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.

18 Sep 2021
  • General
    • Occurrences of vaccine names changed:
      • Pfizer-BioNTech → Comirnaty™ (Pfizer)
      • Moderna → SPIKEVAX™ (Moderna) 
      • AstraZeneca → Vaxzevria™ (AstraZeneca)
14 Sep 2021
  • Q1, Q6, Q7, Q7(i), Q7(ii), Q7(iii)
    • Information added related to NACI's statement of additional doses in immunocompromised individuals.
02 Sep 2021
  • Age, Q1
    • 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
    • Further details added regarding booster doses and doses in those who received non-Health Canada authorized COVID-19 vaccines out of country.
  • Q10
    • Information changed to reflect intervals between COVID-19 vaccine and other vaccines are no longer required.
31 Aug 2021
  • Q1, Q6, Q7, Q7(i), Q7(ii), Q7(iii)
    • Information added regarding booster 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
    • Added history of cerebral venous sinus thrombosis (CVST) associated with thrombocytopenia as per AstraZeneca product monograph.

 

AEFI = Adverse Event Following Immunization
AESI = Adverse Events of Special Interest
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
SIM = Saskatchewan Immunization Manual
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.
  • Vaxzevria™ (AstraZeneca)/COVISHIELD: ≥ 18 years old
  • SPIKEVAX™ (Moderna): ≥ 12 years old (Note: as of September 2 2021, authorized immunizers may administer vaccine to eligible persons ≥ 12 years old and those who are born in 2009 [currently 11 years old and will be 12 by the end of the year]).
  • Comirnaty™ (Pfizer): ≥ 12 years old (Note: as of 20 Aug 2021, authorized immunizers may administer vaccine to eligible persons ≥ 12 years old and those who are born in 2009 [currently 11 years old and will be 12 by the end of the year]).

Informed Consent of Minors (<18 years old)

  • See SIM Chapter 3 for further details if needed.
  • FAQs and examples of different scenarios (e.g. mature minor who wants to be vaccinated but parents object) can be found here.
  • All doses administered in pharmacy require informed consent, 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 patient to determine whether the patient 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 guardian. 

Minors 12 Years and Younger

  • Consent must be obtained from a parent/legal guardian.
  • 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

02 Sep 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 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)
    • PCH resident

  • 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.
Last Updated

27 Aug 2021

Screening Questions

General Information
  • The eHR Viewer needs to be checked for all individuals.
  • Ensure the vaccine recipient is eligible.
    • First and second doses
      • For purposes of vaccine efficacy, a COVID-19 vaccine series is considered complete with two doses of vaccine, with the exception of the Johnson & Johnson vaccine, which requires one dose.
      • All persons ≥ 12 years old and those who are born in 2009 (currently 11 years old and will be 12 by the end of the year) are eligible.
        • NOTES:
          1. Persons in the 12 to 17 age range (including those born in 2009) are eligible for Comirnaty™ (Pfizer) and SPIKEVAX™ (Moderna) vaccines only
          2. Children should receive the same mRNA vaccine brand for their COVID-19 vaccine series. It is important that immunizers double check the immunization records of children presenting for COVID-19 immunization to avoid giving a mixed brand series to children if possible. A mixed vaccine series is acceptable in Canada but may require a future third dose for travel purposes. 
      • All residents who have received their first dose of vaccine are eligible to receive their second dose following a 28-day interval.
        • NOTES: 
          1. 21 days is the minimum interval authorized by Health Canada for Comirnaty™ (Pfizer); 19 days is included in NACI recommendations.  
          2. 28 days is the minimum interval authorized by Health Canada for SPIKEVAX™ (Moderna); 21 days is included in NACI recommendations.
          3. 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 the 2nd dose beyond 16 weeks, provide the dose as soon as possible and consider the series complete.
      • Residents who received immunization in a different jurisdiction will be eligible to receive subsequent dose(s) in Saskatchewan. Individuals in this scenario will need to have documentation of their dose(s) from the jurisdiction in which they were received.

    • Doses to complete series in recipients of non-Health Canada authorized vaccines received out of country
      • Residents who received one or two doses of a non-Health Canada authorized COVID-19 vaccine should be offered one additional dose based on the Public Health Agency of Canada’s guidance document.
      • Non-residents who received one or two doses of a non-Health Canada authorized COVID-19 vaccine and are planning to stay in Canada for longer periods of time (i.e. to live, work or study in Canada) should be offered one additional dose based on the Public Health Agency of Canada’s guidance document.

    • Booster doses
      • As of September 7, 2021, select individuals will be eligible for a booster dose of COVID-19 vaccine.
      • Note: NACI makes a distinction that a primary series of COVID-19 vaccine in immunocompromised individuals includes three doses (i.e. for immunocompromised individuals, this is not considered a booster dose).
      • Current evidence shows that, compared to the general population, specific immune compromised individuals may require a booster dose for optimal immune response after a two-dose COVID-19 vaccine series and that the administration of an additional COVID-19 mRNA dose elicits antibody levels that significantly exceed antibodies seen after any two-dose primary COVID-19 vaccine series in specific populations at higher risk. Currently there are no data regarding the efficacy/effectiveness of these doses (i.e. if or by how much the additional dose reduces symptomatic disease, symptom severity, hospitalizations and death).
      • There is preliminary information on the safety of additional COVID-19 doses. It is expected that individuals may experience mild to moderate symptoms (e.g., fever, chills, aches and pain at the injection site) after additional COVID-19 vaccine doses.
      • Phase One (September 7, 2021):
        • Letters will be sent to eligible individuals of Phase 1 the week of August 30, 2021. This letter must be presented at the time of vaccination in order to receive a booster dose.
        • Eligible individuals:
          • Residents of long-term care and personal care homes
          • Transplant recipients (including solid organ, islet cell, tissue and hematopoietic stem cell transplants)
          • Recipients of stable, active treatment (chemotherapy, targeted therapies, immunotherapy) for malignant hematologic disorders
          • Recipients of an anti-CD20 agent (e.g. rituximab, ocrelizumab, ofatumumab)
      • Phase Two (October 2021) (to be further refined as evidence emerges):
        • Eligible individuals:
          • Other immunocompromised and clinically extremely vulnerable individuals as supported by evidence and expert opinion
          • Individuals aged 80 and older
          • Individuals living in congregate living settings
          • Health Care workers
      • Phase Three (November 2021) (to be further refined as evidence emerges):
        • Eligible individuals:
          • Other identified at-risk populations as informed by emerging evidence
      • The individual should receive a booster dose a minimum of 28 days after their second dose.
      • See table below for recommended vaccine to use for booster depending on first two doses.
        • If the individual received a mixed mRNA schedule for first and second doses, either mRNA product may be used for the booster dose.
        • If the individual received a Vaxzevria™ (AstraZeneca) dose followed by an mRNA dose, the same mRNA vaccine should be used for the booster dose.
        • Any mRNA vaccine can be used after a two-dose Vaxzevria™ (AstraZeneca) series.
          • If there are contraindications to mRNA vaccines, Vaxzevria™ (AstraZeneca) may be used for the booster dose. Vaxzevria™ (AstraZeneca) is only available at public health clinics.
        • Although no research data exists, clinical experts have advised that at this time Janssen/Johnson & Johnson vaccine recipients can receive booster doses as they become eligible.
          • Saskatchewan will offer one mRNA dose as a booster for eligible individuals who have received a Janssen/Johnson & Johnson one dose vaccination.
        • Although no research data exists, clinical experts have advised that at this time non-Health Canada approved vaccine recipients can receive booster doses as they become eligible.
          • Individuals who received a non-Health Canada approved COVID-19 vaccine and have received one additional dose of an mRNA COVID-19 vaccine (based on Public Health Agency of Canada guidelines) would be considered fully immunized (i.e. equivalent to receiving a two dose Health Canada approved COVID-19 vaccine series). See bullet above - Doses to complete series in recipients of non-Health Canada authorized vaccines received out of country.
          • Saskatchewan will offer an additional, second mRNA dose as a booster dose as they become eligible. 

COVID-19 Booster Dose Recommendations

Dose 1

Dose 2

Dose 3

COVISHIELD

COVISHIELD

Comirnaty™ (Pfizer)

COVISHIELD

COVISHIELD

SPIKEVAX™ (Moderna)

COVISHIELD

Vaxzevria™ (AstraZeneca)

Comirnaty™ (Pfizer)

COVISHIELD

Vaxzevria™ (AstraZeneca)

SPIKEVAX™ (Moderna)

Vaxzevria™ (AstraZeneca)

Vaxzevria™ (AstraZeneca)

Comirnaty™ (Pfizer)

Vaxzevria™ (AstraZeneca)

Vaxzevria™ (AstraZeneca)

SPIKEVAX™ (Moderna)

Vaxzevria™ (AstraZeneca)

COVISHIELD

Comirnaty™ (Pfizer)

Vaxzevria™ (AstraZeneca)

COVISHIELD

SPIKEVAX™ (Moderna)

COVISHIELD

Comirnaty™ (Pfizer)

Comirnaty™ (Pfizer)

COVISHIELD

SPIKEVAX™ (Moderna)

SPIKEVAX™ (Moderna)

Vaxzevria™ (AstraZeneca)

Comirnaty™ (Pfizer)

Comirnaty™ (Pfizer)

Vaxzevria™ (AstraZeneca)

SPIKEVAX™ (Moderna)

SPIKEVAX™ (Moderna)

Comirnaty™ (Pfizer)

Comirnaty™ (Pfizer)

Comirnaty™ (Pfizer)

SPIKEVAX™ (Moderna)

SPIKEVAX™ (Moderna)

SPIKEVAX™ (Moderna)

Comirnaty™ (Pfizer)

SPIKEVAX™ (Moderna)

SPIKEVAX™ (Moderna)

Comirnaty™ (Pfizer)

SPIKEVAX™ (Moderna)

Comirnaty™ (Pfizer)

SPIKEVAX™ (Moderna)

Comirnaty™ (Pfizer)

Comirnaty™ (Pfizer)

SPIKEVAX™ (Moderna)

Comirnaty™ (Pfizer)

SPIKEVAX™ (Moderna)

Comirnaty™ (Pfizer)

Vaxzevria™ (AstraZeneca)

Comirnaty™ (Pfizer)

Comirnaty™ (Pfizer)

COVISHIELD

Comirnaty™ (Pfizer)

SPIKEVAX™ (Moderna)

Vaxzevria™ (AstraZeneca)

SPIKEVAX™ (Moderna)

SPIKEVAX™ (Moderna)

COVISHIELD

SPIKEVAX™ (Moderna)

Janssen/Johnson & Johnson

Comirnaty™ (Pfizer)

-

Janssen/Johnson & Johnson

SPIKEVAX™ (Moderna)

-

Note: Vaxzevria™ (AstraZeneca) may be given to individuals who have a contraindication to mRNA vaccines. Vaxzevria™ (AstraZeneca) is only available from Public Health.

 

  • Third and fourth doses for travel purposes
    • The Saskatchewan Ministry of Health has authorized additional doses for those who wish to complete a schedule acceptable for international travel in situations where their current completed immunization series is not approved by the country/agency/venue they intend to visit.
      • These doses are not mandatory and are not considered booster doses.
      • Consider necessity to travel and COVID-19 vaccine requirements at destination(s) –jurisdictions may recognize the individual’s current COVID-19 vaccination history.
      • See Table below for eligible combinations.
      • Doses should be separated by at least 28 days from the most recent COVID-19 immunization.
    • Currently, NACI has no recommendations for more than two doses other than for an additional dose for immunocompromised individuals as noted above.
    • There are preliminary data on the safety of third COVID-19 doses, mainly in the context of giving booster doses to immunocompromised patients. Results from a larger Comirnaty™ (Pfizer) study of a booster dose in healthy adults are still forthcoming. It is expected that individuals may experience mild to moderate symptoms (e.g., fever, chills, aches and pains at the injection site) after additional COVID-19 vaccine doses.

Third and Fourth COVID-19 Vaccine Dose Recommendations
 Dose 1 Dose 2 Dose 3 Dose 4
COVISHIELD COVISHIELD  Comirnaty™ (Pfizer) Comirnaty™ (Pfizer)
 COVISHIELD COVISHIELD  SPIKEVAX™ (Moderna) SPIKEVAX™ (Moderna)
COVISHIELD Vaxzevria™ (AstraZeneca) Comirnaty™ (Pfizer) Comirnaty™ (Pfizer)
COVISHIELD Vaxzevria™ (AstraZeneca) SPIKEVAX™ (Moderna) SPIKEVAX™ (Moderna)
Vaxzevria™ (AstraZeneca) Vaxzevria™ (AstraZeneca) Comirnaty™ (Pfizer) Comirnaty™ (Pfizer)
Vaxzevria™ (AstraZeneca) Vaxzevria™ (AstraZeneca) SPIKEVAX™ (Moderna) SPIKEVAX™ (Moderna)
Vaxzevria™ (AstraZeneca) COVISHIELD Comirnaty™ (Pfizer) Comirnaty™ (Pfizer)
Vaxzevria™ (AstraZeneca) COVISHIELD SPIKEVAX™ (Moderna) SPIKEVAX™ (Moderna)
COVISHIELD Comirnaty™ (Pfizer) Comirnaty™ (Pfizer) -
COVISHIELD SPIKEVAX™ (Moderna) SPIKEVAX™ (Moderna) -
Vaxzevria™ (AstraZeneca) Comirnaty™ (Pfizer) Comirnaty™ (Pfizer) -
Vaxzevria™ (AstraZeneca) SPIKEVAX™ (Moderna) SPIKEVAX™ (Moderna) -
Comirnaty™ (Pfizer) SPIKEVAX™ (Moderna) SPIKEVAX™ (Moderna) -
Comirnaty™ (Pfizer) SPIKEVAX™ (Moderna) Comirnaty™ (Pfizer) -
SPIKEVAX™ (Moderna) Comirnaty™ (Pfizer) Comirnaty™ (Pfizer) -
SPIKEVAX™ (Moderna) Comirnaty™ (Pfizer) SPIKEVAX™ (Moderna) -
Comirnaty™ (Pfizer) Vaxzevria™ (AstraZeneca) Comirnaty™ (Pfizer) -
Comirnaty™ (Pfizer) COVISHIELD Comirnaty™ (Pfizer) -
SPIKEVAX™ (Moderna) Vaxzevria™ (AstraZeneca) SPIKEVAX™ (Moderna) -
SPIKEVAX™ (Moderna) COVISHIELD  SPIKEVAX™ (Moderna) -

*Vaxzevria™ (AstraZeneca) is available through Public Health and may be given to individuals who have contraindications to mRNA vaccines.

References
Last Updated

14 Sep 2021

Reaction to previous COVID-19 vaccine
  • Note: asking about side effects to the previous dose(s) is included to prompt a conversation with the vaccine recipient (e.g. any concerns, what to expect from subsequent dose(s), how to manage side effects). Expected side effects are not to be reported and it is not necessary they be documented on this form.

  • If an AEFI was submitted, communication from the MHO should have been received by whomever submitted the AEFI. The individual should have been provided this information. The AEFI recommendation for further immunization is available in the Immunization tab in the eHR Viewer. See instructions of where to find here

  • If an AEFI has not been submitted, gather as many details as possible, submit an AEFI and wait for MHO communication. Pharmacies are to submit AEFIs to their local Public Health Office.

  • Ensure Adverse Events of Special Interest (AESIs) have been reported, including thrombotic events, hemorrhagic disease/bleeding disorders, thrombocytopenia and other coagulation/blood disorders. More details available here.

  • If the reaction did not warrant AEFI submission, provide reassurance of the safety of the subsequent dose(s) and proceed with consent. Guidance as to which reactions are considered expected and which should be reported is available here.
    • Data regarding the safety of third and fourth doses are limited.

  • Vaxzevria™ (AstraZeneca) (only), is contraindicated in individuals who have experienced any of the following after a viral vector COVID-19 vaccine:
    • venous or arterial thrombosis with thrombocytopenia 
    • capillary leak syndrome

  • mRNA vaccines (Comirnaty™ [Pfizer], SPIKEVAX™ [Moderna]) only - Individuals who developed myocarditis or pericarditis following a dose of mRNA vaccine:
    • Based on international reports as of August 19, 2021, 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 SPIKEVAX™ (Moderna) compared to Comirnaty™ (Pfizer), although verification of this potential difference is ongoing.
    • It is unclear if people who developed myocarditis or pericarditis after a dose of an mRNA COVID-19 vaccine may be at increased risk of further adverse cardiac effects following subsequent dose(s) of the vaccine. As a precautionary measure, the subsequent dose(s) of mRNA COVID-19 vaccine should be deferred in individuals who developed myocarditis or pericarditis following a dose of an mRNA COVID-19 vaccine as an adverse event until more information is available. NACI will continue to monitor the evidence and update recommendations as needed.
    • 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).
      • Level of COVID-19 community transmission and personal risk of infection.
    • These individuals should be informed of the risks of myocarditis and pericarditis following a subsequent mRNA COVID-19 vaccine dose and advised to seek medical attention if they develop symptoms including chest pain, shortness of breath or palpitations.

  • Reactions to 2nd, 3rd or 4th dose - Reporting AEFIs
    • When completing an AEFI form for a second dose (or future immunizations) of a COVID-19 vaccine, include the following for the previous dose(s) of COVID-19 immunization(s) in the table in Section 4b. Medical history of the revised National AEFI Form*:
      • Date of previous COVID-19 immunization(s);
      • Dose number(s); 
      • Vaccine trade name(s); and
      • Vaccine manufacturer(s)
*Until the National AEFI Form is revised, enter this information in the Supplementary Information Section (10). The revised form will include a table in Section 4b for this information.
 
References
Last Updated

14 Jul 2021

  • If the individual tested positive or has had previous COVID-19 disease, the individual should receive vaccination when otherwise appropriate (e.g. at least 28 days following the most recent COVID-19 vaccine dose) as long as they have recovered and no longer need to follow isolation requirements.

  • A complete vaccination series is required for everyone, regardless of past COVID-19 infection.
References
Last Updated

17 May 2021

  • 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
    • 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

09 Aug 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: Comirnaty™ (Pfizer), SPIKEVAX™ (Moderna), Vaxzevria™ (AstraZeneca), COVIDSHIELD 

  • Allergens of particular concern:
    • Polyethylene glycol: avoid Comirnaty™ [Pfizer], SPIKEVAX™ (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 SPIKEVAX™ (Moderna)- found in contrast media, oral and parenteral medications.
    • Polysorbate 80: avoid Vaxzevria™ (AstraZeneca)/COVISHIELD, Janssen – found in medical preparations (e.g., vitamin oils, tablets, and anticancer agents), cosmetics.

  • If individual reports an allergic reaction to previous dose(s):
    • If an AEFI was submitted, communication from the MHO should have been received by whomever submitted the AEFI. The AEFI recommendation for further immunization is available in the Immunization tab in the eHR Viewer. See instructions of where to find here.
    • If an AEFI has not been submitted, gather as many details as possible, submit an AEFI and wait for MHO communication. Pharmacies are to submit AEFIs to their local Public Health Office.
    • If the reaction was an expected reaction and did not warrant AEFI submission, provide reassurance of the safety of subsequent dose(s) and proceed with consent. Guidance as to reactions to report is available here.

 

Reference
Last Updated

17 May 2021

  • Pregnancy is not a contraindication to any of the COVID-19 vaccines.
    • Receiving COVID-19 vaccine (including Vaxzevria™ [AstraZeneca]/COVISHIELD) is not a reason to terminate pregnancy.

  • As of May 21, 2021 only mRNA vaccines (i.e. Comirnaty™ [Pfizer] and SPIKEVAX™ [Moderna]) are to be routinely offered to pregnant individuals
    • Viral vector vaccines (i.e. Vaxzevria™ [AstraZeneca]) 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 recommendations for COVID-19 vaccination in pregnant individuals are now the same as those for the general adult population, which is two doses of an mRNA vaccine.

  • There are no known safety data of third and fourth doses in pregnancy. See Q1 for other considerations.

  • 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 risks of COVID-19 infection in pregnancy
    • the emerging safety and immunogenicity data of 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 have been derived from:
        • international immunization registries
        • preliminary analyses of > 35,000 pregnant women in the US who received mRNA vaccine
      • 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. 

  • This SOGC statement may help guide the informed consent conversation.
References
Last Updated

08 Jun 2021 

  • Based on real world data indicating COVID-19 vaccines are safe during breastfeeding, NACI’s recommendations for COVID-19 vaccination in breastfeeding individuals are now the same as those for the general adult population, which is to receive two mRNA doses.  

  • There are no known safety data of third and fourth doses in breastfeeding. See Q1 for other considerations.

  • 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.
    •  
  • 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 Jun 2021

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

  • For Vaxzevria™ (AstraZeneca) 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.

  • 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 are now the same as those for the general adult population, which is to receive two mRNA doses.

  • Booster doses
    • As of September 7, 2021, stem cell transplant recipients and recipients of an anti-CD20 agent (e.g. rituximab, ocrelizumab, ofatumumab) will be eligible for a booster dose of COVID-19 vaccine.
      • See Q1 for a full list of eligible individuals and more information.
    • There are limited, unpublished (to date) data of booster doses, mostly in individuals who are immunocompromised. These data suggest adverse effects after booster doses are similar in nature to those from 1st and 2nd doses and most are mild to moderate in severity.
    • NACI recommends certain immunocompromised individuals receive an additional dose of mRNA vaccine as part of the primary series.
    • Letters will be sent to eligible individuals the week of August 30, 2021.
    • The required interval for a booster dose must be at least 28 days after receipt of the second mRNA dose.

  • There are limited safety data of third and fourth doses for travel purposes. See Q1 for other considerations.

  • 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 Vaxzevria™ (AstraZeneca) 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

  • 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.   

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
References
Last Updated

14 Sep 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.

  • 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.

  • Based on real world data indicating COVID-19 vaccines are safe in those who are immunosuppressed, NACI’s recommendations for COVID-19 vaccination in these individuals are now the same as those for the general adult population, which is to receive two mRNA doses.

  • Booster doses
    • As of September 7, 2021, stem cell and solid organ transplant recipients; recipients on stable, active treatment (chemotherapy, targeted therapies, immunotherapy) for malignant, hematologic disorders; and recipients of an anti-CD20 agent (e.g. rituximab, ocrelizumab, ofatumumab) will be eligible for a booster dose of COVID-19 vaccine.
      • See Q1 for a full list of eligible individuals and more information.
    • There are limited, unpublished (to date) data of booster doses, mostly in individuals who are immunocompromised. These data suggest adverse effects after booster doses are similar in nature to those from 1st and 2nd doses and most are mild to moderate in severity.
    • NACI recommends certain immunocompromised individuals receive an additional dose of mRNA vaccine as part of the primary series.
    • Letters will be sent to eligible individuals the week of August 30, 2021.
    • The required interval for a booster dose must be at least 28 days after receipt of the second mRNA dose.

  • There are limited safety data of third and fourth doses for travel purposes. See Q1 for other considerations.

  • 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 Vaxzevria™ (AstraZeneca) 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.
References
Last Updated

14 Sep 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. 

  • Booster doses
    • As of September 7, 2021, recipients of an anti-CD20 agent (e.g. rituximab, ocrelizumab, ofatumumab) will be eligible for a booster dose of COVID-19 vaccine.
      • See Q1 for a full list of eligible individuals and more information.
    • There are limited, unpublished (to date) data of booster doses, mostly in individuals who are immunocompromised. These data suggest adverse effects after booster doses are similar in nature to those from 1st and 2nd doses and most are mild to moderate in severity.
    • NACI recommends certain immunocompromised individuals receive an additional dose of mRNA vaccine as part of the primary series.
    • Letters will be sent to eligible individuals the week of August 30, 2021.
    • The required interval for a booster dose must be at least 28 days after receipt of the second mRNA dose.
References
Last Updated

14 Sep 2021

  • Also see 7 - Information for all

  • 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

  • Booster doses
    • As of September 7, 2021, stem cell transplant recipients; recipients on stable, active treatment (chemotherapy, targeted therapies, immunotherapy) for malignant, hematologic disorders; and recipients of an anti-CD20  agent (e.g. rituximab, ocrelizumab, ofatumumab) will be eligible for a booster dose of COVID-19 vaccine.
      • See Q1 for a full list of eligible individuals and more information.
    • There are limited, unpublished (to date) data of booster doses, mostly in individuals who are immunocompromised. These data suggest adverse effects after booster doses are similar in nature to those from 1st and 2nd doses and most are mild to moderate in severity.
    • NACI recommends certain immunocompromised individuals receive an additional dose of mRNA vaccine as part of the primary series.
    • Letters will be sent to eligible individuals the week of August 30, 2021.
    • The required interval for a booster dose must be at least 28 days after receipt of the second mRNA dose.

 

References
Last Updated

14 Sep 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.

  • Booster doses
    • As of September 7, 2021, stem cell and solid organ transplant recipients will be eligible for a booster dose of COVID-19 vaccine.
      • See Q1 for a full list of eligible individuals and more information.
    • There are limited, unpublished (to date) data of booster doses, mostly in individuals who are immunocompromised. These data suggest adverse effects after booster doses are similar in nature to those from 1st and 2nd doses and most are mild to moderate in severity.
    • NACI recommends certain immunocompromised individuals receive an additional dose of mRNA vaccine as part of the primary series.
    • Letters will be sent to eligible individuals the week of August 30, 2021.
    • The required interval for a booster dose must be at least 28 days after receipt of the second mRNA dose.
References
Last  Updated

14 Sep 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.
Reference
Last Updated

08 Jun 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
  • Note: this question applies to Vaxzevria™ (AstraZeneca) vaccines only. Pharmacies offering Comirnaty™ (Pfizer) or SPIKEVAX™ (Moderna) vaccines do not need to ask this question.

  • Vaxzevria™ (AstraZeneca), is contraindicated in individuals with a history of: 
    • heparin-induced thrombocytopenia (HIT)
      • HIT antibody lingering might interfere with the lab assay to detect the Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT) anibody and may complicate management.
    • thrombotic anti-phospholipid syndrome
    • venous or arterial thrombosis with thrombocytopenia following Vaxzevria™ [AstraZeneca]/COVISHIELD vaccines
    • episodes of capillary leak syndrome, which is characterized by acute episodes of limb edema, hypotension, hemoconcentration and hypoalbuminemia

  • Vaxzevria™ (AstraZeneca), is to be used with caution in individuals with a history of cerebral venous sinus thrombosis (CVST) with thrombocytopenia.
    • It is recommended individuals with a history of CVST with thrombocytopenia only receive this vaccine if benefit outweighs risk; mRNA COVID-19 vaccine is preferred.
References
Last Updated

30 Jun 2021

  • Previous direction had been to separate COVID-19 vaccine from all other vaccines based on limited safety, reactogenicity and immunogenicity evidence.
  • As of September 2, 2021, the Ministry of Health is authorizing COVID-19 vaccine to be administered concomitantly with other vaccines; no intervals are required before or after COVID-19 vaccine administration and another vaccine.
    • The Ministry of Health closely monitored simultaneous administration of COVID-19 and other vaccines as implemented in other jurisdictions over the past few months. No additional safety risks or adverse events following immunization have been identified by simultaneous administration of these vaccines.
    • This directive ensures that individuals have the opportunity to be immunized against COVID-19 when they are eligible to receive other vaccines such as influenza and school-aged vaccines.
    • 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).
    • Note that NACI continues to recommend separating COVID-19 vaccine from other vaccines and continues to monitor the evidence.
    • Minimum intervals between two COVID-19 vaccine doses are still required.
References:
Last Updated

02 Sep 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: 18 Sep 2021