorial public health vaccination program)

*Pneu-C-20 should be the product of choice for routine and catch-up immunization in children less than 5 years of age who are at increased risk of IPD. Please refer to Canadian Immunization Guide for recommended schedules.

https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-16-pneumococcal-vaccine.html

           
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VACCINE

Pneumococcal
(polysaccharide) [Pneu-P-23]

CHECK TITRE BEFORE VACCINATION?

No

RECOMMENDATIONS / COMMENTS

Give according to routine schedule§
In adults, if no prior pneumococcal vaccine:

  • Give one dose Prevnar® 13 (or PCV 15), wait 8 weeks minimum, then give one dose Pneumovax® 23 (see below)
  • Alternatively, one dose of Prevnar® 20 can be given


One-time booster after 5 years (if first vaccine was given at > 10 years of age) or 3 years (if first vaccine given at ≤ 10 years) and immunosuppressed.

*PCV-13, PCV-15 and PPSV-23 should not be routinely used in patients at increased risk of invasive pneumococcal disease (IPD) unless PCV-20 is not available (or not funded by the provincial/territorial public health vaccination program)

*Pneu-C-20 should be the product of choice for routine and catch-up immunization in children less than 5 years of age who are at increased risk of IPD. Please refer to Canadian Immunization Guide for recommended schedules.

https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-16-pneumococcal-vaccine.html

           
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VACCINE

Pneumococcal 
(conjugate) [Pneu-C-20]

CHECK TITRE BEFORE VACCINATION?

No

RECOMMENDATIONS / COMMENTS

One-time dose in patients 2 years and older:A

  • No previous or unknown vaccination, or have previously completed primary series with PCV-13/PCV-15
  • ≥ 1 year since PCV-13 only vaccine*
  • ≥ 5 years since PPV-23 or (PCV-13 and PPV-23)


Pneu-C-20 should be the product of choice for routine and catch-up immunization in children less than 5 years of age who are at increased risk of invasive pneumococcal disease (IPD). Please refer to Canadian Immunization Guide for recommended schedules.

PCV20 is currently only covered by private insurance. Coverage may vary based on province

*minimum interval of 8 weeks if rapid completion of series is required

Ahttps://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-16-pneumococcal-vaccine.html

           
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VACCINE

Meningococcal
(conjugate) [Men-C-ACYW]

CHECK TITRE BEFORE VACCINATION?

No

RECOMMENDATIONS / COMMENTS

Give according to routine schedule.
Vaccinate at-risk patients if none previously.

           
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VACCINE

Meningococcal
(conjugate) [Men-B]

CHECK TITRE BEFORE VACCINATION?

No

RECOMMENDATIONS / COMMENTS

Vaccinate at-risk patients (asplenia, HIV, congenital immunodeficiency).

 

           
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VACCINE

Hepatitis A vaccination 
(HAV)

CHECK TITRE BEFORE VACCINATION?

No

RECOMMENDATIONS / COMMENTS

Two doses required: give at 0, 6 to 12 months; or 0, 6 to 18 months.†
If vaccinated during an immunosuppressed period and patient is in an at-risk group, consider booster when no longer immunosuppressed.
Recommended for at-risk groups (e.g., liver disease such as PSC, travellers, MSM).

           
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VACCINE

Hepatitis B vaccination 
(HBV)

CHECK TITRE BEFORE VACCINATION?

Yes

RECOMMENDATIONS / COMMENTS

Give according to routine schedule. Dosing schedule depends on particular vaccine†; check post-vaccine titres at 1 month after finishing last dose. Refer to Canadian Immunization Guide for non-responders.
           
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VACCINE

Twinrix® 
(Combination hepatitis A/B)

CHECK TITRE BEFORE VACCINATION?

Yes

RECOMMENDATIONS / COMMENTS

May be given instead of HAV and HBV individually. Give according to routine schedule.

 

           
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VACCINE

Shingrix®
(RZV vaccine) herpes zoster vaccine (non-live recombinant, AS01B adjuvanted)

CHECK TITRE BEFORE VACCINATION?

No

RECOMMENDATIONS / COMMENTS

The non-live herpes zoster (Shingrix®) vaccine is suggested for all IBD patients who are immunosuppressed, age 18 years and older and is strongly recommended for all IBD patients age 50 and older, whether immunosuppressed or not.

Adults 50 years of age or older:

  • Persons ≥ 18 years of age who are or will be at increased risk of herpes zoster due to immunodeficiency or immunosuppression caused by known disease or therapy.
  • Safety and efficacy in persons younger than 18 years have not been established. The primary vaccination schedule consists of two doses, given 2 to 6 months apart.
  • Immunosuppressed persons can receive the second dose 1 to 2 months after the initial dose.

 

There is no information on the use of Shingrix® in pregnant or breast-feeding women. Providers should consider delaying vaccination.

Shingrix® can be given concomitantly with unadjuvanted seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23), or reduced antigen diphtheria-tetanus-acellular pertussis vaccine (Tdap).

           

MSM: males who have sex with males, PSC: primary sclerosing cholangitis, HIV: human immunodeficiency virus
*CDC now recommends 2 doses of HPV vaccine for people starting the vaccination series before the 15th birthday. Three doses of HPV vaccine are recommended for people starting the vaccination series on or after the 15th birthday and for people with certain immunocompromising conditions (CDC October 2016)
§In patients ≥ 5 years where pneumococcal polysaccharide vaccine is indicated, some experts recommend the use of conjugate vaccine prior to administration of polysaccharide vaccine in immunosuppressed patients (regardless of age) to enhance immune response. In these cases, the polysaccharide vaccine should be given at least 8 weeks after the conjugate, wait 5 years then one time revaccination with Pneumovax® 23 booster dose (NACI 2012). Prevnar® 13 is currently not licensed in patients ≥ 5 years of age, although its use is still recommended in high-risk patients. NACI. Update on the Use of Conjugate Pneumococcal Vaccines in Childhood.; 2010. NACI. Statement on the Use of Conjugate Pneumococcal Vaccine – 13 Valent in Adults (Pneu-C-13), 2013.
†The dosage schedule for hepatitis A and hepatitis B vaccines depend on the vaccine used. See vaccine product monograph for instructions. Accelerated schedules are available for some vaccines.

COVID-19

Reference: COVID-19 vaccines: Canadian Immunization Guide – Canada.ca

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Two (2) doses of Moderna Spikevax XBB.1.5 or 3 doses of Pfizer-BioNTech Comirnaty XBB.1.5 are recommended, with an 8-week interval between doses. An additional dose is recommended for individuals who are moderately to severely immunocompromised, with an interval of 4 to 8 weeks between each dose (see Table 1 for schedules and dosages).

The 8-week interval is longer than the authorized interval and is recommended as a better immune response has been associated with a longer interval between doses. For those who are moderately to severely immunocompromised, the 4 to 8-week interval between doses needs to balance a potentially better immune response with longer intervals with the need for earlier protection due to risk of exposure from circulating SARS-CoV-2 and the risk of severe COVID-19 disease.

Those who are moderately to severely immunocompromised are recommended to receive an additional dose in the primary series compared to those who are not immunocompromised in order to help improve the immune response and vaccine effectiveness in this group (based on data from adults). Those who are moderately to severely immunocompromised generally respond less well to COVID-19 vaccines and are at higher risk for severe illness.

If children 6 months to under 5 years of age started the primary series with a non-XBB.1.5 vaccine (i.e., original monovalent, BA.1 bivalent or BA.4/5 bivalent) but did not complete the series, they should complete the primary series with an XBB.1.5 vaccine (see Table 2).

For children 6 months to under 5 years of age who are moderately to severely immunocompromised, a 3-dose series of the Moderna Spikevax (25 mcg) vaccine is preferred over 4 doses of Pfizer-BioNTech Comirnaty (3 mcg) because there is likely higher acceptability and more feasible implementation due to fewer doses in the schedule using Moderna Spikevax.

A mixed product schedule using vaccines from different manufacturers can be offered for the primary series, however if both Pfizer-BioNTech Comirnaty and Moderna Spikevax vaccine products are used in the same primary series for an individual 6 months to under 5 years of age, the total number of doses in the series should follow the Pfizer-BioNTech Comirnaty schedule (see Table 2).

Children who started the primary series with a non-XBB.1.5 vaccine at less than 5 years of age and turn 5 years of age before completing the series, should receive the number of XBB.1.5 vaccine doses recommended as per Table 2 for those 5 years of age and older (including relevant footnotes). Children who started a primary series with an XBB.1.5 vaccine at less than 5 years of age and turn 5 years of age before completing the primary series, should receive the following with the age-appropriate dosage for their current age:

  • the total number of XBB.1.5 doses for a primary series for those less than 5 years of age (see Table 1 for number of doses and intervals); AND
  • the number of doses they receive after turning 5 years of age should not exceed the number of doses for someone commencing the primary series at 5 years of age or older (i.e., the number of doses should not exceed 1 dose for those not immunocompromised, and 2 doses for those who are moderately to severely immunocompromised).

One dose of XBB.1.5 vaccine is recommended as per the authorized schedule in the product monograph. An additional dose is recommended for individuals who are moderately to severely immunocompromised, with an interval of 4 to 8 weeks between the two doses (see Table 1 for schedules and dosages).

Those who are moderately to severely immunocompromised are recommended to receive an additional dose in the primary series compared to those who are not immunocompromised in order to help improve the immune response and vaccine effectiveness in this group. Those who are moderately to severely immunocompromised generally respond less well to COVID-19 vaccines and are at higher risk for severe illness.

The 4 to 8-week interval for those who are moderately to severely immunocompromised needs to balance a potentially better immune response with the longer interval with the need for earlier protection due to risk of exposure from circulating SARS-CoV-2 and the risk of severe disease. As well, the risk of myocarditis/pericarditis following the second dose has been determined to be lower with longer intervals between doses.

If a person 5 years of age and over started the primary series with a non-XBB.1.5 vaccine (i.e., original monovalent, BA.1 bivalent or BA.4/5 bivalent) but did not complete the series, they should complete the primary series with an XBB.1.5 vaccine based on the total number doses previously recommended (i.e., they should receive a total of 2 COVID-19 vaccine doses in the primary series if not immunocompromised and 3 doses in the primary series if they are immunocompromised) (see Table 2).

For children who started a primary series at less than 5 years of age and turn 5 years of age before completing the primary series, see guidance above for Children 6 months to under 5 years of age.

There is no longer a product preference between Moderna Spikevax and Pfizer-BioNTech Comirnaty with the use of XBB.1.5 COVID-19 vaccines for unvaccinated individuals 12 to 29 years of age. Previously, Pfizer-BioNTech Comirnaty had been preferred over Moderna Spikevax for the primary series among individuals 12 and 29 years of age due to the higher risk of myocarditis/pericarditis observed following the Moderna Spikevax 100 mcg original monovalent vaccine primary series (especially after the second dose). This product preference has now been removed. As compared to the original monovalent primary series, the risk of myocarditis/pericarditis is now expected to be lower due to the use of a 1-dose schedule in most individuals and potentially due to a lower dosage of the available Moderna Spikevax vaccine (50 mcg in the XBB.1.5 formulation compared to 100 mcg in the original monovalent formulation).

mRNA vaccines are the preferred products. It is recommended that a primary series of the authorized protein subunit COVID-19 vaccine (Novavax Nuvaxovid XBB.1.5) should be offered to those 12 year of age and older who are not able or willing to receive an mRNA COVID-19 vaccine. Preference of mRNA vaccines over the protein subunit vaccine is due to the availability of more data with regard to the benefits and risks of mRNA vaccines compared to the protein subunit vaccine. Recommendations regarding the use of the protein subunit vaccine are currently under review by NACI. Both the original mRNA vaccines and Novavax Nuvaxovid original have been associated with a rare risk of myocarditis/pericarditis. Data is not yet available for XBB.1.5 vaccines.

When offering Novavax Nuvaxovid XBB.1.5 as a primary series to those 12 years of age and older who are moderately to severely immunocompromised, it should be noted that the safety and efficacy has not been established in these individuals. Informed consent for use of Novavax Nuvaxovid XBB.1.5 for those who are moderately to severely immunocompromised should include the above information, and the well- documented evidence on the safety profile and effectiveness of mRNA COVID-19 vaccines in these populations based on real world use with large numbers of individuals.

Table 1. Immunization schedule for previously unvaccinated individuals by age starting their vaccinations with XBB.1.5 mRNA COVID-19 vaccines
Age groupImmunization scheduleAProductsRecommended intervalB
Schedule for those not moderately or severely immunocompromised
6 months to under 5 years of age
  • 2-dose (Moderna Spikevax) or
  • 3-dose (Pfizer-BioNTech Comirnaty)
  • 25 mcg Moderna Spikevax
  • 3 mcg Pfizer-BioNTech Comirnaty
8 weeks
5 years of age and older
  • 1-dose

Moderna Spikevax

  • 25 mcg (5 to under 12 years)
  • 50 mcg (12 years of age and older)

Pfizer-BioNTech Comirnaty

  • 10 mcg (5 to under 12 years)
  • 30 mcg (12 years of age and older)
Not applicable
Schedule for individuals who are moderately to severely immunocompromised
6 months to under 5 years of age
  • 3-dose (Moderna Spikevax)C or
  • 4-dose (Pfizer-BioNTech Comirnaty)
As above4 to 8 weeks
5 years of age and older
  • 2-dose
4 to 8 weeks
A  See Table 2 regarding individuals who started but did not complete a primary series with a vaccine that was not an XBB.1.5 formulation.
B  For individuals with recent SARS-CoV-2 infection, these are also the suggested intervals between SARS-COV-2 infection and COVID-19 vaccination.
C   Moderna Spikevax is the preferred product in children 6 months to under 5 years of age who are moderately to severely immunocompromised due to acceptability and feasibility considerations of only requiring three doses instead of four doses for Pfizer-BioNTech Comirnaty.
        
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For individuals who have previously been vaccinated with a complete primary series that did not include an XBB.1.5 COVID-19 vaccine, a dose of XBB.1.5 COVID-19 vaccine is recommended 6 months following previous COVID-19 vaccination or SARS-CoV-2 infection (whichever is later). Shorter intervals (i.e., 3 months to less than 6 months) following previous vaccination or infection have also not been shown to pose a safety risk (see Table 2).

Individuals whose primary series includes the XBB.1.5 COVID-19 vaccine do not require further doses at this time once the series is complete.

An mRNA COVID-19 vaccine dose is preferred for those previously vaccinated. However, Novavax Nuvaxovid XBB.1.5 should be offered to individuals 12 years of age and older who are not able or willing to receive an mRNA COVID-19 vaccine. Preference of mRNA vaccines over the protein subunit vaccine is due to the availability of more data with regard to the benefits and risks of mRNA vaccines compared to the protein subunit vaccine. Recommendations regarding the use of the protein subunit vaccine are currently under review by NACI. Both the original mRNA vaccines and Novavax Nuvaxovid original have been associated with a rare risk of myocarditis/pericarditis. Data is not yet available for XBB.1.5 vaccines.

For information on the management of errors and deviations, see PHAC’s resource: Quick reference guide on the use of COVID-19 vaccines: Managing vaccine administration errors or deviations for additional guidance.

Table 2. Summary of number of recommended XBB.1.5 mRNA COVID-19 vaccine doses based on previous non-XBB.1.5 vaccination history (i.e., previously received original monovalent or BA.1 bivalent or BA.4/5 bivalent vaccines (non-XBB.1.5)A
AgePrevious vaccination with only non-XBB.1.5 mRNA COVID-19 vaccinesNumber of doses and interval of XBB.1.5 mRNA COVID-19 vaccines to be administered
Moderna Spikevax XBB.1.5 scheduleBPfizer-BioNTech Comirnaty Omicron XBB.1.5 scheduleC
For those not moderately to severely immunocompromised
6 months to under 5 yearsD3 or more dosesSee 2 or more doses

1 dose

6 months from last dose

Shorter intervals (i.e., 3 months to less than 6 months) have also not been shown to pose a safety risk

2 or more doses

1 dose

6 months from last dose

Shorter intervals (i.e., 3 months to less than 6 months) have also not been shown to pose a safety risk

See 2 doses or 3 or more doses, as applicable
2 dosesSee 2 or more doses

1 dose

8 weeks from last dose

1 dose

1 dose

8 weeks from last dose

2 doses

8 weeks from last dose and between doses

5 years of age and older2 or more doses

1 dose

6 months from last dose

Shorter intervals (i.e., 3 months to less than 6 months) have also not been shown to pose a safety risk

1 doseE

6 months from last dose

Shorter intervals (i.e., 3 months to less than 6 months) have also not been shown to pose a safety risk

1 dose

1 dose

8 weeks from last dose

1 dose

8 weeks from last dose

For those who are moderately to severely immunocompromised
6 months to under 5 yearsF4 or more dosesSee 3 or more doses

1 dose

6 months from last dose

Shorter intervals (i.e., 3 months to less than 6 months) have also not been shown to pose a safety risk

3 or more doses

1 dose

6 months from last dose

Shorter intervals (i.e., 3 months to less than 6 months) have also not been shown to pose a safety risk

See 3 doses or 4 or more doses, as applicable
3 dosesSee 3 or more doses

1 dose

4 to 8 weeks from last dose

2 doses

1 dose

4 to 8 weeks from last dose

Moderna is preferredF

2 doses

4 to 8 weeks from last dose and between doses

1 dose

2 doses

4 to 8 weeks from last dose and between doses

Moderna is preferredF

3 doses

4 to 8 weeks from last dose and between doses

5 years of age and olderH3 or more doses

1 dose

6 months from last dose

Shorter intervals (i.e., 3 months to less than 6 months) have also not been shown to pose a safety riskH

1 doseE,G

6 months from last doseG

Shorter intervals (i.e., 3 months to less than 6 months) have also not been shown to pose a safety risk

2 doses

1 dose

4 to 8 weeks from last dose

1 doseG

4 to 8 weeks from last dose

1 dose

2 doses

4 to 8 weeks from last dose and between doses

2 doses

4 to 8 weeks from last dose and between doses

A  Further details on the recommendations on the use of the XBB.1.5-containing COVID-19 vaccines in previously vaccinated individuals are available in the NACI Guidance on the use of COVID-19 vaccines in the fall of 2023 and the subsequent Addendum to the guidance on the use of COVID-19 vaccines in the fall of 2023.

 


B  Note for the primary series for children 6 months to under 5 years of age: Follow this column if all past vaccine doses have been Moderna Spikevax vaccines and now also administering Moderna Spikevax XBB.1.5.

 

C  Note for the primary series for children 6 months to under 5 years of age: Follow this column if now administering Pfizer-BioNTech Comirnaty Omicron XBB.1.5, or if one or more past vaccine doses have been Pfizer-BioNTech Comirnaty vaccines (whether giving Pfizer-BioNTech Comirnaty Omicron XBB.1.5 or Moderna Spikevax XBB.1.5 now).

 

D  Children 6 months to under 5 years of age who are at high risk for severe illness due to COVID-19 should be vaccinated against COVID-19 with a primary series and other children in this age group may be vaccinated.

 

E  Children who are not immunocompromised and started their primary series with 2 doses of a non-XBB.1.5 Pfizer-BioNTech product when they were less than 5 years of age and are completing their primary series at 5 years of age or older, are recommended to receive a total of 3 doses of COVID-19 vaccine in their primary series.

 

F  For those 6 months to under 5 years of age who are moderately to severely immunocompromised, Moderna Spikevax is preferred because it requires only 3 doses, while Pfizer-BioNTech Comirnaty requires 4 doses.

 

G  Children who are moderately to severely immunocompromised and started their primary series with 2 or 3 doses of a non-XBB.1.5 Pfizer-BioNTech product (not the preferred product) when they were less than 5 years of age and are completing their primary series at 5 years of age or older, are recommended to receive a total of 4 doses of COVID-19 vaccine in their primary series.

 

H If the primary series was started with non-XBB1.5 COVID-19 vaccine(s), those 5 years of age and older who are moderately to severely immunocompromised are recommended to receive a total of 3 doses of COVID-19 vaccines for the primary series.

 

           
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Pregnancy and breastfeeding

Compared to non-pregnant persons, SARS-CoV-2 infection in pregnancy is associated with increased risk of hospitalization and admission to an intensive care unit (ICU). SARS-CoV-2 infection during pregnancy is also associated with an increased risk in the neonate of preterm birth, low birth weight, and admission to a neonatal intensive care unit (NICU). Vaccination helps to protect the person who is pregnant and vaccination during pregnancy also lowers the risk of hospitalization for their newborn.


Recommendations

People who are pregnant or breastfeeding are recommended to be vaccinated as per the Recommendation for use section, with COVID-19 vaccination recommended for those 5 years of age and older who have not been previously vaccinated. Pregnancy is included in the group of previously vaccinated individuals for whom COVID-19 vaccination is particularly important.

An mRNA vaccine is preferred due to reassuring published data on the safety of these vaccines in pregnancy. COVID-19 vaccines can be given at any stage of pregnancy.


Considerations

Pregnant or breastfeeding individuals were excluded from COVID-19 vaccine clinical trials. However, analysis of data collected through international COVID-19 immunization registries to date have not revealed any maternal or neonatal safety signals.

Informed consent should include discussion that there is real-world evidence on the safety profile and effectiveness of mRNA vaccination with large numbers of individuals who are pregnant or breastfeeding, but that there is currently limited evidence on the use of the protein subunit vaccine.

Rates of adverse effects are similar in people who are pregnant or breastfeeding and those who are not pregnant or breastfeeding. Studies have not found any impacts of mRNA COVID-19 vaccination on the infant/child being fed human milk or on milk production or excretion. Vaccination during pregnancy does not increase risk for adverse pregnancy/birth outcomes, including miscarriage, stillbirth, low birth weight, preterm birth, and NICU admission.

Evidence suggests that COVID-19 mRNA vaccination during pregnancy results in comparable antibody titres to those generated in non-pregnant women. Maternal IgG humoral response to mRNA COVID-19 vaccines transfers across the placenta to the fetus, leading to a significant and potentially protective antibody titre in the neonatal bloodstream 1 week after the second dose. Infants of people who received the second dose of a primary series or a booster dose during pregnancy had a lower risk of hospitalization with COVID-19 (including Omicron) compared to infants born to individuals who were unvaccinated.

The effect was greater with the booster dose than the second dose in a primary series and if the dose was given later in the pregnancy as opposed to earlier. The protection from maternal vaccination against infant hospitalization decreases over time since birth.

Observational studies consistently show that both anti-spike IgG and IgA are present in breastmilk for at least 6 weeks after maternal vaccination with mRNA vaccines. The protection against disease as a result of breastfeeding is currently unknown.

Individuals who have received a COVID-19 vaccine during pregnancy are encouraged to enroll in a COVID-19 vaccine pregnancy registry (see Table 2).

There is a Canadian COVID-19 Vaccine Registry for Pregnant and Lactating Individuals, hosted at the University of British Columbia and supported by the COVID-19 Immunity Task Force (CITF) to assess the safety and effectiveness of COVID-19 vaccines.

Table 3. Pregnancy registry information by vaccine product
Vaccine productRegistry information
Pfizer-BioNTech Comirnaty® COVID-19 vaccinesPfizer-BioNTech does not have a vaccine registry for pregnant persons. Individuals who are vaccinated with the Pfizer-BioNTech COVID-19 vaccine during pregnancy are encouraged to enroll into the Canadian COVID-19 Vaccine Registry for Pregnant and Lactating Individuals described above.
Moderna Spikevax® COVID-19 vaccinesThere is a vaccine registry that monitors pregnancy outcomes in persons vaccinated with the Moderna COVID-19 vaccine during pregnancy. Individuals who are vaccinated with the Moderna COVID-19 vaccine during pregnancy are encouraged to enroll in the registry by calling 1-866-MODERNA (1-866-663-3762).
Novavax Nuvaxovidâ„¢ COVID-19 vaccinesThere is a vaccine registry that monitors pregnancy outcomes in persons vaccinated with NUVAXOVID during pregnancy. Individuals who are vaccinated with NUVAXOVID during pregnancy are encouraged to enroll in the registry by visiting C-VIPER: COVID-19 Vaccines International Pregnancy Exposure Registry.
        

IgG: immunoglobulin G; IgA: immunoglobulin A
For the most updated Canadian Immunization schedule for special populations, please visit http://www.phac-aspc.gc.ca/im/is-cv/#a.

Vaccination of Family Members

  • Family members in close contact with immunosuppressed patients should be vaccinated to help prevent disease transmission
  • All inactivated vaccines can safely be administered to family members
  • Live vaccines are also safe to give family members, with the possible exception of rotavirus and varicella (chickenpox) vaccines (see below):
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SAFE TO GIVE FAMILY MEMBERS?

Yes

CONSIDERATIONS

Safe to give to family members.

           
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SAFE TO GIVE FAMILY MEMBERS?

Yes

CONSIDERATIONS

Approximately 5% of vaccinated patients develop a vesicular rash. Immunosuppressed persons should avoid contact with the family member when the rash is present. Post-exposure prophylaxis (see below) is recommended, as it is not possible to differentiate between rash from vaccine and true varicella infection.

           
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SAFE TO GIVE FAMILY MEMBERS?

Yes

CONSIDERATIONS

Limited data on excretion of live rotavirus in stool after vaccination but the inoculum is likely less than with active infection. Need to consider risks and benefits. If vaccine is given to family members, good hand hygiene should be practised to prevent theoretical transmission.

           
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SAFE TO GIVE FAMILY MEMBERS?

Yes

CONSIDERATIONS

Oral typhoid vaccine is not known to result in live vaccine-strain typhoid being shed in the stool of healthy subjects and there is no documented secondary transmission.

           
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SAFE TO GIVE FAMILY MEMBERS?

Yes

CONSIDERATIONS

Safe to give to family members.