Ministry of Health

COVID-19 Vaccine Guidance

Version 9.0 – October 6, 2023
Summary of Changes
• Addition of Immunization History section (page 4)
• Update to Table 1 (page 5-7)
• Update to recommendations for moderately to severely
immunocompromised individuals to receive one additional dose (page 9)
• Update to Out of Province Vaccines Section (page 21)
• Update to Appendix A to include Pfizer XBB products (page 24-25)
• Addition of Appendix B to outline vaccine scenarios for individuals 6 months
– 4 years completing an mRNA vaccine series with the XBB formulation
(page 26-27)

This guidance provides basic information only. This document is not intended to
provide or take the place of medical advice, diagnosis or treatment, or legal advice.
In the event of any conflict between this guidance document and any applicable
orders, or directives issued by the Minister of Health, Minister of Long-Term Care, or
the Chief Medical Officer of Health (CMOH), the order or directive prevails.
• Please check the Ministry of Health (MOH) COVID-19 website regularly for
updates to this document
This document can be used as a reference for vaccine clinics and vaccine
administrators to support COVID-19 immunization. Complementary resources
include the individual vaccine product monographs, the COVID-19: Vaccine Storage
and Handling Guidance and the COVID-19 Vaccine: Canadian Immunization Guide.
Evidence on vaccine effectiveness for COVID-19 vaccines currently authorized for
use in Canada continues to evolve. For up to date information on vaccine efficacy
and effectiveness, please consult the National Advisory Committee on Immunization
(NACI) statements and publications on the Government of Canada webpage.

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Table of Contents
Ontario’s COVID-19 Vaccine Program .........................................................................................3

Vaccine Recommendations .........................................................................................................3

Table 1: Moderna or Pfizer XBB mRNA COVID-19 vaccine schedule based on

immunization history and immune status ..................................................................................5

Fall 2023 COVID-19 Vaccine Program ........................................................................................8

Recommendations for Moderately to Severely Immunocompromised Individuals ............9

Co-Administration .......................................................................................................................11

Recommended Intervals Between Previous SARS-CoV-2 Infection and COVID-19

Vaccination ...................................................................................................................................11

Table 2: Suggested Intervals between SARS-CoV-2 Infection and COVID-19 Vaccination

........................................................................................................................................................12

COVID-19 Vaccine Precautions & Population Specific Considerations ................................13

Adverse Events Following Immunization .................................................................................19

Out of Province Vaccines ............................................................................................................21

COVID-19 Vaccine Errors and Deviations .................................................................................22

Vaccine Preparation and Administration ..................................................................................23

Appendix A: Vaccines Available for Use in Ontario ................................................................24

Appendix B: Scenarios for immunocompetent individuals 6 months – 4 years completing

a COVID-19 mRNA vaccine series ..............................................................................................26

Appendix C: Interim recommendations for bivalent COVID-19 mRNA vaccines based on

age, dosage, and schedule.........................................................................................................28

Appendix D: Interim recommendations for product preferences when using the bivalent
COVID-19 mRNA vaccines ..........................................................................................................29

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Ontario’s COVID-19 Vaccine Program
Ontario’s COVID-19 vaccine program aims to ensure as many Ontarians as possible
are up to date with their COVID-19 vaccines for the purposes of protecting
individuals against severe COVID-19 disease, including hospitalization and death.
At this time, the seasonality of COVID-19 is not known, and it has not yet been
determined whether people will need an additional COVID-19 vaccine dose at a set
time period (e.g., every 6 months). This guidance outlines current recommendations
based on age and health status. Health equity remains a cornerstone and a priority
of Ontario’s COVID-19 vaccine program. Sustained culturally safe and community
centred efforts need to be prioritized to:
1. Ensure ongoing access to vaccines for Indigenous, racialized, and
marginalized populations disproportionately affected by COVID-19 due to
disparities in the Social Determinants of Health including systemic barriers to
accessing health care; and
2. Promote people remaining up to date with their COVID-19 vaccines.

Vaccine Recommendations
To align with National Advisory Committee on Immunization (NACI) and the product
monographs, as of Fall 2023, the Ontario Ministry of Health (MOH) is moving away
from using the terms ‘primary series’ and ‘booster dose(s)’. This document refers to
an individual’s vaccination status as ‘not previously vaccinated’ and ‘previously
vaccinated’ (see Immunization History for definitions).
1. Individuals who have NOT been previously vaccinated, may use the XBB.1.5-
containing COVID-19 mRNA vaccine (XBB) formulation to complete the dose
schedule as outlined in Table 1.
i. The recommendation for unvaccinated individuals 12-29 years to
receive a Pfizer COVID-19 vaccine rather than a Moderna COVID-19
vaccine is no longer a recommendation with the XBB formulation.
Unvaccinated individuals in this age range may receive either the Pfizer
or Moderna XBB vaccine.
2. Consistent with NACI, the Ontario MOH recommends a dose of the XBB
vaccine for individuals in the authorized age group (i.e., 6 months and older)
who have been previously vaccinated against COVID-19, if it has been 6
months from the previous COVID-19 vaccine dose or known SARS-CoV-2
infection (whichever is later) as outlined in Table 1. NACI notes that a shorter
interval (3 to < 6 months) can be used to support fall vaccine program
implementation.
i. Immunization is particularly important for those at increased risk of
COVID-19. The Ontario MOH strongly recommends that individuals
at high-risk from COVID-19, including those with a potential for
greater impact from infection, receive a dose of the XBB vaccine this
fall, if it has been six months since their last COVID-19 vaccine dose or
confirmed SARS-CoV-2 infection (see Fall 2023 COVID-19 Vaccine
Program).
3. For individuals who are not able or willing to receive an mRNA COVID-19
vaccine, NACI recommends the Novavax COVID-19 vaccine should be
offered. An XBB formulation of Novavax COVID-19 vaccine is expected.

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 Individuals requesting the Novavax vaccine should be made aware that an
updated formulation is under review by Health Canada. NACI guidance on the
XBB formulation of Novavax is anticipated after authorization. In the interim,
individuals who are not able or willing to receive an mRNA COVID-19 vaccine
may be offered a Novavax COVID-19 vaccine targeting the original COVID-19
strain. Those 12 years and older who have not been previously vaccinated
may use the Novavax COVID-19 vaccine to complete a two-dose series; an
additional dose may be needed for individuals who are
immunocompromised. Previously vaccinated individuals, 18 years and older,
who are not able or willing to receive an mRNA COVID-19 vaccine should be
offered a Novavax dose.
4. Immunization with the bivalent COVID-19 vaccine formulation that was
approved by Health Canada last fall, is still available. Individuals who wish to
receive a dose of this formulation should speak with a health care provider
and should be made aware of the recommendation to receive an XBB
vaccine (see Appendices C and D for guidance on bivalent use and
recommendations).
i. Data from Moderna and Pfizer have shown that the BA.4/5 bivalent
vaccines do generate immune responses against the XBB.1.5 variant
and variants that are descendants of XBB.1.5; however, the new XBB.1.5
vaccine formulation generates a stronger immune response to these
more recent variants.

Immunization History
Not previously vaccinated: all those 6 months and older who have never received a
COVID-19 dose.
Previously Vaccinated for those 5 years and older: XBB vaccine schedule
recommendations differ based on the number of previous non-XBB COVID-19 doses
the individual has received and their immune status. Please see Table 1 for
appropriate schedule.
Previously Vaccinated for those 6 months to 4 years: XBB vaccine schedule
recommendations differ based on whether or not the child has previously
completed either a 2-dose series (i.e., Original or Bivalent Moderna) (3-dose series
for immunocompromised) or a 3-dose series (i.e., Original Pfizer) (4-dose series for
immunocompromised).
• Children who have completed a 2-dose series (i.e., Original or Bivalent Moderna)
(3-dose series for immunocompromised) or a 3-dose series (i.e., Original Pfizer)
(4-dose series for immunocompromised) are eligible to receive a dose of the
XBB vaccine this fall if it has been 6 months (minimum 3 months) since their last
COVID-19 vaccine dose or confirmed SARS-CoV-2 infection.
• Children who have not completed an appropriate series (based on the vaccine
product and immune status), should complete the series using the appropriate
number of doses using an XBB vaccine as per Table 1. Please see Appendix B for
specific scenarios with authorized and recommended intervals for this
population.
• NACI recommendations on vaccine interchangeability apply to XBB COVID-19
vaccines if used to complete a vaccine series started with a different formulation
(either original monovalent wild type-containing or bivalent vaccine). Regardless
of which product is offered to start a vaccine series, the previous dose should be
counted, and the series need not be restarted.

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 Table 1: Moderna or Pfizer XBB mRNA COVID-19 vaccine schedule
based on immunization history and immune status
A. For those NOT moderately to severely immunocompromised
Age Immunization Recommended Number of XBB Doses and Interval 2 Between
History 1 Doses
Moderna XBB Pfizer XBB Schedule
Schedule 3
6 3 or more N/A 1 dose
months doses • Recommended: 168 days from
– 4 years last dose
• Minimum: 84 days from last dose 4
2 doses 1 dose 1 dose
• Recommended: 168 • Recommended: 56 days from last
days from last dose dose
• Minimum: 84 days • Minimum:
from last dose4 o 28 days from last dose (if 2nd
dose was Moderna)
o 56 days from last dose (if 2nd
dose was Pfizer)

1 dose 1 dose 2 doses

• Recommended: 56 • Recommended: 56 days from last
days from last dose dose and between doses
• Minimum: 28 days • Minimum:
from last dose o 28 days from last dose (if 1st
dose was Moderna) and
between doses
o If 1st dose was Pfizer:
 21 days between dose 1 & 2
 56 days between dose 2 & 3

0 doses 2 doses 3 doses

• Recommended: 56 • Recommended: 56 days between
days between doses doses
• Minimum: 28 days • Minimum:
between doses o 21 days between dose 1 & 2
o 56 days between dose 2 & 3

5 years + 2 or more 1 dose

doses • Recommended: 168 days from last dose
• Minimum: 84 days from last dose4

1
Refers to the doses of non-XBB COVID-19 vaccine that were previously received.
2
Recommended intervals are based on NACI recommendations. A longer interval between doses of
a COVID-19 vaccine, results in a more robust and durable immune response and higher vaccine
effectiveness. The minimum interval is the shortest interval at which the product should be given and
is outlined in the product monographs.
3
For individuals 6 months – 4 years, this column assumes that all previous non-XBB doses were all
Moderna vaccines. If one or more dose was Pfizer, follow the Pfizer XBB Schedule.
4
Per NACI, a shorter interval (3 to < 6 months) may be used to support fall program implementation.

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 Age Immunization Recommended Number of XBB Doses and Interval 2 Between
History1 Doses
Moderna XBB Pfizer XBB Schedule
Schedule 3
5 years + 1 dose 1 dose
• Recommended: 56 days from last dose
• Minimum:
o 28 days from last dose (if 1st dose was Moderna)
o 21 days from last dose (if 1st dose was Pfizer)
0 doses 1 dose

B. For those moderately to severely immunocompromised

Age Immunization Recommended Number of XBB Doses and Interval 6 Between
History 5 Doses
Moderna XBB 7 Pfizer XBB

6 months 4 or more N/A 1 dose

– 4 years doses • Recommended: 168 days from last
dose
• Minimum: 84 days from last dose 8
3 doses 1 dose 1 dose
• Recommended: 168 • Recommended: 56 days from last
days from last dose dose
• Minimum: 84 days • Minimum:
from last dose8 o 28 days from last dose (if 3rd dose
was Moderna)
o 56 days from last dose (if 3rd
dose was Pfizer)
2 doses 1 dose 2 doses
• Recommended: 56 • Recommended: 56 days from last
days from last dose dose and between doses
• Minimum: 28 days • Minimum:
from last dose o 28 days from last dose (if 2nd
Moderna preferred 9 dose was Moderna)
o If 2nd dose was Pfizer
 56 days between dose 2 & 3
 56 days between dose 3 & 4

5
Refers to the doses of non-XBB COVID-19 vaccine that were previously received.
6
Recommended intervals are based on NACI recommendations. A longer interval between doses of
a COVID-19 vaccine, results in a more robust and durable immune response and higher vaccine
effectiveness. The minimum interval is the shortest interval at which the product should be given and
is outlined in the product monographs.
7
For individuals 6 months – 4 years, this column assumes that all previous non-XBB doses were all
Moderna vaccines. If one or more dose was Pfizer, follow the Pfizer XBB Schedule.
8
Per NACI, a shorter interval (3 to < 6 months) may be used to support fall program implementation.
9
The ministry preferentially recommends the Moderna XBB vaccine over the Pfizer XBB vaccine for
individuals 6 months – 4 years who are moderately to severely immunocompromised. This product
preference reflects acceptability and feasibility considerations for implementing a 3 dose (Moderna)
vs. 4 dose (Pfizer) series and greatly likelihood of series completion in high-risk individuals, with fewer
doses required in the Moderna schedule.

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Age Immunization Recommended Number of XBB Doses and Interval 6 Between
History 5 Doses
Moderna XBB 7 Pfizer XBB

6 months 1 dose 2 doses 3 doses

– 4 years • Recommended: 56 • Recommended: 56 days from last
days from last dose dose and between doses
and between doses • Minimum:
• Minimum: 28 days o 28 days from last dose (if 1st dose
from last dose and was Moderna)
between doses o If 1st dose was Pfizer
Moderna preferred9  21 days between dose 1 & 2
 56 days between dose 2 & 3
 56 days between dose 3 & 4
0 doses 3 doses 4 doses
• Recommended: 56 • Recommended: 56 days between
days between doses doses
• Minimum: 28 days • Minimum:
between doses o 21 days between dose 1 & 2
Moderna preferred 9
o 56 days between dose 2 & 3
o 56 days between dose 3 & 4
5 years + 3 or more 1 dose
doses • Recommended: 168 days from last dose
• Minimum: 84 days from last dose8
2 doses 1 dose
• Recommended: 56 days from last dose
• Minimum:
o 28 days from last dose (if 2nd dose was Moderna)
o 21 days from last dose (if 2nd dose was Pfizer)
1 dose 2 doses
• Recommended: 56 days from last dose and between doses
• Minimum:
o Moderna: 28 days from last dose (if 1st dose was Moderna)
and between doses
o Pfizer: 21 days from last dose (if 1st dose was Pfizer) and
between doses
0 doses 2 doses
Recommended: 56 days between doses
Minimum:
o Moderna: 28 days between doses
o Pfizer: 21 days between doses

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Fall 2023 COVID-19 Vaccine Program
Ontario’s Fall 2023 COVID-19 Vaccine Program will continue to be rolled out with
the 2023-24 Universal Influenza Immunization Program (UIIP). In alignment with the
influenza program, administration of XBB COVID-19 vaccine doses began at the end
of September with preliminary doses prioritized for those at the highest risk from
COVID-19. High-risk criteria have been aligned between programs to help promote
co-administration whenever possible.
Vaccine Rollout:
• Initial doses will be prioritized for:
o Hospitalized individuals and hospital staff,
o Long-Term Care Home and Elder Care Lodge residents, staff, and caregivers
• Vaccines will continue to be distributed, as they become available, to
participating retirement homes, other congregate living settings, pharmacies,
primary care providers and other providers for the immunization of:
o Individuals at high-risk for influenza and/or COVID-19 related complications
or hospitalization:
Residents and staff of congregate living settings (e.g., chronic care
facilities, retirement homes)
 Pregnant individuals
 Individuals ≥ 65 years of age
 All children 6 months to 4 years of age [based on influenza risk] 10
 Individuals who are from a First Nation, Inuit or Métis community,
and/or who self-identify as First Nation, Inuit, or Métis, and their
household members
 Individuals 6 months of age and older with underlying health
conditions per NACI (Influenza & COVID-19)
 Members of racialized and other equity deserving communities
o Health care workers and first responders
COVID-19 vaccine administration will be open to the general population on October
30, 2023.

Children 6 months to 4 years of age are considered a high-risk group for influenza, as they are at
10

heighted risk of influenza-related complications and/or hospitalizations. This recommendation has

been made based on influenza risk and to encourage co-administration of influenza and COVID-19
vaccines whenever possible.

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Recommendations for Moderately to Severely
Immunocompromised Individuals
Individuals 6 months and older who are moderately to severely
immunocompromised are recommended to receive at least one dose of the XXB
vaccine formulation this fall. Please see Table 1 for appropriate schedule based on
number of previous doses received.
The ministry preferentially recommends the Moderna XBB vaccine over the Pfizer
XBB vaccine for individuals 6 months – 4 years who are moderately to severely
immunocompromised. This product preference reflects acceptability and feasibility
considerations for implementing a 3 dose (Moderna) vs. 4 dose (Pfizer) series and
greatly likelihood of series completion in high-risk individuals, with fewer doses
required in the Moderna schedule.

Moderately to Severely Immunocompromised Populations

Moderately to severely immunocompromised populations may include the
following:
• Individuals receiving dialysis (hemodialysis or peritoneal dialysis)
• Recipients of solid-organ transplant and taking immunosuppressive therapy
• Individuals receiving active treatment 11 (e.g., chemotherapy, targeted therapies,
immunotherapy) for solid tumour or hematologic malignancies
• Recipients of chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic
stem cell transplant (within 2 years of transplantation or taking
immunosuppression therapy)
• Individuals with moderate to severe primary immunodeficiency (e.g., DiGeorge
syndrome, Wiskott-Aldrich syndrome)
• HIV with AIDS-defining illness in last 12 months before starting vaccine series, or
severe immune compromise with CD4 count <200 cells/uL or CD4 percentage
<15%, or without HIV viral suppression

11
Active treatment includes patients who have completed treatment within 3 months. Active
treatment is defined as chemotherapy, targeted therapies, immunotherapy, and excludes individuals
receiving therapy that does not suppress the immune system (e.g., solely hormonal therapy or
radiation therapy). See Ontario Health/Cancer Care Ontario’s Frequently Asked Questions for more
information.

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• Individuals receiving active treatment with the following categories of
immunosuppressive therapies: anti-B cell therapies12 (monoclonal antibodies
targeting CD19, CD20 and CD22), high-dose systemic corticosteroids (refer to the
Canadian Immunization Guide for suggested definition of high dose steroids),
alkylating agents, antimetabolites, or tumor-necrosis factor (TNF) inhibitors and
other biologic agents that are significantly immunosuppressive (Appendix D).
• It is recommended that re-vaccination with a new COVID-19 vaccine series be
initiated post-transplantation for hematopoietic stem cell transplant (HSCT),
hematopoietic cell transplants (HCT) (autologous or allogeneic), and recipients of
CAR-T-cell therapy given the loss of immunity following therapy or transplant. 13
Optimal timing for re-immunization should be determined on a case-by-case
basis in consultation with the clinical team. For additional information on organ
transplantation, consult the Canadian Society of Transplantation statement on
COVID-19 vaccination.
• For additional information on rheumatic diseases, consult the Canadian
Rheumatology Association statement on COVID-19 vaccination.
• For additional information on inflammatory bowel disease, consult the Canadian
Association of Gastroenterology statement on COVID-19 vaccination.
• For additional information on immunodeficiency conditions, consult the COVID-
19 resources on the Canadian Society of Allergy and Clinical Immunology
webpage.
• For frequently asked questions about COVID-19 vaccines and adult cancer
patients, consult Cancer Care Ontario.
The safety and efficacy of the Novavax COVID-19 vaccine has not been established
in individuals who are immunocompromised due to disease or treatment. As such,
eligible individuals who choose to be immunized with the Novavax COVID-19
vaccine should be informed that there is currently limited evidence for use of
these vaccines in this population. Individual clinical discretion should be used
when offering an additional dose of Novavax to immunocompromised individuals.

12
Active treatment for patients receiving B-cell depleting therapy includes patients who have
completed treatment within 12 months.
As per the Canadian Immunization Guide, HSCT recipients should be viewed as vaccine naïve (i.e.,
13

never immunized) and require re-immunization after transplant.

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Co-Administration
Individuals 6 months and older, may receive a COVID-19 vaccine simultaneously
with (i.e., same day), or at any time before or after non-COVID-19 vaccines
(including live and non-live vaccines). If vaccines are co-administered,
immunization on separate limbs is recommended, however if the same limb must
be used, the injection sites should be separated by at least 2.5 cm (1 inch).
There are two exceptions. COVID-19 vaccines should not be co-administered with
the Imvamune vaccine for mpox and the Arexvy vaccine for Respiratory Syncytial
Virus (RSV).
Imvamune: it is recommended to wait at least 4 weeks before or after
administration of an Imvamune vaccine. However, the administration of Imvamune
as pre- or post-exposure vaccination should not be delayed in an individual who has
recently received a COVID-19 vaccine. These suggested waiting periods are
precautionary and may help prevent erroneous attribution of an AEFI to one
particular vaccine or the other. Please refer to Mpox Vaccine (Imvamune) Guidance
for Health Care Providers.
Arexvy: it is recommended to wait at least 2 weeks before or after administration of
the RSV vaccine. Please refer to the ministry’s website on RSV for more information.

Recommended Intervals Between Previous

SARS-CoV-2 Infection and COVID-19 Vaccination
The ministry in alignment with NACI, continues to recommend that COVID-19
vaccines be offered to individuals with previous SARS-CoV-2 infection without
contraindications to the vaccine. Below are suggested intervals between previous
SARS-CoV-2 infection and COVID-19 vaccination.

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Table 2: Suggested Intervals between SARS-CoV-2 Infection and
COVID-19 Vaccination
SARS-CoV-2 Population Recommended Interval
Infection timing
relative to COVID-
19 vaccination
Infection in Individuals 6 months and older 8 weeks (56 days) after
individuals who who are not considered symptom onset or positive test
have not been moderately to severely (if asymptomatic)
previously immunocompromised and with no
vaccinated or in previous history of multisystem
those who are in inflammatory syndrome in children
process of and adults (MIS-C and MIS-A)
completing a Individuals 6 months and older 4 to 8 weeks (28 to 56 days)
vaccination series who are moderately to severely after symptom onset or
immunocompromised and with no positive test (if asymptomatic)
previous history of MIS-C and MIS-
A
Individuals 6 months and older Receive vaccine dose when
with a history of MIS-C and MIS-A clinical recovery has been
(regardless of achieved or ≥90 days since the
immunocompromised status) diagnosis of MIS-C and MIS-A,
whichever is longer
Infection in Individuals currently eligible for a Receive vaccine dose 3 – 6
individuals who fall 2023 COVID-19 dose(s) months (84 - 168 days) after
have been previous COVID-19 infection
previously (characterized by positive test
vaccinated or after having symptoms post
contact with someone who
had a positive test) 14.
*A previous infection with SARS-CoV-2 is defined as:

14
As per NACI, vaccination using shorter intervals (i.e. 3 months to < 6 months) following previous
vaccination or infection has not been shown to pose a safety risk, though evidence shows that the
antibody response is higher with longer intervals between infection and vaccination and with longer
intervals between vaccination doses.

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 • Confirmed SARS-CoV-2 infection using a molecular (e.g., PCR) or Health
Canada-approved rapid antigen test; or
• Symptomatic disease compatible with COVID-19 AND a household exposure
to a confirmed COVID-19 case.
These suggested intervals are based on immunological principles and expert
opinion, and may change as evidence on COVID-19, variants of concern (VOCs), and
COVID-19 vaccines emerge. When considering whether or not to administer vaccine
doses according to the intervals outlined in this table, biological and social risk
factors for exposure (e.g., local epidemiology, circulation of VOCs, living settings)
and risk of severe disease should also be taken into account. These intervals are a
guide and clinical discretion is advised.
In accordance with provincial guidance, individuals who have symptoms of COVID-
19 or other infectious agents should self-isolate, including COVID-19 vaccine clinics,
until the following criteria are met:
• Symptoms have been improving for at least 24 hours (or 48 hours if nausea,
vomiting and/or diarrhea were present)
• No fever
• There has not been development of additional symptoms
These suggested waiting times are intended to minimize the risk of transmission of
COVID-19 and other respiratory or gastrointestinal pathogens at an immunization
venue and to enable monitoring for COVID-19 vaccine adverse events following
immunization (AEFI) without potential confounding from symptoms of COVID-19 or
other co-existing illnesses.

COVID-19 Vaccine Precautions & Population

Specific Considerations
See the COVID-19 Vaccine: Canadian Immunization Guide’s section on
Contraindications and Precautions for recommendations for individuals with
bleeding disorders, immune thrombocytopenia, venous thromboembolism,
thrombosis with thrombocytopenia syndrome, myocarditis and/or pericarditis
following vaccination, Guillain-Barré syndrome and Bell’s palsy.

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Myocarditis & Pericarditis following vaccination with an mRNA
COVID-19 vaccine
There have been Canadian and international reports of myocarditis (inflammation of
the heart muscle) and pericarditis (inflammation of the lining around the heart)
following vaccination with COVID-19 mRNA vaccines. Global experience to date has
indicated that the majority of reported cases have responded well to conservative
therapy (rest, treatment with non-steroidal anti-inflammatory drugs (NSAIDS)) and
tend to recover quickly. Symptoms have typically been reported to start within one
week after vaccination. Cases of myocarditis/pericarditis following COVID-19 mRNA
vaccination occur more commonly in adolescents and young adults (12 to 29 years),
more often after the second dose and more often in males than females. Safety
surveillance data from the US suggests that the risk of myocarditis or pericarditis is
lower in children 5 to 11 years following monovalent Pfizer-BioNTech (10 mcg)
vaccination compared to adolescents and young adults (who received a
monovalent Pfizer-BioNTech 30 mcg dose). Among children 5 to 11 years, very rare
cases were most often reported following dose 2 and among males. Post-market
safety surveillance is ongoing (NACI, 2022). Providers are encouraged to consult the
enhanced epidemiologic surveillance summary from Public Health Ontario for
trends and risk of myocarditis/pericarditis following mRNA vaccines in Ontario.
NACI continues to strongly recommend that a complete series with an mRNA
COVID-19 vaccine be offered to all eligible individuals in Canada, including those 5
years and older.
The benefits of vaccination with COVID-19 vaccines continue to outweigh the risks
of COVID-19 illness and related, possibly severe outcomes for all age groups.
• Anyone receiving an authorized mRNA COVID-19 vaccine should be informed of
the risk of myocarditis and pericarditis, and advised to seek medical attention if
they develop symptoms including chest pain, shortness of breath, palpitations
(pounding or heart racing), or feeling of rapid or abnormal heart rhythm (NACI).
In most circumstances, and as a precautionary measure until more information is
available, individuals with a diagnosed episode of myocarditis (with or without
pericarditis) within 6 weeks of receipt of a previous dose of an mRNA COVID-19
vaccine should defer further doses of the vaccine. This includes any person who
had an abnormal cardiac investigation including electrocardiogram (ECG), elevated
troponins, echocardiogram or cardiac MRI after a dose of an mRNA vaccine. This is a
precaution based on recommendations issued by the National Advisory Committee
on Immunization (NACI) in the Canadian Immunization Guide. NACI, Public Health

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Ontario (PHO), and the Ontario Ministry of Health (MOH) are following this closely
and will update this recommendation as more evidence becomes available.
• In situations where there is uncertainty regarding myocarditis diagnosis,
discussion should occur with an appropriate physician or nurse practitioner on
potential options for (re)immunization with the same or alternative COVID-19
vaccine, including a risk-benefit analysis for the individual. Those with a history
compatible with pericarditis and who either had no cardiac workup or had
normal cardiac investigations, can receive the next dose once they are symptom
free and at least 90 days has passed since vaccination.
• Some people with confirmed myocarditis with or without pericarditis may
choose to receive another dose of vaccine after discussing the risks and benefits
with their health care provider. Individuals can be offered the next dose once
they are symptom free and at least 90 days has passed since vaccination.
Informed consent should include discussion about the unknown risk of
recurrence of myocarditis and/or pericarditis following receipt of additional
doses, as well as the need to seek immediate medical assessment and care
should symptoms develop.
o For more information consult Public Health Ontario’s Myocarditis and
Pericarditis Following COVID-19 mRNA Vaccines resource.
o Interim clinical guidance and an algorithm for the identification and
management of myocarditis and pericarditis following mRNA COVID-19
vaccination in children is available from the Hospital for Sick Children.
o A clinical framework is also available from the Canadian Journal of
Cardiology Myocarditis and Pericarditis following COVID-19 mRNA
Vaccination: Practice Considerations for Care Providers

Multi-Inflammatory Syndrome in Children or in Adults (MIS-C/A)

following vaccination with an mRNA COVID-19 vaccine
Children and adolescents with SARS-CoV-2 infection are at risk of multisystem
inflammatory syndrome in children (MIS-C), a rare but serious syndrome that can
occur several weeks following SARS-CoV-2 infection. Very rare cases of MIS-C/A
(multisystem inflammatory syndrome in children and in adults) have been reported
following vaccination with COVID-19 mRNA vaccines in Canada and internationally
among individuals aged 12 years and older. However, on October 29, 2021, the
European Medical Association Pharmacovigilance Risk Assessment Committee
(EMA-PRAC) issued a statement that there is currently insufficient evidence on a
possible link between mRNA COVID-19 vaccines and very rare cases of MIS-C/A.

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For children or adults with a previous history of MIS-C or MIS-A, respectively,
unrelated to any previous COVID-19 vaccination, vaccination should be postponed
until clinical recovery has been achieved or until it has been ≥ 90 days since
diagnosis, whichever is longer.

Bell’s palsy following vaccination with an mRNA COVID-19 vaccine

Very rare cases of Bell’s palsy (typically temporary weakness or paralysis on one
side of the face) have been reported following vaccination with COVID-19 mRNA
vaccines (Pfizer-BioNTech or Moderna) in Canada and internationally among
individuals 12 years and older. Bell’s palsy is an episode of facial muscle weakness
or paralysis. The condition is typically temporary. Symptoms appear suddenly and
generally start to improve after a few weeks. The exact cause is unknown. It’s
believed to be the result of swelling and inflammation of the nerve that controls
muscles on the face.
Symptoms of Bell’s palsy may include:
• uncoordinated movement of the muscles that control facial expressions, such
as smiling, squinting, blinking or closing the eyelid
• loss of feeling in the face
• headache
• tearing from the eye
• drooling
• lost sense of taste on the front two-thirds of the tongue
• hypersensitivity to sound in the one ear
• inability to close an eye on one side of the face
Individuals should seek medical attention if they develop symptoms of Bell’s palsy
following receipt of mRNA COVID-19 vaccines. Health care providers should
consider Bell’s palsy in their evaluation if the patient presents with clinically
compatible symptoms after an mRNA COVID-19 vaccine. Investigations should
exclude other potential causes of facial paralysis.

History of Allergies
See the COVID-19 Vaccine: Canadian Immunization Guide for information on
vaccination for all individuals with allergies (including those with allergic reactions to
previous doses of any COVID-19 vaccine, or vaccine components).

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People who experienced a severe immediate allergic reaction after a dose of an
mRNA COVID-19 vaccine can safely receive future doses of the same or another
mRNA COVID-19 vaccine after consulting with an allergist/immunologist or another
appropriate physician. See the CIG for more information. As per the Canadian
Society of Allergy and Clinical Immunology, individuals with a suspected history of
adverse reactions to tromethamine, including suspected history of systemic allergic
reactions to radiocontrast media and ketorolac, may receive vaccines containing
tromethamine (CSACI, 2023).
Individuals with known allergies to components of the vaccines may speak with an
appropriate physician or nurse practitioner (NP) for evaluation. This assessment will
enable the development of a vaccination care plan which may include receiving the
vaccine under the supervision of your physician. Documentation of the discussion
with the physician/NP may be provided to the immunizing clinic and can include a
vaccination care plan, including the parameters the clinic should meet to provide
safe vaccination administration, such as availability of advanced medical care to
manage anaphylaxis); details/severity of the previous allergic episode(s);
confirmation that appropriate counselling on the safe administration of vaccine has
been provided; and the date, the clinician’s name, signature and contact information,
as well as the individual’s name and date of birth.

Symptoms, either current or displayed recently, of chest pain or

shortness of breath
Vaccine should not be offered to persons displaying current or recent history of
chest pain or shortness of breath.
Persons displaying current or recent history of chest pain or shortness of breath
should consult with a health care provider prior to vaccination and/or if symptoms
are severe, should be directed to the emergency department or call 911.

Side effects
COVID-19 vaccines, like medicines and other vaccines, may cause side effects. In
clinical trials, most of the side effects experienced were mild to moderate, and
usually resolved within a few days. Please see the individual product monographs
for a complete list of reported side effects.

History of Fainting/Dizziness or Fear of Needles

Individuals with a history of fainting/dizziness, or fear of injections/needles can
safely receive the COVID-19 vaccine. Considerations may include:
• Immunize while seated to reduce injuries due to fainting,

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 • If considered high-risk, immunize while lying down.
• These individuals may bring a support person.
• CARD (C-Comfort, A-Ask, R-Relax, D-Distract) is an evidence-based
framework that can help with vaccination. See CARD resources to support
immunization

Pregnant or Breastfeeding
COVID-19 vaccination during pregnancy is effective at protecting pregnant
individuals against severe COVID-19 disease, hospitalization, and ICU admission
from COVID-19 infection, as well as intubation and mortality in those with severe
disease. Pregnant or breastfeeding individuals should receive all recommended
COVID-19 vaccine doses as soon as they are able. In addition, to protecting the
pregnant individual, the benefits of immunization during pregnancy for the fetus
have also been well-documented. Protective antibodies are transferred to the fetus
transplacentally, resulting in increased protection for the infant during the early
postnatal period when they are not yet eligible for vaccination (CIG, 2023).
Recommendations for vaccination during pregnancy and/or breastfeeding:
• A COVID-19 vaccine may be offered at any stage of the pregnancy (i.e., in
any trimester).
• COVID-19 vaccines may be co-administered with other vaccines
recommended during pregnancy or while breastfeeding.
• NACI strongly recommends that individuals who are pregnant or
breastfeeding receive all recommended COVID-19 vaccine doses.
• Pregnancy is a group at higher risk of severe outcomes from COVID-19 and
NACI has identified pregnancy as one of the risk groups for whom receiving a
dose of the XBB vaccine this fall is particularly important.
• The XBB.1.5 COVID-19 vaccine can be used to start a vaccination series for
those previously unvaccinated and can be used to complete a vaccine series
started with a different vaccine.
There have been no serious safety concerns with receiving an mRNA COVID-19
vaccination during pregnancy or lactation. Pregnant or breastfeeding individuals
experience the same rates of expected local and systemic adverse events as
individuals who are not pregnant and/or breastfeeding. Vaccination during
pregnancy does not increase risk of miscarriage, stillbirth, low birth weight, preterm
birth, NICU admission or other adverse pregnancy/birth outcomes. Similarly, studies
have not found any negative impact of vaccination on the child being fed human

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milk or on milk production or excretion. Protective antibodies are transferred to the
child via breast milk, which can help protect the infant during the early postnatal
period when they are not yet eligible for vaccination.
For additional resources, individuals who are pregnant and/or breastfeeding can
access the Provincial Council for Maternal and Child Health’s decision making tool,
the Society of Obstetricians and Gynaecologists of Canada Statement on COVID-19
Vaccination in Pregnancy, Canadian Immunization Guide and the NACI Updated
guidance on COVID-19 vaccines for individuals who are pregnant or breastfeeding.

Adverse Events Following Immunization

An adverse event following immunization (AEFI) is defined as any unexpected
medical occurrence (e.g., unfavourable or unintended sign, abnormal laboratory
finding, symptom or disease) following administration of an active immunizing agent
(CIG, 2023). This event does not necessarily have a causal relationship with the use
of a vaccine.
Guidance on reporting adverse events following immunization (AEFI) for health care
providers
• Health care providers administering vaccines are required to inform vaccine
recipients or their parent/guardian of the importance of reporting adverse
events following immunization (AEFIs) to a health care provider in accordance
with Section 38 of the Health Protection and Promotion Act (HPPA). Vaccine
recipients or their parent/guardian may also contact their local public health
unit to ask questions or to report an AEFI.
• Specified health care providers (e.g., physicians, nurses and pharmacists) are
required under s.38(3) of the HPPA to report AEFIs to their local public health
unit. Reports should be made using the Ontario AEFI Reporting Form.
• See Public Health Ontario’s vaccine safety webpage and Fact Sheet –
Adverse Event Following Immunization Reporting For Health Care Providers
In Ontario for additional guidance.
• The Ontario Ministry of Health in collaboration with Public Health Ontario
monitors reports of AEFIs. This monitoring is done in collaboration with the
Public Health Agency of Canada and Health Canada.
All health care providers administering vaccines must be familiar with the
anaphylaxis protocols for their clinic sites and ensure availability of anaphylaxis
management kits. For additional information please visit the Public Health Ontario

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resource on the Management of Anaphylaxis Following Immunization in the
Community and the Canadian Immunization Guide.
Those administering vaccines should ensure that vaccine recipients or their
parents/guardians are advised to notify clinic staff, or if they have left the clinic, call
their doctor/nurse practitioner or go to the nearest hospital emergency department
if they develop any of the following symptoms:
• Hives
• Swelling of the face, throat or mouth
• Altered level of consciousness/serious drowsiness
• Trouble breathing, hoarseness or wheezing
• High fever (over 40oC or 104oF)
• Convulsions or seizures
• Other serious reactions (e.g., “pins and needles” or numbness)
NACI recommends a 15-minute post-vaccination observation period, as specified
in the Canadian Immunization Guide (CIG). If there is a specific concern about
possible vaccine reaction, 30 minutes is the preferred interval for a post-
vaccination observation. Previous NACI guidance provided consideration for a
reduced post-vaccination observation period, between 5 to 15 minutes for the
administration of COVID-19 vaccine during the COVID-19 pandemic, at times when
appropriate physical distancing in post-vaccination waiting areas could not
otherwise be maintained due to the volume of individuals seeking immunization and
only when specific conditions were met:
• Past history of receipt of COVID-19 vaccine and no known history of severe
allergic reactions (including anaphylaxis) to any component of the COVID-19
vaccine being considered for administration.
• No history of other immediate post-vaccination reactions (e.g., syncope with
or without seizure) after receipt of any vaccines.
• The vaccine recipient is accompanied by a responsible adult who will act as a
chaperone to monitor the vaccine recipient for a minimum of 15 minutes post-
vaccination. In the case of two responsible adults, both can be vaccine
recipients for the purposes of this criterion, if both agree to monitor the other
post-vaccination.

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 • The vaccine recipient will not be operating a motorized vehicle or self-
propelled or motorized wheeled transportation or machinery for a minimum
of 15 minutes after vaccination.
• The vaccine recipient and the responsible adult chaperone are aware of
when and how to seek post-vaccination advice and given instruction on what
to do if assistance and medical services are required.
• The vaccine recipient and the responsible adult agree to remain in the post-
vaccination waiting area for the post-vaccination observation period and to
notify staff if the recipient feels or looks at all unwell before leaving. They
should be informed that an individual exhibiting any symptom suggestive of
an evolving adverse event following immunization (AEFI) at the end of the
shortened post-observation period necessitates a longer period of
observation in the clinic.

Out of Province Vaccines

If an individual, 6 months and older has been vaccinated with one or more doses of
a non-Health Canada approved vaccine(s), they are recommended to receive one or
more doses of an XBB vaccine as per Table 1. Number of recommended XBB doses
will depend on how many previous doses the individual received and their immune
status.
It is particularly important for those individuals at high-risk from COVID-19,
including those with a potential for greater impact from infection, to receive a
dose of the XBB formulation this fall.
Individuals who have received COVID-19 vaccines outside of Ontario or Canada
should contact their local public health unit to have their COVID-19 immunization
record documented in COVaxON. Proof of immunization15 (e.g., an immunization
record, proof of vaccination certificate) is required to verify the COVID-19 vaccine
product received out of province. 16 PHUs are responsible for documenting
immunization information for individuals who have received COVID-19 vaccine
doses outside of Ontario into COVaxON. See the COVaxON job aid and functionality
change communications for more information.

15
See Canadian Immunization Guide section on Immunization records.
16
The Canadian Immunization Guide outlines that vaccination should only be considered valid if there
is written documentation of vaccine administration.

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COVID-19 Vaccine Errors and Deviations
*Please note: PHAC and OIAC have not yet updated the following documents to
reflect NACI’s recommendations on use of the XBB COVID-19 vaccines.
For interim guidance on managing COVID-19 vaccine administration errors and
deviations, please see the Government of Canada’s Planning guidance for
immunization clinics for COVID-19 vaccines: Managing vaccine administration errors
or deviations and the Ontario Immunization Advisory Committee’s (OIAC)
Recommendations: Management of Age-Related COVID-19 Vaccine Administration
Errors .Where there is conflict between the two resources above, please refer to
OIAC recommendations. For inadvertent immunization errors and deviations that are
not addressed in the documents linked above and/or that involve multiple errors or
have additional complexity, health care providers are encouraged to contact their
local public health unit (PHU) for further advice.
The local PHU should be notified, and vaccine administration errors or deviations
should be handled and reported in accordance with both the site (if non-PHU) and
PHU procedures.
• Vaccine administration errors and deviations that should be escalated to the
Ministry of Health include those that may result in public safety concerns,
cause misinformation, serious adverse events or death to any person; where
large volumes of vaccine doses have been impacted or wasted; or where
there is inadvertent administration of exposed and/or expired vaccine to a
large number of patients. When in doubt, err on the side of caution and notify
the Ministry of Health. For all issues that are escalated to the Ministry of
Health, please report these per the following protocol: Email the Ministry of
Health Communications team (media.moh@ontario.ca) and the
Implementation team (covid.immunization@ontario.ca), with the following
header:
• Incident Report for [PHU/Site] on [Date]:
o Description of Incident
o Date of Incident:
o Location of Incident:
o Type of Incident:
o Administration error or deviation:
o Description of Incident:

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 o Summary of action and steps taken to-date:
o Next steps:
If an inadvertent vaccine administration error or deviation results in an adverse event
following immunization (AEFI), complete Ontario’s AEFI reporting form, including
details of the error or deviation. The completed AEFI form should be submitted to
your local PHU.

Vaccine Preparation and Administration

See the individual vaccine product monographs for step-by-step directions on
administration (i.e., thawing prior to dilution, dilution, and preparation) and
information on packaging types and expiry dates.
It is important that proper sized syringes are chosen to ensure the correct volume is
accurately drawn up. Refer to the Canadian Immunization Guide, Table 3: Needle
selection guidelines for assistance in selecting appropriate needle length and
gauge. Safety engineered needles must be used for vaccine administration as
required under O. Reg. 474/07 made under the Occupational Health and Safety Act.
Information on vaccine storage and handling, stability and disposal can be found in
the COVID-19: Vaccine Storage and Handling Guidance document and in the
individual chapter for each vaccine product:
Chapter 1: Storage and Handling of Pfizer-BioNTech’s COVID-19 Vaccines.
Chapter 2: Storage and Handling of Moderna COVID-19 Vaccines
Chapter 3: Storage and Handling of Novavax’s COVID-19 Vaccine

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 Appendix A: Vaccines Available for Use in Ontario 17
Moderna Moderna Moderna Pfizer- Pfizer- Pfizer- Pfizer- Pfizer- Novavax
COVID-19
Bivalent XBB BioNTech BioNTech BioNTech BioNTech BioNTech
Formulations
(BA.4/5) XBB Bivalent XBB Bivalent XBB
Cap and Label
Colour

Royal blue Blue cap and Royal blue cap Maroon cap Orange cap Blue cap Grey cap Grey cap Royal blue cap
cap and grey label and coral blue and label and label and label and label and label
purple label label
(i) 6 months to (i) 6 months - (i) 6 months - 4 6 months – 4 5 - 11 yrs 5 – 11 yrs 12 yrs+ 12 yrs+ 12 yrs+ (primary
Authorized Age
5 years 5 yrs (off yrs years series)
Group
(ii) 6 to 11 label) (ii) 5-11 yrs 18 yrs+ (booster
years (ii) 6 - 11 yrs (iii) 12 yrs+ doses)
(iii) ≥12 yrs
0.1 mg/mL 0.1 mg/mL 0.1 mg/mL 0.015 mg/mL 0.05 mg/mL 0.03 mg/mL 0.1 mg/mL 0.1 mg/mL 0.01 mg/mL
Vial
Concentration
(i) 25 mcg/ (i) 25 mcg/ (i) 25 mcg/ 3 mcg/0.2 mL 10 mcg/0.2 mL 10 mcg/ 30 mcg/ 30 mcg/ 5 mcg/0.5 mL
Dose/
0.25mL 0.25mL 0.25 mL 0.3 mL 0.3mL 0.3mL
Volume
(ii) 50 mcg/ (ii) 25 mcg/ (ii) 25 mcg/
0.5 mL 0.25mL 0.25 mL
(iii) 50 mcg/ (iii) 50 mcg/
0.5mL 0.5 mL
None None None 2.2 mL/vial 1.3 mL/vial None None None None
Dilution

17
Adapted from Manitoba Health.

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 Moderna Moderna Moderna Pfizer- Pfizer- Pfizer- Pfizer- Pfizer- Novavax
COVID-19
Bivalent XBB BioNTech BioNTech BioNTech BioNTech BioNTech
Formulations
(BA.4/5) XBB Bivalent XBB Bivalent XBB
Monovalent Bivalent Monovalent Monovalent Bivalent mRNA Monovalent Bivalent Monovalent Protein Subunit
Vaccine Type
mRNA mRNA mRNA mRNA mRNA mRNA mRNA Vaccine
Unvaccinated Unvaccinated Unvaccinated Unvaccinated Unvaccinated Unvaccinated Unvaccinated Unvaccinated Unvaccinated and
Use
and (off-label) and and previously and and previously and and and previously previously
previously previously vaccinated previously vaccinated previously previously vaccinated vaccinated
vaccinated vaccinated individuals vaccinated individuals vaccinated vaccinated individuals individuals
individuals individuals individuals individuals individuals
02532352 02541866 02533197 02541858 02531461 02541823 02525364
DIN Number 02527685 02541270
Moderna PM Moderna Moderna Pfizer XBB.1.5 Pfizer- Pfizer XBB.1.5 Pfizer- Pfizer XBB.1.5 Novavax
Product
Bivalent PM XBB.1.5 BioNTech BioNTech
Monograph
Bivalent PM Bivalent PM

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Appendix B: Scenarios for immunocompetent
individuals 6 months – 4 years completing a
COVID-19 mRNA vaccine series
No previous doses received

Dose 1 Dose 2 Dose 3

Rec: 56 days
Min: 28 days

Rec: 56 days Rec: 56 days

Min: 21 days Min: 56 days

Received previous does(s) of mRNA vaccine

Dose 1 Dose 2 Dose 3

Rec: 56 days
Min: 28 days

OR

Rec: 56 days
Rec: 56 days
Min: 56 days
Min: 28 days

OR *

Rec: 56 days
Rec: 56 days
Min: 28 days
Min: 21 days

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 Dose 1 Dose 2 Dose 3

Rec: 56 days Rec: 56 days

Min: 21 days Min: 28 days

Rec: 56 days
Rec: 56 days Min: 56 days
Min: 21 days

Rec: 56 days Rec: 56 days

Min: 21 days Min: 56 days

Rec: 56 days Rec: 56 days

Min: 21 days Min: 56 days

The minimum interval listed corresponds with the authorized interval outlined in the
relevant product monograph.
*Where possible, the same vaccine product (Pfizer or Moderna) used for series
initiation should also be used for series completion. If this is not feasible, in
accordance with NACI guidance on vaccine inter-changeability, the Moderna XBB
vaccine product can be used for those who initiated the series with Pfizer original
monovalent and Pfizer XBB vaccine can be used to complete the series for those
who initiated the series with a Moderna vaccine product (original monovalent or
bivalent). Children who are under the age of 5 years who are receiving a mixed
schedule involving both Moderna and Pfizer products are recommended to
complete a 3-dose schedule.

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 Appendix C: Interim recommendations18 for
bivalent COVID-19 mRNA vaccines based on
age, dosage, and schedule
Age Recommended Intervals 19 Minimum Intervals
6 months - 4 Primary Series Primary Series
years Bivalent Moderna (25 mcg) Bivalent Moderna (25 mcg)
• 2nd dose, 56 days after 1st dose • 2nd dose, 21 days after 1st dose
Booster Doses – not eligible
5-11 years Primary Series Primary Series
Bivalent Pfizer-BioNTech (10 mcg)/ Bivalent Pfizer-BioNTech (10 mcg)
Bivalent Moderna (25 mcg)
• 2nd dose, 19 days after 1st dose
• 2 dose, 56 days after 1 dose
nd st
Bivalent Moderna (25 mcg)
• 2nd dose, 21 days after 1st dose
Booster Doses: Bivalent Pfizer-BioNTech (10 mcg) 20/Bivalent Moderna (25 mcg)
6 months (168 days) after last dose or confirmed SARS-CoV-2 infection
12 years + Primary Series Primary Series
Bivalent Pfizer-BioNTech (30 mcg) 21/ Bivalent Pfizer-BioNTech (30 mcg)
Bivalent Moderna (50 mcg) • 2nd dose, 19 days after 1st dose
• 2 dose, 56 days after 1 dose
nd st
Bivalent Moderna (50 mcg)
• 2nd dose, 21 days after 1st dose
Booster Doses Booster Doses
Bivalent Pfizer-BioNTech (30 mcg)/ Bivalent Pfizer-BioNTech (30 mcg)
Bivalent Moderna (50 mcg) • 3 months (84 days) after last dose or
• 6 months (168 days) after last
22
confirmed SARS-CoV-2 infection
dose or confirmed SARS-CoV-2 Bivalent Moderna (50 mcg)
infection
• 4 months (112 days) after last dose or
confirmed SARS-CoV-2 infection
Immuno- An additional dose is required to complete the primary series.
compromised The recommended interval is 56 days (minimum 28 days) from the 2nd dose.
6 months+

18
Interim recommendations as per NACI to use bivalent mRNA vaccines off-label (Moderna remains
off-label, however, bivalent Pfizer has been approved by Health Canada for use in the primary series)
to initiate or complete the primary series. Informed consent is always required for vaccines under the
Health Care Consent Act and express consent is required when a vaccine is being offered off-label.
Bivalent
19
Longer intervals between the first and second doses of COVID-19 vaccines result in more robust
and durable immune response and higher vaccine effectiveness.
20
Bivalent Pfizer (10 mcg) is the only authorized bivalent booster for those 5 years of age.
21
Bivalent Pfizer is preferred for those 12-29 years initiating or completing the primary series due to
lower risk of myocarditis and/or pericarditis.
22
The recommended interval is 6 months; however, vaccine administrators may use their clinical
discretion to decide on administration prior to the 6-month interval.

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 Appendix D: Interim recommendations for
product preferences when using the bivalent
COVID-19 mRNA vaccines
Age Product Preference (mcg/mL)

Primary 6 months to Bivalent Moderna (25 mcg/0.25 mL) is the recommended

Series 4 years and only bivalent product for this age group 23

5 to 11 No preference between bivalent Pfizer-BioNTech (10

years 24 mcg/0.2 mL) or bivalent Moderna (25 mcg/0.25 mL)

12 to 29 Bivalent Pfizer-BioNTech (30 mcg/0.3 mL)

years 25

30 years No preference between bivalent Pfizer-BioNTech (30

and older7 mcg/0.3 mL) or bivalent Moderna (50 mcg/0.5 mL)

Booster 6 months to Not eligible for booster doses

Doses 4 years

5 years Bivalent Pfizer-BioNTech (10 mcg/0.2 mL) is the only

authorized bivalent product for this age group

6 to 11 No preference between bivalent Pfizer-BioNTech (10

years mcg/0.2 mL) or bivalent Moderna (25 mcg/0.25 mL)

12 years No preference between bivalent Pfizer-BioNTech (30

and older mcg/0.3 mL) or bivalent Moderna (50 mcg/0.5 mL)

23
Currently, there is no bivalent Pfizer product available in Canada for individuals 6 months to 4 years
of age.
24
Individuals 6 months and older who are moderately to severely immunocompromised may benefit
from a primary series with bivalent Moderna (25 mcg in 6 months-11 years, 50 mcg in those 12 years
and older) compared to bivalent Pfizer (10 mcg in 5 -11 years, 30 mcg in those 12 years and older).
25
For individuals 12 to 29 years of age, bivalent Pfizer (30 mcg) vaccine is preferred due to the lower
risk of myocarditis and/or pericarditis, however, for some moderately to severely
immunocompromised individuals, administration of the bivalent Moderna (50 mcg) may be
considered based on individual clinician judgement and informed consent.

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