Guide for the Vaccine Screening and Consent Form

October 30, 2023: The medSask Vaccine Screening and Consent Form and Guide have been updated. See Summary of Important Changes/Additions for an overview of the changes.        

This guide is a supporting document for the  medSask Vaccine Screening and Consent Form. The guide is an assessment tool intended to provide direction on managing the screening and administration process for all vaccines.      

See information regarding context and rationale for the Pharmacy Use Only section of the form.

How to Use the Guide

This Guide for Vaccine Screening and Consent Form Questions (the Guide) has been developed by medSask and the Pharmacy Association of Saskatchewan as a support document to the Vaccine Screening and Consent Form (the Form).

This guide is intended to provide rationale for the questions included on the Form and direction in the specific situations. This is not a comprehensive vaccine guide. Pharmacists need to consult the Saskatchewan Immunization Manual (SIM) and/or the Canadian Immunization Guide (CIG) for vaccine eligibility/recommendations and specific vaccine information. Also see references in Appendix 3.

Each section in the Guide has the relevant questions from the Form, with information providing context and intent of the question and how to proceed based on the vaccine recipient’s response. Vaccines are categorized as:

  • COVID-19 vaccine
  • Inactivated Influenza Vaccine
  • Other Inactivated Vaccines (all inactivated vaccines not including COVID-19 and influenza vaccines)
  • Live Vaccines (including live attenuated influenza vaccine)

If the tab is titled "All Inactivated Vaccines", the information pertains to COVID-19 vaccine, inactivated influenza vaccine and all other inactivated vaccines. 

Questions that need to be answered depends on the vaccine(s) received:

  • All vaccine recipients need to answer questions 1-8
  • Recipients of live vaccines need to answer questions 1-12

The accompanying Form meets the record keeping requirements as set out by the Regulatory Bylaws of the Saskatchewan College of Pharmacy Professionals regulating the Administration of Drugs by Injection and Other Routes by a pharmacist. 

Special thanks to the Saskatchewan College of Pharmacy Professionals for providing feedback into the development of this document.

Abbreviations Used in the Guide

AEFI = Adverse Event Following Immunization      
AESI = Adverse Events of Special Interest      
BCG = Bacille Calmette-Guérin      
CIG = Canadian Immunization Guide      
CIP = COVID-19 Immunization Program      
DPEBB = Drug Plan & Extended Benefits Branch      
HIV= Human Immunodeficiency Virus      
IIV = Inactivated Influenza vaccine      
LAIV = Live Attenuated Influenza Vaccine (FluMist®)      
MHO = Medical Health Officer      
MMR = Measles-Mumps-Rubella      
MMRV = Measles-Mumps-Rubella-Varicella      
MoH = Saskatchewan Ministry of Health      
NACI = National Advisory Committee on Immunization      
PCH = Personal Care Home      
SCA = Saskatchewan Cancer Agency      
SCPP =  Saskatchewan College of Pharmacy Professionals      
SIIP = Saskatchewan Influenza Immunization Policy      
SIM = Saskatchewan Immunization Manual      
SOGC = Society of Obstetricians and Gynecologists of Canada

Summary of Important Changes/Additions
30 Oct 2023
  • NEW SELECTION FOR Q4: MIS-C has been moved from the questions specific to COVID-19 vaccine and added to selections of medical conditions.
    • There is direction in the Guide around how to handle patients who report a history of MIS-C not related to vaccination and their next COVID-19 vaccine dose.
    • Note that MIS-C and myocarditis/pericarditis may be reported as AEFIs to COVID-19 vaccine in Question 3 – there is information in the Guide pertaining to these AEFIs (this is not new).
  • REPHRASED QUESTION 7: “Are you nursing/breastfeeding?” to “Are you breastfeeding/chestfeeding?”
    • medSask is committed to providing inclusive materials. 
  • REMOVED FORMER QUESTIONS 9 and 10 SPECIFIC to COVID-19 VACCINE.
    • Q9 had to do with treatment of convalescent plasma (CP) and/or monoclonal antibodies (mAbs) to ensure adequate time passed between treatment and next vaccine dose. However, the Ministry of Health states COVID-19 vaccine can be given any time in relation to treatment with CP and mAbs.
    • The question about history of MIS-C is now captured in Q4 (see above).
    • The Ministry of Health no longer provides specific direction  for individuals who present with a history of myocarditis/pericarditis not related to COVID-19 vaccine.
  • NEW QUESTION: Do you regularly take salicylate medications?
    • There are precautions with use of salicylates in individuals younger than 19 years and some live vaccines. This information used to be in the Guide under Q5: blood thinners. However, not all salicylates are antithrombotics and this information may not have been volunteered by the vaccine recipient/parent/guardian.
    • Because this only applies to live vaccines, it is among the live vaccine questions.
  • Due to the reorganization, individuals receiving inactivated vaccines (including Influenza and COVID-19) will answer Q1-8. Those receiving live vaccines will answer Q1-12. 
31 Jan 2023
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • New interval between COVID-19 booster dose and last dose is at least 6 months (3 months minimum under exceptional circumstances).
08 Nov 2022
  • Q8 - Other vaccinations within 4 weeks
    • Information reorganized  
    • General review and minor edits
03 Nov 2022
  • Q11 - TB skin test scheduled within 4 weeks; previous positive TB skin test
    • General review and edits to improve clarity
  • Q13 - Receipt of blood products/immune globulin
    • Herpes zoster vaccine moved to section in which no interference expected.
    • General review and minor edits
02 Nov 2022
  • Q1 - Do you feel sick today
    • Information has been amalgamated into one section
    • General review and minor edits
  • Q7 - Are you nursing/breastfeeding
    • General review and minor edits
31 Oct 2022
  • Q3 - Severe adverse event to prior immunization
    • Added section for MIS-C/MIS-A
    • Add info re: GBS following COVID-19 vaccine
    • General review and minor edits
  • Q10 - History of myocarditis/pericarditis or MIS-C/MIS-A
    • Some information was moved to Q3
    • General review and minor edits
  • General
    • Where pertinent, Live Attenuated Influenza Vaccine has been amalgamated into Live Vaccine sections
28 Oct 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Information has been added regarding number of doses in primary series for children who start the primary series with Pfizer-BioNTech Comirnaty® 3 mcg (Maroon cap).
26 Oct 2022
  • Q4 - Other medical conditions
    • General review and minor edits
25 Oct 2022
  • Q9 - Previous COVID-19 infection
    • General review and updated information regarding SK's recommended interval to wait between COVID-19 infection and COVID-19 vaccination.
24 Oct 2022
  • Q2 - Severe allergies to medications, food, a vaccine component or latex
    • General review and minor edits
17 Oct 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Information has been added regarding Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5 30 mcg for individuals 12 years and older.
11 Oct 2022
  • Q7 - Breastfeeding
    • Incorporated NACI recommendations for fall COVID-19 booster
    • General review and minor edits
06 Oct 2022
  • Q6 - Pregnancy/planning pregnancy
    • Incorporated NACI recommendations for fall COVID-19 booster
    • General review and minor edits
29 Sep 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Information has been added regarding expansion of eligibility of Moderna Spikevax™ Bivalent to all individuals ≥18 years.
21 Sep 2022
  • Q5 - Concomitant medications
    • General review and minor edits
12 Sep 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Information has been added regarding Moderna Spikevax™ Bivalent.
31 Aug 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Expansion of 1st booster eligibility to those ≥ 5 years to < 12 years.
30 Aug 2022
  • Q8 - Upcoming or previous vaccines      
     
    • Information has been added regarding timing of smallpox/monkeypox vaccine in relation to COVID-19 vaccine
15 Aug 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Expansion of 2nd booster eligibility to those 18 years and older added.
08 Aug 2022
  • General updates througout pertaining to new COVID-19 vaccine formulations
    • Note
      • if information applies to all formulations of a COVID-19 vaccine, only the brand name will appear (Pfizer-BioNTech Comirnaty™ or Moderna Spikevax™)
      • if information applies to specific formulations of a COVID-19 vaccine, the formluation is identified by cap colour (e.g. Pfizer-BioNTech Comirnaty™ Grey Cap)
11 Jul 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals), Travel Dose  Algorithm
    • Individuals with on dialysis or with chronic kidney disease (stage 5) are now considered moderately to severely immuncompromised 
30 Jun 2022
  • Q3 - Previous serious reaction
    • tab added for thrombosis with thrombocytopenia syndrome following vaccination
  • Q5 - Medications that affect the immune system
    • information about anti-SARS-CoV-2 monoclonal antibodies added
22 Jun 2022
  • Q8 - upcoming or previous vaccines
    • minor updated regarding NACI's recommendation of COVID-19 vaccine given concurrently with other vaccines in children 5 to <12 years
06 May 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals), Travel Dose  Algorithm
    • Updates to reflect the changes in determining what additional doses (e.g., travel doses) are considered booster doses.
04 May 2022
  • Minor edits:
    • Qs 6,7 - added information related to Novavax Nuvaxovid™ and removed information related to AstraZeneca Vaxzevria™ (use discontinued)
    • Q9 - related to suspension of use of sotrovimab
    • Q11 - updated information regarding TB testing around the time of COVID-19 vaccine administration
29 Apr 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • An algorithm has been added to help determine if additional doses (e.g., travel doses) are considered booster doses.
26 Apr 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Expansion of 2nd booster eligibility to those 50 years and older added.
    • Format of the section "Additional/Booster Doses -> Eligibility and Intervals" has been changed considerably.
20 Apr 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Regarding 1st and 2nd booster doses, addition of example scenarios for those who had previously received additional doses (e.g. travel doses) and their eligibility for booster doses available in the tab "Non-Immunocompromised Individuals Who Have Received 3 or More Doses (E.g., Travel Doses)". 
11 Apr 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Expansion of 2nd booster eligibility details added.
    • 1st booster dose intervals changed for some groups.
18 Mar 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Booster dose intervals changed.
18 Feb 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Information updated pertaining to the authorization of Moderna Spikevax™ in children 6 to 11 years.
10 Feb 2022
  • Q9 Previous COVID-19 Infection
    • Information added pertaining to NACI guidance on interval between SARS-CoV-2 infection and COVID-19 vaccine doses.
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • New tab added under "Supplementary Information" regarding NACI guidance on intervals.
08 Feb 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Booster dose eligibility updated to include children 12-17 years old.
04 Feb 2022
  • Updated Form
    • Q11 (Are you receiving a 3rd or 4th COVID-19 vaccine dose for travel purposes?) removed 
  • Q11 Are you receiving a 3rd or 4th COVID-19 vaccine dose for travel purposes?  
    • Information deleted as COVID-19 vaccine doses for travel purposes have been discontinued.
  • Qs 12-14
    • Renumbered to Qs 11-13
01 Feb 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Amendment to interval between 1st and 2nd booster doses for LTC residents added. 
28 Jan 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Information added regarding recommendation for a 3-dose primary series for immunocompromised children 5 to 11 years.
24 Jan 2022
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Re-organization of the Additional/Booster Dose Eligibility section (changed from organized by interval to organized by population).
    • Booster dose eligibility updated.
19 Jan 2022
  • Q3 Have you ever had a serious reaction after receiving a vaccination? → Myocarditis and Pericarditis
    • Information updated.
  • Q10 Do you have a history of myocarditis/pericarditis or MIS-C?
    • Information for myocarditis/pericarditis clarified.
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Information added regarding preference of Pfizer-BioNTech Comirnaty™, if easily accessible, over Moderna Spikevax™ in those 30 years and younger because of risk of myocarditis and/or pericarditis.
28 Dec 2021
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Clarifications added regarding booster eligibility for non-immunocompromised individuals who have already received 3rd/4th doses (e.g. for travel). 
22 Dec 2021
  • Updated Form
    • A place for type of vaccine being administered when child is being accompanied by designated adult has been added under Declaration of Consent.
17 Dec 2021
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Note has been added regarding new booster dose eligibility effective Monday December 20, 2021.
  • Updated Form
    • A place for name of designated adult accompanying child has been added under Declaration of Consent.
07 Dec 2021
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Eligibility criteria updated as announced by the Saskatchewan Ministry of Health including:      
       
      • For those who had been eligible for a booster dose at 6 months, the interval has been reduced to 5 months.
        • Changes to eligibility criteria in this category:  
          • Ages have been lowered for general population (now 50 years or older) and individuals living in the Far North and those living on First Nation communities (now 18 years or older).
          • People with diabetes have been added - eligibility letters are not required for this group.
          • Awaiting clarification regarding those who received AstraZeneca Vaxzevria™ in the primary series.
02 Dec 2021
  • Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
    • Moderna Spikevax™ booster doses updated
    • Addition of individuals eligible for booster doses at least 6 months following 2nd dose
26 Nov 2021
  • Updated Form
    • Vaccine Recipient Information: "Sex" has been changed to "Sex shown on health card" with selections of M, F, X, Not on card
    • Screening Questions: Q10 is new regarding previous history of myocarditis/pericarditis or MIS-C when screening for mRNA COVID-19 vaccines
    • Declaration of Consent: content added
  • Q10  *NEW QUESTION* History of myocarditis/pericarditis or MIS-C
    • Information has been included to support the new question.
  • Former Q10-13 are now Q11-14 When screening, recipients should answer:
    • Inactivated vaccines including Influenza Vaccine: Q1-8
    • COVID-19 vaccine: Q1 -11
    • Live vaccines: Q1-8 and 12-14
24 Nov 2021
  • General
    • Incorporated Pediatric Pfizer-BioNTech Comirnaty™ where applicable.
  • Q8 Upcoming or past vaccinations
    • Added information relevant to Pediatric Pfizer-BioNTech Comirnaty™.
  • Appendices 1 and 2
    • Appendix 1 (COVID-19 Vaccine Eligibility) and Appendix 2 (COVID-19 Vaccine Additional Doses) have been amalgamated into Appendix 1 (COVID-19 Vaccine Doses, Eligibility, and Intervals)
04 Nov 2021
  • Q4 Transplant
    • Inactivated influenza vaccine tab added.
31 Oct 2021
  • COVID-19 Vaccine Additional Doses – Additional/Booster Doses to Increase Immunity -  General Information
    • NACI’s revised recommendations for booster doses added.
25 Oct 2021
  • Q2 Severe Allergies (Allergen Information); Q3 Serious Reaction (Anaphylactic Shock)
    • Information added regarding NACI's recommendation of future mRNA COVID-19 vaccine doses in those who experienced severe immediate allergic reaction to mRNA COVID-19 vaccine. Details are in Q3.
  • Q4 Autoimmune Disorder; Q4 Immunocompromised because of condition (General, Cancer, Transplant); Q5 Immunocompromised because of medications; Appendix 1- COVID-19 Vaccine eligibility
    • Information about additional doses has been linked to this page.
  • Q4 Immunocompromised because of condition (General, Cancer); Q5 Immunocompromised because of medications
    • Updated SCA Influenza Guidelines document linked.
  • Declaration of Consent
    • New tab added regarding obtaining informed consent. 
  • Appendix 1
    • Information added regarding NACI's recommendation for optimal interval between COVID-19 vaccine doses 1 and 2.
21 Oct 2021
  • Appendix 1- COVID-19 Vaccine eligibility
    • Information added regarding Phase 3 eligibility for Additional Doses, which as of Oct 25, is available here
30 Sep 2021
  • General
    • The forms that had been separate for COVID-19 Vaccine and Influenza/Other Vaccines are now combined into one form and this guide.
    • There is no longer a question regarding precautions/contraindications for the COVID-19 viral vector vaccines (AstraZeneca Vaxzevria™/COVISHIELD) as pharmacies will not be administering these vaccines.
    • Information about COVID-19 Vaccine eligibility is available in Appendix 1.      

       
  • Q4 Autoimmune Disorder; Q4 Immunocompromised because of condition (all); Q5 Immunocompromised because of medications; Appendix 1- COVID-19 Vaccine eligibility
    • New information regarding eligibility of additional doses for vulnerable individuals as part of Phase 2A, which is in effect Oct. 4, 2021.      

       
  • Q8 Any vaccines in last 4 weeks or planned in upcoming 4 weeks
    • Information changed to reflect NACI's new recommendation that COVID-19 vaccine can be given concomitantly or at any time before or after any other vaccines.
Archive of Important Changes/Additions from the COVID-19 Vaccine Guide
NOTE: These are updates transferred from the previously available COVID-19 Vaccine Screening and Consent Form Guide. The question numbers in these updates do not correspond with the questions on the current form. Find the corresponding information in the guide based on the question description/title. For example, Q6 Autoimmune Disorder found in these updates corresponds with Q4 Autoimmune Disorder in this guide.
18 Sep 2021
  • General
    • Occurrences of vaccine names changed:
      • Pfizer-BioNTech → Pfizer-BioNTech Comirnaty®
      • Moderna → Moderna Spikevax™
      • AstraZeneca → AstraZeneca Vaxzevria™
14 Sep 2021
  • Q1 Previous COVID-19 vaccine, Q6  Autoimmune Disorder, Q7 Immunocompromised, Q7(i) Medications, Q7(ii) Cancer, Q7(iii) Transplant      
     
    • Information added related to NACI's statement of additional doses in immunocompromised individuals.
02 Sep 2021
  • Age, Q1 Previous COVID-19 vaccine
    • Changes to align with authorization for all immunizers to provide Moderna vaccine to those ≥ 12 years old and those who are born in 2009.
  • Q1 Previous COVID-19 vaccine
    • Further details added regarding additional doses and doses in those who received non-Health Canada authorized COVID-19 vaccines out of country.
  • Q10 Any Vaccine in past 14 days
    • Information changed to reflect intervals between COVID-19 vaccine and other vaccines are no longer required.
31 Aug 2021
  • Q1 Previous COVID-19 vaccine, Q6  Autoimmune Disorder, Q7 Immunocompromised, Q7(i) Medications, Q7(ii) Cancer, Q7(iii) Transplant
    • Information added regarding additional doses for immunocompromised individuals.
27 Aug 2021
  • Age
    • Changed note to indicate that although Health Canada has authorized the use of Moderna for eligible persons 12 years of age and older, the Saskatchewan Ministry of Health has not yet authorized pharmacists to administer to eligible persons in the 12 to 17 year age range.
20 Aug 2021
  • Age
    • Changed note to indicate pharmacies are authorized to provide Pfizer-BioNTech vaccine to eligible individuals ≥ 12 years old and those who are born in 2009 (currently 11 years old and will be 12 by the end of the year). 
  • Form
    • Space has been added to the 2nd page to document up to three previous doses received, when applicable (in the context of 3rd and 4th doses for travel).
  • Q1 Previous COVID-19 vaccine
    • Information has been added regarding 3rd and 4th doses.
  • General
    • Verbiage has been updated as required to align with possibility of 3rd and 4th doses.
09 Aug 2021
  • Q2a Treated with Convalescent Plasma or Monoclonal Antibodies
    • Newly approved Anti-SARS-CoV-2 monoclonal antibody added.
14 Jul 2021
  • Q1a Side Effects to COVID-19 Vaccine      
     
    • Information added regarding pericarditis or myocarditis following mRNA vaccine.
  • Q2a Treated with Convalescent Plasma or Monoclonal Antibodies
    • Clarifications regarding monoclonal antibodies added.
07 Jul 2021
  • Q1a Side Effects to COVID-19 Vaccine
    • Instructions regarding reporting AEFIs to 2nd doses added.
30 Jun 2021
  • Form
    • Q1 has been separated into 1 and 1a. 
    • Capillary leak syndrome has been added to Q9.      

       
  • Q1 Previous COVID-19 Vaccine      
     
    • Q1 is now Q1 and Q1a so that side effects from the first dose can be addressed separately.      
       
  • Q9 Contraindications/Precautions to AZ/COVISHIELD vaccines
    • Added capillary leak syndrome as a contraindication to AstraZeneca/COVISHIELD vaccines as per Health Canada.
22 Jun 2021
  • Q1 Previous COVID-19 Vaccine
    • Intervals between vaccine doses updated.
    • Wording regarding interchanging between mRNA vaccines updated.
08 Jun 2021
  • Q4 Pregnancy; Q5 Breastfeeding; Q6 Autoimmune Conditions; Q7  Immunosuppression
    • Changes to reflect that NACI now has the same recommendations for these individuals as for the general adult population based on emerging safety and immunogenicity data.
    • Algorithms and Benefit-Risk Information links have been removed as they are no longer in use/available within SHA.
04 Jun 2021
  • Q1 Previous COVID-19 Vaccine
    • Information added regarding minimum intervals between doses when vaccine for 2nd dose differs from vaccine received for 1st dose.
    • Clarification regarding interchanging mRNA vaccines.
02 Jun 2021
  • Q1 Previous COVID-19 Vaccine
    • Updated with interchangeability information for second dose.
21 May 2021
  • Q4 Pregnancy
    • As of May 21, 2021, only mRNA vaccines are to be routinely offered to pregnant individuals. Be sure to read the information in the tab for more details and nuances.
17 May 2021
  • Do you work in a healthcare facility or live in a personal care home?
    • PCH residents have been added to those to enter in the Vaccine Risk Factor Portal      

       
  • Q1 Previous COVID-19 Vaccine
    • Many points added including:
      • Ensuring minimum intervals met and individual is eligible
      • Ensuring the recipient will be receiving the same vaccine as the first dose
      • Managing adverse events to first dose      

         
  • Q2 Previous COVID-19 Infection
    • Added information regarding when to administer doses in those who tested positive for COVID-19 after their first dose.      

       
  • Q3 Severe allergies
    • Information added regarding how to proceed if individual reports allergic reaction to first dose.      

       
  • Q4 Pregnancy
    • Added guidance to those becoming pregnant after the first dose.      

       
  • Q9 Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT) related
    • Added history of thrombosis with thrombocytopenia after first dose of AstraZeneca/COVISHIELD to list of those who should not receive AstraZeneca/COVISHIELD as second dose.
14 May 2021
  • Age
    • Added some information regarding informed consent for mature minors.      

       
  • Q2 Previous COVID-19 Infection
    • Direction has changed from the Saskatchewan Ministry of Health such that no delay is required to receive COVID-19 vaccination following COVID-19 infection so long as the individual has recovered and no longer needs to follow isolation requirements.
11 May 2021
  • Age
    • Changed note to indicate pharmacies are authorized to provide Pfizer-BioNTech vaccine to eligible individuals ≥ 12 years old.
08 May 2021 
  • Q6 Autoimmune Conditions      
     
    • Removed: "Patients with ANY autoimmune condition that involves the NEUROLOGICAL SYSTEM - other than Multiple Sclerosis - must discuss with the primary physician / specialist before immunization is provided."
05 May 2021
  • Age
    • Changed approved age for Pfizer ≥ 12 years old. Added note that pharmacies are not yet authorized to provide the vaccine to individuals <16 years of age). (See 11 May update.)      
       
  • Q9 Contraindications/Precautions to AZ/COVISHIELD vaccines
    • Added history of cerebral venous sinus thrombosis (CVST) associated with thrombocytopenia as per AstraZeneca product monograph.

Q1. Do you feel sick today?

All Vaccines
Applies to All Vaccines 
  • There is no evidence that mild to moderate acute illness reduces vaccine efficacy or increases vaccine adverse events. Mild to moderate illnesses (such as otitis media, upset stomach, and diarrhea) are NOT contraindications to vaccination. Vaccination should be deferred in individuals who have any new or worsening respiratory symptoms (e.g., fever, cough, sore throat, runny nose).  
  • A severe acute illness, with or without a fever, may be reason to delay immunization. Benefits need to be weighed against risks. Expert opinion is strongly recommended in this situation.
    • Reasons to vaccinate may include:
      • protection in a high-risk exposure situation
      • short window of opportunity
    • Reasons to delay vaccination may include:
      • vaccine-related adverse event (particularly fever) could complicate the management of the individual
      • events associated with the acute illness may be misperceived as vaccine-related adverse events
REFERENCES
LAST UPDATED: 11 oct 2023
COVID-19 Vaccine
  • Individuals previously infected with SARS-CoV-2 should receive COVID-19 vaccination as vaccination provides more reliable and stronger immune protection.
  • A stronger immune response occurs with a longer (e.g., ≥ 6 months) interval between SARS-CoV-2 infection and subsequent COVID-19 vaccine dose. 
  • In Saskatchewan, individuals who have been infected with SARS-CoV-2 need to wait at least 6 months (minimum 3 months) before receiving COVID-19 vaccine doses. 
References
Last Updated: 11 Oct 2023
Other Inactivated Vaccines
Oral Cholera and Traveller’s Diarrhea
  • Administration of this vaccine should be postponed in persons with acute gastrointestinal illness.
Reference
Last updated: 11 Oct 2023
Live Vaccines
Live Attenuated Influenza Vaccine
  • In addition to the information that applies to all vaccines, if significant nasal congestion is present that might interfere with delivery of live attenuated influenza vaccine (LAIV) to the nasopharyngeal mucosa, inactivated influenza vaccine can be administered instead; LAIV can be deferred until resolution of the illness but taking the opportunity to vaccinate at time of presentation is preferred.
REFERENCE
Last updated: 11 Oct 2023

Q2. Do you have severe allergies to medications, food, a vaccine component, or latex?

General Information and Reporting
  • Vaccines should not be administered to individuals who have had an anaphylactic reaction to any of the vaccine components, with the exception of egg (see Allergen Information). Refer patients who report a severe reaction to other ingredients to their primary care provider or Public Health for further assessment.
  • Individuals can be asked if they have been seen by an allergy specialist; if so, allergies may be confirmed, allergens identified, and advice provided by allergist regarding future exposures/what to avoid.
  • Consult vaccine product monographs for full list of ingredients.       

     
  • If individual reports an allergic reaction to previous dose(s) of a publicly funded vaccine (COVID-19 vaccine and influenza vaccine):
    • If an AEFI report was submitted, communication from the MHO should have been received by whomever submitted the AEFI report. The AEFI recommendation for further immunization may be available in the Immunization tab in the eHR Viewer; this only applies to publicly funded vaccines. See instructions of where to find   here.
    • If an AEFI report has not been submitted, gather as many details as possible and submit an AEFI report using the form found here.
    • If the reaction was an expected reaction and did not warrant AEFI report submission, provide reassurance of the safety of subsequent dose(s) and proceed with consent.
    • The Saskatchewan User Guide for Completion and Submission of AEFI Reports, which contains guidance as to reportable reactions, is available  here.      

       
  • If individual reports an allergic reaction to previous dose(s) of a non-publicly funded vaccine:
    • If an AEFI report was submitted for a non-publicly funded vaccine, the prescriber or primary care provider is to make a decision going forward (continuing the series, etc.).
    • If an AEFI report has not been submitted, gather as many details as possible and submit an AEFI report using the form found here.
      • Pharmacies are to submit AEFI reports related to non-publicly funded vaccines to Health Canada, the prescriber and the primary care practitioner (if different from prescriber).
      • The prescriber or primary care practitioner is to make a decision regarding future vaccination and provide this information to the reporter. It is the reporter's responsibility to relay this information to the vaccine recipient.
    • If the reaction was an expected reaction and did not warrant AEFI report submission, provide reassurance of the safety of subsequent dose(s) and proceed with consent.
    • The Saskatchewan User Guide for Completion and Submission of AEFI Reports, which contains guidance as to reportable reactions, is available  here.
    • Because  there is no central repository of these reports, the individual must understand they are responsible to communicate reactions and decisions to future immunizers.
REFERENCES
LAST REVIEWED: 10 oct 2023
Allergen Information

If the individual reports an anaphylactic reaction to the vaccine to be administered or an ingredient within, refer to primary care provider (for allergy specialist follow up) or Public Health. If the individual reports an anaphylactic reaction to a different vaccine/product that contains a common ingredient to the vaccine to be administered, refer (unless the common ingredient is encountered regularly, such as sodium chloride or potassium chloride, in which case referral is not necessary and the vaccine can be provided).  

Vaccine Antigens
  • These are the active components of the vaccine.
  • A vaccine is contraindicated in an individual with a history of anaphylaxis after previous administration of the same vaccine or same antigen. Refer to primary care provider for further investigation.
    • An exception may be mRNA COVID-19 vaccine. See Q3 Anaphylactic Shock for more information.
Nonmedicinal Ingredients 
  • Nonmedicinal ingredients may be present in vaccine products, usually only in trace amounts. Consult individual vaccine monographs for the list of nonmedicinal ingredients contained in each product. See General Information and Reporting regarding management of those who report allergic reactions to vaccines or vaccine components. The Canadian Immunization Guide provides a table with contents of vaccines available for use in Canada. 
    • Adjuvants - added to enhance the immune response of a vaccine 
      • Examples: aluminum hydroxide, aluminum phosphate, AS01B, AS01E, AS04, MF59
      • If the vaccine to be administered contains an adjuvant and the vaccine recipient reports an anaphylactic reaction to a previous vaccine containing the same adjuvant, refer to primary care provider (for allergy specialist follow up) or Public Health.
    • Antibiotics - added to prevent contamination
      • Examples: gentamicin sulphate, neomycin sulphate, polymyxin B sulphate, kanamycin sulphate
        • gentamicin, neomycin, and kanamycin are aminoglycosides
        • polymyxin B is classified as miscellaneous
      • Consider if the reported allergen is a listed antibiotic or in the same class as a listed antibiotic.
        • If the reported reaction is not anaphylactic (e.g. is a contact allergy or delayed type immune reaction) the product can be administered.
      • ‘Sulfa’ allergy typically refers to allergic reaction to sulfonamide antibiotics. There is no cross-reaction between sulfonamide antibiotic allergies and sulphate salts, sulfites, or sulfur-containing medications.
    • Egg proteins (ovalbumin) - involved during the manufacturing process of some vaccines
      • Studies show that egg-allergic individuals, even those who report a severe reaction, may be vaccinated with the full dose of most vaccines without prior vaccine skin testing, even if the vaccines contain trace amounts of eggs.
      • Inactivated influenza vaccine and MMR/MMRV may have trace amounts of eggs but have been found to be safe in egg-allergic individuals.
      • **Exceptions are the rabies vaccine RabAvert® and Yellow fever vaccine, which generally should not be received by patients reporting anaphylactic reactions to eggs.
    • Latex
      • Some tips of syringe plungers, tips of prefilled syringes and vial stoppers contain latex. These products need to be avoided in those reporting anaphylactic allergic reaction to latex. For reactions other than anaphylactic (often contact allergy), latex-containing products may be used.
      • Most products will include in their monograph if their formulation contains latex.
      • For non-anaphylactic latex allergies (often contact allergy), latex-containing products may be used.
    • Polyethylene glycol - helps stabilize nanoparticles (such as in mRNA vaccines)  
      • PEG may also be found in over-the-counter (e.g. cough syrup, laxatives), and prescription medications, medical bowel preparation products for colonoscopy, skin care products, dermal fillers, cosmetics, contact lens care solutions, products such as ultrasound gel.
      • PEG may cross-react with polysorbates.
      • Avoid vaccines containing PEG if reaction was anaphylactic.
        • An exception may be previous anaphylactic reaction to PEG-containing mRNA COVID-19 vaccine. See Q3 -Anaphylactic Shock for more information.
    • Thimerosal - added as a preservative in some multidose vials
      • Thimerosal is not present in single dose vials, prefilled syringes, or intranasal vaccine (Flumist® Quadrivalent).
      • Most vaccines available for use in Canada do not contain thimerosal.
      • Thimerosal is considered safe in pregnancy.
      • Inactivated influenza vaccine - refer patients with documented allergy to thimerosal (or those requesting) to Public Health to receive a thimerosal-free product.
        • Fluzone® HD is supplied in single-dose syringes and does not contain thimerosal.
      • Other vaccines - if an individual reports a cutaneous reaction to thimerosal, thimerosal-containing vaccines do not need to be avoided. In the rare instances that an anaphylactic reaction is reported and a thimerosal-free product is not available, refer to the primary care provider or Public Health.  
    • Tromethamine [trometamol or Tris] - added as a buffer
      • This may also be found in contrast media, oral and parenteral medications.
      • Avoid vaccines containing tromethamine if reaction was anaphylactic.
        • An exception may be previous anaphylactic reaction to tromethamine-containing mRNA COVID-19 vaccine. See Q3 - Anaphylactic Shock for more information.
    • Other common ingredients:
      • buffers (such as sodium chloride [also to adjust tonicity], potassium chloride, disodium hydrogen phosphate heptahydrate, potassium dihydrogen phosphate)
      • inactivating agents (such as formaldehyde and glutaraldehyde)
      • medium nutrients (such as amino acids, calcium chloride, galactose, hydrocortisone, yeast proteins)
      • stabilizers (such as ethanol, gelatin, lactose, monosodium L-glutamate, sorbitol, sucrose)
References
LAST UPDATED: 10 oct 2023

Q3. Have you ever had a serious reaction after receiving a vaccination?

General Information and Reporting
All Vaccines
  • Note: asking about side effects to previous dose(s) can prompt a conversation with the vaccine recipient (e.g. any concerns, what to expect from subsequent dose(s), how to manage side effects).
  • If an individual reports a serious adverse reaction to previous dose(s) of a publicly funded vaccine (COVID-19 vaccine and influenza vaccine):
    • If an AEFI report was submitted, communication from the MHO should have been received by whomever submitted the AEFI report. The AEFI recommendation for further immunization may be available in the Immunization tab in the eHR Viewer; this only applies to publicly funded vaccines. See instructions of where to find   here.
    • If an AEFI report has not been submitted, gather as many details as possible and submit an AEFI report using the form found here.
    • If the reaction was an expected reaction and did not warrant AEFI report submission, provide reassurance of the safety of subsequent dose(s) and proceed with consent.
    • The Saskatchewan User Guide for Completion and Submission of AEFI Reports, which contains guidance as to reportable reactions, is available  here.
  • If an individual reports a serious adverse reaction to previous dose(s) of a non-publicly funded vaccine:
    • If an AEFI report was submitted for a non-publicly funded vaccine, the prescriber or primary care provider is to make a decision going forward (continuing the series, etc.).
    • If an AEFI report has not been submitted, gather as many details as possible and submit an AEFI report using the form found here
      • Pharmacies are to submit AEFI reports related to non-publicly funded vaccines to Health Canada, the prescriber and the primary care practitioner (if different from prescriber).
      • The prescriber or primary care practitioner is to make a decision regarding future vaccination and provide this information to the reporter. It is the reporter's responsibility to relay this information to the vaccine recipient.
    • If the reaction was an expected reaction and did not warrant AEFI report submission, provide reassurance of the safety of subsequent dose(s) and proceed with consent.
    • The Saskatchewan User Guide for Completion and Submission of AEFI Reports, which contains guidance as to reportable reactions, is available  here.
COVID-19 Vaccine

Adverse Events of Special Interest (AESI)

  • The Public Health Agency of Canada requires reporting of specific Adverse Events of Special Interest (AESI) following immunization with any COVID-19 vaccine.
  • The national AEFI form has been revised to include a section on COVID-19 AESIs (9e), which lists several reactions. However, the list of reactions designated as AESIs is evolving and users of the form are directed to Brighton Collaboration for the most current list of COVID-19 AESIs.
  • Complete the national AEFI form; indicate the AESI in Section 9e and provide details in Section 10.
  • Submit immediately to local Public Health Office.
REFERENCES
LAST UPDATED: 25 Sep 2021
LAST REVIEWED: 23 sep 2023
Anaphylactic Shock
mRNA COVID-19 Vaccines (Pfizer-BioNTech Comirnaty® and Moderna Spikevax®)
  • According to the Canadian Immunization Guide:
    • It has been shown that individuals who experience a severe immediate allergic reaction (e.g. anaphylaxis) following a 1st dose of mRNA COVID-19 vaccine can safely receive future doses of the same or another mRNA COVID-19 vaccine if a risk assessment deems that the benefits outweigh the potential risks for the individual and if informed consent is provided. The individual should:
      • Consult with an allergist or another appropriate physician before receiving future doses of an mRNA COVID-19 vaccine;
      • Receive future doses of an mRNA COVID-19 vaccine in a controlled setting with someone who is experienced in managing anaphylaxis; and
      • Be observed for at least 30 minutes after vaccination (the usual observation period for people who have not experienced a severe immediate allergic reaction after vaccination is 15 minutes).
    • For individuals  where consultation with an allergist or another appropriate physician is not possible, which precludes vaccination, Novavax Nuvaxovid™ should be offered if age-appropriate and there are no contraindications. The individual should be observed for at least 30 minutes after vaccination.
All Vaccines Other than mRNA COVID-19 Vaccine
  • Vaccines are contraindicated for individuals who have had an anaphylactic reaction to a previous dose. 
  • Refer vaccine recipients who have previously experienced severe lower respiratory symptoms (wheeze, chest tightness, difficulty breathing) within 24 hours of a vaccination, an apparent significant allergic reaction to the vaccine or any other symptoms (e.g. hives, throat constriction, difficulty swallowing) that raise concern regarding the safety of re-immunization to their primary care provider or Public Health for further assessment. Consultation with an allergist is advised. 
  • Because of the morbidity and mortality associated with vaccine-preventable diseases, a diagnosis of vaccine allergy should not be made without confirmation from medical experts.
REFERENCES
LAST UPDATED: 10 Oct 2023
Guillain-Barré Syndrome (GBS)

Guillain-Barré Syndrome (GBS) is a neurological condition that can cause paralysis.

COVID-19 Vaccine

  • Individuals who developed GBS following a dose of COVID-19 vaccine may receive subsequent doses, with informed consent, after consultation with their healthcare provider.
  • Individuals with a past history of GBS unrelated to COVID-19 vaccine should receive an mRNA COVID-19 vaccine.
  • To date, an increased risk of GBS has only been associated with viral vector COVID-19 vaccines (no longer available in Canada); no increased risk has been found with mRNA COVID-19 vaccines.
Inactivated Influenza and Live Attenuated Influenza Vaccines
  • The evidence associating influenza vaccine and GBS is inadequate to accept or reject a causal relationship and it appears there is a higher risk of GBS following influenza infection.
  • Avoiding subsequent influenza vaccination of all individuals known to have had GBS within six weeks of previous influenza vaccination is considered prudent at this time, unless another cause was identified. Refer to Public Health. 
  • Individuals who develop GBS outside the 6-week interval may receive subsequent doses of the influenza vaccine
Tetanus Toxoid-Containing Vaccine
  • Cases of GBS following toxoid-containing vaccination have been reported, though population studies have not found a causal association. Individuals who develop GBS within 6 weeks of receipt of tetanus toxoid-containing vaccine should not receive a further dose. Refer to Public Health. 
  • Individuals who develop GBS outside the 6-week interval may receive subsequent doses of the vaccine. 
REFERENCES
LAST UPDATED: 10 Oct 2023
Multisystem Inflammatory Syndrome in Children/Adolescents (MIS-C)
COVID-19 Vaccine

mRNA vaccines only (all formulations of Pfizer-BioNTech Comirnaty® and Moderna Spikevax®)

NOTE: For individuals with a history of MIS-C (not related to COVID-19 vaccination), see Q4

  • Individuals infected with SARS-CoV-2 are at risk of multisystem inflammatory syndrome (MIS), an uncommon but serious condition of hyperinflammation and multi-organ involvement that occurs 2-12 weeks following initial infection.
  • MIS has been reported rarely following vaccination with mRNA COVID-19 vaccine in individuals 12 years and older but causation has not been established.
  • There were no reports of MIS-C in the Pfizer-BioNTech (≥ 6 months to < 12 years) or Moderna Spikevax® (≥ 6 months to < 6 years) trials, though ongoing monitoring is important as such rare events would not be expected to occur in the size of these trials.
    • Because MIS is associated with SARS-CoV-2 infection, it is an Adverse Event of Special Interest. (See General Information and Reporting for information about reporting adverse events following vaccination.)
  • For individuals with a previous history of MIS, vaccination with COVID-19 vaccine should be postponed until clinical recovery has been achieved or until it has been ≥90 days since diagnosis, whichever is longer.
REFERENCES
LAST UPDATED: 31 Oct 2022
Last reviewed: 10 Oct 2023
Myocarditis and Pericarditis
COVID-19 Vaccine

mRNA (all formulations of Pfizer-BioNTech Comirnaty®, Moderna Spikevax®) and protein subunit (Novavax Nuvaxovid™) vaccines 

Individuals who developed myocarditis or pericarditis following a dose of mRNA vaccine:

  • It is unclear if individuals who developed myocarditis or pericarditis after a dose of an mRNA COVID-19 vaccine are at increased risk of further adverse cardiac effects following subsequent dose(s) of the vaccine.
  • As a precautionary measure, further doses of mRNA COVID-19 vaccine should be deferred in most individuals who developed myocarditis (with or without pericarditis) within 6 weeks of receiving a previous dose of an mRNA COVID-19 vaccine. This includes any individual who had an abnormal cardiac investigation including electrocardiogram (ECG), elevated troponins, echocardiogram or cardiac MRI after a dose of mRNA vaccine.
  • Those with a history of pericarditis following a dose of mRNA COVID-19 vaccine and who either had no cardiac workup or had normal cardiac investigations can be revaccinated once they are symptom free and at least 90 days has passed since previous COVID-19 vaccine dose. 
  • Among those with confirmed myocarditis (with or without pericarditis) following a dose of mRNA COVID-19 vaccine, administration of further doses of an mRNA COVID-19 vaccine may be considered in certain circumstances upon consultation with the individual’s specialist(s). 
    • Administration of subsequent dose(s) of an mRNA COVID-19 vaccine may be considered in certain circumstances upon consultation with the individual’s specialist(s). Considerations for subsequent dose administration may include personal risk of severe acute COVID-19 (e.g., age, underlying conditions) as well as level of COVID-19 community transmission and personal risk of infection. 
      • These individuals should be informed of the unknown risk of recurrence of myocarditis and pericarditis following a subsequent mRNA COVID-19 vaccine dose.
      • If vaccination with a dose of mRNA COVID-19 vaccine is chosen, they should wait at least until their episode of myocarditis or pericarditis has completely resolved. This includes resolution of symptoms attributed to myocarditis or pericarditis, as well as no evidence of ongoing heart inflammation or sequelae as determined by the individual's clinical team. 
    • Individuals should be advised to seek medical attention if they develop symptoms including chest pain, shortness of breath or palpitations.      
       
  • Background Information
    • Cases of myocarditis and/or pericarditis occur more often in adolescents and adults under 30 years of age, more often in males than in females, and more often after a second dose of an mRNA vaccine than after a first dose. 
    • A higher rate of cases of myocarditis and/or pericarditis had been reported after the administration of Moderna Spikevax® 100 mcg compared to Pfizer-BioNTech Comirnaty® 30 mcg. However, no  reports of vaccine-related myocarditis or pericarditis have been reported with the later formulations (i.e., bivalent) of Moderna Spikevax® or Pfizer-BioNTech Comirnaty®, though data are too small to detect rare events.
    • To date, the majority of affected individuals, while hospitalized, have responded well to conservative therapy and tend to recover quickly.
    • Symptoms of myocarditis/pericarditis can include shortness of breath, chest pain, or the feeling of a rapid or abnormal heart rhythm. 
REFERENCES
LAST UPDATED: 10 Oct 2023
Oculorespiratory Syndrome (ORS)
Inactivated Influenza and Live Attenuated Influenza Vaccines
  • Oculorespiratory syndrome (ORS) has been reported rarely in association with influenza vaccine.
  • The syndrome consists of bilateral conjunctivitis plus at least one respiratory symptom with or without facial edema that begins within 24 hours of influenza vaccination.
    • Respiratory symptoms include cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, and sore throat.
  • Individuals who have experienced ORS with lower respiratory tract symptoms and/or in whom an anaphylactic reaction cannot be ruled out need to be referred.
  • Individuals who have experienced ORS without lower respiratory tract symptoms may safely receive subsequent influenza vaccination.
  • ORS is a reportable AEFI when bilateral conjunctivitis AND at least one respiratory symptom (with or without facial edema) occurs within 24 hours of influenza vaccination.
References
Last updated: 10 Oct 2023
Thrombosis with Thrombocytopenia Syndrome (TTS) (including VITT)
COVID-19 Vaccine

NOTE: In Canada, thrombosis with thrombocytopenia syndrome (TTS) following vaccination with viral vector COVID-19 vaccines in combination with the presence of a specific biomarker is termed vaccine-induced thrombotic thrombocytopenia (VITT) and considered a subset of TTS.

  • The combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been reported post-market following vaccination with viral vector COVID-19 vaccines.
    • Viral vector COVID-19 vaccines are no longer available in Canada. 
  • Individuals who have experienced TTS following vaccination with a viral vector COVID-19 vaccine may receive further doses of mRNA COVID-19 vaccines following consultation with their clinical team, which may include a hematologist.
REFERENCE
LAST UPDATED: 10 Oct 2023
Reactions of No Concern

Reactions from past vaccines that may be reported but do not warrant withholding future vaccinations:

  • extensive limb swelling
  • syncope
  • febrile seizure
  • cutaneous reactions
REFERENCE
LAST REVIEWED: 25 Sep 2021
LAST REVIEWED: 10 Oct 2023

Q4. Do you have any of the following medical conditions?

Asthma, Severe
Live Attenuated Influenza Vaccine (LAIV)
  • LAIV is not recommended for individuals with severe asthma (defined as currently on oral or high dose inhaled glucocorticoids or active wheezing) or those who have had to seek medical attention for wheezing in the 7 days prior to vaccination.
  • LAIV can be given to individuals with stable, non-severe asthma.
REFERENCE
LAST REVIEWED: 21 Sep 2023
Autoimmune Disorder
All Vaccines
  • Autoimmune conditions are generally not immunosuppressive. However, several of these conditions may be treated with medications that cause moderate to severe immunosuppression. If individual takes medication(s) that may be immunosuppressive, also see information for:
    • Q4 - Condition that affects the immune system
    • Q5 - Medications that cause immunosuppression
COVID-19 Vaccine
  • Preferably patients discuss the vaccine with their primary care provider (PCP)/specialist prior to presenting. Document details if they report having the discussion. However:
    • If they have not discussed vaccination with their PCP/specialist AND their condition is UNSTABLE, refer to PCP/specialist or area Medical Health Officer.
    • If they have not discussed vaccination with their PCP/specialist AND their condition is STABLE, consider immunization. Timing of the vaccine and dosing of some disease-specific drugs and a patient's immune status may need to be considered and warrant referral to a specialist (see below).
    • Refer recipients of stem cell transplants to specialist.     
  • Informed consent in this population may include the following considerations:
    • the individual's risk of COVID-19 including comorbidities and level (if any) of immunosuppression,
    • the individual's level of exposure to COVID-19,
    • current stability/control of the autoimmune condition,
    • data regarding safety and effectiveness
      • data from primarily mRNA COVID-19 vaccine indicates the safety (frequency and severity of adverse effects) in those with autoimmune conditions is comparable to those without autoimmune conditions,
      • the vaccine antibody response in individuals with autoimmune conditions who take immunosuppressive therapy may not be as strong as the immune response in individuals not taking these therapies; immunized individuals still need to take precautions against COVID–19 disease.

Common Autoimmune Conditions* (not an exhaustive list)

Addison'sErythema nodosumKawasaki diseasePsoriatic arthritis
Alopecia areataFibromyalgiaLupusRaynaud's syndrome
AmyloidosisGraves' diseaseMeniere's diseaseRestless legs syndrome
Ankylosing spondylitisGuillain-Barré syndromeMultiple SclerosisRheumatoid arthritis
Celiac diseaseHashimoto's thyroiditisMyasthenia gravisSarcoidosis
Crohn's diseaseHemolytic anemiaNeutropeniaScleroderma
Diabetes Type 1Henoch-Schonlein purpuraOptic neuritisThrombocytopenia  purpura
EndometriosisJuvenile arthritisPsoriasisUlcerative colitis

*list obtained from American Autoimmune Related Disease Ltd. https://www.aarda.org/diseaselist/  

REFERENCES
LAST UPDATED:16 oct 2023
Bleeding problems (e.g. haemophilia, thrombocytopenia)
All Vaccines: 
  • Bleeding disorders are NOT contraindications to injectable vaccine administration. To reduce bleeding risk:
    • A fine gauge needle (23, 25, or 27 G) should be used.
    • Apply direct pressure (without rubbing) to the injection site for ≥2 minutes after injection to stop the bleeding.
  • For patients with haemophilia, if there is concern that the injection may stimulate bleeding, schedule the injection shortly after the administration of anti-haemophilia therapy. It is advisable to administer the vaccine approximately 3-4 hours after the anti-haemophilia therapy that decreases the risk of bleeding and haematoma. See Saskatchewan Immunization Manual - Chapter 7 for more details.
Measles-Mumps-Rubella (MMR) and Measles-Mumps-Rubella-Varicella (MMRV) Vaccines
  • Always consult with the individual’s physician/specialist prior to MMR immunization if they have had an episode of idiopathic thrombocytopenia in the past.
REFERENCES
LAST UPDATED: 21 Sep 2023
Lymphatic circulation impairment (e.g. lymphedema, axillary lymph node removal, amputation)
All Vaccines
  • Injection of a vaccine into an area where lymphatic circulation may be impaired (e.g. deltoid injection in an individual with local lymphedema, lymphangioma, axillary lymph node dissection, A-V fistula, upper limb amputation) could theoretically result in an impaired immune response due to impaired vaccine absorption, although there are no data to support this. Consider an alternative injection site if possible.
    • Note that axillary lymph node dissection is most commonly associated with mastectomy and lumpectomy, though not all patients who have undergone these procedures have lymph node dissection so this should be clarified if possible.
    • If lymphatic circulation impairment is unilateral, inject in the opposite arm; if bilateral, the vastus lateralis is a suitable alternate site.
      • Landmarking for vastus lateralis
        • With the individual in the seated position, visually divide the length of the muscle from the greater trochanter of the femur to the lateral border of the kneecap into thirds.
        • Visually divide the width of the outer thigh in two with a horizontal line.
        • The injection site is in the middle third, just above the horizontal line.
          • See the vastus lateralis landmarking demonstration video.
    • Dorsogluteal is NOT an acceptable alternative site.
      • This injection site is not used for active immunization because it is less immunogenic for vaccines.
  • As this is a theoretical concern, some individuals, in consultation with their healthcare providers, may decide to use the deltoid even if bilateral involvement.
REFERENCES
LAST REVIEWED: 21 Sep 2023
Multisystem Inflammatory Syndrome in Children (MIS-C)

mRNA COVID-19 vaccines only (all formulations of Pfizer-BioNTech Comirnaty® and Moderna Spikevax™)

NOTE: this question relates to MIS-C unrelated to COVID-19 vaccination. If MIS was experienced following receipt of mRNA COVID-19 vaccine, see Q3.

  • Individuals infected with SARS-CoV-2 are at risk of multisystem inflammatory syndrome (MIS), an uncommon but serious condition of hyperinflammation and multi-organ involvement that occurs 2-12 weeks following initial infection.
  • For individuals with a previous history of MIS, vaccination with COVID-19 vaccine should be postponed until clinical recovery has been achieved or until it has been ≥ 90 days since diagnosis, whichever is longer.
REFERENCES
LAST UPDATED: 30 Oct 2023
Condition Affecting the Immune System
  • As applicable, also see information for:
    • Q4 - Autoimmune Disorder
    • Q4 - Cancer
    • Q4 - HIV Infection
    • Q4 - Transplant
    • Q5 - Medications that Affect the Immune System
  • See the Saskatchewan Immunization Manual - Chapter 7 and the Canadian Immunization Guide - Immunization of Immunocompromised Persons for more details.
  • Individuals may be immunocompromised because of medications/treatments and/or their condition(s). 
  • In general, immunocompromised individuals are more susceptible to vaccine-preventable infections and may have severe infections, making vaccination even more important. The safety and effectiveness of vaccines in immunocompromised individuals are determined by the type of immunodeficiency and degree of immunosuppression.
  • Moderately to severely immunocompromised individuals can include those with the following conditions:
    • immunocompromised due to solid tumour or hematologic malignancies or treatment of these conditions
    • recipients of solid-organ transplant and taking immunosuppressive therapy
    • recipients of hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppressive therapy)
    • recipients of chimeric antigen receptor (CAR)-T-cell therapy
    • moderate to severe primary immunodeficiency with associated humoral and/or cell-mediated immunodeficiency or immune dysregulation
    • HIV with AIDS-defining illness or TB diagnosis in last 12 months before starting vaccine series, or severe immune compromise with CD4 count < 200 cells/µL or CD4% < 15%, or without HIV viral suppression  
    • recipients of active treatment with the following categories of immunosuppressive therapies:
      • anti-B cell therapies (monoclonal antibodies targeting CD19, CD20 and CD22)
      • high-dose systemic corticosteroids (prednisone equivalent of ≥ 40 mg per day for more than 1 week)
      • alkylating agents, antimetabolites, or tumor-necrosis factor (TNF) inhibitors and other biologic agents that are significantly immunosuppressive
      • see Immunosuppressive Potential of Medications (not including oncological agents) for more information
    • chronic kidney disease on dialysis
COVID-19 Vaccine
  • Immunocompromised individuals should discuss the COVID-19 vaccine with their primary care provider (PCP)/specialist prior to presenting. The main concern is diminished response to the vaccine.
  • See Q4-Cancer & HSCT and Q4-Solid Organ Transplant, as applicable, for patients who must consult with their primary care provider/specialist and for timing of doses with respect to procedures and treatments.
  • If the individual discussed the vaccine with their PCP/specialist, document these details. However:  
    • If they have not discussed vaccination with their PCP/specialist AND their condition is UNSTABLE, refer to PCP/specialist or their area Medical Health Officer.
    • If they have not discussed vaccination with their PCP/specialist AND their condition is STABLE, consider immunization. Timing of the vaccine and dosing of some disease-specific drugs and a patient's immune status may need to be considered and warrant referral to a specialist. 
  • Individuals who are moderately to severely immunocompromised may need to receive a different number of doses at different intervals compared to immunocompetent individuals. Refer to the Saskatchewan Immunization Manual Chapter 10  or COVID-19 Vaccines→ Vulnerable Populations for details.  
  • Informed consent in this population may include the following considerations:
    • the individual’s risk of COVID-19 including level of immunosuppression and comorbidities,
    • the individual’s level of exposure to COVID-19,
    • data regarding safety and effectiveness
      • data from primarily mRNA COVID-19 vaccine indicates the safety (frequency and severity of adverse effects) in those who are immunosuppressed is comparable to those who are not immunosuppressed,
      • immunogenicity and vaccine effectiveness of COVID-19 vaccines are lower in those who are moderately to severely immunocompromised compared to those who are not
        • immunized individuals who are immunosuppressed still need to take precautions against COVID-19 infection
Inactivated Influenza and Other Inactivated Vaccines
  • The immune response to inactivated vaccines may be suboptimal (depending on level of immunodeficiency).
    • Try to immunize before immunosuppression ensues (if possible); otherwise, try to immunize at time of anticipated maximum immune response (though this is often not established).
Live Vaccines
  • Administration of live vaccines may cause uncontrollable replication of the virus or bacterium and result in serious adverse events in immunocompromised patients.
  • If available, use an inactivated form of the antigen (e.g. herpes zoster, influenza, typhoid).
  • If live vaccine is required and no inactivated form is available/suitable, refer to Travel Health Centre/ Specialty Immunization Clinic (Saskatoon, Regina, or Prince Albert). Contact Public Health or Travel Health Centres to be directed in other areas of the province.
    • Some live vaccines (e.g. MMR, varicella) are given to some of these patients depending on degree of immunosuppression, susceptibility, age and vaccine history. See the Saskatchewan Immunization Manual - Chapter 7 for details but refer these patients.
REFERENCES
LAST UPDATED: 16 oct 2023

Q4. Cancer and Hematopoietic Stem Cell Transplant (HSCT)

COVID-19 Vaccine
  • Also see information for:
    • Q4 - Condition Affecting the Immune System
    • Q4 - Lymphatic Circulation (if applicable)
    • Q5 - Medications that Affect the Immune System (if applicable) 
       
  • Cancer survivors should be offered vaccination if there are no contraindications. Vaccinate as any other individual who does not have a precaution or contraindication.
  • Most patients being treated for cancer should be offered vaccination, though the timing around treatment needs to be considered.
  • It is preferred that all clients with cancer or being treated for cancer consult their cancer care team.
  • Patients being treated for cancer with the following treatments can receive the vaccine at any time:
    • targeted hormonal treatments
    • single agent immune therapy
    • radiation therapy
  • Timing of vaccination around treatments may need to be considered for patients receiving the agents listed below. See the COVID-19 Contraindications & Precautions Background Document for details and/or consult Saskatchewan Cancer Agency team.
    • cytotoxic chemotherapy
    • hematopoietic stem cell transplant (MUST consult with oncology team prior to vaccination - see more details below)
    • B-cell directed therapy 
      • Anti CD20 antibodies (rituximab, afutuzumab)
      • Anti CD19 antibodies (blinatumomab)
      • Anti CD22 antibodies (inotuzumab ozogamicin)
      • BTK inhibitors (ibrutinib)
    • T-cell directed therapy
      • calcineurin inhibitors (cyclosporine)
      • ATG (antithymocyte globulin – rabbit and equine)
      • alemtuzumab
  • Hematopoietic Stem Cell Transplant (HSCT) recipients MUST speak to their cancer care team / specialist. See the Contraindications and Precautions Background Document or COVID-19 Vaccines→ Vulnerable Populations for more details about recommended COVID-19 schedules and timing for HSCT recipients. 
 REFERENCE
LAST UPDATED: 19 Oct 2023
Inactivated Influenza Vaccine
  • Also see information for:
    • Q4 - Condition Affecting the Immune System
    • Q4 - Lymphatic Circulation (if applicable)
    • Q5 - Medications that Affect the Immune System (if applicable) 
       
  • Inactivated influenza vaccine (IIV) is strongly recommended for individuals with cancer unless medically contraindicated. Refer to the Saskatchewan Cancer Agency’s (SCA) Influenza Immunization Guideline 2023 for all individuals with cancer. This document addresses:
    • medical contraindications to IIV
    • timing of IIV in relation to anticancer treatments
    • recommendations for candidates, donors and recipients of stem cell transplants (SCT)
    • how to determine specific anticancer treatments of individuals
    • encouragement to immunize close contacts with IIV 
       
  • Hematopoietic Stem Cell Transplant (HSCT) recipients  
    • HSCT recipients should not receive IIV if the stem cell transplant was less than 4 months previous in adults and less than 6 months previous for pediatrics.
    • HSCT candidates: if transplant planned for influenza season, IIV should be received ≥ 2 weeks prior to beginning the conditioning regimen.
    • HSCT donors: if harvest planned for influenza season, IIV should be received ≥ 2 weeks prior to harvest. 
    • Autologous HSCT patients: if harvest planned for influenza season, IIV should be received ≥ 2 weeks prior to harvest. 
    • Contacts of of HSCT recipients who have received transplant within the last 2 months or who have graft-versus-host disease: receive IIV (not live attenuated). 
       
  • Tip: For the vast majority of patients receiving cancer treatment, influenza immunization is recommended and even more so with COVID-19 circulating. However, there are a few exceptions that can be found in the Saskatchewan Cancer Agency’s (SCA) Influenza Immunization Guideline 2023.
    • If possible, inquiring if an individual has/is receiving cancer treatment before arriving for vaccination (e.g., through online or phone booking) is helpful in catching these particular individuals who should not receive IIV.
REFERENCE
LAST Updated: 16 Oct 2023
Other Inactivated Vaccines
General
  • Also see information for:
    • Q4 - Condition Affecting the Immune System
    • Q4 - Lymphatic Circulation (if applicable)
    • Q5 - Medications that Affect the Immune System (if applicable)
  • Inactivated vaccines can be safely administered at any time before, during or after immunosuppression; however, response may be suboptimal depending on degree of immunosuppression during anticancer treatment.
  • Refer to SCA’s Influenza Immunization Guideline 2023, which provides durations to wait before administering inactivated influenza vaccine.
    • The durations in this document would be minimum durations for other inactivated vaccines.
    • Depending on the vaccine and risk of infection, the decision may be made to defer vaccination until immune function has been restored (or improved).
    • Consult with SCA regarding suitability and timing of other inactivated vaccines.
    • Timing and vaccine requirements vary among those who have received stem cell transplant (SCT). Refer to or consult with SCA to ensure appropriate vaccination and timing.
    • SCT donors should receive inactivated vaccines at least 2 weeks prior to stem cell collection.
  • In general, if a patient is 3 months post-chemotherapy or if immunosuppression has been discontinued for at least 3 months (6 months or more for anti-B cell antibodies), the cancer is in remission and T cell function is normal, the individual is no longer considered immunocompromised.
Hepatitis B Vaccine
  • For immunocompromised individuals, hepatitis B vaccine should be given at double the dose and using a 3- or 4-dose schedule.
Human Papillomavirus Vaccine
  • For immunocompromised individuals, human papillomavirus vaccine should be given following routine age indications but using a 3-dose schedule, regardless of age.
REFERENCES
LAST reviewed: 16 oct 2023
Live Vaccines
  • Also see information for:
    • Q4 - Condition Affecting the Immune System
    • Q4 - Lymphatic Circulation (if applicable)
    • Q5 - Medications that Affect the Immune System (if applicable)
  • Live vaccines should not be administered during anticancer treatment and for at least:
    • 3 months after completion of chemotherapy and/or radiotherapy, if cancer is in remission and T cell function is normal.
    • 6 months or more after completion of anti-B cell antibodies (e.g. rituximab, obinutuzumab, alemtuzumab), if cancer is in remission and T cell function is normal.
    • 24 months post stem cell transplant. Consultation with the Saskatchewan Cancer Agency (SCA) or Travel Health Centre/ Specialty Immunization Clinic is required prior to immunization with live vaccines.
  • Live vaccines should be given at least 4 weeks before the start of immunosuppressive therapy to reduce risk of disease caused by the antigen.
  • If available, use an inactivated form of the antigen (e.g. herpes zoster, influenza, typhoid).
  • Consult SCA if immune status unknown and live vaccine is only option.
REFERENCE
LAST REVIEWED: 22 Sep 2023

Q4. HIV infection

COVID-19 and Inactivated Influenza Vaccines
General
  • Also see information for Q4 - Condition Affecting the Immune System
  • HIV infection is not a contraindication to inactivated vaccines.
  • Inactivated vaccines can be administered at any point in course of infection.
    • If immune suppression is severe in an untreated or newly treated individual and likelihood of exposure to the vaccine-preventable disease is low, may consider deferring vaccination pending immune recovery after effective antiretroviral therapy. These individuals should be referred to Travel Health Centre/ Specialty Immunization Clinic (Saskatoon, Regina, or Prince Albert). Contact Public Health or Travel Health Centres to be directed in other areas of the province.
COVID-19 Vaccine
  • Individuals living with HIV who are considered immunocompetent may be vaccinated at any time. If there is doubt regarding immunocompetency status, consult or refer to primary care provider/ specialist.
  • Individuals living with poorly controlled HIV (i.e. AIDS-defining illness or TB diagnosis in last 12 months before starting vaccine series, or severe immune compromise with CD4 count <200 cells/µL or CD4% <15%, or without HIV viral suppression) are considered moderately to severely immunocompromised. 
Inactivated Influenza Vaccine
  • Inactivated influenza vaccine is recommended annually for those 6 months and older.
REFERENCES
LAST UPDATED: 16 oct 2023
Other Inactivated Vaccines
General
  • Also see information for Q4 - Condition Affecting the Immune System.
  • HIV infection is not a contraindication to inactivated vaccines.
  • Inactivated vaccines can be administered at any point in the course of infection.
    • If immune suppression is severe in an untreated or newly treated individual and likelihood of exposure to the vaccine-preventable disease is low, may consider deferring vaccination pending immune recovery after effective antiretroviral therapy. These individuals should be referred to Travel Health Centre/ Specialty Immunization Clinic (Saskatoon, Regina, or Prince Albert). Contact Public Health or Travel Health Centres to be directed in other areas of the province.
 Hepatitis B Vaccine
  • Hepatitis B vaccine should be given at double the routine dose and using a 3- or 4-dose schedule.
  • Post-immunization titres should be done one month after completing a primary hepatitis B vaccine series.
 Human Papillomavirus Vaccine (HPV)
  • In individuals with HIV who are considered immunodeficient, HPV vaccine should be given following routine age indications but using a 3-dose schedule, regardless of age.
Rabies Vaccine
  • Post-immunization titres should be done one month after completing a rabies vaccine series.
REFERENCES
LAST REVIEWED: 22 Sep 2023
Live Vaccines
  • Also see information for Q4 - Condition Affecting the Immune System.
Live Attenuated Influenza Vaccine (LAIV)
  • Children: NACI recommends inactivated influenza vaccine be used in children with HIV infection but if IM injection is unacceptable by parent or substitute decision maker, LAIV can be administered to children with HIV infection who meet the following criteria:
    • age 2–17 years; and
    • have been receiving HAART for ≥4 months; and
    • have a CD4 count ≥500/µL if 2–5 years of age, or ≥200/µL if 6–17 years of age (measured within 100 days before administration of LAIV); and
    • have HIV plasma ribonucleic acid (RNA) <10,000 copies/mL (measured within 100 days before administration of LAIV).
  • Adults: LAIV is contraindicated in adults with HIV infection due to the lack of evidence for its immunogenicity and safety in this population, and given that LAIV may be less effective than inactivated influenza vaccine in adults.
 Other Live Vaccines
  • If available, use an inactivated form of the antigen (e.g. herpes zoster, typhoid).
  • Refer to Travel Health Centre/ Specialty Immunization Clinic (Saskatoon, Regina, or Prince Albert). Contact Public Health or Travel Health Centres to be directed in other areas of the province. While some live vaccines may be appropriate, the risks and benefits need to be carefully considered in consultation with an infectious disease specialist/immunologist.
REFERENCES
LAST REVIEWED: 22 Sep 2023

Q4. Solid Organ Transplant

All Vaccines Other than COVID-19 and Inactivated Influenza
  • Also see information for:
    • Q4 - Condition Affecting the Immune System
    • Q5 - Medications that Affect the Immune System
  • Most transplant candidates and recipients require vaccinations pre- and post-transplant; the vaccines and their scheduling will be determined by the transplant program and administered by Public Health.
    • Refer patients to Public Health for vaccinations, with the exception of COVID-19 and inactivated influenza vaccines.
REFERENCE
LAST UPDATED: 04 Nov 2021
LAST REVIEWED: 26 Oct 2022
COVID-19 Vaccine
  • Also see information for:
    • Q4 - Condition Affecting the Immune System
    • Q5 - Medications that Affect the Immune System 
       
  • Medically stable solid organ transplant patients followed up by the Saskatchewan Transplant Program DO NOT NEED to consult their specialist prior to immunization with COVID-19 vaccine.
  • See the Contraindications and Precautions Background Document or COVID-19 Vaccines→ Vulnerable Populations for information about recommended COVID-19 schedules and timing for SOT candidates and recipients.
REFERENCE
LAST UPDATED: 19 oct 2023
Inactivated Influenza Vaccine
  • Also see information for:
    • Q4 - Condition Affecting the Immune System
    • Q5 - Medications that Affect the Immune System
  • Solid Organ Transplant Recipients
    • Medically stable solid organ transplant patients followed up by the Saskatchewan Transplant Program DO NOT NEED to consult their specialist prior to immunization with inactivated influenza vaccine.
    • EXCEPTIONS – The following patients need to contact the Saskatchewan Transplant Program to determine if and when they should receive the vaccine:
      • those who received a recent transplant (less than 1 month ago),
      • those who were recently treated for rejection (less than 1 month ago), and
      • those for whom the immunizer is unsure of eligibility.
REFERENCES
  • Communication with Nicola Rosaasen, Pharmacist, the Saskatchewan Transplant Program
LAST UPDATED: 04 Nov 2021
LAST REVIEWED: 26 Oct 2022

Q5. Do you take any of the following medications?

Anticoagulants/Antiplatelets 

Includes, but not limited to: 

  • Anticoagulants
    • direct acting anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban)
    • heparin, unfractionated
    • low molecular weight heparins (LMWH) (e.g., dalteparin, enoxaparin, nadroparin, tinzaparin) 
    • warfarin
  • Antiplatelets
    • acetylsalicylic acid (i.e., ASA, aspirin)
    • dipyridamole + ASA
    • irreversible P2Y12 inhibitors (e.g., clopidogrel, prasugrel, ticagrelor)
All Vaccines
  • Use of anticoagulants/antiplatelets is NOT a contraindication to injectable vaccine administration. To reduce bleeding risk:
    • A fine gauge needle (23, 25, or 27 G) should be used.
    • Apply direct pressure (without rubbing) to the injection site for ≥2 minutes after injection to stop the bleeding.
REFERENCE
LAST updated: 30 oct 2023
Medications that Affect the Immune System
  • As applicable, also see information for:
    • Q4 - Autoimmune Disorder
    • Q4 - Condition Affecting the Immune System
    • Q4 - Cancer
    • Q4 - HIV Infection
    • Q4 - Transplant
  • In general, immunocompromised individuals are more susceptible to vaccine-preventable infections and may have severe infections, making appropriate vaccination even more important. The safety and effectiveness of vaccines in immunocompromised individuals are determined by the type of immunodeficiency and degree of immunosuppression.
  • Certain medications (e.g. calcineurin inhibitors, monoclonal antibodies, other biologics, cytotoxic drugs) used post-transplant or to treat conditions such as cancer, and inflammatory conditions such as rheumatoid arthritis, Crohn’s disease, psoriasis, etc. may have a significant effect on the immune system.
  • Corticosteroid therapy is not considered immunosuppressive when:
    • steroid therapy is short-term (i.e., less than 14 days)
      • e.g. 75 mg prednisone once daily x 5 days 
    • a low to moderate dose (i.e. < 2 mg/kg/day for a child or < 20 mg/day for an adult of prednisone or its equivalent)
      • e.g. 15 mg prednisone (adult) once daily x 4 months
    • long-term, alternate-day treatment with short-acting preparations
      • e.g. 7.5 mg prednisone (adult) every other day
    • maintenance physiologic replacement therapy
    • administered topically, inhaled, or locally injected (e.g. intra-articular injection).
  • There should be an interval of at least 4 weeks after discontinuation of high-dose systemic steroids (if taken for more than 14 days) before vaccines are administered.
COVID-19 Vaccine
Inactivated Influenza Vaccine and Other Inactivated Vaccines
ALL INACTIVATED VACCINES
  • As these individuals are at greater risk of infection, up-to-date immunization, including annual inactivated influenza vaccine, is important, even if a lower immune response is expected.
  • If risk of exposure is low, consideration may be given to deferring inactivated vaccines until the individual is the least immunosuppressed.
  • Doses may need to be repeated when the individual is no longer immunosuppressed unless antibody response can be demonstrated.
  • For those receiving anticancer treatment, refer to the Saskatchewan Cancer Agency’s (SCA) Influenza Immunization Guideline 2023, which provides durations to wait before administering inactivated influenza vaccine.
    • The durations in this document would be minimum durations for other inactivated vaccines.
    • Depending on the vaccine and risk of infection, the decision may be made to defer vaccination until immune function has been restored (or improved).
    • Consult with SCA regarding suitability and timing of other inactivated vaccines.
HEPATITIS B VACCINE
  • For individuals who are taking immunosuppressive medications, hepatitis B vaccine should be given at double the dose and using a 3- or 4-dose schedule.
 HUMAN PAPILLOMAVIRUS VACCINE
  • For individuals who are taking immunosuppressive medications, HPV vaccine should be given following routine age indications but using a 3-dose schedule, regardless of age.
Live Vaccines
ALL LIVE VACCINES
  • In most cases, live vaccines are contraindicated in immunocompromised individuals due to the risk of uncontrollable replication of the virus or bacterium which could result in serious adverse events.
  • Live vaccines should be given prior to initiation of immunosuppressive therapy (≥ 4 weeks) or at least 3 months (6 months if anti-B cell antibodies, e.g. rituximab) after therapy is discontinued to reduce the risk of disease caused by the vaccine strain.
  • If available, use an inactivated form of the antigen (e.g. influenza, typhoid).
  • If live vaccine is required and no inactivated form is available/suitable, refer to Travel Health Centre/ Specialty Immunization Clinic (Saskatoon, Regina, or Prince Albert). Contact Public Health or Travel Health Centres to be directed in other areas of the province.
    • Some live vaccines (e.g. MMR, varicella) are given to some of these patients depending on degree of immunosuppression, susceptibility, age and vaccine history. See the Saskatchewan Immunization Manual Chapter 7 for details but refer these patients.
  • The safety and efficacy of live vaccines during low dose intermittent or maintenance therapy with non-corticosteroid immunosuppressive drugs are generally unknown. 
    • A careful risk-benefit assessment should be done if live vaccines are to be considered in patients on low dose immunosuppression.
    • See varicella vaccines below for definition and exceptions.
VARICELLA VACCINES
  • These live vaccines can be considered in those taking low-dose immunosuppression defined as:
    • methotrexate ≤ 0.4 mg/kg/week
    • azathioprine ≤ 3 mg/kg/day
    • 6-mercaptopurine ≤ 1.5 mg/kg/day
    • prednisone or its equivalent (< 2 mg/kg/day for a child or < 20 mg/day for an adult) 
  • If combination low dose immunosuppression is being used, consult or refer to Travel Health Centre/ Specialty Immunization Clinic (Saskatoon, Regina, or Prince Albert). Contact Public Health or Travel Health Centres to be directed in other areas of the province. 
REFERENCES
LAST UPDATED: 17 Oct 2023
Antiviral Medications or Antibiotics
COVID-19, Inactivated Influenza, and Other Inactivated Vaccines
  • Individuals with any new or worsening respiratory symptoms (e.g., fever, cough, sore throat, runny nose) should defer vaccination.
  • There is no reason to withhold inactivated vaccines for the sole reason that an individual is taking antibacterials or antivirals (including those active against COVID-19 [e.g. Paxlovid™, remdesivir], influenza [e.g. oseltamivir, zanamivir], and varicella [e.g. acyclovir, famciclovir, valacyclovir]).
Live Vaccines
LIVE ATTENUATED INFLUENZA VACCINE
  • Live Attenuated Influenza Vaccine (LAIV) should not be administered for at least 48 hours after antiviral agents active against influenza (oseltamivir, zanamivir) are stopped, and these antiviral agents, unless medically indicated, should not be administered until two weeks after receipt of LAIV so that the antiviral agents do not kill the replicating virus.
    • If these antiviral agents are administered within this time frame (i.e., between 48 hours before and two weeks after LAIV is given), revaccination should take place at least 48 hours after the antivirals are stopped.
MEASLES-MUMPS-RUBELLA-VARICELLA (MMRV) and VARICELLA VACCINES
  • Systemic antiviral therapy active against varicella zoster virus (e.g. acyclovir, valacyclovir, famciclovir) should be avoided for at least 24 hours before vaccine administration and not be restarted until at least 14 days after vaccine administration.
    • Antivirals could affect the reproduction of and reduce the efficacy of varicella-containing vaccine.
LIVE ORAL TYPHOID VACCINE
  • Live oral typhoid vaccine should be finished at least 3 days before starting, or initiated at least 3 days after completing, treatment with antibiotics active against Salmonella typhi.
REFERENCES
LAST updated: 17 oct 2023

Q6. Are you pregnant, could you be pregnant or are you planning on becoming pregnant?

COVID-19 Vaccine
  • Pregnancy is not a contraindication to any of the COVID-19 vaccines.
    • Receiving COVID-19 vaccine of any type is not a reason to terminate pregnancy.
    • Those who are trying to become pregnant do not need to avoid pregnancy after vaccination with an mRNA vaccine.
  • It is highly recommended that pregnant individuals receive COVID-19 vaccination, regardless of the trimester of pregnancy; mRNA COVID-19 vaccines are preferred on account of more safety data.
    • Pregnant individuals are at higher risk of acquisition of and complications from COVID-19 infection compared to non-pregnant individuals.
    • Data from original mRNA COVID-19 vaccines have shown that vaccination during pregnancy confers protection to the pregnant individual as well as the infant, especially during the first 2 months of life due to the maternal immune response and antibodies transferring across the placenta to the fetus.
  • No adverse effects specific to pregnancy have been identified.
  • Recombinant protein subunit (e.g. Novavax Nuvaxovid™) COVID-19 vaccine can be offered if the individual is not willing or able to receive an mRNA COVID-19 vaccine; the individual should be informed that safety and effectiveness of this vaccine in pregnancy have not been established. 
  • Informed consent in this population may include the following considerations:
    • the individual’s risk of COVID-19 including comorbidities
    • the individual’s level of exposure to COVID-19
    • the potential for greater risk of complications in pregnant individuals who are infected with SARS-CoV-2 compared to individuals who are infected with SARS-CoV-2 and not pregnant
    • the safety and immunogenicity data of mRNA COVID-19 vaccinations in pregnancy
    • the lack of safety and efficacy data for non-mRNA COVID-19 vaccines in pregnancy
    • this SOGC statement may help guide the informed consent conversation
REFERENCES
LAST UPDATED: 17 oct 2023
Inactivated Influenza Vaccine
  • It is particularly recommended that pregnant individuals, at all stages, receive inactivated influenza vaccine for the following reasons:
    • risk of influenza-associated morbidity in pregnant individuals,
    • evidence of adverse neonatal outcomes associated with maternal respiratory hospitalization or influenza during pregnancy,
    • evidence that vaccination during pregnancy protects the newborn from influenza and influenza-related hospitalizations, and
    • evidence that infants born during the influenza season to vaccinated individuals are less likely to be premature, small for gestational age, and of low birth weight compared to those born to unvaccinated pregnant individuals.
  • The risk of influenza-related hospitalizations increases throughout gestation.
  • No harms to fetuses or pregnant individuals have been identified.
    • While active studies of influenza vaccine in pregnant individuals are relatively few, a large body of surveillance data exists from widespread use of the inactivated influenza vaccine during pregnancy over several decades.  
REFERENCE
LAST UPDATED: 06 Oct 2022
Last reviewed: 11 oct 2023
Other Inactivated Vaccines
General
  • Vaccination during pregnancy protects the pregnant individual as well as the fetus/infant from vaccine-preventable diseases.
  • There are no precautions or concerns with most inactivated vaccines in pregnancy (see exceptions below).
  • Several vaccines are recommended during pregnancy. See Canadian Immunization Guide-Immunization in Pregnancy and Breastfeeding for details.

The following vaccines should be avoided in pregnancy:   

Human Papillomavirus Vaccine
  • This vaccine is not recommended during pregnancy due to limited safety and effectiveness data.
  • Initiation or continuation of the series should be delayed until after pregnancy; however, if a dose is inadvertently received during pregnancy, no intervention is required.
Recombinant Herpes Zoster Vaccine
  • This vaccine should be used with caution in pregnant individuals due to no data in this population (though is unlikely to be indicated).
REFERENCE
LAST REVIEWED: 11 oct 2023
Live Vaccines
General
  • In general, live vaccines are contraindicated in pregnancy, as there is a theoretical risk to the fetus.
    • There may be some individual cases in which the benefits outweigh the theoretical risk (e.g. rubella outbreak).
  • If a live vaccine is indicated, pregnancy should be delayed for 1 month.
REFERENCES
LAST updated: 17 oct 2023

Q7. Are you breastfeeding/chestfeeding?

COVID-19
  • Breastfeeding/chestfeeding is not a contraindication to receiving any of the COVID-19 vaccines nor is receiving a COVID-19 vaccine a reason to stop breastfeeding/chestfeeding.
  • NACI recommends COVID-19 vaccination in breastfeeding/chestfeeding individuals; mRNA COVID-19 vaccines are preferred on account of more safety data.
    • No adverse events have been identified in breastfeeding/chestfeeding individuals or their nursing infants.
  • Recombinant protein subunit COVID-19 vaccine (i.e. Novavax Nuvaxovid™) may be offered if the individual is not willing or able to receive an mRNA COVID-19 vaccine; however, safety and efficacy of this vaccine in breastfeeding/chestfeeding individuals have not been established.
  • Informed consent in this population may include the following considerations:
    • the individual’s risk of COVID-19 including comorbidities
    • the individual’s level of exposure to COVID-19
    • safety data of COVID-19 vaccinations in breastfeeding individuals
      • observational studies consistently show that both anti-spike IgG and IgA are present in breastmilk after maternal vaccination with mRNA vaccines
      • no specific safety signals have been identified in breastfeeding individuals who receive mRNA vaccination
    • the lack of safety and efficacy data for recombinant protein subunit and viral vector COVID-19 vaccines in breastfeeding
  • An SOGC statement discusses COVID-19 vaccines in pregnancy and breastfeeding; it focuses on pregnancy but may have some information to help guide the informed consent conversation with a breastfeeding/chestfeeding individual.
REFERENCES
LAST UPDATED: 17 oct 2023
Inactivated Influenza and Other Inactivated Vaccines
All Inactivated Vaccines
  • Individuals who are breastfeeding should be offered inactivated influenza vaccine if not received while pregnant.
  • There are no precautions or concerns with inactivated vaccines; breastfeeding/chestfeeding individuals should be offered all recommended immunizations according to schedule.
Inactivated Influenza Vaccine
  • Individuals who are breastfeeding/chestfeeding should be offered influenza vaccine if not received while pregnant; more data is available for inactivated influenza vaccine in this population.
REFERENCES
LAST REVIEWED: 11 Oct 2023
Live Vaccines
  • Live Attenuated Influenza Vaccine can be administered to breastfeeding/chestfeeding  individuals.
  • MMR and varicella vaccines should be administered to breastfeeding individuals if indicated.
  • If typhoid vaccination is required, the inactivated formulation should be used.
  • Safety data are not well established for yellow fever, smallpox, ebola, and BCG vaccines, which are unlikely to be administered in a pharmacy. See Canadian Immunization Guide- Immunization in Pregnancy and Breastfeeding for details.
REFERENCE
LAST updated: 17 oct 2023

Q8. Have you received any vaccinations in the past 4 weeks or have any scheduled vaccines in the upcoming 4 weeks?

General

These questions are asked:

  • to coordinate the timing of vaccines for those who have received vaccines in the last 4 weeks and/or may be receiving vaccines in the upcoming 4 weeks, and
  • to ensure minimum intervals have been met for doses within select vaccine series – note that minimum intervals vary according to the vaccine and is often more than 4 weeks.

As a general vaccination principle, interruption of a vaccine series resulting in an extended interval between doses does not require restarting the vaccine series, regardless of the interval between doses. Should an individual present for a dose beyond the recommended/optimal interval, provide the dose as soon as possible and consider the dose valid. If more doses are to be given (e.g., to complete the primary series, booster doses), provide the next dose at the recommended interval from the last dose received.

Use the current vaccination opportunity to provide other vaccinations that the individual may have scheduled in the future (as long as minimum intervals are still being met). 

  • Separate injection sites and separate needles and syringes should be used when administering > 1 vaccine at the same visit.
    • Preferably use two different limbs but if there is a need to inject >1 vaccine into the same limb, separate the two injection sites by at least 2.5 cm (1 inch).
      • Using different limbs allows for more accurate identification of the offending vaccine if local side effects occur.
    • If both arms are unsuitable, the vastus lateralis is a suitable alternate site.
      • Landmarking for vastus lateralis
        • With the individual in the seated position, visually divide the length of the muscle from the greater trochanter of the femur to the lateral border of the kneecap into thirds.
        • Visually divide the width of the outer thigh in two with a horizontal line.
        • The injection site is in the middle third, just above the horizontal line.
        • Video is available here.
      • Dorsogluteal is NOT an acceptable alternative site.
        • This injection site is not used for active immunization because it is less immunogenic for vaccines. 
REFERENCES
LAST UPDATED: 17 oct 2023
COVID-19 Vaccine
Also see Q8 - General
Timing within a COVID-19 Vaccine Series
Timing with Respect to Other Vaccines
  • Data are still limited in terms of effect of concurrent administration of other vaccines on safety, immunogenicity, and reactogenicity of the COVID-19 vaccines. However, vaccine principles and the lack of concerning signals guide the recommendation.
    • NACI will continue to monitor the research.
  • The Saskatchewan Ministry of Health and NACI endorse that all authorized COVID-19 vaccines can be administered at the same time as, or at any time before or after, other vaccines, including live, inactivated, adjuvanted, or unadjuvanted vaccines.
    • *POTENTIAL EXCEPTION: orthopoxvirus (smallpox and mpox) vaccine, Imvamune® 
      • If Imvamune® administration can be timed (e.g. prior to occupational exposure), preferentially separate Imvamune® from mRNA COVID-19 vaccination by at least 4 weeks (either before or after). 
        • Myocarditis has been reported following use of previous generation orthopoxvirus vaccine. The risk of myo- or pericarditis from Imvaune® is unknown. Separation is a precautionary measure to help determine to which vaccine AEFI(s) should be attributed, if they occur. 
      • If Imvamune® is being administered because of unplanned exposure risk (post-exposure or pre-exposure) to smallpox or mpox, do not delay Imvamune® regardless of recent COVID-19 vaccination.
REFERENCES
LAST UPDATED: 17 oct 2023
Inactivated Influenza and Other Inactivated Vaccines

Also see Q8 – General      

Timing within a Vaccine Series

  • Many vaccines require >1 dose (=vaccine series) to provide optimal immunity.
    • NOTE: Minimum intervals vary according to the vaccine and is often more than 4 weeks
INACTIVATED INFLUENZA VACCINE
  • Children under 9 years of age who have not received influenza vaccine before require two doses that are at least 4 weeks apart. Ensure the first dose has not been within the last 4 weeks.
    • Children of this age who have been properly vaccinated with one or more doses of seasonal influenza vaccine in any previous season should receive 1 dose of influenza vaccine per season thereafter.
Timing with Respect to Other Vaccines
  • No precautions or concerns in relation to timing of other vaccines.
    • Inactivated vaccines can be administered concomitantly or at any time before or after the administration of any other live or inactivated vaccine using different injection sites and separate needles and syringes.
  • EXCEPTION
    • Different formulations of vaccine that protect against the same disease (e.g. pneumococcal vaccine, meningococcal vaccine) should not be administered concomitantly.
REFERENCES
LAST UPDATED: 08 Nov 2022
Last reviewed: 12 oct 2023
Live Vaccines

Also see Q8 – General

Timing within a Vaccine Series  
  • Many vaccines require >1 dose (=vaccine series) to provide optimal immunity.
    • NOTE: Minimum intervals vary according to the vaccine.
LIVE ATTENUATED INFLUENZA VACCINE  
  • Children under 9 years of age who have not received influenza vaccine before require two doses that are at least 4 weeks apart. Ensure the first dose has not been within the last 4 weeks.
    • Children of this age who have been properly vaccinated with one or more doses of seasonal influenza vaccine in any previous season should receive 1 dose of influenza vaccine per season thereafter.
Timing with Respect to Other Vaccines
Oral and Intranasal Vaccines
  • Live vaccines given by the intranasal or oral routes may be administered concomitantly with all other vaccines on the same day or at any time before or after administration of any other live (parenteral, oral, or intranasal) or inactivated vaccine.
  • EXCEPTION
    • Administration of live oral typhoid vaccine and live oral cholera vaccine needs to be separated by at least 8 hours.
parenteral vaccines
  • Live vaccines given by the parenteral route may be administered concomitantly with all other vaccines on the same day, using different injection sites and separate needles and syringes.
  • In general, if two live parenteral vaccines are not administered concomitantly on the same day, there should be a period of at least 4 weeks before the second live parenteral vaccine is given. See exception below.
    • If live parenteral vaccines are given too close together, the immune response to the second live parenteral vaccine may be affected by the first vaccine and is considered invalid; the second live parenteral vaccine should be repeated at the recommended interval.
  • Live parenteral vaccines may be administered concomitantly with other live oral or intranasal vaccines as well as all inactivated vaccines during the same visit or at any time before or after the administration of the live parenteral vaccine.
  • Minimum intervals for vaccine series (e.g. varicella-containing vaccines) still apply such that often > 4 weeks is required between doses.
    • Exception
      • Live varicella-containing vaccine should not be administered at the same time as smallpox/mpox vaccine; separate immunizations by at least 4 weeks.
REFERENCES
LAST UPDATED: 17 oct 2023

Q9. Are you under 19 years old and regularly take a salicylate medication(s)

LAIV and Varicella-Containing Vaccines

This includes regular ongoing use of oral salicylates including, but not limited to:

  • acetylsalicylic acid (i.e., ASA, aspirin)
  • bismuth subsalicylate
  • mesalamine
  • olsalazine
  • sulfasalazine

Live Attenuated Influenza Vaccine

  • Live attenuated influenza vaccine (LAIV) is contraindicated for children and adolescents, 2 to <18 years of age, currently receiving aspirin/salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection. They should receive inactivated influenza vaccine instead.
  • It is recommended that initiation of salicylate-containing products be delayed for four weeks after receipt of LAIV in children <18 years of age.
Measles-Mumps-Rubella-Varicella (MMRV)  and Varicella Vaccines
  • An association exists among use of salicylates (acetylsalicylic acid, aspirin, or ASA) in children and adolescents, wild-type varicella virus and Reye’s syndrome.
  • Ideally, children and adolescents requiring chronic salicylate therapy should receive varicella vaccination prior to initiating the chronic salicylate therapy.
  • Refer children and adolescents taking chronic salicylate therapy to Public Health so that theoretical risks associated with varicella vaccine can be weighed against the known risks associated with wild-type varicella infection and for close monitoring if varicella vaccine is administered.
  • Ideally, salicylate therapy is avoided for at least 6 weeks following varicella-containing vaccination in all individuals. Weigh theoretical risks of Reye’s syndrome from the vaccine versus risks of wild-type varicella.
REFERENCES
LAST UPDATED: 30 oct 2023

Q10. Do you require a TB skin test within the next 4 weeks or have you ever had a positive TB skin test?

All Live Vaccines
Interaction between live vaccine and tuberculin skin testing (TST)
  • A false negative result can occur if a live vaccine is given BEFORE the TST. If a live vaccine is given, wait at least 4 weeks before performing the TST if possible. However, perform TST if opportunity is otherwise likely to be missed as this is a theoretical precaution.. 
  • Live vaccines can be given on the same day (different site) or at any time AFTER a TST. 
Contraindication to vaccine administration in presence of positive TST (indicating active, untreated tuberculosis [TB])
  •  Active, untreated TB is a contraindication for MMR (measles- mumps-rubella), MMRV, (measles-mumps-rubella-varicella) and monovalent varicella vaccines as a precautionary measure.
REFERENCES
LAST UPDATED: 17 oct 2023

Q11. Do you have close contact with anyone with a weakened immune system?

LAIV and Varicella-Containing Vaccines
Live Attenuated Influenza Vaccine
  • Inactivated Influenza Vaccine is preferred.
  • Live attenuated influenza vaccine recipients should avoid close association with individuals with severe immune compromising conditions (e.g. hematopoietic stem cell transplant recipients requiring isolation in hospital) for at least two weeks following vaccination, because of the theoretical risk for transmission.
Measles-Mumps-Rubella-Varicella (MMRV) and Varicella Vaccines
  • If a varicella-like rash develops following immunization, the vaccine recipient should cover the rash and avoid contact with the immunocompromised person while the rash is present.
REFERENCES
LAST UPDATED: 31 Oct 2022
Last reviewed: 12 oct 2023

Q12. In the past year, have you received a transfusion of blood/blood products or immune globulin (ig)?

Measles-Mumps-Rubella (MMR), Measles-Mumps-Rubella-Varicella (MMRV), and Varicella Vaccines
  • Blood products and Ig may reduce effectiveness of these live vaccines if given too closely together.
  • Refer to Canadian Immunization Guide Blood products, human immunoglobulin and timing of immunization (Table 1) for details regarding the recommended intervals to wait before vaccination with MMR, MMRV or monovalent varicella vaccines following Ig or blood product administration. These intervals are based on antibody degradation times of the specific products. Vaccine doses should be repeated at the recommended interval if:
    • provided < 14 days prior to administration of Ig or blood product
    • provided after administration of Ig or blood product sooner than the minimum recommended interval for the particular product
REFERENCEs
LAST UPDATED: 03 Nov 2022
Last reviewed: 12 oct 2023

Declaration of Consent

Declaration of Consent

As per SCPP:

  • Informed consent is a patient’s authorization to carry out a treatment or procedure after they are provided the information and facts needed to make an informed decision.
  • Patients have the right to be informed about the benefits and risks of any treatment or procedure offered to them and to make a voluntary decision about whether to undergo the treatment or procedure.
  • Consent must be informed, specific, given voluntarily and documented.
  • Prior to administering a drug, the process of informed consent shall consist of a discussion between the patient and the pharmacist which includes:
    • A description of the drug and the administration procedure including benefits, side effects and life-threatening risks
    • Confirm information provided is understood
    • Provide opportunity for questions and answers
  • A signature on a consent form is NOT a substitute for having a conversation with a patient.
Informed Consent of Minors (<18 years old)
  • See the Saskatchewan Immunization Manual - Chapter 3 for further details and some scenarios (e.g. decision-making rights in different parental arrangements; right of other guardians such as foster parents) if needed.
  • Each dose administered in pharmacy requires informed consent from vaccine recipient/caregiver, regardless of consent that may have been obtained through other programs (e.g. school-based clinics).

Mature Minors (ages 13 to < 18 years)

  • Individuals ages 13 to < 18 years are considered to be mature minors. Children aged 13 years and older can legally consent to, refuse and revoke immunizations on their own behalf if they demonstrate capability and understanding of the standard information.
  • It is up to the individual health care provider to use their professional judgement to assess the individual to determine whether the individual has demonstrated the capacity to make that decision. 
  • If the health care provider does not deem them to be a mature minor, then they would fall into the same category and consent requirements as a child (ages 12 and under), which would require consent from a parent/legal

Minors 12 Years and Younger

  • Consent must be obtained from a parent/legal guardian.
    • Parental/guardian accompaniment is required for children aged 5 to < 12 years receiving vaccines in order to ensure parental consent and support for the child receiving that vaccine.
    • If a parent/guardian is not able to attend the vaccination, they may designate an adult to attend on their behalf by naming the adult on the consent form; the specific vaccine(s) to which the parent/guardian consents must be specified. 
  • All biological and adoptive parents have the authority to give, refuse, and revoke informed consent for their children’s immunizations, except when their decision-making rights have been      
    legally revoked and another legal guardian has been appointed (e.g., social worker). 

If an individual does not communicate in English, French versions of immunization fact sheets as well as links to other translated health resources are available in the Saskatchewan Immunization Manual - Chapter 14.

References 

Last updated

08 Nov 2022

Appendices

Appendix 1 - COVID-19 Vaccine Doses, Eligibility, and Intervals

Information can be found at COVID-19 Vaccines

Appendix 2 - Guidance for Pharmacy Use Only Section

Pharmacy Use Only

Appendix 3 - References and Recommended Resources

Saskatchewan Immunization Manual, especially:

eHealth COVID-19 Immunization Manual

 Canadian Immunization Guide, especially:

National Advisory Committee on Immunizations (NACI)

Drug Plan and Extended Benefits Branch