The medSask Vaccine Screening and Consent Form has been updated Feb 4, 2022. 

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 here.

NOTE: This Guide and the Vaccine Screening and Consent Form are to be used for ALL vaccines. The previous guides and forms for COVID-19 Vaccine Consent Form and Vaccine Consent Form have been combined and will no longer be separately maintained.

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 Attenuated Influenza Vaccine
  • Other Live Vaccines (all live vaccines not 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. Similarly, "All Live Vaccines" includes live attenuated influenza vaccine.

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

  • All vaccine recipients need to answer questions 1-8
  • Recipients of COVID-19 vaccine need to answer questions 1-10
  • Recipients of live vaccines need to answer questions 1-8 and 11-13

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 = 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

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
    • 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 - 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)
    • Amendent 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 eligiblity 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 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)
17 Nov 2021
  • Pharmacy Use Only - Administered By
    • Changed information to reflect authorization of non-traditional immunizers to administer publicly funded influenza vaccine.
  • Pharmacy Use Only - Provided Record of Immunization
    • Added information regarding issuance of wallet cards.
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.
28 Oct 2021
  • Pharmacy Use Only
    • This is a new section to provide context and rationale to the Pharmacy Use Only section on page 2 of the form.
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.
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 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 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
  • Q4 Pregnancy
  • 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?

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, upper respiratory infections, upset stomach, and diarrhea) are NOT contraindications to vaccination, acknowledging that during the COVID-19 pandemic, individuals with any symptoms of acute respiratory infection, including minor symptoms such as sore throat or runny nose, should defer vaccination until they have recovered if being immunized in a community setting.

  • 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 Reviewed

25 Sep 2021

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, upper respiratory infections, upset stomach, and diarrhea) are NOT contraindications to vaccination, acknowledging that during the COVID-19 pandemic, individuals with any symptoms of acute respiratory infection, including minor symptoms such as sore throat or runny nose, should defer vaccination until they have recovered if being immunized in a community setting.

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.

  • 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 Reviewed

25 Sep 2021

General

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, upper respiratory infections, upset stomach, and diarrhea – see exception below) are NOT contraindications to vaccination, acknowledging that during the COVID-19 pandemic, individuals with any symptoms of acute respiratory infection, including minor symptoms such as sore throat or runny nose, should defer vaccination until they have recovered if being immunized in a community setting.

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
Oral Cholera and Traveller's Diarrhea Vaccine
  • Administration of this vaccine should be postponed in persons with acute gastrointestinal illness.
References
Last Reviewed

25 Sep 2021

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

  • 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 tab). 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.
      • Pharmacies are to submit AEFI reports related to publicly funded vaccines to their local  Public Health Office.
    • 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.
References
Last Reviewed

25 Sep 2021

Vaccine Antigens
  • 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. CIG provides a table with contents of vaccines available for use in Canada. 
    • Adjuvants - e.g. aluminum hydroxide, aluminum phosphate, AS01B, 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 (such as gentamicin, neomycin or kanamycin)
      • If the reaction reported is not anaphylactic (e.g. is a contact allergy or delayed type immune reaction) the product can be administered.
    • Egg proteins (ovalbumin) - 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.
        • Eggs are not used in the manufacturing of the rabies vaccine Imovax®. See SIM–Chapter 6 for more details.
    • 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.
    • Polyethylene glycolavoid Pfizer-BioNTech Comirnaty™ (all formulations), Moderna Spikevax™ (both formulations), and Medicago Covifenz® (trace amounts) COVID-19 vaccines– 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.
    • Thimerosal - minute amount is present in some multi-dose vials as a preservative but not in single dose vials, prefilled syringes, or intranasal vaccine (Flumist® Quadrivalent).
      • Inactivated influenza vaccine - refer patients with documented allergy to thimerosal (or those requesting) to Public Health to receive a thimerosal-free product.
      • Other vaccines - If thimerosal-free products are not available for other vaccines, refer to the primary care provider or Public Health. Note that thimerosal is considered safe in pregnancy.
    • Tromethamine: avoid Pfizer-BioNTech Comirnaty™ (Orange and Grey Cap; not Purple Cap), and Moderna Spikevax™ (both formulations) COVID-19 vaccines - found in contrast media, oral and parenteral medications.
    • Other common ingredients: buffers (such as sodium chloride, potassium chloride, disodium hydrogen phosphate heptahydrate, potassium dihydrogen phosphate), gelatin, surfactants (such as α-tocopheryl hydrogen succinate, cetrimonium bromide, polysorbate 80, sodium deoxycholate, Triton X-100) ethanol, formaldehyde and sucrose.
      • If the vaccine to be administered contains one of these ingredients and the vaccine recipient reports an anaphylactic reaction to this ingredient or a previous vaccine/product containing the same ingredient, refer to primary care provider (for allergy specialist follow up) or Public Health, unless it can be confidently discounted such as ingredients the recipient encounters regularly such as sodium chloride and potassium chloride.
References
Last Updated

08 Aug 2022

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

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.
      • Pharmacies are to submit AEFI reports related to publicly funded vaccines to their local  Public Health Office.
    • 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

mRNA COVID-19 Vaccines (Pfizer-BioNTech Comirnaty™ and Moderna Spikevax™)
  • Based on recent studies, NACI recommends 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 normal observation period for people who have not experienced a severe immediate allergic reaction after vaccination is 15 minutes).
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

23 Nov 2021

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

Inactivated Influenza and Live Attenuated Influenza Vaccines
  • Although the evidence associating influenza and GBS is inadequate to accept or reject a causal relationship, avoiding subsequent influenza vaccination of all individuals known to have had GBS within six weeks of previous influenza vaccination is recommended at this time. Refer to Public Health. Individuals who develop GBS outside the 6-week interval may receive subsequent doses of the 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.
References
Last Updated

25 Sep 2021

COVID-19 Vaccine

mRNA vaccines (Pfizer-BioNTech Comirnaty™, Moderna Spikevax™) only

NOTE: For individuals with a history of myocarditis or pericarditis (not related to COVID-19 vaccination), see Q10

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). 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 individual risk of infection.
    • 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. Recently, a higher rate of cases of myocarditis and/or pericarditis has been reported after the administration of Moderna Spikevax™ compared to Pfizer-BioNTech Comirnaty™, although verification of this potential difference is ongoing.
    • To date, the majority of affected individuals, while hospitalized, have responded well to conservative therapy and tend to recover quickly.
    • It is currently unknown whether myocarditis/pericarditis will occur after vaccination of children < 12 years of age with the lower doses of mRNA present in Pfizer-BioNTech Comirnaty™ (Orange Cap; 10 mcg dose) or Moderna Spikevax™ (Royal Blue Cap; 25 mcg dose).
    • For younger individuals who are receiving their primary COVID-19 vaccine series and both age-appropriate Moderna Spikevax™ and Pfizer-BioNTech Comirnaty™ are readily available, Comirnaty™ is the preferred vaccine as there is a lower risk of myocarditis compared to Spikevax™.
      • NACI makes this recommendation for those 6 to 30 years of age.
      • Saskatchewan makes this recommendation for those 12 to 29 years of age.
    • Symptoms of myocarditis/pericarditis can include shortness of breath, chest pain, or the feeling of a rapid or abnormal heart rhythm. 
References
Last Updated

19 Jan 2022

COVID-19 Vaccine

NOTE: In Canada, thrombosis with thrombocytopenia syndrome (TTS) following vaccination (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.
  • Individuals who have experienced TTS following vaccination with a viral vector COVID-19 vaccine should not receive a subsequent dose of a viral vector COVID-19 vaccine. They may receive further doses of mRNA COVID-19 vaccines following consultation with their clinical team, which may include a hematologist.
Reference
Last Updated

30 Jun 2022

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

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

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 SIM - Chapter 7 for more details.
MMR and MMRV Vaccines
  • Always consult with the patient’s physician/specialist prior to MMR immunization if they have had an episode of thrombocytopenia in the past, which may or may not have occurred within 6 weeks of a previous MMR/MMRV vaccine.
References
Last Updated

24 Nov 2021

Live Attenuated Influenza Vaccine (LAIV)
  • LAIV is not recommended for patients with severe asthma (defined as currently on oral or high dose inhaled glucocorticosteroids 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 patients with stable, non-severe asthma.
Reference
Last Reviewed

25 Sep 2021

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 patients, in consultation with their healthcare providers, may decide to use the deltoid even if bilateral involvement.
References

Last Reviewed

25 Sep  2021

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.
    • 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.

  • Based on real world data indicating COVID-19 vaccines are safe in those with autoimmune conditions, NACI’s recommendations for COVID-19 vaccination in these individuals is a complete vaccine series with an mRNA COVID-19 vaccine.
  • 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,
    • emerging real-world data regarding safety and immunogenicity
      • 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,
      • efficacy and effectiveness data (i.e. effect on illness/hospitalizations/death) are not available but data from observational trials indicate immune responses to mRNA or AstraZeneca Vaxzevria™ COVID-19 vaccines were only diminished in those on immunosuppressive therapy
        • 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.

  • Those Who Are Immunocompromised Due to Medication

Common Autoimmune Conditions* (not an exhaustive list)

Addison's Erythema nodosum Lupus Psoriatic arthritis
Alopecia areata Fibromyalgia Meniere's disease Raynaud's syndrome
Amyloidosis Graves' disease Multiple Sclerosis Restless legs syndrome
Ankylosing spondylitis Guillain-Barré syndrome Myasthenia gravis Rheumatoid arthritis
Celiac disease Hashimoto's thyroiditis Neutropenia Sarcoidosis
Crohn's disease Hemolytic anemia Henoch-Schonlein purpura Scleroderma
Diabetes Type 1 Juvenile arthritis Optic neuritis Thrombocytopenia  purpura
Endometriosis Kawasaki disease Psoriasis Ulcerative colitis

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

References
Last Updated

10 Feb 2022

 

  • As applicable, also see information for:
    • Q4 - Autoimmune disorder
    • Q4 - Cancer
    • Q4 - HIV infection
    • Q4 - Transplant
    • Q5 - Medications that may cause immunosuppression

  • See SIM – Chapter 7 and CIG- 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.
COVID-19 Vaccine
  • It is preferred immunocompromised individuals discuss the COVID-19 vaccine with their primary care provider (PCP)/specialist prior to presenting. The main concern is diminished response to the vaccine.

  • Individuals who MUST consult with their PCP/specialist include those:
    • with cancer being treated with immune checkpoint inhibitors (pembrolizumab, nivolumab, atezolizumab)
    • with cancer being treated with chimeric antigen receptor (CAR)-T therapy
    • being treated with blood and bone marrow stem cell transplant (autologous or allogeneic) (pre and post)

  • For other immunosuppressed/immunocompromised patients, it is preferred that the vaccine be discussed with the 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.
    • 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. 

  • The primary series consists of 3 doses for individuals who are moderately to severely immunocompromised; they should receive booster doses when eligible. See details of primary series and booster doses here.

  • 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,
    • emerging real-world data regarding safety and immunogenicity
      • 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,
      • efficacy and effectiveness data (i.e. effect on illness/hospitalizations/death) are not available but data from observational trials indicate immune responses to mRNA or AstraZeneca Vaxzevria™ COVID-19 vaccines were diminished or delayed in those on immunosuppressive therapy
        • 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 Attenuated Influenza and Other 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 SIM-Chapter 7 for details but refer these patients.
References
Last Updated

10 Feb 2022

Q4. Cancer

  • Also see information for:
    • Q4 - Condition affecting the immune system
    • Q4 - Lymphatic circulation (if applicable)
    • Q5 - Medications that may cause immunosuppression (if applicable)
  • See the SCA documents: Cancer Patients and the COVID-19 Vaccine and COVID-19 Vaccine Information for Patients
  • Cancer survivors should be offered vaccination.
  • Most patients being treated for cancer should be offered vaccination, though the timing around treatment needs to be considered.

  • Patients being treated for cancer with the following treatments can receive the vaccine at any time:
    • targeted and hormonal treatments
    • radiation therapy

  • Timing of vaccination around treatments may need to be considered for patients being treated for cancer with the following treatments and patients should consult their cancer care team:
    • immune checkpoint inhibitors (MUST consult)
    • hematopoietic stem cell transplant (MUST consult)
    • chemotherapy
    • 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

  • The primary series consists of 3 doses for individuals who are moderately to severely immunocompromised; they should receive booster doses when eligible. See details of primary series and booster doses here.
 References
Last Updated

10 Feb 2022

  • Also see information for:
    • Q4 - Condition affecting the immune system
    • Q4 - Lymphatic circulation (if applicable)
    • Q5 - Medications that may cause immunosuppression (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 2021 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

  • 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 2021.
    • Inquiring if an individual has/is receiving cancer treatment at the time of first contact regarding the flu shot is helpful in catching these particular individuals who should not receive IIV this year.
Reference
Last Reviewed

25 Sep 2021

General
  • Also see information for:
    • Q4 - Condition affecting the immune system
    • Q4 - Lymphatic circulation (if applicable)
    • Q5 - Medications that may cause immunosuppression (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 2021, 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

25 Sep 2021

  • Also see information for:
    • Q4 - Condition affecting the immune system
    • Q4 - Lymphatic circulation (if applicable)
    • Q5 - Medications that may cause immunosuppression (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 SCA or Travel Health Centre/ Specialty Immunization Clinic is required prior to immunization with live vaccines.

  • Live vaccines should not be given within 4 weeks of the start of immunosuppressive therapy.

  • 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

25 Sep 2021

Q4. HIV infection

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. current CD4 count <200 cells/mm3 for adults or children) are considered moderately to severely immunocompromised. The primary series consists of 3 doses for individuals who are moderately to severely immunocompromised; they should receive booster doses when eligible. See details of primary series and booster doses here.
Inactivated Influenza Vaccine
  • Inactivated influenza vaccine is recommended annually for those 6 months and older.
References
Last Updated

10 Feb 2022

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.
 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

25 Sep 2021

  • 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

25 Sep 2021

Q4. Transplant

  • Also see information for:
    • Q4 - Condition affecting the immune system
    • Q5 - Medications that cause immunosuppression

  • 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

  • Also see information for:
    • Q4 - Condition affecting the immune system
    • Q5 - Medications that cause immunosuppression

  • 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 COVID-19 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), 
      • those for whom the immunizer is unsure of eligibility, and
      • those receiving  belatacept.

  • Hematopoietic Stem Cell Transplant (HSCT) recipients MUST speak to their cancer care team / specialist.

  • The primary series consists of 3 doses for individuals who are moderately to severely immunocompromised; they should receive booster doses when eligible. See details of primary series and booster doses here.   
References
Last Updated

10 Feb 2022

  • Also see information for:
    • Q4 - Condition affecting the immune system
    • Q5 - Medications that cause immunosuppression

  • 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.

  • Hematopoietic Stem Cell Transplant (HSCT) recipients 
    • HSCT recipients should not receive inactivated influenza vaccine if the stem cell transplant was less than four months previous in adults and less than six months previous for pediatrics.
References
Last Updated

04 Nov 2021

Q5. Do you take any of the following medications?

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.
Live Attenuated Influenza Vaccine
  • Live attenuated influenza vaccine (LAIV) is contraindicated for children and adolescents, 2 to 17 years of age, currently receiving aspirin therapy because of the association of Reye's syndrome with aspirin and wild-type influenza infection. They should receive inactivated influenza vaccine instead. It is recommended that initiation of aspirin-containing products be delayed for four weeks after receipt of LAIV in children less than 18 years of age.
MMRV and Varicella Vaccines
  • An association exists among use of salicylates 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.
References
Last Reviewed

25 Sep 2021

Immunosuppressive Medications

  • 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 drugs (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.
    • Examples of medications that may be immunosuppressive can be found here

  • 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. joint injection).
  • There should be an interval of at least 4 weeks after discontinuation of high-dose systemic steroids before vaccines are administered.
COVID-19 Vaccine
  • Little information is available regarding the best time to administer COVID-19 vaccine in relation to dosing of immunomodulators to elicit the maximal vaccine response. As such, preference is to have patients discuss vaccination timing with prescriber/specialist.

  • The primary series consists of 3 doses for individuals who are moderately to severely immunocompromised; they should receive booster doses when eligible. See details of primary series and booster doses here. .
Inactivated Influenza Vaccine and Other 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 SCA’s Influenza Immunization Guideline 2021, 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
  • Hepatitis B vaccine should be given at double the dose and using a 3- or 4-dose schedule.
 Human Papillomavirus Vaccine
  • HPV vaccine should be given following routine age indications but using a 3-dose schedule, regardless of age.
Live Attenuated Influenza Vaccine and Other Live Vaccines
  • Administration of live vaccines may cause uncontrollable replication of the virus or bacterium and result in serious adverse events in immunocompromised patients and is contraindicated in most cases.

  • Live vaccines should be given prior to initiation of agents causing immunosuppression (≥ 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. 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 SIM – 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 and live herpes zoster vaccines below for definition and exceptions.

Varicella and Live Herpes Zoster Vaccines
  • For herpes zoster, use recombinant herpes zoster vaccine (Shingrix®) unless unavailable or contraindicated.
  • These live vaccines can be considered in those taking low-dose immunosuppression defined as:
    • low dose methotrexate (≤ 0.4 mg/kg/week)
    • azathioprine (≤ 3 mg/kg/day)
    • 6-mercaptopurine (≤ 1.5 mg/kg/day)
    • < 2 mg/kg/day for a child or < 20 mg/day for an adult of prednisone or its equivalent
  • 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.

 

Anti-SARS-CoV-2 Monoclonal Antibodies

COVID-19 Vaccine

For treatment of COVID-19 (e.g., sotrovimab)

  • Based on expert opinion, vaccination with COVID-19 vaccine should be delayed for at least 90 days after treatment with anti-SARS-CoV-2 monoclonal antibodies for treatment of COVID_19 infection, as this therapy may interfere with and delay response to the COVID-19 vaccine. The period of 90 days is based on the half-life of the therapy.

For pre-exposure prophylaxis of COVID-19

  • Evusheld™ (tixagevimab / cilgavimab)
    • NACI recommends delaying administration of Evusheld™ for at least 14 days following COVID-19 vaccination.
    • Information regarding effect of Evusheld™ on future COVID-19 vaccination is not available and NACI recommends timing be assessed on a case-by-case basis in consultation with clinical experts.
References
Last Updated

30 Jun 2022

COVID-19, Inactivated Influenza and Other Inactivated Vaccines
  • During the COVID-19 pandemic, individuals with any symptoms of acute respiratory infection, including minor symptoms such as sore throat or runny nose, should defer vaccination until they have recovered if being immunized in a community setting.
  • There is no reason to withhold inactivated vaccines for patients taking antivirals (including those active against COVID-19, influenza and varicella) or antibacterials.
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.
Other Live Vaccines
MMRV, Varicella and Live Attenuated Herpes Zoster 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 as it may affect the reproduction of and reduce the efficacy of a varicella-containing vaccine or a live zoster vaccine.
    • If taking these antivirals and herpes zoster vaccination is required, use the recombinant herpes zoster vaccine.
  • Systemic antiviral therapy active against varicella zoster virus (e.g. acyclovir, valacyclovir, famciclovir) should not be started until at least 14 days following administration of a varicella-containing vaccine or a live zoster vaccine as the antivirals to prevent the antiviral from killing the replicating virus.
  • On the basis of expert opinion, it is recommended that individuals taking long-term antiviral therapy should discontinue these drugs, if possible, from at least 24 hours before administration of a varicella-containing vaccine or a live zoster vaccine, and should not restart antiviral therapy until 14 days after vaccine administration.
Live Oral Typhoid Vaccine
  • Live oral typhoid vaccine should be delayed 48 to 72 hours after completing treatment with antibiotics active against Salmonella typhi.
  • Antibiotics active against Salmonella typhi should not be initiated until at least 72 hours following the last dose of the oral typhoid vaccine series.
References
Last Reviewed

25 Sep 2021

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

  • 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.

  • Only mRNA vaccines (i.e. Pfizer-BioNTech Comirnaty™ and Moderna Spikevax™) are to be routinely offered to pregnant individuals
    • Viral vector (e.g. Janssen [Johnson & Johnson]), recombinant protein subunit (e.g. Novavax Nuvaxovid™), or virus-like particle (e.g., Medicago Covifenz®) COVID-19 vaccines can be offered if: 
      • allergy to any of the mRNA vaccine components, or
      • mRNA vaccine is not readily available

    • The reasons for this recommendation:
      • concern about increased complexity in medical care if Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT) were to occur following a viral vector vaccine
      • the majority of safety data are from mRNA vaccines

    • Based on real world data indicating COVID-19 vaccines are safe in pregnancy, NACI’s recommendation for COVID-19 vaccination in these individuals is a complete vaccine series with an mRNA COVID-19 vaccine.
    • 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 pregnant individuals who are not
      • the safety and immunogenicity data of mRNA COVID-19 vaccinations in pregnancy
        • There are now real world data emerging in which no maternal or neonatal safety signals have been raised. These data are primarily based on mRNA vaccines.
        • Data are available indicating mRNA vaccination in pregnant individuals results in comparable antibody titres to those generated following mRNA vaccination in non-pregnant individuals.
        • Maternal IgG humoral response to mRNA COVID-19 vaccines transfers across the placenta to the fetus, leading to a significant and potentially protective, antibody titre in the neonatal bloodstream one week after the second dose. 
      • the lack of safety and efficacy data for Novavax Nuvaxovid™ in pregnancy.
      • This SOGC statement may help guide the informed consent conversation.
References
Last Updated

08 Aug 2022

  • Pregnant individuals, at all stages, are highly encouraged to receive the 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 women.
  • The risk of influenza-related hospitalizations increases throughout gestation.
  • No harms to the fetus or mother 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

25 Sep 2021

General
  • There are no precautions or concerns with most inactivated vaccines in pregnancy (see exceptions below).
  • Vaccination during pregnancy protects the mother from vaccine-preventable diseases that may otherwise be acquired and be transmitted to the fetus or infant.
  • Several vaccines are recommended during pregnancy. See CIG- 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.
  • If a vaccine dose has inadvertently been administered during pregnancy, no intervention is indicated, but completion of the series should be delayed until after pregnancy.
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

25 Sep 2021

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).
Live Attenuated Influenza Vaccine  (LAIV)
  • Due to a lack of safety data at this time, LAIV should not be administered to pregnant individuals due to the theoretical risk to the fetus from administering a live virus vaccine.
References
Last Reviewed

25 Sep 2021

Q7. Are you nursing/breastfeeding?

  • Based on real world data indicating COVID-19 vaccines are safe during breastfeeding, NACI’s recommendation for COVID-19 vaccination in breastfeeding individuals is a complete vaccine series with an mRNA COVID-19 vaccine. 

  • 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 emerging safety data of COVID-19 vaccinations in breastfeeding individuals
      • Early studies consistently show that both anti-spike IgG and IgA are present in breastmilk after maternal vaccination with mRNA vaccines.
      • In one small cohort study, mRNA from COVID-19 vaccines was undetectable in breastmilk 4-48 hours post-vaccination. 
    • the lack of safety and efficacy data for Novavax Nuvaxovid™ and Medicago Covifenz® in breastfeeding
  • Receipt of the COVID-19 vaccine is not a reason to stop 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 individual.
References
Last Updated

08 Aug 2022

  • Women who are breastfeeding should receive inactivated influenza vaccine if not received while pregnant.

  • There are no precautions or concerns with inactivated vaccines in breastfeeding; breastfeeding women should receive all recommended immunizations according to schedule.
References
Last Reviewed

25 Sep 2021

  • Live Attenuated Influenza Vaccine can be administered to breastfeeding women.

  • MMR and varicella vaccines should be administered to breastfeeding women if indicated.

  • If herpes zoster (unlikely to be indicated in a breastfeeding woman) or typhoid vaccinations are required, inactivated vaccines should be used.

  • Safety data are not well established for yellow fever, smallpox and BCG, which are unlikely to be administered in a pharmacy. See CIG - Immunization in Pregnancy and Breastfeeding for details.
References
Last Reviewed

25 Sep 2021

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

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. 
Timing within a COVID-19 Vaccine Series
  • All residents who have received their first dose of a 2-dose vaccine are eligible to receive their second dose following a 28-day interval. *Families may choose to receive the second dose of the pediatric vaccine as early as 21 days after the initial dose.
    • NOTES:
      • 21 days is the minimum interval authorized by Health Canada for Pfizer-BioNTech Comirnaty™; 19 days is included in NACI recommendations.  
      • 28 days is the minimum interval authorized by Health Canada for Moderna Spikevax™; 21 days is included in NACI recommendations.
      • 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 eligible 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.

  • Individuals who have received Janssen (Johnson & Johnson), which is a single dose vaccine, are eligible to receive an mRNA COVID-19 vaccine dose at least 2 months after the Janssen dose.

  • See information regarding eligibility and approved intervals for additional COVID-19 vaccine doses here.
Timing with Respect to Other Vaccines
  • The Ministry of Health and NACI endorse that all authorized COVID-19 vaccines (including those for children 5 years and older) can be administered at the same time as, or at any time before or after, other Health Canada approved vaccines, including live, non-live, adjuvanted, or unadjuvanted vaccines.
    • When COVID-19 vaccines were first approved, there had been direction to separate COVID-19 vaccine from all other vaccines based on limited safety, reactogenicity, and immunogenicity evidence.
    • Concurrent administration of vaccines improves uptake of vaccines such as COVID-19, influenza, and those for routine immunization.
    • Data are still limited in terms of effect of concurrent administration 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.

  •  Separate injection sites should be used when administering > 1 vaccine.
    • Preferably use two different limbs but if need to inject >1 vaccine into the same limb, separate the two injection sites by at least 2.5 cm (1 inch).
    • 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

22 Jun 2022

Timing for Children Requiring Two Doses
  • 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 influenza vaccine can be administered concomitantly or at any time before or after the administration of any other live attenuated or inactivated vaccine using different injection sites and separate needles and syringes.
      • Preferably use two different limbs but if need to inject >1 vaccine into the same limb, separate the two injection sites by at least 2.5 cm (1 inch).
        •  
      • 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

23 Nov 2021

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. 
Timing with Respect to Other Vaccines
  • No precautions or concerns with inactivated vaccines 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 attenuated or inactivated vaccine using different injection sites and separate needles and syringes.
      • Preferably use two different limbs but if need to inject >1 vaccine into the same limb, separate the two injection sites by at least 2.5 cm (1 inch).
        •  
      • 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.
            Exception
    • Different formulations of vaccine that protect against the same disease (e.g. pneumococcal vaccine, meningococcal vaccine) should not be administered concomitantly.
Reference
Last Updated 

23 Nov 2021

Timing for Children Requiring Two Doses
  • 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
  • Given the lack of data for immune interference, and that LAIV is not a parenteral vaccine, LAIV can be administered concomitantly or at any time before or after the administration of any other live attenuated or inactivated vaccine.
References
Last Updated

25 Sep 2021

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. 
Timing with Respect to Other 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.
    • Preferably use two different limbs but if need to inject >1 vaccine into the same limb, separate the two injection sites by at least 2.5 cm (1 inch).
    • 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.

  • 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 exceptions 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 be not administered at the same time as smallpox vaccine; separate immunizations by at least 4 weeks.
Reference
Last Updated

25 Sep 2021

Timing within a Vaccine Series
  • Many vaccines require >1 dose (=vaccine series) to provide optimal immunity.
    • NOTE: Minimum intervals vary according to the vaccine.   
Timing with Respect to Other Vaccines
  • Live vaccines given by the oral route may be administered concomitantly with all other vaccines on the same day or at any time before or after of the 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.
Reference
Last Updated

25 Sep 2021

Q9. Have you had a previous COVID-19 infection?

  • If the individual tested positive or has had previous SARS-CoV-2 infection, the individual should receive vaccination when otherwise appropriate (as per current eligibility guidelines) as long as they have recovered. Following public health self-isolation recommendations is suggested.
    • This is to reduce transmission of COVID-19 to those at the vaccine clinic and to determine if any arising symptoms are due to infection or vaccination
  • A complete vaccination series is required for everyone, regardless of past SARS-CoV-2 infection.
    • COVID-19 vaccination is well-tolerated and considered safe in those with previous SARS-CoV-2 infection.
  • NACI has suggested intervals between SARS-CoV-2 infection and COVID-19 vaccination:
    • Note that these are suggested, not required intervals. These intervals have not been recommended in Saskatchewan, but there are also no recommendations in Saskatchewan against these longer intervals.
    • Based on vaccine and immunology principles, longer intervals between infection and vaccination are expected to produce more robust and durable responses to the vaccine.
    • See table below for suggestions. 

Table: NACI Suggested Intervals Between Previous SARS-CoV-2 Infection and COVID-19 Vaccination

SARS-CoV-2 Infection Timing Relative to COVID-19 Vaccination

Population

Suggested Interval between SARS-CoV-2 Infection and Vaccination

Infection prior to initiation or completion of primary vaccination series

(Primary series for individuals moderately to severely immunocompromised is 3 doses)

 

 

Individuals 5 years and older

No previous history of MIS-C

Not moderately to severely immunocompromised

Vaccine dose 8 weeks after symptom onset or positive test (if asymptomatic)

Individuals 5 years and older

No previous history of MIS-C

Moderately to severely immunocompromised

Vaccine dose 4-8 weeks after symptom onset or positive test (if asymptomatic)

Individuals 5 years or older

Previous history of MIS-C

Regardless of immunocompromised status

Vaccine dose when recovered clinically or at least 90 days since onset of MIS-C, whichever is longer

Infection after primary series but before booster dose

Individuals 12 years and older currently eligible for a booster dose

3 months after symptom onset or positive test (if asymptomatic) so long as it is at least 6 months from completing primary series

MIS-C = multisystem inflammatory syndrome in children

References
Last Updated

10 Feb 2022

  • Answers “Yes”: Based on expert opinion, vaccination with COVID-19 vaccine should be delayed for at least 90 days after treatment with anti-SARS-CoV-2 monoclonal antibodies or convalescent plasma as these therapies may interfere with and delay response to the COVID-19 vaccine. The period of 90 days is based on the half-life of the therapies.
    • Anti-SARS-CoV-2 monoclonal antibodies approved in Canada include:
      • bamlanivimab  
      • casirivimab and imdevimab 
      • sotrovimab
    • Sotrovimab had been in use in Saskatchewan. However, its use has been discontinued due to reduced efficacy against the Omicron BA.2 subvariant.
    • Currently no anti-SARS-CoV-2 monoclonal antibodies are in use in Saskatchewan.
    • The deferral does not apply to non-SARS-CoV-2 monoclonal antibodies that may be used for treatment of SARS-CoV-2 infection such as sarilumab and tocilizumab.

  • Answers “No”: Proceed with vaccination.

  • Answers “I don’t know”: If individual had COVID-19 infection and did not receive intravenous treatment, proceed with vaccination. If intravenous treatment for COVID-19 was received in the previous 90 days, or the individual is unsure, refer to primary care provider.
References
Last Updated

04 May 2022

Q10. Do you have a history of myocarditis/pericarditis or MIS-C?

mRNA COVID-19 vaccines (Pfizer-BioNTech Comirnaty™ and Moderna Spikevax™)

NOTE: this question relates to myocarditis or pericarditis unrelated to COVID-19 vaccination. If myocarditis or pericarditis was experienced within 6 weeks of an mRNA COVID-19 vaccine, see Q3.

Children (≥ 6 months to < 12 years)

  • This is not a contraindication. However, for children who have a history of myocarditis and/or pericarditis unrelated to mRNA COVID-19 vaccination, their clinical team should be consulted for individual considerations and recommendations. If they are no longer being followed clinically for cardiac issues, they may receive the vaccine.

Adolescents and Adults (12 years and older)

  • This is not a contraindication to being immunized with COVID-19 vaccines (including mRNA vaccines).

Regardless of history of myocarditis or pericarditis, the age-appropriate Pfizer-BioNTech Comirnaty™ formulation is preferred to Moderna Spikevax™ in younger individuals because of a higher rate of myocarditis and pericarditis following immunization with Moderna Spikevax™. NACI makes this recommendation for those 6 to 30 years of age whereas Saskatchewan makes this recommendation for those 12 to 29 years of age.

REFERENCES
LAST UPDATED

08 Aug 2022

mRNA COVID-19 vaccines (Pfizer-BioNTech Comirnaty™ and Moderna Spikevax™)

  • Children and adolescents infected with SARS-CoV-2 are at risk of MIS-C, an uncommon but serious condition.
  • Multisystem inflammatory syndrome has been reported rarely following vaccination with mRNA COVID-19 vaccine in adolescents and adults.
  • There were no reports of MIS-C in the Pfizer-BioNTech (≥ 5 years to < 12 years) or Moderna (≥ 6 months to < 6 years) trials, though ongoing monitoring is important.
    • Because MIS-C is associated with SARS-CoV-2 infection, it is an Adverse Event of Special Interest. 
  • For individuals with a previous history of MIS-C, 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

08 Aug 2022

Q11. Do you require a TB skin test within the next 4 weeks or have you ever had a positive TB skin test?

  • Testing for TB infection with one of the immune-based methods, either the tuberculin skin test (TST) or an interferon-gamma release assay (IGRA), can be done before, after, or during the same encounter as COVID-19 vaccination.
Reference
Last Updated

04 May 2022

  • No contraindications or precautions exist in those who require a TB skin test in the next 4 weeks.
  • Inactivated vaccines can be given on the same day or at any time after a TB skin test. 
  • No contraindications or precautions exist in those who have a history of a positive TB skin test.
References
Last Reviewed

25 Sep 2021

  • A false negative skin test can occur if a live vaccine is given BEFORE the TB skin test. If a live vaccine is given, wait at least 4 weeks before doing the TB skin test. 
  • Live vaccines can be given on the same day or at any time AFTER a TB skin test.
  • A positive TB test (at any time) is NOT a contraindication to live attenuated influenza vaccine.
MMR, MMRV, Varicella, Live Herpes Zoster and BCG Vaccines
  • A positive test indicative of active, untreated TB is a contraindication for MMR (measles, mumps, and rubella), MMRV (measles, mumps, rubella and varicella), univalent varicella, live herpes zoster, and BCG (Bacille Calmette-Guérin) vaccines as a precautionary measure.
References
Last Updated

25 Sep 2021

Q12. Do you have close contact with anyone with a weakened immune system?

  • No precautions or concerns.
  • Inactivated influenza vaccination and maintaining up-to-date routine immunizations should be encouraged for all close contacts of anyone with a weakened immune system.
Reference
Last Reviewed

25 Sep 2021

  • Inactivated Influenza Vaccine is preferred.
  • Live attenuated influenza vaccine recipients should avoid close association with individuals with severe immune compromising conditions (e.g. bone marrow transplant recipients requiring isolation) for at least two weeks following vaccination, because of the theoretical risk for transmission.
Reference
Last Reviewed

25 Sep 2021

MMRV, Varicella and Live Attenuated Herpes Zoster Vaccines
  • For herpes zoster vaccination, preferably use the recombinant vaccine.
  • If a vaccine recipient develops a varicella-like rash within 42 days of vaccine administration, the rash should be covered and the vaccinee should avoid direct contact with the immunocompromised individual for the duration of the rash.
Reference
Last Reviewed

25 Sep 2021

Q13. In the past year, have you received a transfusion of blood/ blood products, or immune globulin (Ig)?

  • Based on expert opinion, vaccination with COVID-19 vaccine should be delayed for at least 90 days after treatment with convalescent plasma for treatment of COVID-19 infection, as this therapy may interfere with and delay response to the COVID-19 vaccine. The period of 90 days is based on the half-life of the therapy.

  • For persons receiving antibody therapies not specific to COVID-19 treatment (e.g., intravenous immunoglobulin, RhoGAM), a full COVID-19 vaccine series is recommended, either simultaneously with or at any interval before or after treatment.
References
Last Updated

25 Sep 2021

 

  • Blood products and Ig preparations have minimal or no interaction with these vaccines.
Reference
Last Reviewed

25 Sep 2021

Reference
Last Reviewed

25 Sep 2021

Declaration of Consent

As per SCPP:

  • Informed consent is a patient’s authorization to carry out a treatment or procedure after he or she is 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 SIM 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 13-17 years)

  • Individuals ages 13-17 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 five to 11 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). 

References 

Last updated

23 Dec 2021

Appendices

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