Ministry of Health

COVID-19 Vaccine Administration

Version 1.0 October 20, 2021

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
emergency 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 immunization for COVID-19. Complementary resources
include the individual vaccine product monographs and the COVID-19: Vaccine
Storage and Handling Guidance.
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
Quick Reference: Health Canada Authorized COVID-19 Vaccines Available for Use in Ontario
......................................................................................................................................................................................................... 3

COVID-19 Vaccine Precautions & Population Specific Considerations ................................................. 9

Adverse Events Following Immunization ............................................................................................................. 13

Out of Province Vaccines ............................................................................................................................................... 14

Point-of-Care Guidance for COVID-19 Vaccines .............................................................................................. 14

Third Doses for Special Populations ........................................................................................................................ 15

COVID-19 Vaccine Errors and Deviations ............................................................................................................. 15

Chapter 1: Pfizer-BioNTech COVID-19 Vaccine ................................................................................................. 16

Chapter 2: Moderna COVID-19 Vaccine................................................................................................................ 22

Chapter 3: AstraZeneca/COVISHIELD COVID-19 Vaccine ........................................................................ 27

Appendix A: General Clinic Precautions ............................................................................................................... 37

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 Quick Reference: Health Canada Authorized COVID-19 Vaccines
Available for Use in Ontario
Pfizer-BioNTech COVID-19 AstraZeneca/COVISHIELD
Product Brand Name Moderna COVID-19 Vaccine
Vaccine COVID-19 Vaccine
Product Generic Name BNT162b2 mRNA-1273 ChAdOx1-S/AZD1222
Date of authorization in Canada December 9, 2020 December 23, 2020 February 26, 2021
(May 2, 2021 for ages 12-15) (August 27, 2021 for ages 12-
17)
Manufacturer Pfizer-BioNTech Moderna AstraZeneca/Verity
Pharmaceuticals & Serum
Institute of India
Type of Vaccine Messenger ribonucleic acid Messenger ribonucleic acid Non-replicating viral vector
(mRNA) (mRNA) (ChAd)
Link to Health Canada Product pfizer-biontech-covid-19- moderna-covid-19-vaccine- AZ: astrazeneca-covid-19-
Monograph vaccine-pm1-en.pdf pm1.pdf (canada.ca) vaccine-pm-en.pdf
(canada.ca) COVISHIELD: covishield-pm-
en.pdf
Nature of antigen Prefusion spike (S) Prefusion spike (S) Transmembrane spike protein
glycoprotein glycoprotein
Adjuvant None None None

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 Pfizer-BioNTech COVID-19 AstraZeneca/COVISHIELD
Product Brand Name Moderna COVID-19 Vaccine
Vaccine COVID-19 Vaccine
Format Multi-dose vial: 6 Multi-dose vial: 10 and 14 Multi-dose vial: 8 and 10
doses/vial doses/vial doses/ vial
*Canada has received
foreign labelled product from
the US. Please read the vial
label closely.
Preservative None None None
Dose 0.3 mL (30 mcg of mRNA) 0.5 mL (100 mcg of mRNA) 0.5 mL (5 x 1010 viral particles)
following reconstitution
Health Canada Authorized 2 doses, 21 days apart 1 2 doses, 28 days apart 2 doses, 4 to 12 weeks apart 2
Schedule
Minimum Interval3 19 days apart 21 days apart 28 days apart

1
An interval of 28 days may be considered for operational feasibility.
2
Ministry of Health recommended interval is 8-12 weeks apart. See Q&A for Health Care Providers on Mixed (Heterologous)
COVID-19 Vaccine Schedules for more information.
3
NACI’s Minimum Interval Recommendation (Table 3 : Immunization schedule, by COVID-19 vaccine).
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 Pfizer-BioNTech COVID-19 AstraZeneca/COVISHIELD
Product Brand Name Moderna COVID-19 Vaccine
Vaccine COVID-19 Vaccine
Reconstitution Yes: each vial None None
diluted with
1.8 mL sterile
0.9% Sodium
Chloride
Injection,
USP, supplied
by Pfizer. See
product
monograph
for more
information.
Route Intramuscular Intramuscular (IM)
Intramuscular (IM)
(IM)

Authorized Age Indication 12 years of age and older 4 12 years of age and older4 18 years of age and older

4
Ontario has made a preferential recommendation for the Pfizer-BioNTech vaccine for individuals ages 12-24. See Vaccination
Recommendations for Special Populations for details.
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 Pfizer-BioNTech COVID-19 AstraZeneca/COVISHIELD
Product Brand Name Moderna COVID-19 Vaccine
Vaccine COVID-19 Vaccine
Potential allergen included in Polyethylene glycol (PEG) 6 Polyethylene glycol (PEG) 6 Polysorbate 806
vaccine and/or its container5 Tromethamine (tromethamol
or Tris)
Vaccine Product for third Eligible individuals should Eligible individuals should Individuals eligible for a third
doses 7 receive a third dose of an receive a third dose of an dose are recommended to
mRNA vaccine (Pfizer- mRNA vaccine (Pfizer- receive an mRNA vaccine
BioNTech or Moderna), and BioNTech or Moderna), and (Pfizer-BioNTech or Moderna)
the same vaccine product the same vaccine product as unless there are
as their second dose if their second dose if possible. contraindications towards an
possible. mRNA vaccine; Individuals that
received an mRNA vaccine for
their second dose should
receive the same vaccine
product as their second dose if
possible.

5
This table identifies ingredients of the authorized, available COVID-19 vaccines that have been associated with allergic
reactions in other products (NACI). This is not a complete list of substances. Any component of the COVID-19 vaccine or its
container could be a potential allergen.
6
Potential cross-reactive hypersensitivity between PEG and polysorbates has been reported in the literature.
7
See COVID-19 Vaccine Third Dose Recommendations for details.
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 Pfizer-BioNTech COVID-19 AstraZeneca/COVISHIELD
Product Brand Name Moderna COVID-19 Vaccine
Vaccine COVID-19 Vaccine
Very common and common Pain, swelling, or Pain, swelling, or Pain, swelling, or
side effects 8 redness/erythema at the redness/erythema at the redness/erythemat the
injection site injection site injection site
Fatigue Fatigue Fatigue
Headache Headache Headache
Muscle pain Muscle pain Muscle pain
Chills Chills Chills
Joint pain Joint pain Joint pain
Fever Nausea/Vomiting Fever
Diarrhea Lymphadenopathy Nausea/Vomiting
Nausea/vomiting
Uncommon side effects 9 Lymphadenopathy Fever (very common after Lymphadenopathy
second dose)
Rare or very rare adverse Pericarditis/Myocarditis Pericarditis/Myocarditis Vaccine-Induced Thrombotic
events 10 Thrombocytopenia (VITT)
Capillary Leak Syndrome (CLS)

8
Very common side effects occur in 10% or more of vaccine recipients, while common side effects occur in 1 to less than 10%
of vaccine recipients (NACI).
9
Uncommon side effects occur in 0.1% to less than 1% of vaccine recipients (NACI)
10
Rare and very rare adverse events occur in 0.01% to less than 0.1% and less than 0.01% of vaccine recipients respectively
(NACI)
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 Pfizer-BioNTech COVID-19 AstraZeneca/COVISHIELD
Product Brand Name Moderna COVID-19 Vaccine
Vaccine COVID-19 Vaccine
Primary Storage Requirements Ultracold Frozen Refrigerated
Pre-Puncture -90oC to -60oC -25oC to -15oC +2oC to +8oC
Guidance on short term
storage can be found in the
COVID-19: Vaccine Storage
and Handling Guidance
document
Storage Requirements Pre- Up to 31 days at +2oC to Up to 30 days at +2oC to +8oC +2oC to +8oC
Puncture +8oC OR at room OR 24 hours at +8oC to +25oC
temperature (up to +25oC)
for no more than 2 hours
Post-Puncture Shelf Life 6 hours from time of 24 hours at +2oC to +25oC 6 hours at room temperature
reconstitution at +2oC to (up to +30oC) OR 48 hours at
+25oC +2oC to +8oC

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 COVID-19 Vaccine Precautions & Population Specific Considerations
Group Context Action

All individuals with Consult: Vaccination Recommendations for Special Point-of-care guidance for these individuals
allergies (including those Populations can be found in the COVID-19 Vaccine – Pre-
with allergic reactions to Screening Assessment Tool for Health Care
• Components that may rarely cause type I
previous doses of any Providers
hypersensitivity reactions found in COVID-19
COVID-19 vaccine or vaccines include polyethylene glycol (PEG),
vaccine components). polysorbate 80 and tromethamine
(tromethamol or Tris). Details for each vaccine
can be found in:
o Chapter 1: Pfizer-BioNTech COVID-19
Vaccine,
o Chapter 2: Moderna COVID-19 Vaccine, and
o Chapter 3: AstraZeneca/COVISHIELD
COVID-19 Vaccine.
History of fainting/ See CARDS resources to support immunization Can receive the vaccine
dizziness, or fear of • Immunize while seated to reduce injuries
injections/ needles due to fainting,
• If considered high-risk, immunize while
lying down.
• These individuals may bring a support
person.

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Group Context Action

Individuals who have a • Individuals taking long-term anticoagulation Can receive the vaccine
bleeding disorder, bruise (e.g. warfarin or heparin therapy) are not • There is some evidence to suggest that IM
easily or are taking considered to be at higher risk of bleeding administration with a small gauge needle
blood-thinners complications following immunization and may (23 gauge or smaller) may be preferred to
be safely immunized without discontinuation of minimize the risk of bleeding, with firm
their anticoagulation therapy (NACI). pressure applied to the injection site for 5
• In individuals with bleeding disorders, the to 10 minutes.
condition should be managed prior to
immunization to minimize the risk of bleeding
(NACI).

Breastfeeding or Consult: Vaccination Recommendations for Special Can receive the vaccine
Pregnant Populations See the Vaccination Recommendations for
See Vaccination in Pregnancy & Breastfeeding Special Populations for further details.
Decision Making Support Tool to support
immunization

Autoimmune Conditions Consult: Vaccination Recommendations for Special See the Vaccination Recommendations for
Immunocompromised Populations Special Populations for further details.
due to disease or
treatment

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Group Context Action
Prior SARS-CoV-2 Vaccine should be offered to Can receive the vaccine
infection persons regardless of history of • If the patient is seriously debilitated, still under active
prior symptomatic or asymptomatic investigation, or has evidence of recent deterioration,
SARS-CoV-2 infection, as per NACI deferral of vaccination may be considered to avoid
recommendations.
incorrect attribution of any change in the person’s
Having prolonged COVID–19 underlying condition to the vaccine.
symptoms (sometimes called Long
• Common side effects of the vaccine (e.g., fatigue,
COVID or Post-Acute COVID-19
myalgia, arthralgia) may be similar to ongoing prolonged
Syndrome) is not a contraindication
COVID-19 symptoms
to receiving the COVID-19 vaccine

Confirmed or suspected To avoid attributing any Defer vaccination

SARS-CoV-2 infection complications resulting from • It would be prudent to wait for all symptoms of an acute
infection with SARS-CoV-2 or other
Symptoms of COVID-19 illness to completely resolve before receiving the
illnesses to vaccine-related adverse vaccine.
Other acute illnesses events
Risk of COVID-19 transmission at an
immunization clinic/venue

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Group Context Action
Symptomatic and Risk of COVID-19 transmission at an Defer vaccination
asymptomatic immunization clinic/venue • Should not attend a vaccine clinic and should wait to get
individuals who have their vaccine until their isolation period is over.
been advised to self-
isolate due to: • Follow specific Guidance for COVID-19 Immunization in
Long-Term Care (LTC) Homes and Retirement Homes
• Suspected or (RH) for individuals living and working in LTC homes and
confirmed SARS-
RHs.
CoV-2 infection
• Close contact
with a COVID-19
positive case

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Adverse Events Following Immunization
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:

• Public Health Ontario resource on the Management of Anaphylaxis Following

Immunization in the Community
• The Canadian Immunization Guide

Those administering vaccines should ensure that the 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 40 oC or 104 o F)
• Convulsions or seizures
• Other serious reactions (e.g. “pins and needles” or numbness)

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 immediately reporting
adverse events following immunization (AEFIs) to a physician or nurse 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) have a
duty under s.38 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
(publichealthontario.ca) for additional guidance.

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• 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.

Out of Province Vaccines

For guidance on managing and documenting individuals who have received COVID-
19 vaccines outside of Ontario, please consult COVID-19 Guidance for Individuals
Vaccinated outside of Ontario/Canada (gov.on.ca)

Point-of-Care Guidance for COVID-19 Vaccines

• Do not mix the COVID-19 vaccines with other vaccines/products in the same
syringe.
• NACI recommends that COVID-19 vaccines may be given at the same time as, or
any time before or after, other vaccines, including live, non-live, adjuvanted or
unadjuvanted vaccines.
• NACI recommendations on the use of a different COVID-19 vaccine product to
complete a two-dose COVID-19 vaccine series are being followed in Ontario:
1. NACI recommends that if readily available*, the same mRNA COVID-19 vaccine
product should be offered for the subsequent dose in a two-dose vaccine series
started with an mRNA COVID-19 vaccine.
o However, when the same mRNA COVID-19 vaccine product is not readily
available*, or is unknown, another mRNA COVID-19 vaccine product
recommended for use in that age group should be offered as the second
dose in the vaccine series.
o The previous dose should be counted, and the series need not be restarted.
*readily available has been defined by NACI as easily available at the time of
vaccination without delay or vaccine wastage
Where a different vaccine product is used to complete the two-dose vaccine series,
the second dose should be given at the Health Canada product monograph
authorized interval of the vaccine used for the first dose (see below), or as soon as
possible thereafter based on operational feasibility.

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 Vaccine for first dose Vaccine for second Interval between first
dose and second doses
Pfizer Pfizer 21 days†*
Pfizer Moderna 21 days†*
Moderna Moderna 28 days†
Moderna Pfizer 28 days†
AstraZeneca/COVISHIELD Pfizer 8-12 weeks∞
AstraZeneca/COVISHIELD Moderna 8-12 weeks∞
AstraZeneca/COVISHIELD AstraZeneca 8-12 weeks∞

† Health Canada authorized interval as per product monograph of the vaccine used
for the first dose.

* An interval of 28 days may be considered for operational feasibility.

∞
The AstraZeneca/COVISHIELD COVID-19 vaccine may be provided at the Health
Canada authorized interval of 4-12 weeks as per the product monograph for
those with medical exceptions to the extended dose interval. See the Q&A for
Health Care Providers on Mixed (Heterologous) COVID-19 Vaccine Schedules for
more information

Third Doses for Special Populations

Third doses of an mRNA COVID-19 vaccine is now recommended for select
populations.

Please see the COVID-19 Vaccine Third Dose Recommendations for population
descriptions and details.

COVID-19 Vaccine Errors and Deviations

For guidance on managing COVID-19 vaccine administration errors and deviations,
please see COVID-19 Vaccine Errors and Deviations.

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Chapter 1: Pfizer-BioNTech COVID-19 Vaccine
Considerations for Administration
Following a thorough review of the current global and Canadian experience and
provincial vaccine safety surveillance data, Ontario will continue using the Pfizer-
BioNTech vaccine for youth ages 12-17 (including those turning 12 in 2021).
See the Vaccination Recommendations for Special Populations for more details.
Based on advice from Ontario’s Vaccine Clinical Advisory Group, the Ministry of
Health is issuing a preferential recommendation for the use of Pfizer-BioNTech
COVID-19 vaccine for individuals 12-24 (including those turning 12 in 2021). This
recommendation stems from an observed, important increase in the number of
reports in Ontario of pericarditis/myocarditis following vaccination with Moderna
relative to Pfizer-BioNTech in the 18-24 year old age group, particularly among
males. See Vaccination Recommendations for Special Populations for more details.
As a precautionary measure, NACI has recommended that individuals who have
experienced myocarditis or pericarditis following vaccination with a first dose of an
mRNA COVID-19 vaccine defer their second dose in the vaccination series until
more information is available. The National Advisory Committee on Immunization,
Public Health Ontario and The Ministry of Health continue to follow this closely and
will update this recommendation as more evidence becomes available. See
Warnings and Precautions below for more details.

Warnings & Precautions

Pericarditis & Myocarditis

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. Providers are encouraged to consult the enhanced
epidemiologic summary from Public Health Ontario for trends and risk of
myocarditis/pericarditis following mRNA vaccines in Ontario..

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NACI continues to strongly recommend that a complete series with an mRNA
COVID-19 vaccines be offered to all eligible individuals in Canada, including those 12
years of age and older. In the context of adequate Pfizer-BioNTech COVID-19
vaccine supply, the preferential recommendation for the use of Pfizer-BioNTech
COVID-19 vaccine for individuals 12-24 (including those turning 12 in 2021) is
anticipated to reduce the rare number of events of myocarditis/pericarditis in
Ontario. Evidence on this topic continues to evolve and this recommendation may
be amended as more information becomes available. Vaccines are safe, effective
and continue to be the best way to protect young adults, their families and our
community from COVID-19.
The benefits of vaccination with COVID-19 vaccines continue to outweigh the risks
of COVID-19 illness and related, possibly severe consequences for all age groups.
mRNA COVID-19 vaccines also continue to be recommended internationally. This
situation is being monitored closely in Canada and internationally.
• 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).
• As a precautionary measure, the NACI has recommended that individuals who
have experienced myocarditis or pericarditis following vaccination with a first
dose of an mRNA COVID-19 vaccine defer their second dose in the vaccination
series until more information is available. The National Advisory Committee on
Immunization, Public Health Ontario and The Ministry of Health continue to
follow this closely and will update this recommendation as more evidence
becomes available
o For more information consult Public Health Ontario’s Myocarditis and
Pericarditis Following COVID-19 mRNA Vaccines resource, and the
Myocarditis/Pericarditis FAQ resource for Health Care Providers resource
from The Hospital for Sick Children.
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

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Allergies
Refer to Vaccination Recommendations for Special Populations for information on
vaccination for all patients with allergies (including those with allergic reactions to
previous doses of any COVID-19 vaccine, or vaccine components).
Vaccine components include the potential allergen of Polyethylene Glycol (PEG).
Allergic reactions to PEG are rare. PEG is found in products such as prescription
medications, bowel preparation products for colonoscopy, over the counter
products (e.g. laxatives, cough syrups), cosmetics, dermal fillers, skin care products,
products such as ultrasound gel, and contact lens care solution. PEG also can be
found in foods or drinks but is not known to cause allergic reactions from foods or
drinks. Due to potential cross-reactivity with PEG, allergies to polysorbate must also
be considered. Allergic reactions to polysorbates are rare. Polysorbates can be
found in products such as medical preparations (such as vitamin oils, tablets, and
anticancer agents) or cosmetics among others.
Any component of the COVID-19 vaccine or its container could be a potential
allergen. For a full list of vaccine components, please consult the product
monograph.

Side effects
The Pfizer-BioNTech COVID-19 vaccine, 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 product
monograph for a complete list of reported side effects.

• Pain at injection site

• Fatigue
Very Occur in 10% or
• Headache
common more of vaccine
• Muscle pain
side effects recipients
• Chills
• Fever (common after first dose for adults)
• Localized redness/erythema or swelling at
injection site
Occur in 1 to less
Common • Joint pain (very common after second dose)
than 10% of
side effects • Diarrhea
vaccine recipients
• Nausea and/or vomiting (uncommon after first
dose for adults)

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 Occur in 0.1% to
Uncommon
less than 1% of • Enlarged lymph nodes (Lymphadenopathy)
side effects
vaccine recipients

Source: National Advisory Committee on Immunization, Appendix E: Frequency of

solicited adverse events following immunization for COVID-19 vaccines in clinical
trials.

See the Warnings and Precautions section above for information about the rare
cases of myocarditis and pericarditis that have been reported following vaccination
with mRNA COVID-19 vaccines. See the product monograph for further details on
post-market adverse reactions.

Vaccine Preparation
Detailed information on vaccine preparation and transport can be found in the
product monograph and the COVID-19: Vaccine Storage and Handling Guidance.

• The Pfizer-BioNTech COVID-19 vaccine multiple dose vial contains a frozen

suspension that does not contain preservative and must be thawed and diluted
prior to administration. See the Preparation for Immunization Clinics section of
the COVID-19: Vaccine Storage and Handling Guidance and product
monographfor detailed thawing instructions.
• Once thawed, unpunctured vials may be stored for up to 31 days at +2 oC to +8 oC
or at room temperature (up to +25 oC) for no more than 2 hours.
o During storage, minimize exposure to room light and avoid exposure to
direct sunlight and ultraviolet light. Thawed vials can be handled in room
light conditions.
o Appropriate labelling including “must use by dating/timing” can provide
visual cues to indicate product viability of use.
• Before dilution and after thawing, the vial must be inverted gently 10 times to
mix the vaccine. Do not shake.
• Prior to dilution, the thawed suspension is a white to off-white suspension and
may contain white to off-white opaque amorphous particles. Do not use if liquid
is discoloured or if other particles are observed
• Strict adherence to aseptic techniques must be followed.

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• The contents of the vial must be diluted with sterile 0.9% Sodium Chloride
Injection, USP. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. Do
not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent.
• Using aseptic technique, withdraw 1.8 mL of 0.9% Sodium Chloride Injection, USP
into a transfer syringe (21 gauge or narrower needle).
• Cleanse the vaccine vial stopper with a single-use antiseptic swab.
• Add 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP into the vaccine vial.
• Equalize vial pressure before removing the needle from the vial by withdrawing
1.8mL air into the empty diluent syringe.
• After dilution, the vial containing the Pfizer-BioNTech COVID-19 vaccine should
be gently inverted 10 times to mix. Do not shake.
• To minimize the risk of contamination never use the same diluent vial more than
once. Make sure to discard any remaining saline in the diluent vial in a sharps
container (Pfizer-BioNTech COVID-19 Vaccine Resources). In Ontario Pfizer-
BioNTech vaccine is shipped with a diluent to vaccine ratio that supports single
use of diluent.
• After dilution, the vaccine will be an off-white suspension. Inspect vial to confirm
there are no particulates and no discolouration is observed. Do not use if the
vaccine is discoloured or contains particulate matter.

Record the time and date of dilution on the vial label and store the vial between
+2oC to +25oC. Any unused vaccine must be discarded 6 hours after dilution.

• During storage, minimize exposure to room light and avoid exposure to direct
sunlight and ultraviolet light.
• Thawed and diluted vials can be handled in room light conditions.

Preparation of an Individual Dose

• The vaccine is authorized as a 6-dose vial.

• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic
swab and withdraw 0.3mL of vaccine, preferentially using low dead-volume
syringes and/or needles
• Each dose must contain 0.3mL of vaccine
• For guidance on what to do when there is leftover solution in the vial or if more
than 6 doses can be obtained from a vial, please see the COVID-19: Vaccine
Storage and Handling Guidance document

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Vaccine Administration
• 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 as required under O. Reg. 474/07 made under
the Occupational Health and Safety Act.
• Visually inspect each dose in the dosing syringe prior to administration. The
diluted vaccine will be an off-white suspension.
• During the visual inspection:
o Verify the final dosing volume of 0.3 mL, and
o Confirm there are no particulates and that no discolouration is observed.
• If the visual inspection fails, do not administer the vaccine.
• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic
swab.
• Withdraw each 0.3 mL dose of vaccine from the vial using a new sterile needle
and syringe for each injection. Pierce the stopper preferably at a different site
each time.
• Administer Pfizer-BioNTech COVID-19 vaccine immediately, and no later than 6
hours after dilution
• Administer Pfizer-BioNTech COVID-19 vaccine intramuscularly in the deltoid
muscle.
o Do not inject the vaccine intravascularly, subcutaneously or intradermally.
• Any non-viable/unused vaccine or waste material should be disposed of in
accordance with local requirements. See Appendix G of the COVID-19: Vaccine
Storage and Handling Guidance for details.
All clients should be reminded to continue to practice recommended public
health measures for prevention and control of COVID-19 infection and
transmission regardless of receipt of COVID-19 vaccine.
Information on vaccine storage, stability and disposal can be found in the COVID-19:
Vaccine Storage and Handling Guidance

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Chapter 2: Moderna COVID-19 Vaccine
Considerations for Administration
Following a thorough review of the current global and Canadian experience and
provincial vaccine safety surveillance data, Ontario will continue using the Pfizer-
BioNTech vaccine for youth ages 12-17 (including those turning 12 in 2021).
See the Vaccination Recommendations for Special Populations for more details.
Based on advice from Ontario’s Vaccine Clinical Advisory Group, the Ministry of
Health is issuing a preferential recommendation for the use of Pfizer-BioNTech
COVID-19 vaccine for individuals 12-24 (including those turning 12 in 2021). This
recommendation stems from an observed, important increase in the number of
reports in Ontario of pericarditis/myocarditis following vaccination with Moderna
relative to Pfizer-BioNTech in the 18-24 year old age group, particularly among
males. Should individuals aged 12 to 24 request Moderna, they can access it with
informed consent, which should include a review of the Vaccine Information Sheet
that outlines the possible elevated risk of myocarditis/pericarditis. See Vaccination
Recommendations for Special Populations for more details
As a precautionary measure, NACI has recommended that individuals who have
experienced myocarditis or pericarditis following vaccination with a first dose of an
mRNA COVID-19 vaccine defer their second dose in the vaccination series until
more information is available. The National Advisory Committee on Immunization,
Public Health Ontario and The Ministry of Health continue to follow this closely and
will update this recommendation as more evidence becomes available. See
Warnings and Precautions below for more details.

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Warnings & Precautions
Pericardits & Myocarditis

There have been Canadian and international reports of myocarditis (inflammation of

the heart muscle) and pericarditis (inflammation of the lining of the heart) following
vaccination with COVID-19 mRNA vaccines (Public Health Agency of Canada). Cases
have occurred more frequently in males than in females, most frequently in
adolescents and young adults, and more commonly after the second dose of
vaccine. There has been an important increase in the number of reports in Ontario
of pericarditis/myocarditis following vaccination with Moderna relative to Pfizer-
BioNTech in the 18-24 year old age group, particularly among males, leading to a
preferential recommendation for the use of Pfizer-BioNTech vaccine in this age
group. See Vaccination Recommendations for Special Populations for more details.
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. Further information on
trends in myocarditis/pericarditis following mRNA vaccines in Ontario are
summarized in an enhanced epidemiologic summary from Public Health Ontario.
NACI continues to strongly recommend that a complete series with an mRNA
COVID-19 vaccines be offered to all eligible individuals in Canada, including those 12
years of age and older. mRNA COVID-19 vaccines also continue to be
recommended in other countries where mRNA vaccines are being used. This
situation is being monitored closely in Canada and internationally.
• 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).
• As a precautionary measure, the NACI has recommended that individuals
who have experienced myocarditis or pericarditis following vaccination with a
first dose of an mRNA COVID-19 vaccine defer their second dose in the
vaccination series until more information is available. The National Advisory
Committee on Immunization, Public Health Ontario and The Ministry of Health
continue to follow this closely and will update this recommendation as more
evidence becomes available

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 o For more information consult Public Health Ontario’s Myocarditis and
Pericarditis Following COVID-19 mRNA Vaccines resource, and the
Myocarditis/Pericarditis FAQ resource for Health Care Providers resource
from The Hospital for Sick Children.
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
Allergies
Refer to Vaccination Recommendations for Special Populations for information on
vaccination for all patients with allergies (including those with allergic reactions to
previous doses of any COVID-19 vaccine, or vaccine components).
Vaccine components include the potential allergens Polyethylene Glycol and
Tromethamine (trometamol or Tris). Allergic reactions to PEG are rare. PEG is found
in products such as prescription medications, bowel preparation products for
colonoscopy, over the counter products (e.g. laxatives, cough syrups), cosmetics,
dermal fillers, skin care products, products such as ultrasound gel, and contact lens
care solution. PEG also can be found in foods or drinks but is not known to cause
allergic reactions from foods or drinks. Due to potential cross-reactivity with PEG,
allergies to polysorbate must also be considered. Allergic reactions to polysorbates
are rare. Polysorbates can be found in products such as medical preparations (such
as vitamin oils, tablets, and anticancer agents) or cosmetics among others.
Allergic reactions to Tromethamine are rare. Tromethamine is found in products
such as contrast media, oral and parenteral medications.
Any component of the COVID-19 vaccine or its container could be a potential
allergen. For a full list of vaccine components, please consult the product
monograph.

Side effects
The Moderna COVID-19 vaccine, like medicines and other vaccines can cause side
effects. In clinical trials most of the side effects experienced were mild to moderate
and on average did not last longer than three days. Please see the product
monograph for a complete list of reported side effects.

24 | P a g e
 • Pain at injection site
• Lymphadenopathy/ Axillary swelling and
Occur in 10% or tenderness (enlarged lymph nodes)
Very common
more of vaccine • Fatigue
side effects
recipients • Headache
• Joint pain
• Muscle pain
• Localized redness/erythema and swelling at
Occur in 1 to less injection site (very common after second dose)
Common side
than 10% of • Chills (very common after second dose)
effects
vaccine recipients • Nausea and/or vomiting (very common after
second dose)
Occur in 0.1% to
Uncommon
less than 1% of • Fever (very common after second dose)
side effects
vaccine recipients
Source: National Advisory Committee on Immunization, Appendix E: Frequency of
solicited adverse events following immunization for COVID-19 vaccines in clinical
trials.

See the Warnings and Precautions section above for information about the rare
cases of myocarditis and pericarditis that have been reported following vaccination
with mRNA COVID-19 vaccines.

Vaccine Preparation
Detailed information on vaccine preparation and transport can be found in the
product monograph and the COVID-19: Vaccine Storage and Handling Guidance.
• The COVID-19 vaccine Moderna must be thawed prior to administration. No
reconsitution is required.
Thaw each vial before use:
o Thaw in refrigerated conditions between +2°C to +8°C for 2 hours and 30
minutes. Let each vial stand at room temperature for 15 minutes before
administering.
o Alternatively, vials can be thawed at room temperature between +15oC to
+25oC for 1 hour.
o Do not re-freeze vials after thawing.
• Swirl the vial gently after thawing and between each withdrawal. Do not shake.
• The vaccine is authorized as a 10-dose vial.
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 o Canada has received foreign labelled product from the US, some of which
comes in a 14 dose per vial format. Please read the vial label carefully prior
to administration to determine the number of doses available per vial.
• For guidance on what to do when there is leftover solution in the vial or if more
than the stated number of doses can be obtained, please see the COVID-19:
Vaccine Storage and Handling Guidance document.

Vaccine Administration
• Moderna COVID-19 vaccine is a white to off-white suspension. It may contain
white or translucent product-related particulates. Inspect vials visually for foreign
particulate matter and/or discoloration prior to administration. If either of these
conditions exists, the vaccine should not be administered.
• The vaccine should be administered by the intramuscular (IM) route only. Do not
inject the vaccine intravascularly, subcutaneously or intradermally. The preferred
site is the deltoid muscle of the upper arm.
• 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 as required under O. Reg. 474/07 made under
the Occupational Health and Safety Act.
• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic
swab.
• Withdraw each 0.5 mL dose of vaccine from the vial using a new sterile needle
and syringe for each injection. Pierce the stopper preferably at a different site
each time. The dose in the syringe should be used as soon as feasible and no
later than 24 hours after the vial was first entered (needle-punctured).
• Moderna COVID-19 vaccine is preservative free. Once the vial has been entered
(needle-punctured), it should be discarded after 24 hours. Do not refreeze.
Thawed vials and filled syringes can be handled in room light conditions.
• Any non-viable/unused vaccine or waste material should be disposed of in
accordance with local requirements. See Appendix G of the COVID-19: Vaccine
Storage and Handling Guidance for details
All clients should be reminded to continue to practice recommended public
health measures for prevention and control of COVID-19 infection and
transmission regardless of receipt of COVID-19 vaccine.
Information on vaccine storage, stability and disposal can be found in the COVID-
19: Vaccine Storage and Handling Guidance document.

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Chapter 3: AstraZeneca/COVISHIELD COVID-19
Vaccine
Health Canada has authorized two manufacturers of the COVID-19 ChAdOx1-S
vaccine:

• AstraZeneca (brand name AstraZeneca COVID-19 Vaccine)

• Verity Pharmaceuticals and Serum Institute of India in collaboration with
AstraZeneca (brand name COVISHIELD vaccine)

AstraZeneca COVID-19 VACCINE (manufactured by AstraZeneca) and COVISHIELD

(manufactured by Serum Institute of India) are ChAdOx1-S recombinant vaccines
developed by AstraZeneca and the University of Oxford. Health Canada has
reviewed the manufacturing information for these vaccines and found them to be
comparable (COVISHIELD vaccine & AstraZeneca COVID-19 vaccine).

AstraZeneca /COVISHIELD COVID-19 vaccine (ChAdOx1-S [recombinant])

Schedule 2 doses

Minimum 28 days
Interval 11

Authorized 4 to 12 weeks
Interval 12

Recommended 8-12 weeks^

Interval 13 See the Q&A for Health Care Providers on Mixed
(Heterologous) COVID-19 Vaccine Schedules for details
^There is specific guidance for medical exceptions
which can be found in the COVID-19 Vaccine Series
Second Dose Eligibility Quick Reference

11
National Advisory Committee on Immunization (NACI). Recommendation on the use of
COVID-19 vaccines
12
Health Canada Product Monographs: COVISHIELD vaccine & AstraZeneca COVID-19
vaccine
13
In clinical trials, the AstraZeneca/COVISHIELD COVID-19 vaccine demonstrated optimal
2-dose vaccine efficacy when the interval between the first and second doses was ≥ 12
weeks (NACI)
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Considerations For Administration
As of May 11th, 2021 Ontario has paused the rollout and administration of first
doses of the AstraZeneca /COVISHIELD COVID-19 vaccine. This decision was
made out of an abundance of caution due to an observed increase in reports of a
rare, serious blood clotting condition called Vaccine-Induced Immune Thrombotic
Thrombocytopenia (VITT) following vaccination with the AstraZeneca/COVISHIELD
COVID-19 vaccine. More information on the decision can be found in the press
release: Ontario Pauses Administration of AstraZeneca Vaccine | Ontario Newsroom.
At this time, first doses should only be given in extenuating circumstances (i.e. on
the recommendation of an allergist/immunologist where a confirmed allergy exists
to components of the mRNA vaccines).
Individuals that received AstraZeneca/COVISHIELD COVID-19 vaccine for their first
and second doses are recommended to receive an mRNA COVID-19 vaccine for
their third dose unless contraindicated. Individuals who are unable to receive an
mRNA vaccine due to contraindications may be offered a viral vector vaccine.
Informed consent for an additional dose of viral vector vaccine should include
discussion of potential risks with a health care provider. Informed consent for an
additional dose of viral vector vaccine should include discussion about the lack of
evidence on the use of an additional dose of viral vector COVID-19 vaccine in
immunocompromised populations and the increased risk of Vaccine-Induced
Immune Thrombotic Thrombocytopenia (VITT), Capillary Leak Syndrome (CLS), and
Guillain-Barre syndrome (GBS) following viral vector COVID-19 vaccines (NACI,
2021).
Ontario is following NACI recommendations for completion of a series started with
the AstraZeneca/COVISHIELD COVID-19 vaccine. NACI states that while either an
AstraZeneca/COVISHIELD COVID-19 vaccine or an mRNA COVID-19 vaccine
product may be offered for the second dose in a vaccine series started with an
AstraZeneca/COVISHIELD COVID-19 vaccine, an mRNA COVID-19 product is
preferred as a second dose, due to emerging evidence, including the possibility of
better immune response, and the safety of a “mixed” (heterologous) COVID-19
vaccine schedule.
• In Ontario, AstraZeneca/COVISHIELD for second doses are currently only
available to individuals with a contraindication to the COVID-19 vaccine as
identified by an allergist/immunologist or specialist.
• Regardless of which product is offered, a complete two-dose series is important
for protection; the previous dose should be counted, and the series does not
need to be restarted.

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• Individuals who receive two doses of the AstraZeneca/COVISHIELD COVID-19
vaccine are considered protected and do not require further vaccination. For
guidance on special populations that may require a third dose of a COVID-19
vaccine, please consult the Vaccination Recommendations for Special
Populations
• A supplemental document has been developed for patients who received a first
dose of the AstraZeneca/COVISHIELD COVID-19 vaccine: COVID-19 Vaccine
Information for Individuals who received a first dose of the AstraZeneca
/COVISHIELD COVID-19 vaccine. Consent for the second dose will be informed
through understanding the benefits and risks of the choices, supported by
discussion with a health care provider.
• For more information see the Q&A for Health Care Providers on Mixed
(Heterologous) COVID-19 Vaccine Schedules

Contraindications
AstraZeneca /COVISHIELD COVID-19 vaccine is contraindicated in individuals who
have experienced major venous and/or arterial thrombosis with thrombocytopenia
following vaccination with any vaccine.

The AstraZeneca /COVISHIELD COVID-19 vaccine is contraindicated in individuals

who have experienced a previous cerebral venous sinus thrombosis (CVST) with
thrombocytopenia or who have experienced heparin-induced thrombocytopenia
(HIT). Individuals who think they have experienced a previous CVST with
thrombocytopenia or heparin-induced thrombocytopenia (HIT) should not receive
the vaccine.

The above recommendations were provided by the province’s Vaccine Clinical

Advisory Group (VCAG).

The AstraZeneca/COVISHIELD COVID-19 vaccine is contraindicated in individuals

who have previously experienced episodes of capillary leak syndrome (CLS)
(COVISHIELD vaccine & AstraZeneca COVID-19 vaccine).

Warnings & Precautions

Thrombosis (blood clots) and thrombocytopenia (low platelets) following
vaccination with viral vector COVID-19 vaccines: Vaccine Induced Immune
Thrombotic Thrombocytopenia (VITT)

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 Very rare reports of serious thrombosis (blood clots), including cerebral sinus vein
thrombosis (CSVT), splanchnic vien thrombosis and arterial thrombosis, associated
with thrombocytopenia (low platelets), and in some cases bleeding, have been
reported following vaccination with the AstraZeneca /COVISHIELD COVID-19
vaccine (Health Canada, COVISHIELD vaccine & AstraZeneca COVID-19 vaccine).
• In Canada, the Canadian Adverse Events Following Immunization Surveillance
System (CAEFISS) use case definitions of Thrombosis with Thrombocytopenia
Syndrome (TTS) to describe these events, which have also been refered to as
Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) (NACI).
• Per the product monographs (COVISHIELD vaccine, AstraZeneca COVID-19 vaccine)
whilst specific risk factors for thrombosis in combination with thrombocytopenia
have not been identified, cases have occurred in patients with a previous history of
thrombosis, as well as in patients with autoimmune disorders, including idiopathic
thrombocytopenic purpura. The benefits and risks of vaccination should be
considered in these patients.
• These events often occur between 4 and 28 days after receipt of the vaccine, and
patients should monitor for symptoms for up to 42 days.
o Early identification and appropriate treatment are critical.
o Clots related to VITT can be very aggressive and can be challenging to treat
with potential associated long-term morbidity. Ontario’s Science Advisory
Table has provided treatment and diagnosis guidance for Emergency
Department and Inpatient Settings and Outpatient Settings.
o The reported case fatality rate of VITT varies between countries, and ranges
between 20 and 50% (NACI). Case fatality rates may vary with increased
awareness of the adverse event and appropriate early treatment (NACI).
Currently, the reported risk of VITT after the second dose of AstraZeneca/
COVISHIELD COVID-19 vaccine is lower than after the first dose. With
increased observation times, VITT rates have generally increased, including
the risk estimate following the second dose. Risk estimates are continually
updated as new data become available.
o The rate of VITT is estimated to be between 1 per 26,000 and 1 per 100,000
persons vaccinated with a first dose of an AstraZeneca/COVISHIELD COVID-
19 vaccine (NACI). The rate of VITT in Canada after a first dose has been
estimated to be approximately 1 per 55,000 doses administered (Ontario
Science Advisory Table).

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• At this time, data from the United Kingdom (UK) suggests that the rate of VITT
following the first dose is 14.9 per million doses and 1.8 per million following the
second dose (based on doses administered as up to Aug. 25, 2021).
• Anyone receiving the AstraZeneca /COVISHIELD COVID-19 vaccine should be
informed of the risk of Vaccine-Induced Immune Thrombotic Thrombocytopenia
(VITT) and advised to seek immediate medical attention if they develop symptoms
of VITT (NACI).
• Symptoms to be vigilant for include: persistent and severe headache, seizures, or
focal neurological symptoms including blurred or double vision (suggesting CSVT or
arterial stroke); shortness of breath, chest, back, or abdominal pain (suggesting
pulmonary embolism, acute coronary syndrome, abdominal vein thrombosis, or
adrenal hemorrhage); unusual bleeding, bruising, petechiae, or blood blisters
(suggesting thrombocytopenia or disseminated intravascular coagulation); or limb
swelling, redness, pallor, or coldness (suggesting deep vein thrombosis or acute
limb ischemia) (Ontario Science Advisory Table).
• Individuals diagnosed with thrombocytopenia within 3 weeks of vaccination with the
AstraZeneca/COVISHIELD COVID-19 vaccine should be actively investigated for
signs of thrombosis, and similarly individuals who present with thrombosis within 3
weeks of vaccination should be evaluated for thrombocytopenia
• Healthcare providers should maintain vigilance for thrombosis and
thrombocytopenia in vaccinated individuals and report any suspected adverse
events following immunization (AEFI) to their local public health unit (as outlined in
the section on “Adverse Events Following Immunization” below).
• Since medical management of a post-vaccine thrombosis with thrombocytopenia
may be different than medical management of other thromboses, if a patient
presents with thrombosis with thrombocytopenia, healthcare professionals should
consult with current guidance and hematologic specialists to diagnose and treat this
post-vaccine event.
• Guidance for health care providers in diagnosing and treating VITT (Vaccine-
induced thrombotic thrombocytopenia), are available from Ontario’s Science
Advisory Table Science Brief for healthcare professionals in Emergency Department
and Inpatient settings and Outpatient settings.

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Capillary Leak Syndrome

Capillary leak syndrome (CLS) has been observed very rarely after vaccination with
AstraZeneca/COVISHIELD COVID-19 vaccine. A history of CLS has been reported in
some cases. CLS is a rare, serious condition that causes fluid leakage from small
blood vessels (capillaries) and is characterized by acute episodes of limb edema,
hypotension, hemoconcentration and hypoalbuminemia leading to organ damage.
Symptoms are often associated with feeling faint due to low blood pressure.
Patients with an acute episode of CLS following vaccination require urgent medical
attention and treatment. Intensive supportive therapy is usually warranted, as the
condition can be life-threatening. Individuals with a known history of CLS should not
be vaccinated with this vaccine. Please see the product monographs for
AstraZeneca COVID-19 vaccine and COVISHIELD vaccine for further details.

Allergies
Refer to Vaccination Recommendations for Special Populations for information on
vaccination for all patients with allergies (including those with allergic reactions to
previous doses of any COVID-19 vaccine, or vaccine components).

Vaccine components include the potential allergen polysorbate 80. Polysorbate 80

is found in products such as medical preparations (such as vitamin oils, tablets, and
anticancer agents) or cosmetics.

Due to potential cross-reactivity with polysorbate, allergies to polyethylene glycol

(PEG) must also be considered. Allergic reactions to PEG are rare. PEG is found in
products such as prescription medications, bowel preparation products for
colonoscopy, over the counter products (e.g. laxatives, cough syrups), cosmetics,
dermal fillers, skin care products, products such as ultrasound gel, and contact lens
care solution. PEG also can be found in foods or drinks but is not known to cause
allergic reactions from foods or drinks.

Any component of the COVID-19 vaccine or its container could be a potential

allergen. For a full list of vaccine components, please consult the product
monographs for COVISHIELD vaccine & AstraZeneca COVID-19 vaccine.

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Side Effects
The AstraZeneca /COVISHIELD COVID-19 vaccine, like medicines and other
vaccines can cause side effects. In clinical trials most of the side effects
experienced were mild to moderate and on average resolved within a few days.
Please see the product monographs for AstraZeneca COVID-19 vaccine and
COVISHIELD vaccine for a complete list of reported side effects/adverse reactions.

Very Occur in 10% or • Pain and tenderness at the injection site

common more of • Localized redness/erythema, warmth and
side effects vaccine pruritus (common after second dose)
recipients • Fatigue
• Chills (common after second dose)
• Headache
• Muscle pain
• Nausea (common after second dose)
• Joint pain
Common Occur in 1 to • Localized swelling at the injection site
side effects less than 10% • Induration
of vaccine • Vomiting (uncommon after second dose)
recipients • Fever/ Feverishness (feverishness very
common after first dose)
Uncommon Occur in 0.1% to
side effects less than 1% of • Enlarged lymph nodes (Lymphadenopathy)
vaccine
recipients
Source: National Advisory Committee on Immunization, Appendix E: Frequency of
solicited adverse events following immunization for COVID-19 vaccines in clinical
trials.

See the Warnings and Precautions section above for information about the very rare
cases of VITT and CLS that have been reported following vaccination with the
AstraZeneca/COVISHIELD COVID-19 vaccine. Very rare events of demyelinating
disorders, such as Guillain-Barré Syndrome (GBS), have been reported following
vaccination with AstraZeneca COVID-19 Vaccine /COVISHIELD during post-
authorization use. See the product monographs for further details on post-market
adverse reactions (AstraZeneca COVID-19 vaccine and COVISHIELD vaccine).

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Vaccine Preparation
Additional information on vaccine preparation can be found in the respective
product monographs for AstraZeneca COVID-19 vaccine and COVISHIELD vaccine.

• AstraZeneca /COVISHIELD COVID-19 vaccine must not be reconstituted, mixed

with other medicinal products, or diluted
• The unopened multi-dose vial can be stored in a refrigerator (+2ºC to +8ºC)
• Do not freeze
• Store in original packaging in order to protect from light.
• Use the product before the expiration date on the vial label.
• The vaccine does not contain any preservative. After first opening, use the vial
within:
o 6 hours when stored at room temperature (up to +30ºC), or
o 48 hours when stored in a refrigerator (+2ºC to +8ºC ).
• The vial can be re-refrigerated, but the cumulative storage time at room
temperature must not exceed 6 hours, and the total cumulative storage time
must not exceed 48 hours. After this time, the vial must be discarded.

AstraZeneca COVID-19 vaccine COVISHIELD vaccine

AstraZeneca COVID-19 vaccine is packaged in COVISHIELD vaccine is packaged in:
(not all pack sizes may be available): • 5 mL of solution in a 10-dose vial
• 5 mL of solution in a 10-dose vial (clear (clear type I glass) with stopper
type I glass) with stopper (elastomeric with (elastomeric with aluminium
aluminium overseal). overseal).
• 4 mL of solution in an 8-dose vial (clear
type I glass) with stopper (elastomeric with
aluminium overseal).
• Vaccines should be mixed with a careful swirling motion until a uniform
suspension is achieved prior to administration. Do not shake.
• Each vaccine dose of 0.5 mL is withdrawn into a syringe for injection to be
administered intramuscularly, preferably in the deltoid muscle. Use a separate
sterile needle and syringe for each individual.
• Each vial contains at least the number of doses stated. It is normal for residual
liquid to remain in the vial after withdrawing the final dose. When low dead
volume syringes and/or needles are used, the amount remaining in the vial may
be sufficient for an additional dose.

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• Care should be taken to ensure a full 0.5 ml dose is observed.
o Where a full dose cannot be extracted, the remaining volume should
be discarded.
• Strict adherence to aseptic techniques must be followed.

Vaccine Administration
• 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 as required under O. Reg. 474/07 made under
the Occupational Health and Safety Act.
• Visually inspect each dose in the dosing syringe prior to administration.

AstraZeneca COVID-19 vaccine COVISHIELD vaccine

clear to slightly opaque, colourless to clear to slightly opaque, colourless to
slightly brown, sterile, particle free, slightly brown essentially free from
preservative-free, solution for visible particles, preservative-free,
intramuscular injection solution for intramuscular injection

• Discard the vial if the solution is discoloured or visible particles are observed.
• During the visual inspection:
o Verify the final dosing volume of 0.5 mL and
o Confirm there are no particulates and that no discolouration is observed.
• If the visual inspection fails, do not administer the vaccine.
• Administer the vaccine intramuscularly in the deltoid muscle.
• Do not inject the vaccine intravascularly, subcutaneously or intradermally.
• Any non-viable/unused vaccine or waste material should be disposed of in
accordance with local requirements. See Appendix G of the COVID-19: Vaccine
Storage and Handling Guidance for details.

All clients should be reminded to continue to practice recommended public

health measures for prevention and control of COVID-19 infection and
transmission regardless of receipt of COVID-19 vaccine.

Information on vaccine storage, stability and disposal can be found in the COVID-19:
Vaccine Storage and Handling Guidance document.

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Appendix A: General Clinic Precautions
All staff working in the clinic must take appropriate infection prevention and control
measures, including donning appropriate personal protective equipment (PPE)
when interacting with clients as they move through the immunization clinic and
when responding to any adverse events following immunization (AEFI). All clinic
staff and management must also ensure they are working in accordance with the
Occupational Health and Safety Act and its regulations.

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