Moderna COVID-19 - 2021 Created By: Clinical Standards and Professional Practice Saskatchewan Health Authority
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Moderna
COVID-19
Vaccine
Learning
Module
2021
Created By: Clinical Standards and Professional Practice
Saskatchewan Health Authority
CV-19 LM0002 January 18, 2021
TABLE OF CONTENTS
Purpose of Learning Module 3
Care Providers This Applies To 4
COVID-19: A Global Pandemic 5
COVID-19: The Disease 5
COVID-19 Signs and Symptoms 6
The Immune System 7
Immunizing Agents 8
The Moderna COVID-19 Vaccine 9
Management of Biological Products 11
Vaccine Preparation 12
Vaccine Administration 13
Informed Consent 14
Screening Questions 15
Moderna COVID-19 Vaccine Contraindications
16
and Precautions
Post Administration 20
Documentation 21
Common Reactions after Immunization 21
Adverse Events After Immunization 22
Appendix A 24
References and Resources 26
Quiz 27
Moderna COVID-19 Immunization Learning Module V2
CV-19 LM0002 January 18, 2021
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Moderna COVID-19 Immunization
PURPOSE OF THE LEARNING MODULE
This learning module is designed to provide authorized immunizers (as defined in the Moderna
COVID-19 Immunization procedure) who are qualified to immunize
with the information and education required to provide COVID-19
immunizations to clients within an applicable setting. COVID-19
The purpose of this education and training is to develop individual
Immunization
knowledge and competence in providing Pfizer COVID-19 Competency
immunization. Requirements:
General
The method of education delivery and the depth and breadth of the Immunization
education required will vary between individuals. Education for Competency
immunization needs to be assessed on a case by case basis and may Moderna COVID-19
require more in-depth training than is provided throughout this Learning Module
learning module. Further assistance and clarification must be sought Moderna COVID-19
by the individual reviewing the education. Evaluation may require Immunization Quiz
demonstration the skill of the individual within the clinical setting. Return
demonstration of
Before any COVID-19 immunization can be considered, the provider skills as needed
needs to be aware of their responsibilities regarding the and appropriate
immunization including but not limited to storage, preparation and Completion of
administration as well as how to manage adverse events and Anaphylaxis
determine appropriate practice context, and specific information Learning and
related to the individual manufactured vaccine. certification
Moderna COVID-19 Immunization Learning Module V2
CV-19 LM0002 January 18, 2021
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CARE PROVIDERS THIS APPLIES TO:
This learning module applies to all Saskatchewan Health Authority (SHA) health care providers that have
administration of immunizations within their scope of practice.
Successful completion of this learning module is required prior to ANY SHA health care provider administering
the Moderna COVID-19 Vaccine.
Health Care Providers MUST complete the Anaphylaxis Learning Module prior to
providing any immunizations.
General Immunization information can be found in the Saskatchewan
Immunization Manual (SIM):
https://www.ehealthsask.ca/services/Manuals/Pages/SIM.aspx
This Learning Module can be found
through MyConnection and can be
completed online.
Moderna COVID-19 Immunization Learning Module V2
CV-19 LM0002 January 18, 2021
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COVID-19: A GLOBAL PANDEMIC
The novel coronavirus disease of 2019 (COVID-19) is caused by the severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2). The virus was first recognized in December of 2019 in Wuhan, China. The World
Health Organization (WHO) declared an outbreak in China on January 5, 2020. On January 11, 2020, China
reported its first death related to the virus and on January 13, 2020, the first recorded case outside of China
was found in Japan. At that time, WHO indicated that other cases around the world, given the global travel
patterns, was likely.
International travel recommendations were first announced on January 16, 2020. On January 21, 2020, the
first case in North America was reported in the United States of America. However, not until January 22, WHO
indicated that human to human transmission evidence was available. WHO encouraged countries to have
readiness plans for rapid detection for those who travelled internationally. On January 30th, the Director-
General declared a novel coronavirus outbreak a “public health emergency of international concern”, the
highest level of alarm at WHO.
By February 24, 2020, WHO warned that the “global community is not yet ready, in mindset and materially, to
implement the measures that have been employed to contain COVID-19 in China.” WHO was encouraging
large scale implementation of public health measures such as case detection, isolation, contact tracing,
monitoring and quarantine, and community engagement.
On March 11, 2020, WHO declared COVID-19 a global pandemic.
COVID-19: THE DISEASE
INFECTIOUS AGENT
Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2)
7 coronaviruses affect humans
Other serious diseases that are caused be a
coronavirus include Severe Acute Respiratory
Syndrome (SARS) AND Middle East Respiratory syndrome (MERS)
RESEVOIR
SARS-CoV-2 is a zoonotic virus – currently bats are the suspected reservoir but the intermediate host(s)
has not yet been identified.
INCUBATION PERIOD
Ranges from 1 to 14 days.
Median is 5 to 6 days between exposure and symptom onset.
Most people (97.5%) develop symptoms within 11.5 days of exposure.
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TRANSMISSION
The principal mode of infection with SARS-CoV-2 is through exposure to respiratory droplets.
Transmission of SARS-CoV-2 can occur through direct, indirect, or close contact with infected people by
infected secretions such as their saliva, respiratory secretions or respiratory droplets, which are
expelled when an infected person coughs, sneezes, talks or sings.
Recent research suggests that COVID-19 may also be spread through the fecal-oral route, although
likely less commonly (WHO, 2020b) ².
A person may be infectious for up to three days before showing symptoms.
Airborne transmission of SARS-CoV-2 can occur during medical procedures that generate aerosols
(aerosol generating procedures/AGMPs).
COVID-19: SIGNS AND SYMPTOMS
There is a spectrum of COVID-19 disease severity, ranging from asymptomatic or mild, to moderate, severe
and critical disease.
Symptoms are often similar to other illnesses, particularly other respiratory viruses such as rhinovirus or
influenza, amongst others.
More severe/critical symptoms can lead to dyspnea, hypoxia, respiratory failure, shock, or multiorgan
system dysfunction.
In children, the reported signs and symptoms have been similar to those observed in adults, though they
may often be less severe or altogether absent.
In children, gastrointestinal symptoms are often predominant in clinical presentation, including abdominal
pain, diarrhea, nausea, and vomiting.
Most frequent signs and symptoms are:
Fever (44-91%)
Cough (57-74%)
Shortness of breath (31-63%)
Fatigue (31-70%)
Loss of appetite (39-84%
Loss of smell and/or taste (54-88%)
Less frequently (less than 50%)
Sputum production (28-33%)
Muscle aches (11-44%)
Chest pain (16-36%)
Diarrhea (5-24%)
Nausea / vomiting (5-19%
Headache (6-17%)
Dizziness (9-17%)
Sore throat (11-13%)
Moderna COVID-19 Immunization Learning Module V2
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Rare symptoms occurring less than 10% of the time are:
Confusion
Runny nose
Fainting
Skin manifestations.
Use caution – symptoms in those 65 or older, with underlying medical conditions, may be atypical or subtle.
They may be more likely to present WITHOUT fever or respiratory symptoms.
THE IMMUNE SYSTEM
The immune system is complex. The primary function of the immune system is to prevent or limit infections
caused by microorganisms/pathogens. Pathogens are foreign substances such as viruses, bacteria, toxins, and
parasites that are surrounded by antigens. When introduced into the body, antigens are capable of inducing a
response by the immune system.
Antigens are a foreign protein, bacteria or virus that causes the formation of antibodies that react specifically
with that antigen. When an antibody response is elicited by lymphocytes in the blood, they induce the
production of immunoglobulin complexes which attempt to bind to and inactivate the antigen. The
lymphocytes within the body are specialized white blood cells. White blood cells are differentiated into several
specialized forms such as phagocytes, T-cells and B cells. These types of white blood cells have a specific
function to fight off infection, diseases and viruses.
When an individual gets sick, the white blood cells counteract the virus by producing more white blood cells
that can recognize, bind to and inactivate the foreign antigen. The antibody-antigen binding complex is very
specific and could be described as a “lock and key” fit. This is why different strains of a virus require a new and
unique vaccine. Immunity occurs when the immune system (white blood cells and the Lymphatic system) can
tolerate the presence of the foreign antigen by being able to recognize and deactivate it with the formation of
antibodies. Immunity is then achieved and protection from the foreign virus/bacteria/disease is complete.
Immunity can be measured with a blood test that indicates antibodies to the offending disease strain are
present within the body.
The body achieves immunity in several different forms: Passive immunity or active immunity. Passive immunity
is achieved by producing the “fitting” antibody inside the cells of another person or animal that is subsequently
injected or infused to another individual. This is referred to as passive immunity because the antibodies are
produced by another source, and then injected via blood or blood products. Examples include: rabies, varicella,
and tetanus immunoglobulins; trans-placental (mom-babe in utero) and through breast feeding. This form of
immunity is effective, but short lived, and no memory is created. It is called passive because the individual did
not create the antibodies, but instead received it pre-formed.
Active immunity is when the body is exposed to pathogens, and the cells in the immune system actively
respond by producing antibodies. The immune system ideally engages both the T cells and B cells to provide
long term immunity. Active immunity can occur through natural infection or through immunization. After the
exposure (or immunization), the host (individual) actively produces antibodies through the immune response.
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Vaccines take the luck out of building immunity. An individual can be vaccinated and develop good immunity
without the risk of complications from the disease.
IMMUNIZING AGENTS
Immunizing agents are classified as passive or active. Active agents are further classified as live or replicating
(attenuated or weakened) or non-replicating.
Replicating (live) agents contain whole, living viruses or bacteria which induce immunity by actively replicating
in the person. When an organism is “attenuated” it means that the organism has been weakened by chemical
or physical processes so if an active infection occurs when the vaccine is introduced to the body there are little
or very mild effects on the person. Immunity in this form is long lasting, and can be life-long. This form of
vaccine is contraindicated in pregnancy and in individuals with immunodeficiency.
Non-replicating vaccines may have had the virus/bacteria inactivated by heat or a chemical process. Other
types of non-replicating vaccines may only contain purified parts of the virus or bacteria. These vaccines
cannot replicate in the host, therefore often require more doses or a series of vaccinations to help build
immunity. Once immunity is achieved, it may be permanent, or may fall resulting in the need for booster
immunizations. These vaccines are safe in immunocompromised patients.
Vaccine immune responses vary due to several factors.
Vaccine related factors include:
The nature of the antigen- each vaccine type generates immune responses of differing intensity and
duration.
Dose of the antigen – the amount of antigen present in the vaccine. The amount may change based on
age or even vaccines used for certain chronic illnesses.
Presence of vaccine adjuvants (additives) – they are added to increase the immune response to the
vaccine.
NOTE:
BE SURE you are always verifying with the Saskatchewan.ca COVID-19 web
site for the MOST CURRENT information on all things Moderna vaccine
related
https://www.saskhealthauthority.ca/news/service-alerts-emergency-
events/covid-19/vaccine-info-health-care-providers
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MODERNA COVID-19 VACCINE
Route: Intramuscular only
Dose: 0.5 mL
Site: Deltoid preferred
10 dose vial
Approved for ages 18 years and older
Preservative free
Latex free
NOTE: Expiry date on box is listed as month and year. The actual date is the LAST day of the
month listed.
Packaged in a box of 10 vials
White to off white sterile suspension
The Moderna COVID-19 vaccine was approved for use on December 23, 2020 by Health Canada.
As this is an exceptional time, some exceptions were also made. These include:
Labelling of vials and cartons will be in English only
The Drug Information Number (DIN) will be absent
The name and address of the Canadian importer and distributor is absent
As time goes on, these issues will be rectified and Canadian standards will be added to the packaging
MODERNA COVID-19 VACCINE SCHEDULE
2-dose series administered 28 days apart
Day 0 and day 28
Minimum spacing between doses is 21 days
Recommended spacing between doses is 28 days
If administration of the second dose is delayed, the second dose should be provided as soon as
possible.
It is not interchangeable with other brands
NOTE:
Some multi-dose vials (not all) may contain 11 doses of vaccine. This dose may be used
only if the entire dose (0.5 mL) can be removed from the SAME vial.
You CANNOT provide a dose that comes from 2 different vials.
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MODERNA COVID-19 VACCINE PHARMACOLOGY
Moderna vaccine is a modified RNA
vaccine contain the genetic instructions
for making the SARS-CoV-2 spike protein.
This protein is found on the surface of
the virus that causes COVID-19.
The Moderna is a modified mRNA
vaccine containing lipid particles which
deliver the mRNA into the host cells to
allow expression of the SARS-CoV-2 spike
protein antigen.
The vaccine elicits both a neutralizing antibody
and cellular immune response to the spike
protein antigen, which protects against COVID-
19
.
Each dose contains: 100 micrograms of nucleoside-
modified messenger RNA (mRNA) encoding the pre-fusion
“S” spike glycoprotein containing the SARS-CoV-2 virus
MODERNA COVID-19 VACCINE COMPONENTS
Active Ingredient:
Suspension, (0.20 mg /mL), mRNA, encoding the pre fusion stabilized Spike glycoprotein of 2019 novel
Coronavirus (SARS-CoV-2)
NO
Non-medicinal ingredients include:
1, 2 distearoyl-sn-glycerol-3-phosophocholine (DSPC) preservatives
Acetic acid NO
Cholesterol antibiotics
Lipid SM-102 NO adjuvants
1,2-dimyristoyl-rac-glycerol, methoxy-polyethyleneglycol (PEG2000 DMG) NO human or
Sodium acetate
animal
Sucrose
Tromethamine
derived
Tromethamine hydrochloride material
Water for injection No Latex
EFFICACY
Presently as there are only short term studies the duration of Moderna COVID-19 vaccine efficacy and
vaccine effectiveness are currently unknown.
Individuals may not be optimally protected until at least 7 days after their second dose of vaccine.
Moderna COVID-19 Immunization Learning Module V2
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Page 10 of 30 Safety and efficacy in children (under 18), pregnant and/or breastfeeding women,
immunocompromised or those with autoimmune disorders have not been established.
In clinical studies with the Moderna COVID-19 vaccine, efficacy 2 weeks after the second dose was
94.1% in those aged 18 to 65 and 86.4% in those greater than age 65.
Decreased response in those who are immunosuppressed
ADMINISTRATION OF OTHER PRODUCTS
In the absence of evidence, COVID-19 vaccines should not be given simultaneously with other live or
inactivated vaccines
o Due to the potential for immune interference and the need to be able to monitor for potential
symptoms of COVID-19 and COVID-19 vaccine adverse events without potential confusion from
adverse events following other vaccines.
If a COVID-19 vaccine is inadvertently administered at the same time as another vaccine, neither dose
should be repeated.
As only short term studies the duration of COVID-19 vaccine efficacy and vaccine effectiveness are
currently unknown. Individuals may not be optimally protected until at least 7 days after their second
dose of vaccine.
The safety and efficacy in children under 16 years, pregnant and/or breastfeeding woman,
immunocompromised or those with autoimmune disorders have not been established.
MANAGEMENT OF BIOLOGICAL PRODUCTS
PRINCIPLES
The cold chain refers to the process used to maintain optimal conditions during the transport, storage,
and handling of vaccines.
Understanding the principles of cold chain is a key concept in the handling and the storage of vaccines.
It is crucial that extreme care be taken to transport, store and administer the Moderna COVID-19
vaccine to protect its potency.
Vaccines are sensitive biological products which may become less effective, or even destroyed, when
exposed to temperatures outside the recommended range.
Agents that have decreased potency may fail to stimulate the desired immune response resulting in
lower protection.
If the vaccine is compromised, the preventable disease can reoccur within a population and thus cause
preventable transmission.
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Page 11 of 30STORANGE AND HANDLING
• The Moderna COVID-19 Vaccine is a multiple dose vial containing a frozen suspension that does not
contain preservative and must be thawed prior to administration.
• Expiry dates must be reviewed prior to administration of the vaccine. When a vaccine is dated with a
month and a year, the vaccine can be used up to the last day of the month listed on the vial.
• Store in original carton, protect from light.
• Can be stored in a freezer between -25°C and -15°C.
• Do not store in dry ice below -40ᵒ C.
• Vials can be stored in fridge between 2ᵒC and 8ᵒC for up to 30 days prior to use.
• Un-punctured vials may be stored at room temperature between 8ᵒ C and 25ᵒ C for up to 12 hours.
VACCINE PREPARATION
Thawing and Storage
2 options:
1. Remove from freezer and thaw in fridge between 2ᵒC to 8ᵒC for 2 hours and 30 minutes. Let stand for
15 minutes at room temperature before administering
OR
2. Remove from the freezer and thaw at room temperature (15°C to 25°C) for 60 minutes.
DO NOT refreeze once the vaccine is thawed.
NOTE: Vials must be marked with date and time to track vaccine stability in the following situations:
• When vial is moved from freezer to the fridge.
• When the vial is moved from the fridge to room temperature – Vials not punctured can sit can sit at
room temperature up to 12 hours.
• When punctured.
IF Moderna COVID-19 vaccine is punctured it must be used within 6 hours. Discard after 6 hours.
Ready to Use
DO NOT SHAKE - Swirl vial gently after thawing and between each withdrawal.
• Thawed, punctured vials (first dose is withdrawn) can be stored at +2°C to +25°C for 6 hours.
• 10 doses per vial
• Moderna COVID-19 Vaccine is a white to off-white suspension. It may contain white or translucent
product-related particulates view prior to withdrawing.
Moderna COVID-19 Immunization Learning Module V2
CV-19 LM0002 January 18, 2021
Page 12 of 30COLD CHAIN BREAK
If the cold chain has been broken at any stage, you must take action.
1. Do NOT discard the vaccine.
2. IMMEDIATELY place the exposed vaccines in a paper bag.
3. LABEL the bag
“DO NOT USE – Cold chain break”
Include the Date and time of exposure
4. STORE exposed vaccines separately under the conditions in the
Saskatchewan Immunization Manual (SIM) – Chapter 9.
5. FOLLOW SIM – Chapter 9 and a local process.
Inspect the product for particulates and discoloration. If found, must be discarded.
VACCINE ADMINISTRATION
Ensure that you have completed the Anaphylaxis management module and exam PRIOR to
immunizing.
IDENTIFY THE PATIENT
Every former Regional Health Authority in the Province of Saskatchewan has a Policy that states you MUST
verify your patient’s identity prior to providing any service or procedure, and at the first point of contact.
A minimum of 2 single source identifiers must be used.
Identifiers must be specific to the individual.
Identifiers can be:
Full name – first and last
Registration Number (if in a facility)
Date of Birth
Full address
Health Services Number
Treaty Number
Where the patient is not able to identify themselves, their caregiver must confirm the patient’s identity using 2
identifiers from a single source.
Use of two individual identifiers is an Accreditation Canada requirement and is also required prior to
immunization.
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Page 13 of 30INFORMED CONSENT
Public immunization programs are voluntary. Individuals and caregivers are free to decide whether or not to
immunize themselves. Individuals may choose not to immunize based on personal reasons, concerns about
vaccine safety, perceived harm and negative perceptions of risk associated with immunizations.
Informed consent is the professional and legal responsibility of the immunization provider to obtain valid
informed consent prior to immunization by providing:
Health care providers in facilities need to follow current rules and policies around obtaining consent.
Where possible, the health care provider administering the immunization will obtain consent at the time the
immunization is being administered. Consent can be verbal.
Where consent must be obtained from someone other than individual being immunized (substitute decision
maker is involved), consent may be obtained by someone other than the immunizer. The individual obtaining
consent is responsible to provide the information required for informed consent. There must be a written
record of any consent obtained by another party so the immunizer can verify consent was obtained prior to
immunization.
STEPS TO OBTAINING CONSENT
1. Determining the authority for the client or representative to provide informed consent.
2. Assessing ability to provide informed consent
Was the discussion understood?
Is there a language barrier?
o Do you need an interpreter (follow local process)
3. Provide standard information:
The vaccine information sheet (this will assist with the informed consent process).
Benefits of vaccination
Risks of not being vaccinated
Common side effects of vaccines
Possible serious, severe or unusual adverse events and their frequency
Contraindications
4. Allow the opportunity to ask questions and confirm understanding
Moderna COVID-19 VACCINE INFORMATION SHEET
The Information Sheet must be provided prior to immunization, where appropriate.
ALWAYS use the most current Information Sheet from the Saskatchewan COVID-19 Web Site
Moderna COVID-19 Immunization Learning Module V2
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Page 14 of 30NOTE: SAMPLE OF SHEET ONLY
SCREENING PRIOR TO IMMUNIZATION
ALWAYS USE the most current screening questions for the Moderna
COVID-19 Vaccine. They can be found on Saskatchewan.ca COVID-19
web site under Information for Health Care Providers.
Saskatchewan COVID-19 Web Site
Prior to immunizing an individual, the screening process must be completed each and every time the client
presents for immunization. They must be screened to ensure that they are well enough and can safely receive
the recommended vaccines. Common colds and/or low grade fever alone are not contraindications to receiving
vaccines.
Moderna COVID-19 Immunization Learning Module V2
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Page 15 of 30NOTE: SAMPLE OF SHEET ONLY
VACCINE CONTRAINDICATIONS
Known severe hypersensitivity to any component of the vaccine.
Anaphylaxis to a previous dose of COVID-19 mRNA vaccine. One non-medicinal ingredient in the
vaccine known to cause type 1 hypersensitivity reactions is polyethylene glycol (PEG). The potential
allergen may be found in bowel preparation products for colonoscopy, laxatives, cough syrup,
cosmetics, contact lens care solutions, skin products and some food and drinks.
Anyone under the age of 18 years.
VACCINE PRECAUTIONS
Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate
intramuscular injection should not be given the vaccine unless the potential benefit clearly outweighs
the risk of administration.
Administration should be postponed in individuals suffering from acute severe febrile illness.
Timing of administration and potential interference between COVID-19 vaccine and monoclonal
products are currently unknown and expert clinical opinion should be sought on a case-by-case basis.
There are a number of precautions for the Moderna COVID-19 Vaccine. The vaccine precautions and
recommendations continue to be updated frequently due to the ongoing research and investigations into the
vaccine efficacy.
We cannot list all the precautions here safely. You will need to verify precautions and warnings before
immunization.
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Page 16 of 30Moderna is offering a Pregnancy Exposure Registry that is monitoring outcomes in pregnant women who have
been exposed to the Moderna COVID-19 Vaccine. Pregnant women who receive the immunization are
encouraged to enroll directly with Moderna by calling 1-866-MODERNA (1-866-663-3762).
A number of immunocompromised and auto immune conditions have been identified also.
Common Auto Immune Conditions*¹
*This is not an exhaustive list
Addison’s Guillain-Barre syndrome Optic Neuritis
Alopecia areata Hashimoto’s thyroiditis Psoriasis
Amyloidosis Hemolytic anemia Psoriatic arthritis
Ankylosing spondylitis Henoch-Schonlein purpura Raynaud’s syndrome
Celiac disease Juvenile arthritis Restless legs syndrome
Crohn’s disease Kawasaki disease Rheumatoid arthritis
Diabetes (type 1) Lupus Sarcoidosis
Endometriosis Meniere’s disease Scleroderma
Erythema nodosum Multiple Sclerosis Thrombocytopenic purpura
Fibromyalgia Myasthenia gravis Ulcerative Colitis
Graves’ disease Neutropenia
¹list obtained American Autoimmune Related Disease Ltd. https://www.aarda.org/diseaselist/
The MOST current information is found in the Saskatchewan Immunization Manual, as an Appendix in Chapter
6 Contraindications and Precautions
You are responsible for verifying the most current information.
The SHA is asking for written consent for the following conditions:
1. Pregnancy
2. Breastfeeding
3. Immunosuppressed
4. Auto Immune Conditions.
The Risk/Benefit Information for these populations can be found inside the Saskatchewan Immunization
Manual, Chapter 6 – as listed above.
However, before administering the vaccine, ensure the patient has signed the Risk/Benefit Information that
applies specifically to them.
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Page 17 of 30The Risk/Benefit Information documents for the 4 conditions are found on the
Saskatchewan.ca COVID-19 web site. You can click HERE for the latest documents.
NOTE: THIS IS A SAMPLE OF ONE OF THE FORMS ONLY
VACCINE PREPARATION
When preparing any biological product ensure:
Right client Right dose*
Right assessment Right route*
Right client education Right time*
Right to refuse Right documentation
Right product* Right evaluation
*Check three times
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Page 18 of 30Moderna COVID-19 Vaccine is a white to off-white suspension. It may contain white or translucent product-
related particulates.
Using aseptic technique
Inspect the new vial for foreign particulates and discoloration. Do NOT administer if found.
o The vial should be white or off white in colour.
o The vial may contain white or translucent product – related particulates.
o If unusual findings, report to your local supervisor for local process follow up.
Remove cap covering the vial.
Cleanse the stopper with an alcohol swab.
Allow to air dry (do not fan dry).
Gently swirl the vial. DO NOT SHAKE.
Place the vial right side up and insert the needle through the center of the rubber stopper.
Hold the vial upside down and withdraw the required quantity (0.5 mL) of the Moderna COVID-19
vaccine into the syringe.
Withdraw immediately before use ONLY.
Once vial is punctured, it must be used within 6 hours (discard unused portions after 6 hours)
Pre-loading of syringes is not acceptable. Vaccine is drawn up only at the time of
administration.
SITE SELECTION
Preferred site is the deltoid.
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Page 19 of 30Deltoid muscle factors – Clean with alcohol swab for 5 seconds prior to administering.
Needle length is 1” to 1.5” needle
22 to 25 gauge needle
3 mL Syringe
Maximum volume is 2 mL
INAPPROPRIATE LANDMARKING
Intramuscular
vaccines in the arm
must be placed in
the belly of the
deltoid. This
vaccine is not in
the deltoid.
This vaccine is placed posterior and also too
high. This may have been administered into
the bursa.
POST ADMINISTRATION
Discourage prophylactic antipyretic analgesics
As this does not reduce injection pain
May decrease vaccine immunogenicity.
If required ideally when the client has pain or fever as opposed to prophylactically
Advise all clients they need to wait for 15 minutes post vaccination in case of allergic reaction.
Always provide client with:
Current Ministry of Health Moderna COVID-19 vaccine fact sheet.
Counsel them when to seek medical attention post-immunization.
Provide all clients with the wallet card for their record of immunization.
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Page 20 of 30 Observe patient for 15 minutes following immunization for signs of anaphylaxis. Observe for 30
minutes if higher risk. Anaphylaxis usually begins within a few minutes after immunization.
For emergency reactions: Activate the Emergency Response
System in your area.
DOCUMENTATION:
Follow local process for documentation.
Documentation should include:
Verbal consent obtained, where appropriate –
o Documentation of consent can be in a local patient care chart, or by following local processes
for SHA staff and out-patient clinics.
Date and time of immunization
Quantity of vaccine administered
Administration site and route
Brand and generic name
Lot number and expiry date of vial
COMMON REACTIONS FOLLOWING IMMUNIZATION
Approximately 90% of patients who received the Moderna COVID-19 vaccine reported pain at
the injection site.
The majority of patients had mild to moderate reactions and lasted 2 to 3 days after
immunization.
Other side effects included:
Reaction Approximate number of patients who reported
Fatigue 67%
Headache 63%
Myalgia 62%
Chills 45%
Joint Pain 45%
Others also reported lymphadenopathy.
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Page 21 of 30Rare reactions included:
Facial Swelling
Anaphylaxis
Typically symptoms were mild to moderate and resolved within a few days of vaccination.
Reactions tend to be increased with the second dose and for those under age 65.
ADVERSE EVENTS
Adverse Events Following Immunization (AEFI) is defined as a medical occurrence which follows
immunization that does not necessarily have a causal relationship with the use of a vaccine. The adverse event
may be any unfavorable or unintended sign, abnormal laboratory finding, symptom or disease.
The general definition of AEFI specifies that the event is not necessarily due to the vaccine
Expected side effects from immunizations do not require reporting.
A faint is not considered an AEFI.
Saskatchewan Public Health Act 1994:
It is mandatory to complete the adverse events following immunization form for any reportable AEFI
Who should report an AEFI?
All vaccine providers have a professional responsibility/obligation
Any HCW caring for patients who may have had an AEFI
When should an AEFI be reported?
ASAP after the event occurs. Remind the client to contact you ASAP if a serious reaction occurs, rather
than waiting until the next visit.
Severe reactions must be reported within 24 hours.
When you receive a concern
Determine if symptoms fit the reporting criteria listed in the Saskatchewan Immunization Manual
Chapter 11 Adverse Events Following Immunization, Appendix 11.1
Adverse events that are severe, unusual or unexpected require reporting
For publicly funded vaccines, complete the AEFI and send to local Public Health within 24 hours.
The Public Health Agency of Canada user guide and form can be found at: HERE - Health Canada AEFI
Reporting Form
Completion of information is required in every category as data is analyzed by event, demographic
information, product, lot number, manufacturer and number in the series.
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Page 22 of 30NOTE: SAMPLE OF FORM ONLY
The local Medical Health Officer will make recommendations for future immunizations.
LOCAL REPORTING IS ALSO REQUIRED
Follow your local adverse event reporting process.
In addition to your local processes:
Notify your supervisor
Adverse events that occur as a result of an immunization administered by a SHA Employee at an SHA
operated immunization clinic must be reported through local mechanisms by completing your local
adverse event documentation.
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Page 23 of 30APPENDIX A – Intramuscular Injections
•Deltoid muscle is preferred
•IM -25 gauge 1 inch
How to administer an IM Injection:
The IM route is used to deposit a biological product deep into a muscle at a 90° angle, where it can elicit the
best immune response (see figure 1). If such a product is erroneously injected into the dermis or adipose tissue,
irritation, induration, inflammation, or an abscess may form at the injection site.
Figure 1
Three techniques are acceptable to administer IM injections:
1. Use the thumb and index finger to gently stretch the skin over the site while inserting the needle at a 90
degree angle to the skin;
2. Use the free hand to gently bunch the muscle while inserting the needle at a 90 degree angle to the skin;
3. Use the Z-track method. Z-tracking is appropriate to administer IM injections to all age groups,
except for infants. Z-tracking involves using the free hand to displace the skin and adipose
tissue at least one inch laterally in relation to the underlying muscle, prior to 90 degree insertion of the needle
into the muscle. The Z-tracking must be kept in place until after the biological product is deposited into muscle
and the needle is withdrawn, therefore preventing reflux of the medication into the subcutaneous tissue
(see figure 2). This technique seals off the puncture tract and traps the product within the muscle, minimising
pain, irritation and bleeding at the site.
Figure 2
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Page 24 of 30Vastus Lateralis IM Injections
To landmark the site:
1. Visually divide the length of the muscle that originates on the
greater trochanter of the femur and the lateral border of the
kneecap into thirds.
2. The anterolateral aspect of the middle third is where the belly
of the vastus lateralis muscle lies, and the injection site is in
the middle of this area.
3. In width, the site extends from the midline of the top of the
thigh to the midline of the outer side of the thigh. (see figures 3 and 4 below)
Ventrogluteal IM Injections
If the deltoid and vastus lateralis sites cannot be used, then the ventrogluteal is the tertiary administration site
for IM injections in adolescents and adults. This site provides the greatest thickness of gluteal muscle, and is
free of penetrating nerves and blood vessels.
To landmark this site:
1. Use the right hand to locate the site on the left hip, and the left hand to locate the site on the right hip.
2. Place heel of the hand over the greater trochanter of the client’s hip with wrist almost perpendicular to the
femur.
3. Point the thumb toward the client’s groin and the fingers toward the client’s head.
4. Point index finger to the anterior superior iliac spine, and extend the middle finger back along the iliac crest
toward the buttock. The index finger, the middle finger, and the iliac crest form a V-shaped triangle.
5. The injection site is the centre of the triangle (see figure 7).
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Page 25 of 30Additional Resources and References
Canadian Immunization Information: Government of Canada: https://www.canada.ca/en/public-
health/services/canadian-immunization-guide.html
Centers for Disease Control and Prevention: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-
guidance-management-patients.html
Health Canada: Reporting Adverse Events Following Immunization: https://www.canada.ca/en/public-
health/services/immunization/reporting-adverse-events-following-immunization/user-guide-
completion-submission-aefi-reports.html
National Advisory Committee on Immunization (2020) Recommendations on the use of COVID-19 Vaccine(s).
Naqvi, A. A., Fatima, K., Mohammad, T., Fatima, U., et al (2020). Insights into SARS-CoV-2 genome, structure,
evolution, pathogenesis and therapies: Structural genomics approach. BBA- Molecular Basis of Disease.
Retrieved December 22, 2020 from doi.org/10.1016/j.bbadis.2020.165878
Pfizer COVID-19 Product Monograph: https://covid-vaccine.canada.ca/info/pdf/pfizer-biontech-covid-19-
vaccine-pm1-en.pdf
Saskatchewan Association of Licensed Practical Nurses: https://salpn.com/wp-content/uploads/Immunization-
Practice-Guideline-Oct-2020.pdf
Saskatchewan Communicable Disease Manual. https://www.ehealthsask.ca/services/Manuals/Documents/cdc-
section2.pdf#page=12
Saskatchewan Immunization Services: https://www.ehealthsask.ca/services/Manuals/Pages/SIM.aspx
Saskatchewan Health Authority Influenza Resource: 4Flu.ca
World Health Organization: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/interactive-
timeline#event-80
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Page 26 of 30Name: __________________________________
Facility/Department: ______________________
Date: ___________________________________
Pfizer COVID-19 Vaccine QUIZ:
Name: _________________________________________ Date: ________________________
NOTE: A minimum grade of 80% is expected
1. Consent for the vaccine is to be obtained prior to administration
a. True
b. False
2. Consent for the Pfizer COVID-19 vaccine must include (choose all correct answers):
a. Risks and benefits of receiving the vaccine or not receiving
b. Expected and potential side effects of the vaccine
c. Management of side effects
d. Written vaccine information sheet to be provided to the patient / client
3. Why is the cold chain an essential step in immunization safety?
a. The cold chain is not important. The vaccine just needs to be administered to be
effective.
b. If the cold chain is not maintained, the agent can have decreased potency and may fail
to stimulate an adequate immune response, resulting in lower protection.
c. If the cold chain is not maintained, the vaccine is inactive.
d. Storage in the lunch room fridge is adequate for cold chain maintenance.
4. Multi-dose vials, once diluted, can be stored at room temperature for how long?
a. 30 days
b. 15 minutes
c. 6 hours
d. 12 hours
5. A low grade fever is a contraindication to receiving the Pfizer COVID-19 vaccine.
a. True
b. False
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Page 27 of 306. Once I have received one dose of the Pfizer COVID-19 vaccine, I can only receive the Pfizer
COVID-19 vaccine for the second dose.
a. True - If you receive a vaccine from one manufacturer, you must stick with the same
manufacturer for the second dose. They are NOT interchangeable.
b. False - once I receive one dose, it does not matter who manufactured the second
dose. I can receive any as they are interchangeable.
7. It is possible to get COVID-19 from the Pfizer COVID-19 vaccine.
a. True
b. False
8. Identify some of the most common symptoms of COVID-19 - select all correct answers
a. Vertigo
b. Fever
c. Cough
d. Shortness of Breath
9. The Pfizer COVID-19 vaccine may be given to a 12 or 13 year old person.
a. True
b. False
10. Identify the preferred route and site of administration of the Pfizer COVID-19 vaccine.
a) Intramuscular into the deltoid
b) Subcutaneously into the upper arm
c) Intramuscular into the vastus lateralis
d) Subcutaneously into the thigh
11. What is the acceptable schedule for the multi-dose administration of the Pfizer COVID-19
vaccine?
a. Two doses, 14 days apart
b. Two doses, 21 days apart
c. Two doses, 28 days apart
d. One dose, one time only
12. The most common side effects of the Pfizer COVID-19 vaccine are (select all correct answers):
a. Injection site pain
b. Fatigue
c. Headache
d. Myalgia
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Page 28 of 3013. In order to alleviate injection pain, it is appropriate to give your patient acetaminophen before
COVID-19 vaccine administration.
a. True - prophylactic treatment is always recommended in adults.
b. False - symptoms should be treated after they appear.
14. You have administered the Pfizer COVID-19 vaccine and are observing your patient. At
approximately 8 minutes after immunization, they develop unexpected and unanticipated
adverse effects. After you have managed your patient, you need to report the adverse event
to who? Select all correct answers.
a. Your local supervisor so it can be escalated to the Medical Health Officer.
b. No reporting is necessary - you managed it, document it, and the patient or client is fine.
c. You must document the adverse event on the Health Canada Adverse Event Following
Immunization (AEFI) Record.
d. You must document the event on your local adverse event reporting forms.
15. Documentation of the immunization, after administration includes - select all correct answers.
a. Date and time of administration
b. Site, route of administration, and quantity of dose
c. Brand name and generic name
d. Lot number and expiry date of vial
Managers and educators – contact clinicalstandards@saskhealthauthority.ca for the answer key.
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Page 29 of 30CV-19 LM0002
January 18, 2021
clinicalstandards@saskatchewanhealthauthority.ca
Moderna COVID-19 Immunization Learning Module V2
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