This guide is to be used in conjunction with the medSask COVID-19 Vaccine Screening and Consent Form. It is intended to provide guidance and management of patients during the screening process.

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
    • Added history of cerebral venous sinus thrombosis (CVST) associated with thrombocytopenia as per AstraZeneca product monograph.

 

AEFI = Adverse Event Following Immunization
DPEBB = Drug Plan & Extended Benefits Branch
HIV= Human Immunodeficiency Virus
LTC = Long-Term Care
MHO = Medical Health Officer
NACI = National Advisory Committee on Immunization
PCH = Personal Care Home
SCA = Saskatchewan Cancer Agency
SHA = Saskatchewan Health Authority
SOGC = Society of Obstetricians and Gynecologists of Canada

Vaccine Recipient Information

Ensure the vaccine recipient is within the authorized age group of the vaccine being provided.

AstraZeneca/COVISHIELD: ≥ 18 years old
Janssen: ≥ 18 years old
Moderna: ≥ 18 years old
Pfizer-BioNTech: ≥ 12 years old (Note: as of 11 May 2021, authorized immunizers may administer vaccine to eligible persons 12 years and older.)

NOTE: The AstraZeneca/COVISHIELD COVID-19 Vaccines are currently not recommended in individuals younger than 40 years in Saskatchewan.

NOTE: Whether individuals in an age group are eligible for vaccination at any given time in SK will depend on SHA’s phased rollout. Patients who are clinically exceptionally vulnerable are included in Phase 2 (Mar 2021) and will have received a letter from SHA.

References 
Last updated

11 May 2021

Individuals who work in healthcare facilities will need to be documented via the Vaccine Risk Factor Portal. The DPEBB guide to this portal is available here.

To register for login access, phone the CGI Help Desk: 1-800-667-6080 or 306-761-4286

The information MUST be entered into the portal BEFORE entering the prescription and billing to DPEBB.

The five categories of healthcare workers that can be flagged on the form are:

  • SHA (i.e. staff employed by the SHA)
  • SHA LTC (i.e. staff working at a LTC facility operated by the SHA)
  • Non-SHA (e.g. dentist, nurse at a private physician clinic, community pharmacists) 
  • Non-SHA LTC (i.e. staff working at privately operated or SHA affiliated LTC facilities)
  • PCH (i.e. staff working at a personal care home)

For more specific information regarding eligibility, non-SHA professions, as well as other groups such as teachers, pharmacists can refer to the government eligibility lists.  

This table outlines Vaccine Eligibility Groups, as well as information regarding proof of employment/eligibility and is also posted on the website above.

Note: The Vaccine Portal Risk Factor User Guide includes an additional category: Personal Care Home Resident. Currently this category is not included on the medSask COVID-19 Vaccine Screening and Consent Form as PCH residents have received their first dose through Public Health. The form will be updated accordingly when the Second Dose Strategy is established.

Last Updated

03 May 2021

Screening Questions

If the answer to this question is “yes”, stop the process if dose is confirmed on PanoramaNo second doses are being administered at this time.

Panorama needs to be checked for all individuals to ensure a prior dose has not been received (even if reported as “no”).

The form and guide will be updated to align with the Second Dose Strategy when it is available.

Last Updated

12 Apr 2021

COVID-19 infection does elicit an immune response; however, even those with prior infection should be offered the full series of COVID-19 vaccine.

  • Residents of LTC Facilities and PCHs and persons age 80 years and older living in the community should be immunized regardless of whether and when they had COVID-19 infection as long as they have recovered from their acute illness and have no other contraindications.
  • Those younger than 80 years of age: Immunization with COVID-19 vaccine may be delayed until 90 days following the confirmed infection if the infection occurred before the first COVID-19 vaccine dose. However, if this is not feasible or the individual presents for immunization, immunization may be provided before the 90 days as long as the person has recovered from the acute illness and criteria have been met for them to discontinue isolation.
References
Last Updated

12 Apr 2021

Answers “Yes”: Based on expert opinion, vaccination with either first or second dose of 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.

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.

Reference
Last Updated

12 Apr 2021

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.

COVID-19 vaccine should not be offered to individuals with a proven severe allergic reaction (e.g., anaphylaxis) to any component of the specific COVID-19 vaccine or its container. Refer to Public Health.
Product Monographs: Pfizer-BioNTech, Moderna, AstraZeneca, COVIDSHIELD, Janssen

Allergens of particular concern:

Polyethylene glycol: avoid Pfizer-BioNTech, Moderna – 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.

Tromethamine: avoid Moderna  - found in contrast media, oral and parenteral medications.

Polysorbate 80: avoid AstraZeneca/COVISHIELD, Janssen – found in medical preparations (e.g., vitamin oils, tablets, and anticancer agents), cosmetics.

Reference
Last Updated

12 Apr 2021

Currently there are limited data regarding safety and efficacy of COVID-19 vaccines during pregnancy. SHA and NACI recommend a risk assessment taking into consideration:

  • the individual’s risk of COVID-19 including comorbidities
  • the individual’s level of exposure to COVID-19
  • the unknown efficacy and safety of COVID-19 vaccinations in pregnancy because of limited data
  • the potential risks of COVID-19 infection in pregnancy

For those contemplating pregnancy, it is recommended to complete the entire COVID-19 vaccination series (where possible) to achieve maximal vaccine efficacy ahead of pregnancy. Based on expert opinion, it is recommended to wait a period of at least 28 days following the 2nd dose of the vaccine series before conceiving, if possible.

The SOGC states: “Women who are pregnant or breastfeeding should be offered vaccination at any time during pregnancy if they are eligible and no contraindications exist. This decision is based on the women’s personal values and an understanding that the risk of infection and/or morbidity from COVID-19 outweighs the theorized and undescribed risk of being vaccinated during pregnancy or while breastfeeding.”

Being unknowingly pregnant and receiving the COVID-19 vaccine is not a reason to terminate the pregnancy.

If an individual has a scheduled immunization appointment (eligible based only on pregnancy) but is no longer pregnant at the time of the appointment, proceed with immunization.

SHA has an Algorithm to aid decision making 
(If link broken, go here: Algorithms - ​​​​​Precautions, Recommendations, and Scripts →  CV-19 A0027 Pregnancy - Vaccine Precautions Algorithm)

SHA Benefit/Risk Information may help guide the conversation. (Note: this is a consent form but it does not need to be signed in community pharmacy.) 
(If link broken, go here. Go to appropriate vaccine tab on left → Vaccine Consent → SHA 0107 ​Pregnant Women - Benefit/Risk Information)

References
Last Updated

08 May 2021 

Currently there are limited data regarding safety and efficacy of COVID-19 vaccines during breastfeeding. It is unknown whether the vaccines are excreted in human milk and there are no data on outcomes in breastfeeding individuals or their breastfed infants. There have been no theoretical concerns about these vaccines in breastfeeding individuals or their breastfed infants.

SHA and NACI recommend a risk assessment taking into consideration:

  • the unknown efficacy and safety of COVID-19 vaccinations in breastfeeding because of limited data
  • the individual’s risk of COVID-19 including comorbidities
  • the individual’s level of exposure to COVID-19

Receipt of the COVID-19 vaccine is not a reason to stop breastfeeding.

The SOGC states: “Women who are pregnant or breastfeeding should be offered vaccination at any time during pregnancy if they are eligible and no contraindications exist. This decision is based on the women’s personal values and an understanding that the risk of infection and/or morbidity from COVID-19 outweighs the theorized and undescribed risk of being vaccinated during pregnancy or while breastfeeding.”

SHA has an Algorithm to aid decision making. 
(If link broken, go here: Algorithms - ​​​​​Precautions, Recommendations, and Scripts → CV-19 A0024 Breastfeeding - Vaccine Precautions Algorithm)

SHA Benefit/Risk Information may help guide the conversation. (Note: this is a consent form but it does not need to be signed in community pharmacy.) 
(If link broken, go here. Go to appropriate vaccine tab on left Vaccine Consent SHA 0108 Breastfeeding Women - Benefit/Risk)

References
Last Updated

12 Apr 2021

See table at end for common autoimmune conditions (not comprehensive).

For AstraZeneca/COVISHIELD COVID-19 Vaccine only: individuals with a previous history of thrombosis associated  with lupus anticoagulant (thrombotic anti-phospholipid syndrome) should not receive this vaccine due to very rare reports of a combination of blood clots and low levels of blood platelets following immunization.

Preferably patients discuss the vaccine with their primary care provider/specialist prior to presenting. Document details if they report having the discussion. However:

  • If they have not discussed vaccination with their primary care provider/specialist AND their condition is UNSTABLE, refer to PCP/specialist.
  • If they have not discussed vaccination with their primary care provider/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.

Currently there are limited data regarding safety and efficacy of COVID-19 vaccines in those with autoimmune conditions. SHA and NACI recommend a risk assessment taking into consideration:

  • the unknown efficacy and safety of COVID-19 vaccinations in those with autoimmune conditions because of limited data,
  • current stability/control of the autoimmune condition,
  • the individual's risk of COVID-19 including comorbidities and level (if any) of immunosuppression,
  • the individual's level of exposure to COVID-19, and
  • that the vaccine antibody response in individuals with autoimmune conditions may not be as strong as the immune response in individuals who do not have autoimmune conditions. This will depend on the disease process and the individual's treatment. Immunized individuals still need to take precautions against COVID–19 disease.

Examples of medications that may be immunosuppressive can be found here

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. SHA's algorithm (link below) provides guidance for timing around treatments used for Multiple Sclerosis.   

SHA has an Algorithm to aid decision making.
(If link broken, go here → Algorithms - ​​​​​Precautions, Recommendations, and Scripts → ​CV-19 A0023 Autoimmune Conditions - Vaccine Precautions Algorithm)

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-Barre 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 from SHA Algorithm (CV-19 A0023 Autoimmune Conditions)

References
Last Updated

08 May 2021

As applicable, also see:

  • 7(i) Medications
  • 7(ii) Cancer
  • 7(iii) Transplant
  • 7(iv) HIV

Individuals may be immunosuppressed/ immunocompromised because of medications/ treatments and/or their condition(s). It is preferred all such individuals discuss the vaccine with their primary care provider /specialist prior to presenting. The main concern is diminished response to the vaccine.

Currently there are limited data regarding safety and efficacy of COVID-19 vaccines in those who are immunocompromised. SHA and NACI recommend a risk assessment taking into consideration: 

  • the unknown efficacy and safety of COVID-19 vaccinations in those who are immunocompromised,
  • the individual’s risk of COVID-19 including level of immunosuppression and comorbidities, 
  • the individual’s level of exposure to COVID-19, and
  • that the individual may have a diminished immune response to the vaccine and that immunized individuals still need to take precautions against COVID–19 disease.

Individuals who MUST consult with their primary care provider/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 primary care provider/specialist prior to presenting. Document details if they report having the discussion. However: 

  • If they have not discussed vaccination with their primary care provider/specialist AND their condition is UNSTABLE, refer to PCP/specialist.
  • If they have not discussed vaccination with their primary care provider/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 7(i) Medications; 7(ii) Cancer; 7 (iii) Transplant; and/or 7(iv) HIV as applicable.

SHA has algorithms to aid decision making: Immunosuppressed / OncologyImmunocompromised
(If link(s) broken, go here→ Algorithms - ​​​​​Precautions, Recommendations, and Scripts → CV-19 A0025 Immunosuppressed / Oncology - Vaccine Precautions Algorithm and CV-19 A0026 Immunocompromised - Vaccine Precautions Algorithm)

References
Last Updated

12 Apr 2021

Also see 7 - Information for all

As applicable, also see:

  • 7(ii) Cancer
  • 7(iii) Transplant
  • 7(iv) HIV

Examples of medications that may be immunosuppressive can be found here

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. 

References
Last Updated

05 May 2021

Also see 7 - Information for all

See the SCA document: 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

SHA has an Algorithm to aid decision making
(If link broken, go here → Algorithms - ​​​​​Precautions, Recommendations, and Scripts → CV-19 A0025 Immunosuppressed / Oncology - Vaccine Precautions Algorithm)

References
Last Updated

12 Apr 2021

Also see 7 - Information for all

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 vaccines.

However, if the patient had a recent transplant (less than 1 month ago) or was recently (less than 1 month ago) treated for rejection or if the immunizer is unsure of the individual's eligibility, please ask the individual to contact the Saskatchewan Transplant Program to determine if and when they should receive the vaccine.

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

SHA has an Algorithm to aid decision making
(If link(s) broken, go here → Algorithms - ​​​​​Precautions, Recommendations, and Scripts → CV-19 A0026 Immunocompromised - Vaccine Precautions Algorithm)

References
Last  Updated

12 Apr 2021 

Also see 7 - Information for all

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.

SHA has an Algorithm to aid decision making
(If link(s) broken, go here → Algorithms - ​​​​​Precautions, Recommendations, and Scripts → CV-19 A0026 Immunocompromised - Vaccine Precautions Algorithm)

Reference
  • SHA Algorithm (CV-19 A0026 Immunocompromised) 
Last Updated

12 Apr 2021

Having an increased risk of bleeding due to condition or treatment is NOT a contraindication to vaccine administration. To reduce bleeding risk:

  • Apply direct pressure (without rubbing) to the injection site for 5 minutes or longer after injection to stop the bleeding.
References
Last Updated
12 Apr 2021

Precaution is advised with the AstraZeneca/COVISHIELD (only) vaccines in individuals with a history of the following conditions: 

  • heparin-induced thrombocytopenia
  • thrombosis associated with lupus anticoagulant (thrombotic anti-phospholipid syndrome)
  • cerebral venous sinus thrombosis (CVST) with thrombocytopenia

Preferably these individuals are directed to receive an mRNA vaccine (i.e. Pfizer-BioNTech, Moderna). If mRNA vaccines are not readily accessible, individuals with a history of these conditions should be referred to their primary care provider/specialist for a risk/benefit assessment.

Reference
Last Updated

05 May 2021

Because of no data, simultaneous administration with other vaccines should be avoided to maximize benefits of COVID-19 vaccination while minimizing any risks of harm. Recommended intervals: 

  • ≥14 days after receiving another vaccine before receiving COVID-19 vaccines
  • ≥ 28 days after receiving COVID-19 vaccine before receiving other vaccines

There may be exceptions in consultation with PCP. If another vaccine(s) is administered within these time intervals, consider all vaccine doses valid.

Reference
Last Updated

08 May 2021

No part of this work may be reproduced, distributed, or transmitted in any form or by any means unless authorized by medSask. For copyright permission requests, please contact druginfo@usask.ca.
Last updated: 11 May 2021