Download pdf - 2020-2021 COVID-19 Immunization Orientation...COVID-19 vaccine will be offered to all Albertans in a staged approach. • The staged approach is based on vaccine availability, vaccine

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2020-2021 COVID-19 Immunization Orientation

Presented by Provincial Population & Public Health Provincial CDC Immunization Team

June 16, 2021

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• To provide clinical information related to COVID-19 disease and immunization

o NOTE: always use the online resources for up-to-date information

• Operational questions will NOT be addressed during this presentation (i.e., scheduling, vaccine distribution specifics)

Objective

PresenterPresentation NotesInsite: Immunization Program Standards Manual (IPSM) COVID-19 vaccine related information found under “Biological Product Information” tab https://insite.albertahealthservices.ca/cdc/Page11322.aspx External AHS website: COVID-19 Health Professional Immunization Information https://www.albertahealthservices.ca/topics/Page17314.aspx

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For more detailed information it is important to refer to additional program resources such as:

• AHS COVID-19 Health Professional Immunization Information

o Insite for AHS employees or External site for non-AHS employees

• AHS Immunization Program Standards Manual (IPSM) Vaccine Biological pages are located at

o Insite for AHS employees or External site for non-AHS employees

• COVID-19 Vaccine Product Monographs

• AHS Vaccine Storage and Handling Standard and e-learning modules*

• Alberta Health Adverse Events Following Immunization (AEFI) Policy

• Site specific reporting requirements and data collection guidelines

Introduction

PresenterPresentation Notes*AHS Vaccine Storage and Handling Standard e-learning modules located on MyLearningLink for AHS employees and ABSORB for vaccine providers outside of AHS.

Once again, a reminder that the COVID-19 information contained in this power point is valid on the date it has been presented and it is important to refer back to the COVID-19 Immunization weblinks for the most up to date information.

https://insite.albertahealthservices.ca/tools/Page25471.aspxhttps://www.albertahealthservices.ca/topics/Page17314.aspxhttps://insite.albertahealthservices.ca/cdc/Page11322.aspxhttps://www.albertahealthservices.ca/info/page10802.aspxhttps://www.albertahealthservices.ca/info/Page14001.aspxhttps://open.alberta.ca/publications/aefi-policy-for-alberta-immunization-providers

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• Coronaviruses are a large family of viruses. o Some coronaviruses cause respiratory illness in people, ranging from a

mild common cold to severe pneumonia. o Other coronaviruses cause illness in animals only. Rarely animal

coronaviruses can infect people and these can spread from person to person through close contact.

• COVID-19 is the disease caused by SARS-CoV-2 coronavirus, a new virus that was first recognized in 2019. It’s referred to as a novel coronavirus strain as it has not been previously identified in humans.

• Due to it being a novel virus there is no herd immunity and there are no specific treatments.

• COVID-19 poses a serious risk to public health and the healthcare system.

What is COVID-19?

PresenterPresentation NotesCoronaviruses are a large family of viruses

They can cause illness in people and the presentation can be a mild cold to severe pneumonia

Coronaviruses can infect animals and very rarely animal coronaviruses can infect people and spread from person to person via close contact.

COVID-19 disease is caused by the SARS-CoV-2 coronavirus, which was first recognized in Wuhan, China in December 2019. COVID-19 (19 refers to the year it was recognized) is a new virus not previously identified in humans.

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What are COVID-19 Variant Strains?

• Mutations in the COVID-19 virus over time are expected, and can cause variant strains of COVID-19 to emerge.

• Variant strains of COVID-19 have been identified in the United Kingdom, South Africa, Brazil and India, and have since been identified in many other countries around the world. These strains are known as variants of concern, as they appear to spread more easily than other COVID-19 strains.

• Studies are ongoing to determine the effectiveness of the currently authorized vaccines against these variants.

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How is COVID-19 Spread?

• The virus is spread mainly from person-to-person through coughing or sneezing (droplet spread). o The droplets are propelled about 3 feet through the air

• People may also become infected by touching an object or a surface that has the COVID-19 virus on it and then touching their mouth, eyes or nose.

• Median incubation period is estimated at 5-6 days from exposure to onset.

• Most people (97.5%) develop symptoms within 11.5 days.

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COVID-19 Infectivity

• People infected with COVID-19 can spread the disease to others while they have symptoms and sometimes before they know they are ill. A person may be infectious for two days before showing symptoms.

• Some people can be infected but have no symptoms. o These individuals can spread the virus to others

• This is important information for those caring for others, such as parents and all health care workers.

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COVID-19 Signs and Symptoms

• Common – fever, new cough or worsening chronic cough, sore throat, runny nose.

• Additional – stuffy nose, painful swallowing, headache, chills, muscle/joint aches, fatigue or severe exhaustion, GI symptoms, loss of sense of smell or taste, conjunctivitis.

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How Serious is COVID-19?

• New cases are reported daily across Canada, increasing hospitalizations and intensive care unit (ICU) admissions.

• Some individuals are at higher risk of developing complications from COVID-19 disease, including:

o Seniors

o Adults with existing chronic health conditions

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Treatment of COVID-19Treatment will vary depending on severity of disease. Some Albertans will be able to stay home and manage symptoms with comfort measures such as:

• rest• analgesics• fluids• time

Other Albertans will require care in an acute care facility, perhaps in an ICU.

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Universal COVID-19 Immunization ProgramAlberta Health (AH) will be making COVID-19 vaccine available:

• All eligible Albertans can receive the vaccine at no charge.

• The COVID-19 vaccine is being offered in phases.

o Please follow current operational guidelines to assess eligibility

• More information on eligibility (phases) can be found on the Alberta Health website.

https://www.alberta.ca/covid19-vaccine.aspx

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Vaccine Efficacy & Effectiveness• Vaccine efficacy:

o Percentage reduction of disease in an immunized group of people compared to an unimmunized group.

o Calculated in clinical trials where the study conditions are controlled. o Does not describe whether an immunized person can still transmit the

virus.• Vaccine effectiveness:

o Describes how the vaccine works in the real world where conditions cannot be controlled.

• For example: previous exposure to the virus, immune status of the individual, receipt of recommended doses.

Vaccine effectiveness will continue to be evaluated as the COVID-19 immunization program is rolled out.

PresenterPresentation Notes

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COVID-19 Vaccines Available in Alberta

• Viral Vector-based o AstraZeneca/COVISHIELD

• mRNA o Pfizer Ultra Frozen Vaccineo Moderna Frozen Vaccine

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What are Viral Vector COVID-19 Vaccines?• AstraZeneca/COVISHIELD COVID-19 vaccines based on viral vector

platforms use a modified adenovirus virus to carry genes that encode SARS-CoV-2 spike proteins into the host cells.

• The vector virus is a type of adenovirus that has been modified to carry COVID-19 genes and to prevent replication.

o These modifications are intended to prevent the viral vector from causing disease. (i.e., they are non-replicating).

• Once inside the cell, the SARS-CoV-2 (or COVID-19) spike protein genes are transcribed into mRNA in the nucleus and translated into proteins in the cytosol of the cell.

• AstraZeneca/COVISHIELD vaccines use a modified chimpanzee adenovirus vector (ChAd).

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• Pfizer and Moderna COVID-19 vaccines use the messenger RNA (mRNA) manufacturing platform.

• mRNA (messenger ribonucleic acid) vaccines contain the genetic instructions for making the COVID-19 spike protein. This protein is found on the surface of the virus that causes COVID-19.

• When a person is given the vaccine, their cells will read the genetic instructions like a recipe and produce the spike protein.

• After the protein piece is made, the cell breaks down the instructions and gets rid of them.

• The cell then displays the protein piece on its surface. Our immune system recognizes that the protein doesn’t belong there and begins building an immune response and making antibodies.

• mRNA vaccines do not affect, interact with or alter your DNA in any way.

What are mRNA COVID-19 Vaccines?

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Vaccine Storage and Handling PrinciplesProtection of COVID-19 vaccine potency and stability is important

• Vaccines not kept in proper conditions may become ineffective

• The public trusts that the vaccine they receive will be effective

• COVID-19 vaccines are sensitive products and variances from the recommended handling may cause wastage due to:

o Cold chain excursions

o Rough handling causing vaccine to be jostled

o Use of vaccine beyond time limits / expiry

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Every immunizer must:

• Understand cold chain excursions and the implications of them• Identify the key staff members at the clinic responsible for vaccine

management• Understand the specific vaccine storage and handling

recommendations for each product• Understand how to monitor and interpret min/max thermometer

readings• Understand the actions required when a cold chain excursion is

identified (quarantine product and notify clinic lead)

Review AHS Vaccine Storage and Handling webpage (see next slide)

Vaccine Storage and Handling Principles

https://www.albertahealthservices.ca/info/Page14001.aspx

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Vaccine Storage and Handling Principles

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AstraZeneca/COVISHIELD Vaccine Efficacy

Vaccine Efficacy:

• 82% in preventing symptomatic COVID-19 disease beginning 2 weeks after the second dose with spacing interval of 12 weeks between dose 1 and 2.

• Clinical trials have shown that delaying the second dose to greater than 12 weeks resulted in a better efficacy against symptomatic disease compared to shorter intervals between doses.

PresenterPresentation NotesData from clinical trials show a good vaccine efficacy against symptomatic COVID-19 disease after the first dose of the AstraZeneca vaccine. See National Advisory Committee on Immunization - Recommendations on the use of COVID-19 Vaccine(s) for efficacy information.

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AstraZeneca/COVISHIELD COVID-19 VaccineDosage/Route 0.5 mL / IM

Packaging Multi-dose: 5 mL vial (10 doses)

Diluent No

Eligibility This vaccine is being offered in a phased approach, please follow operational guidelines to assess eligibility

Indication Albertans 18 years of age and older* Refer to vaccine biological page for more details

Ingredients• Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2

Spike (S) glycoprotein• No adjuvants or preservatives

Schedule

2 doses (refer to biological page for more details)• 8-12 weeks (56-84 days) apart • While an interval of 8 to 12 weeks between dose 1 and 2 is recommended in order to provide

maximum benefit, the second dose may be given as early as 4 weeks after the first dose.• * The interval between dose 1 and dose 2 could be extended up to 4 months (16 weeks/112

days) for all populations with some exceptions* (refer to vaccine biological page)• Minimum interval: 28 days

AstraZeneca/COVISHIELD Vaccine Summary

PresenterPresentation Notes*Persons 18 years of age and olderAstraZeneca/COVISHIELD may be considered for individuals 18 years of age and older for whom mRNA vaccines are contraindicated (e.g., anaphylaxis to PEG), individuals who decline mRNA COVID-19 vaccine, or as a second dose for individuals who have received AstraZeneca/COVISHIELD to complete a two dose series.

Second dose for individuals who have been immunized with AstraZeneca/COVISHIELD vaccine :For individuals with a contraindication or declination of mRNA COVID-19 vaccine, second dose of AstraZeneca/COVISHIELD vaccine will be given as per schedule indicated above. For other individuals, the series can be completed with either an AstraZeneca or mRNA (Pfizer/Moderna) vaccine based on the individual’s choice. See https://www.alberta.ca/covid19-vaccine.aspx information on second doses to help individuals make the choice. Regardless of the choice of vaccine product, it is recommended to wait for a least 8 weeks after the first dose to receive the second dose in order to get maximum benefit. Data from clinical trials show a good vaccine efficacy against symptomatic COVID-19 disease after the first dose of the AstraZeneca vaccine. (See National Advisory Committee on Immunization - Recommendations on the use of COVID-19 Vaccine(s) for efficacy information). Interval exceptions will be discussed later in the presentation.

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AstraZeneca/COVISHIELDVaccine Storage

AstraZeneca/COVISHIELDVaccine Storage temperatures and time limits

Pre-puncture storage: Vaccine refrigerator +2°C to +8°C until expiration date

Post-puncture storage:+2°C to +8°C for 48 hours

OR+8°C to +30°C for 6 hours

Post-punctureusage limit:

Vial must be discarded 48 hours after 1st withdrawn doseNOTE: Can be re-refrigerated but cumulative storage time at room temperature must not exceed 6 hours & total cumulative storage time must not exceed 48 hours

Check puncture date/time and storage time limits prior to administrationDO NOT FREEZE

PROTECT FROM LIGHT

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AstraZeneca/COVISHIELD Vaccine Reactions

Common Uncommon Rare

• Pain, tenderness, redness, bruising, warmth, itching, swelling and induration at injection site

• Chills, fever• Fatigue, malaise• Headache, myalgia, arthralgia• Nausea, vomiting and diarrhea

• Hyperhydrosis• Decreased appetite• Lymphadenopathy• Pruritus (itching)• Rash• Dizziness• Somnolence

• Anaphylaxis• Vaccine-Induced

Thrombotic Immune Thrombocytopenia (VITT)*

As with any immunization, unexpected or unusual side effects can occur. Refer to product monograph for more detailed information.

PresenterPresentation Notes*VITT will be talked about in the next slides.

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• A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely in Europe & Canada following immunization with AstraZeneca/COVISHIELD COVID-19 vaccine. o This adverse event is being referred to as Vaccine-Induced

Immune Thrombotic Thrombocytopenia (VITT).o This entity is associated with the development of antibodies that

"activate" platelets, which stimulate the formation of clots and result in thrombocytopenia.

o The exact mechanism by which the AstraZeneca/COVISHIELD vaccine triggers VITT is still under investigation. At this time, no other risk factors have consistently been identified in clients who develop VITT.

Viral Vector COVID-19 Vaccine Rare Events

PresenterPresentation NotesSee AZ Biological pages for further details.

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• Cases have been reported in women and men in all age groups.

• Published estimates of the risk of VITT from countries with moderate to high data quality range from 1 case per 26,500 to 1 case per 127,300 first doses of vaccine administered. The risk of VITT in Canada as of May 8, 2021 has been estimated to be approximately 1 per 55,000 first doses. The rate is evolving as cases continue to be reported and investigated and varies between countries. The rate of VITT after a second dose is not clear yet; data from the United Kingdom currently suggests it is much rarer than after first doses –roughly 1 case per 600,000 doses were reported after 9 million second doses given.

• Prior to receiving the AstraZeneca/COVISHIELD vaccine, individuals should be informed of what is currently known about the risk of the rare but serious events characterized by thrombosis with thrombocytopenia that were reported following immunization of the vaccine. This should be part of the benefit-risk discussion to help them make an informed decision.


PresenterPresentation NotesHealth Canada has assessed the available data and after a thorough, independent assessment of the currently available scientific data, Health Canada has concluded that these very rare events may be linked to use of the vaccine. This is in line with the findings of other regulators. As a result, the Department has updated warnings in the product information to inform Canadians of the possible side effects and to provide information about the signs and symptoms and when to seek prompt medical attention following immunization.Healthcare professionals should be alert to the signs and symptoms of thromboembolism and or thrombocytopenia and be aware of VITT including how to diagnose and treat the condition.

See:Important Safety Information on AstraZeneca COVID-19 Vaccine and COVISHIELD: Risk of Thrombosis with ThrombocytopeniaVaccine-Induced Prothrombotic Immune Thrombocytopenia (VIPIT) Following AstraZeneca COVID-19 Vaccination. Health Canada provides update on safety review of AstraZeneca and COVISHIELD COVID-19 vaccines

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• Severe headache that does not go away

• Seizure• Difficulty moving part(s) of the body• New blurry vision that does not go

away

• Difficulty speaking• Shortness of breath• Chest pain• Severe abdominal pain• New severe swelling, pain or colour

change of an arm or leg

• Those immunized should be instructed to seek immediate medical attention if they develop symptoms of thromboembolism and/or thrombocytopenia between days 4 and 42 following receipt of the AstraZeneca/COVISHIELD vaccine such as:


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Pfizer mRNA Vaccine Efficacy & Effectiveness Vaccine Efficacy:• Data from clinical trials show a high vaccine efficacy after the initial

dose of the Pfizer vaccine. Estimated efficacy 92.3% against symptomatic COVID-19 disease 14 days after the first dose and before dose two.

Vaccine Effectiveness: • Evidence from England, Quebec and BC shows 70 to 80% protection

from infection for up to two months with no significant waning. It is important to note that vaccine effectiveness in a general population setting is typically lower than efficacy seen in a controlled setting of a clinical trial.

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Pfizer mRNA COVID-19Vaccine Summary

Pfizer COVID-19 Ultra FrozenDosage/Route 0.3 mL / IM

Packaging Multi-dose: 2 mL vial (6 doses)

Diluent Yes


Indication Albertans 12 years of age and older (those born in 2009 or earlier)

Ingredients• mRNA (new technology) – nucleoside-modified mRNA (modRNA) platform• formulated in lipid nanoparticles (LNPs)• no adjuvants or preservatives

Schedule

2 doses• 21 to 28 days apart • * The interval between dose 1 and dose 2 could be extended up to 4 months (16 weeks/112 days)

for all populations with some exceptions* (refer to vaccine biological page)• Minimum interval: 19 days

PresenterPresentation NotesNote: • mRNA COVID-19 vaccine is preferentially recommended for eligible individuals who are at highest risk of severe illness and death and highest risk of exposure to COVID-19. Licensure updated to include individuals 12 years of age and older (born in 2009 or earlier)

*Exceptions reviewed later on in PP

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Pfizer mRNA COVID-19 Vaccine Reactions

Common Uncommon Rare

• Pain, redness or swelling at injection site

• Chills, fever• Fatigue• Headache, myalgia, arthralgia• Nausea• Vomiting• Diarrhea

• Lymphadenopathy• Feeling unwell

• Allergic reactions• Anaphylaxis


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Pfizer mRNA COVID-19 Vaccine Storage

Pfizer COVID-19 Ultra Frozen Storage temperatures and time limits

Primary storage: ULTRA Freezer -80°C to -60°C for 6 months

Lab grade freezer -25°C to -15°C for up to 2 weeks

Storage:Thawed, Undiluted

+2°C to +8°C for up to 31 daysAND/OR

up to +25°C for 2 hours

Diluent Yes

Usage limit:Thawed, diluted with 0.9% sodium chloride USP diluent

+2°C to +25°C for up to 6 hours

DO NOT SHAKEDO NOT REFREEZE

PROTECT FROM LIGHTAfter dilution, the vaccine vials can be handled in room light conditions.

PresenterPresentation NotesIf an ultra-low temperature freezer is not available, the thermal container in which the vaccine arrives may be used as temporary storage up to 30 days when consistently refilled to the top of the container with dry ice.

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Pfizer mRNA Vaccine – Management• All multi-dose vials to be removed from ULTRA freezer to be stored in lab grade

freezer (-25°C to -15°C) must be marked with the date and time of removal from the ULTRA freezer.

• All multi-dose vials to be thawed in the fridge must be marked with the date and time of removal from freezer (ULTRA freezer or lab grade freezer).o Pfizer COVID-19 vaccine must be used within 31 days of removal from

freezer.• All multi-dose vials must be marked with the date and time of dilution.

o Pfizer COVID-19 vaccine must be used within 6 hours of dilution. • Check expiry date, dilution date and time prior to administration.• Communicate use of near expiry vials to other staff members, so the vaccine can

be used before it expires, this becomes more important at the end of a clinic.• Vaccine should be withdrawn from the vial by the immunizer administering the

vaccine when vaccine preparation stations are not being used.

PresenterPresentation NotesTwo Notes:

NOTE: High-Volume Clinics may have Vaccine Preparation Stations so please follow direction from the Operational Site Leads.

NOTE: There may be special circumstances where dose of vaccine could be drawn up and transported in a syringe. This temporary measure has been approved in special circumstances only and should not be routine practice. Please check with your Immunization Site Lead for further instructions/details.

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• The Pfizer COVID-19 Vaccine multiple dose vial contains a frozen suspension of 0.45mL that does not contain preservative and primarily stored in an ULTRA freezer (-80°C to -60°C). The frozen vial will need to be thawed before dilution.

• Vaccine can be thawed in 2 ways: o From the freezer to room temperature (up to +25°C)

• thaw for 30 minutes from frozen state. o From the freezer to a vaccine refrigerator at +2°C to +8°C

• thaw for 3 hours in the refrigerator from frozen state.• allow the vial to come to room temperature before dilution

Note: Sodium Chloride diluent will be supplied in a 10 mL vial. This vial is SINGLE USE only and must be discarded after diluting ONE vial of COVID-19 vaccine. It cannot be used to dilute multiple vials of vaccine.

Pfizer mRNA Vaccine – Preparation

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Pfizer mRNA Vaccine – Preparation See Preparation of Pfizer-BioNTech COVID-19 Vaccine

PresenterPresentation NotesIn general “tapping” the syringe should be minimized to avoid potentially damaging the vaccine or diminishing the quality of the vaccine.

https://www.albertahealthservices.ca/assets/info/hp/cdc/if-hp-cdc-ipsm-covid-19-prep-pfizer-biontech-covid-vaccine.pdf

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Remember to • Inspect the vial to confirm

there are no particulates and no discoloration is observed.

• Inspect syringe prior to dilution.

• Record date and time of dilution on label.

• Store diluted vaccine between +2˚C to +25˚C for up to 6 hours.

• Low Dead Space Syringes Patient Safety Memo

Pfizer mRNA Vaccine – Preparation

PresenterPresentation NotesAdminister immediately – exception applies for the transport of pre-filled syringes and when vaccine preparation stations are in use.Refer to practice memo re: correct use of low dead space syringesSeveral incidents of cracked syringes have been noted in many Zones. Please check with your site lead on how to report defective syringes.

https://insite.albertahealthservices.ca/main/assets/tls/ep/tls-ep-patient-safety-memo-low-dead-space-syringes.pdf

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Temporary Processes for Preparing COVID-19 Vaccine Doses in Advance for Administration by another Healthcare Professional

• For high-volume settings only

• For general practice questions related to vaccine preparation stations, please contact the Site Lead at the clinic

PresenterPresentation Notes22 March 2021 CDCIMM will NOT be answering questions related to the vaccine prep stations, they are to be re-directed as per the slide above

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Moderna mRNA Vaccine Efficacy & Effectiveness

Vaccine Efficacy:• Estimated efficacy 95.2% against symptomatic COVID-19 disease 14

days after the first dose and before dose 2.

Vaccine Effectiveness: • Evidence from England, Quebec and BC shows 70 to 80% protection

from infection for up to two months with no significant waning. It is important to note that vaccine effectiveness in a general population setting is typically lower than efficacy seen in a controlled setting of a clinical trial.

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Moderna mRNA COVID-19 Vaccine Summary

Moderna COVID-19 FrozenDosage/Route 0.5 mL / IM

Packaging Multi-dose: Canadian packaging - 5 mL vial (10 doses)U.S. packaging – 8 mL vial (14 doses)

Diluent No


Indication Albertans 18 years of age and older (those born 2003 or earlier)

Ingredients• mRNA (new technology) – nucleoside-modified mRNA (modRNA) platform• formulated in lipid nanoparticles (LNPs)• no adjuvants, preservatives and antibiotics

Schedule

2 doses• 21 to 28 days apart • * The interval between dose 1 and dose 2 could be extended up to 4 months (16

weeks/112 days) for all populations with some exceptions* (refer to vaccine biological page)

• Minimum interval: 21 days

PresenterPresentation NotesNote: • mRNA COVID-19 vaccine is preferentially recommended for eligible individuals who are at highest risk of severe illness and death and highest risk of exposure to COVID-19.

*will cover exceptions later on in PP

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Common Rare

• Pain, redness or swelling at injection site• Chills, fever• Fatigue• Headache, myalgia, arthralgia• Nausea, vomiting• Lymphadenopathy

• Facial swelling• Anaphylaxis


Moderna mRNA COVID-19 Vaccine Reactions

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Moderna mRNA Vaccine Storage temperatures and time limits

Primary storage: Freezer -25°C to -15°C until expiration date

Storage:Thawed, Unpunctured

+2°C to +8°C for 30 daysOR

+8°C to +25°C for 24 hours

Usage Limit: Thawed, Punctured +2°C to +25°C for 24 hours

DO NOT REFREEZE OR STORE ON DRY ICE OR BELOW -40°CDO NOT SHAKE

PROTECT FROM LIGHT

Moderna mRNA COVID-19 Vaccine Storage

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• All multi-dose vials to be thawed in the fridge must be marked with the date and time of removal from freezer.

– Moderna COVID-19 vaccine must be used within 30 days of removal from freezer and stored in fridge at +2°C to +8°C

• All multi-dose vials must be marked with the date and time when thawed and stored at room temperature.

– Moderna COVID-19 vaccine must be used within 24 hours if stored at room temperature

• All multi-dose vials must be marked with the date and time when punctured.

– Moderna COVID-19 vaccine must be used within 24 hours if first dose is withdrawn

• Communicate use of near expiry vials to other staff members, so the vaccine can be used before it expires, this becomes more important at the end of a clinic.

• Vaccine should be withdrawn from the vial by the immunizer administering the vaccine.

Moderna mRNA Vaccine Management

PresenterPresentation NotesTwo Notes:

NOTE: High-Volume Clinics may have Vaccine Preparation Stations so please follow direction from the Operational Site Leads.

NOTE: There may be special circumstances where dose of vaccine could be drawn up and transported in a syringe. This temporary measure has been approved in special circumstances only and should not be routine practice. Please check with your Immunization Site Lead for further instructions/details.

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Moderna mRNA Vaccine – Preparation• The Moderna COVID-19 Vaccine is primarily stored in a freezer

(-25°C to -15°C) and vaccine must be thawed prior to administration.

• Vaccine can be thawed in 2 ways:o From the freezer to room temperature (+15°C to +25°C)

• thaw for 1 hour from frozen state.

o From the freezer to a vaccine fridge at +2°C to +8°C• thaw for 2 hours and 30 minutes from frozen state. • let the vial stand at room temperature for 15 minutes

before administering.

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• No dilution is required.

• The Moderna COVID-19 Vaccine multiple dose vial contains a frozen suspension that does not contain preservative and must be thawed prior to administration. Strict adherence to aseptic techniques must be followed.

o thaw as indicated in the Storage section on biological page

• Swirl vial gently after thawing and swirl gently between each withdrawal.

• Do Not Shake

Moderna mRNA Vaccine – Preparation

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mRNA COVID-19 Vaccine Transport• First choice is to transport vaccine in an ultra frozen (Pfizer only) or frozen state• In extenuating circumstances only, can be transported in a thawing/thawed state at +2°C to

+8°C in appropriate validated containerso Undiluted vials can be transported a maximum of three separate occasions in a

thawing/thawed state; e.g., vaccine depot to public health office(1), public health office to outreach site(2), and outreach site to public health office(3)

o The total transportation time for the maximum allowance of three separate shipments should be no longer than 10 hours

o The transported vaccine must be labelled “transported thawing/thawed” and the total time in transportation must be tracked.

• Temperature must be maintained and recorded during transport• Full cartons or individual vials can be transported and care should be taken to minimize extra

movement in the thawed stateo Prevent contact with ice packs in packing containerso Prevent movement in packing containers; keep vials upright in packing containerso Packing containers should be secured in a vehicle so vaccine does not move around

PresenterPresentation NotesRefer to COVID-19 Immunization: Prefilled Syringes Policy for transport of prefilled syringesRefer to Vaccine Storage & Handling documents for additional details.

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mRNA COVID-19 Vaccine Transport • Pfizer vaccine: time in transit in the thawing/thawed state should be

considered part of the 31 days allowed for storage at +2°C to +8°C o Pfizer diluent: should be transported at room temperature; ensure diluent

does not freeze• Moderna vaccine: time in transit in the thawed state should be considered

part of the 30 days allowed for storage at +2°C to +8°C • Do not refreeze thawed product• Do not transport vaccine at room temperature• Do not transport vials that have been diluted/reconstituted or punctured• Record transportation locations, dates and times, including the duration of

time in transit


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Viral Vector COVID-19 Vaccine Transport

• Vaccine cold chain maintained at +2°C to +8°C during transportation

• Temperature must be maintained and recorded during transport

• Vaccine may be transported post-puncture with infection control considerations including: hand hygiene, cleaning vial with alcohol wipe pre-puncture and post puncture before returning to vaccine bags.


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COVID-19 Vaccine – ContraindicationsCOVID-19 vaccine should not be administered to individuals who:

• Have had an anaphylactic reaction to a previous dose of same COVID-19 vaccine

• Pfizer vaccine: less than 11 years of age and born 2010 or later

• Moderna vaccine: less than 17 years of age and born 2004 or later

• AstraZeneca/COVISHIELD vaccine:

o Less than 18 years of age

o Experienced previously major venous and/or arterial thrombosis with thrombocytopenia following immunization with AstraZeneca/COVISHIELD COVID-19 vaccine

PresenterPresentation NotesEligibility will be rolled out in cohorts by year of birth, therefore persons may receive the vaccine if born in an eligible year.

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COVID-19 Vaccine – Contraindications• Have a known type 1 hypersensitivity to any component of the vaccine:

o For Pfizer and Moderna vaccines: One non-medicinal ingredient in the vaccine known to cause type 1 hypersensitivity reactions is polyethylene glycol (PEG). This potential allergen may be found in bowel preparation products for colonoscopy, skin care products, dermal fillers, cosmetics, contact lens solutions, products such as ultrasound gel, laxatives, cough syrup, and some food and drinks.

o For Moderna vaccine: Tromethamine (trometamol or Tris) –component found in contrast media, oral and parenteral medications.

o For AstraZeneca/COVISHIELD vaccine: One non-medicinal ingredient in the vaccine that has the potential to cause type 1 hypersensitivity reactions is polysorbate 80. Polysorbate 80 may be found in medical preparations (e.g., vitamin oils, tablets, anticancer agents) and cosmetics.

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• 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.

• Prior to receiving the AstraZeneca/COVISHIELD vaccine, individuals should be informed of what is currently known about the risk of the rare but serious events characterized by thrombosis with thrombocytopenia that were reported following immunization of the vaccine. This should be part of the benefit-risk discussion to help them make an informed decision.

• NOTE – mRNA vaccines: Individuals who have had a serious allergic reaction to another vaccine, drug or food should talk to their health care provider before receiving the vaccine.

COVID-19 Vaccine – Precautions

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COVID-19 Vaccine – Other Considerations• Individuals with a history of lab confirmed COVID-19 infection who

have no contraindications can be immunized with COVID-19 vaccine.

• Individuals presenting for immunization do not need to be tested for previous COVID-19 infection.

• Immunization of individuals who may be currently infected with COVID-19 is not known to have a detrimental effect on the illness.

o However, individuals with COVID-19-like symptoms should not go to an immunization venue in order to minimize the risk of COVID-19 transmission and their immunization should be deferred.

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COVID-19 Vaccine – Other Considerations

• Timing of administration and potential interference between COVID-19 vaccine and monoclonal products are currently unknown. Medical consultation with primary care physician is advised.

• Timing of administration and potential interference between COVID-19 vaccine and convalescent plasma as part of COVID-19 treatment are currently unknown and the primary health care provider or medical specialist should be consulted on a case-by-case basis.

• COVID-19 vaccines may be given at any time before or after an immunoglobulin preparation (including RhIg) or blood product has been administered. There is no recommended minimum interval between these products and COVID-19 vaccine.

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Pregnancy• The safety and efficacy of authorized COVID-19 vaccine in pregnant

women has not yet been established in the clinical trials, however preliminary data on mRNA vaccines administered in pregnancy is now available from post marketing surveillance with no safety signals detected.

• mRNA COVID-19 vaccine can be offered to individuals in the eligible group who are pregnanto It is recommended that individuals consult with their primary health

care provider or obstetrician for any vaccine related questions or concerns.

o However, consultation with a primary health care provider or obstetrician is not required to receive COVID-19 vaccine.

o Ensure appropriate documentation.

PresenterPresentation NotesAdditional resource: Society of Obstetricians and Gynecologists of Canada Statement on COVID-19 Immunization in Pregnancy.

COVID-19 vaccine can be offered to individuals in the eligible group who are pregnant as they are more at risk for severe illness from COVID-19 compared with non-pregnant individuals. Response for immunizers if individual has not consulted with their primary health care provider: “Vaccine studies are not complete on the use of this vaccine in pregnant women. Early information has not identified any safety issues. If you have questions about the immunization, we recommend you speak to your physician but it is not required to receive the vaccine.”

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Pregnancy• AstraZeneca/COVISHIELD COVID-19 vaccine may be offered to pregnant

women if a risk assessment with their primary health care provider or obstetrician determines that the benefits outweigh the potential risks for the woman and fetuso However, the individual may also be immunized without consulting their

primary health care provider or obstetrician following their acknowledgment of the absence of evidence on the use of a viral vector COVID-19 vaccine in this population.

o There is a preference for mRNA vaccine use in pregnancy due to published safety data and concerns about the complexities of the treatment of Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) in pregnancy should it occur after immunization.


PresenterPresentation NotesAdditional resource: Society of Obstetricians and Gynecologists of Canada Statement on COVID-19 Immunization in Pregnancy.

COVID-19 vaccine can be offered to individuals in the eligible group who are pregnant as they are more at risk for severe illness from COVID-19 compared with non-pregnant individuals. Response for immunizers if individual has not consulted with their primary health care provider: “Vaccine studies are not complete on the use of this vaccine in pregnant women. Early information has not identified any safety issues. If you have questions about the immunization, we recommend you speak to your physician but it is not required to receive the vaccine.”

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Breastfeeding• It is unknown whether COVID-19 vaccine is excreted in human milk as

breastfeeding individuals were excluded from the initial trials. A risk to the newborns/infants cannot be excluded.

• However, based on how these vaccines work, COVID-19 vaccines are not expected to be a risk to lactating individuals or their breastfed newborns/infants.

• COVID-19 vaccine can be offered to individuals in the eligible group who are breastfeedingo It is recommended that individuals consult with their primary health care

provider or medical specialist for any vaccine related questions or concerns.

o However, consultation with a primary health care provider or medical specialist is not required to receive COVID-19 vaccine.


PresenterPresentation NotesBreastfeeding individuals can be immunized following routine informed consent discussion.Response for immunizers if individual has not consulted with their primary health care provider: “Vaccine studies are not complete on the use of this vaccine in breastfeeding women. Early information has not identified any safety issues. If you have questions about the immunization, we recommend you speak to your physician but it is not required to receive the vaccine.”

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• At this time, there is limited data on the use of COVID-19 vaccine in immunocompromised individuals and those with auto-immune disorders.– Participants in the COVID-19 vaccine clinical trials only included individuals who were not

immunosuppressed, such as those with stable infection with human immunodeficiency virus (HIV), and those not receiving immunosuppressive therapy during the trial.

– Participants with autoimmune conditions who were not immunosuppressed were not excluded from trials, however, they constitute a very small proportion of trial participants and represent a very narrow range of autoimmune conditions.

• For those that have received Pfizer or Moderna vaccine, emerging data in these individuals has not detected any safety signals

• Evidence of a diminished immune response is emerging in individuals who are immunocompromised and those with auto-immune disorders who are receiving immunosuppressive therapy. The type of immunosuppressive therapy or condition affected the immune response to COVID-19 vaccines. Given the limited number of participants and the lack of an immunological correlate of protection against SARS-CoV-2 infection, there are limitations in interpreting the significance of these results.

Immunocompromised & Auto-Immune Disorders

PresenterPresentation NotesAdditional resources:COVID-19 Scientific Advisory Group Rapid Evidence Report.

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• COVID-19 vaccine may be offered to eligible individuals in this group if a risk assessment with their primary health care provider/medical specialist determines that the benefits outweigh the potential risks. Risks would include that: o Immunocompromised persons may have a diminished immune response to the vaccine o There is a theoretical concern that viral vector and mRNA COVID-19 vaccines may elicit

an inflammatory response and possibly exacerbate existing autoimmune diseases. However, current applications of mRNA technology for COVID-19 vaccines have been optimized to reduce this risk.

• However, with the exception of SOT and HSCT clients, the individual may also be immunized without consulting their primary health care provider or medical specialist following their acknowledgment of the risks mentioned above and the absence of evidence on the use of COVID-19 vaccine in these populations.o SOT and HSCT clients require consultation with primary health care provider or medical

specialist prior to immunization, including timing of when vaccine should be given.• Ensure appropriate documentation

Immunocompromised & Auto-Immune Disorders

PresenterPresentation NotesAdditional resources:COVID-19 Scientific Advisory Group Rapid Evidence Report.

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COVID-19 Vaccine Schedule ExceptionsInterval between dose 1 & 2 could be extended up to 4 months for all populations with the following exceptions:• SOT candidates and recipients• HSCT candidates and recipients while in immunosuppressed state

o Post-HSCT individuals are generally considered to be immunocompetent after 3 years as long as they are not on immunosuppressive treatment

• Individuals with malignant hematologic disorders & non-hematologic malignant solid tumors prior to receiving or receiving active treatment which includes chemotherapy, targeted therapies, and immunotherapy (does not include individuals receiving solely hormonal therapy, radiation therapy or a surgical intervention).

• Individuals on anti-CD20 monoclonal antibodies (e.g., rituximab, ocrelizumab, ofatumumab).• Individuals with chronic kidney disease on peritoneal dialysis or hemodialysis.Immunization for the above groups should occur when the individuals are most likely to mount immune responses. Physician consultation is recommended regarding optimal spacing recommendations based on client’s treatment and the recommended interval between doses as per vaccine biological page.

PresenterPresentation NotesThese individuals are eligible to receive their second dose with the recommended interval after dose 1:Pfizer or Moderna vaccine: these individuals are eligible to receive 2nd dose 21-28 days after dose 1.AstraZeneca/COVISHIELD vaccine: These individuals are eligible to receive their 2nd dose 8 to12 weeks after dose 1, however, the second dose can be offered as soon as 4 weeks after the first dose.

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Rationale: COVID-19 Vaccine Schedule Exceptions• Emerging evidence shows suboptimal/poor immune responses after one dose

in individuals with cancer or SOT.

• The exceptions are focused only on those with the most profound immune compromising conditions given the currently available evidence and the fact that increasing population level protection as quickly as possible also protects those with immune compromising conditions.

• For those who have received AstraZeneca/COVISHIELD vaccine as the first dose, second doses are recommended at 8 to 12 weeks. This is based on currently available data in order to provide maximum benefit; however, the second dose can be offered as soon as 4 weeks after the first dose.

• Physician consultation is recommended regarding the optimal spacing recommendations based on the client’s treatment.

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Interchangeability & InterruptionFor Pfizer/Moderna vaccine: • If readily available, the same mRNA COVID-19 vaccine product should be offered for the

subsequent dose in a 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 can be considered interchangeable and should be offered to complete the vaccine series.

o The previous dose should be counted, and the series need not be restarted.• No data currently exist on the interchangeability of COVID-19 mRNA vaccines. However, in

line with basic principles of vaccinology, it is expected that combining different COVID-19 vaccines that induce an immune response against the SARS-CoV-2 spike protein will lead to a robust immune response.o The spike protein encoded by either of the authorized mRNA vaccines is stabilized in the

same manner to remain in the prefusion conformation, though other vaccine components like the lipid nanoparticle and the mRNA sequence may be different.

o There is no reason to believe that mRNA vaccine series completion with a different authorized mRNA vaccine product will result in any additional safety issues or deficiency in protection.

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Interchangeability & InterruptionFor AstraZeneca/COVISHIELD vaccine:• The vaccine series can be completed with either an AstraZeneca/COVISHIELD or

mRNA (Pfizer/Moderna) vaccine based on the individual’s choice.o See Second dose for AstraZeneca recipients for information on second doses to

help individuals make the choice.

Currently, no data on a maximum interval between doses or on medium or long-term efficacy of COVID-19 vaccines are available. In general, regardless of the time between doses, interruption of a vaccine series does not require restarting the series.

https://www.alberta.ca/assets/documents/health-second-dose-az-recipients-factsheet-public.pdf

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COVID-19 Vaccine & Other Vaccine Products• In the absence of evidence, COVID-19 vaccines should not be given

simultaneously with other live or inactivated vaccines due to the potential for immune interference and the need to be able to monitor for potential symptoms of COVID-19 disease and COVID-19 vaccine adverse events without potential confounding symptoms from adverse events following other vaccines.o If a COVID-19 vaccine is inadvertently administered at the same time as

another vaccine, neither dose should be repeated.• In the absence of evidence, it would be prudent to wait for a period of at least

14 days between the administration of a dose of COVID-19 vaccine and the administration of another vaccine (except in the case where another vaccine is required for post-exposure prophylaxis).

• In the absence of evidence, it would be prudent to wait for a period of at least 14 days after the administration of another vaccine before administering a dose of COVID-19 vaccine.

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There is a theoretical risk that COVID-19 vaccines may result in false-negative tuberculin skin testing (TST) or IGRA (QFT) test results.• If TST or IGRA test is required for baseline screening, it should be

administered and read before administration of any COVID-19 vaccine immunization or delayed for at least 28 days after a dose of COVID-19 vaccine.

• COVID-19 vaccines may be administered any time after all steps of TST (including read) have been completed.

• If TST is required for other reasons (e.g. contact tracing, immigrants, query LTBI), testing should not be delayed.o Re-testing (at least 28 days after a dose of COVID-19 vaccine) of

individuals with negative results for whom there is high suspicion of TB infection may be prudent in order to avoid missing cases due to potentially false-negative results.

Tuberculin Skin Testing & COVID-19 Vaccines

PresenterPresentation NotesFrom COVID-19 Bio pages:

Currently there is no data on the impact of the COVID-19 vaccines on tuberculin skin testing or IGRA (interferon gamma release assay (or sometimes referred to as QuantiFERON - QFT) test results. There is a theoretical risk that COVID-19 vaccines may temporarily affect cell-mediated immunity, resulting in false-negative tuberculin skin testing or IGRA (QFT) test results.

(FYI: QuantiFERON (QFT) is an interferon-gamma release assay (IGRA) that aids in the evaluation of tuberculosis (TB) infections (latent or active) and is recommended as an alternative to the tuberculin skin test (TST) in certain situations.)

If TST or IGRA test is required for baseline screening, it should be administered and read before administration of any COVID-19 vaccine immunization or delayed for at least 28 days after a dose of COVID-19 vaccine.

Immunization with COVID-19 vaccines may take place at any time after all steps of tuberculin skin testing (including read) have been completed.

If tuberculin skin testing is required for other reasons (e.g., contact tracing, immigrants, query LTBI), testing should not be delayed, as these are theoretical considerations. However, re-testing (at least 28 days a dose of COVID-19 vaccine) of individuals with negative results for whom there is high suspicion of TB infection may be prudent in order to avoid missing cases due to potentially false-negative results.

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Fit to Immunize AssessmentThe immunizer will:• Assess the need for immunization.• Confirm the client has not received a dose of

COVID-19 vaccine previously, or if they have, determine which vaccine was given.

• If client is presenting for second dose ensure proper vaccine product is used and meets recommended spacing between doses.

• Complete a “Fit To Immunize” assessment for COVID-19 vaccine:– health status today– history of allergies – previous reactions (check if previously

reported adverse event)– chronic health condition/medications– autoimmune condition/immunocompromised– pregnancy/breastfeeding

PresenterPresentation NotesRefer to Fit To Immunize Assessment for COVID-19 Vaccine

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Informed Consent• Clients must give informed consent before immunization• Prior to immunizing the immunizer must:

o Determine that the client is eligible (based on current phase and/or eligibility requirements)

o Review the disease being preventedo Review vaccineo Discuss:

• risks and benefits of getting the vaccine and not getting the vaccine

• side effects and after care • how the vaccine is given

o Provide the opportunity to ask questionso Affirm verbal consent

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7 Rights of Immunization, ensure that you have:

Right product (vaccine and diluent)

Right client

Right dose

Right time (date/time, interval between doses, usage expiry of vial)

Right route, needle length, site/land marking and technique

Right reason (meets eligibility criteria)

Right documentation (including reason code)

COVID-19 Vaccine Administration

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• Expose and position the client’s limb for injection. • Cleanse the injection site with a single-use antiseptic swab.• Allow the site to dry.• Secure the injection site using the appropriate stabilization technique.• Insert the needle at a 90º angle.• Administer the vaccine with controlled pressure.• Activate the safety engineered device.• Discard the needle and syringe, and empty vaccine vials into an

appropriate sharps container.• Use a cotton ball and apply pressure to the injection site.• Reinforce the 15 min wait period with the client or parent/guardian.

COVID-19 Vaccine Administration

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Intramuscular Injections

Recommended Immunization Site:

• Mid portion of deltoid

• 1 mL or 3 mL syringe

• 25G - 1” to 1½” needle depending on muscle mass and adipose tissue

• Insert at 90 degree angle

PresenterPresentation NotesReference the dark circle drawn mid deltoid as the correct location for administration for a single injection into the deltoid

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Limb Integrity

• Do not administer an immunizing agent in a limb that is likely to be affected by a lymphatic system problem.

• Individuals who present with A-V fistula (vascular shunt for hemodialysis) and those who have had mastectomies with lymph node curettage, lymphedema, axilla lymphadenectomies, limb paralysis and upper limb amputations may have short term or long term circulatory (e.g., lymphatic systems) implications that may impair vaccine absorption and antibody production.

• Vastus lateralis is an alternative site.

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Intramuscular Injections

Alternate site when deltoidis not suitable

• Vastus lateralis – middle third of anterior thigh and slightly lateral to the midline.

• 1 mL or 3 mL syringe

• 25G 1” to 1½” needle depending on muscle mass and adipose tissue.

• Insert at 90 degree angle.

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Infection Prevention & Control (IPC)• Infection Prevention and Control is dedicated to preventing infections

acquired within healthcare facilities. IPC’s mandate is to reduce the incidence of healthcare associated infections in patients, residents, and clients by:o process and outcome surveillanceo outbreak identification and managemento consultation and educationo guideline, policy, and procedure developmento research

• For more information go to the AHS Infection Prevention & Controlo Personal Protective Equipment – Infection Prevention & Controlo Hand Hygiene – Infection Prevention & Control

PresenterPresentation NotesMake sure to follow the IPC measures at your site and if you want more info about IPC in general, please go to the links on the slide.

https://www.albertahealthservices.ca/info/page6410.aspxhttps://www.albertahealthservices.ca/info/Page6422.aspxhttps://www.albertahealthservices.ca/info/Page6426.aspx

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Commitment to Comfort

Needle Fears• Up to 25% of adults have needle fears• Up to 10% of those are significant enough to

avoid immunizations – This translates to 350,000 Albertans

Solution: The AHS Commitment to Comfort (CTC) • There is strong evidence that these principles improve

immunization experience, health outcomes, satisfaction, and repeat attendance to healthcare encounters

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Make a Comfort Plan • Establish client preference and offer choice

Use Positive Language• Always say: “you did well”, and leave them

with a positive memory “by doing this today, you are saving lives”

• Avoid: pain descriptors; focus on what the client can do – to make the immunization feel better (see shift attention)

Use Comfort Positions• When safe, sit client in an upright comfortable

position• Brief muscle tense and release or lie down if

client feels faint

Shift Attention • Shift client attention to a more pleasant

activity or thought (e.g., smartphone game, music, small talk)

Use Numbing Cream • Needs to be obtained and applied by the

person being immunized prior to their appointment

• Numbing cream will not be offered at the immunization sites

• Client needs to talk with a pharmacist to select and obtain a product that is right for them

Commitment to Comfort – 5 Core Principles

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AnaphylaxisAll clients are encouraged to wait for 15 minutes after immunization.• For clients with any known anaphylactic allergies, extend this

recommended wait period to 30 minutes.• Have clients remain within the clinic area and return immediately for

assessment if they feel unwell.o Alberta Health Services employees need to ensure they have

completed the AHS Anaphylaxis Management >> Learning Moduleo Covenant Health employees need to ensure they have completed

Covenant Health Anaphylaxis Learning Module found on CLiC.o Community providers should follow the anaphylaxis policies within

their facilities.

https://insite.albertahealthservices.ca/hpsp/Page21541.aspxhttps://ahamms01.https.internapcdn.net/ahamms01/Content/InSite_Videos/HPSP/modules/tms-hpsp-anaphylaxis/index.html

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COVID-19 Vaccine RecordingInformation required to be recorded on all clients includes:• Client demographic information

o full name, personal health number, date of birth, gender, address including postal code

• Reason code for immunization• Dose number• Vaccine name & lot number• Dosage administered• Site of injection• Route of administration• Date of immunization• Immunizer’s first initial and last name, designation & signature

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COVID-19 Vaccine Recording• All Zone Public Health will be doing direct data entry into the Meditech

system where possible. When Meditech is unavailable, a downtime work sheet will be available for documentation and should be entered into Meditech as soon as possible.

• The COVID-19 Client Immunization Record and Care After Immunization document is available for immunizers to provide to clients after immunization.

• Community Providers may use the COVID-19 Immunization Record or their own client record.

• Please follow your zone/site process for client specific reporting of administration of COVID-19 vaccine to Alberta Health.

https://www.albertahealthservices.ca/frm-21763.pdfhttps://www.albertahealthservices.ca/frm-21221.pdf

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Return Visit – Second Dose • If a 2nd dose of COVID-19 vaccine is indicated, note the date to return on the

client’s COVID-19 Immunization Record and provide the form to the client. o Check site process regarding how to book for 2nd dose.

• Refer to current COVID-19 vaccine biological pages for spacing recommendations.

• Second dose for individuals who have been immunized with Pfizer/Moderna vaccine :o If readily available, the same mRNA COVID-19 vaccine product should be

offered for the subsequent dose in a vaccine series 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 can be considered interchangeable and should be offered to complete the vaccine series.

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Return Visit – Second Dose • Second dose for individuals who have been immunized with

AstraZeneca/COVISHIELD vaccine :o For individuals with a contraindication or declination of mRNA

COVID-19 vaccine, second dose of AstraZeneca/COVISHIELD vaccine will be given as per schedule.

o For other individuals, the series can be completed with either an AstraZeneca/COVISHIELD or mRNA (Pfizer/Moderna) vaccine based on the individual’s choice. See Second dose for AstraZeneca recipients information on second doses to help individuals make the choice. Regardless of the choice of vaccine product, it is recommended to wait for a least 8 weeks after the first dose to receive the second dose in order to get maximum benefit, however it may be given as early as 4 weeks after the first dose.

https://www.alberta.ca/assets/documents/health-second-dose-az-recipients-factsheet-public.pdf

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Reason CodesWhen completing documentation include the immunization “reason code”:

Start at the top of the priority list

Choose the first code that applies

e.g. If the client is a resident of a LTC facility and is 80+ years old, choose code #22 “LTC/DSL Residents” because it is higher on the list.

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• To be provided to every client receiving vaccine.

• Outlines expected side effects and aftercare for same.

• Will also serve as client’s record of immunization.

Care After Immunization

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• Individuals who only experience a local reaction at site of injection do not need to stay home or isolate.

• If individuals experience side effects that:o are the same as COVID-19 symptoms, they must stay home and away

from others (isolate) even if they think the symptoms are from the vaccine.

o start within 24 hours and go away within 48 hours, isolation is not required and return to normal activities can occur. However, if isolation has been advised for other reasons, then isolation must continue.

o start after 24 hours or last longer than 48 hours, individuals must maintain isolation. They are to contact Health Link (811) or complete the COVID-19 Self-Assessment for Albertans (ahs.ca/testing) to make an appointment for the COVID-19 test. If testing for COVID-19 does not occur, isolation must continue for 10 days from the start of the symptoms or until symptoms resolve, whichever is longer.

Care After Immunization

https://www.albertahealthservices.ca/topics/Page17058.aspx

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Adverse Events Following Immunization Reporting• An adverse event following immunization (AEFI) is defined as a

serious or unexpected event temporally associated with immunization.

• Alberta Health developed an Active Surveillance and Reporting of AEFI Policy for COVID-19 vaccine, found in the IPSM and on the Alberta Health website. The policy includes a list of reportable AEFI and Adverse Events of Special Interest (AESI). AESI are additional reportable events specific to COVID-19 vaccine.

• Severe reactions, i.e., anaphylaxis, death and other high-profile / serious events (VITT), should be reported within 24 hours and all other reactions within 3 days to the AEFI Team.

• “Reportable AEFIs” are reported to Alberta Health, and in turn to the National Surveillance Program.

https://open.alberta.ca/publications/covid-19-vaccine-aefi

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• AHS Public Health - AEFI reporting will continue to follow the procedure outlined in the AEFI Standard in the Immunization Program Standards Manual (IPSM).

• Non-AHS Public Health Practitioners report AEFI through the AEFI report form found at: www.ahs.ca Search “AEFI” in the search box (see next slide)

• Consult with AHS Adverse Event Following Immunization (AEFI) Team at [email protected] or 1-855-444-2324 as soon as possible for any case where there is uncertainty as to whether a symptom following immunization is related to the immunization.

Adverse Events Following Immunization Reporting

https://www.albertahealthservices.ca/assets/info/hp/cdc/if-hp-cdc-imm-std-reprtg-aefi-11-100.pdfhttps://insite.albertahealthservices.ca/cdc/Page11322.aspxhttp://www.ahs.ca/mailto:[email protected]

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Adverse Events Following Immunization Reporting

Non-Public Health Practitioners report AEFI through the AEFI report form found at: www.ahs.ca Search “AEFI” in the search box

PresenterPresentation NotesAEFI Reporting Page link:https://www.albertahealthservices.ca/info/page16187.aspx

http://www.ahs.ca/

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Active Surveillance• Some of the COVID-19 vaccines being used have been developed

using new technology.

• Due to the centralized follow up of AEFIs in the province, Health Canada has asked Alberta to participate in active surveillance to provide closer monitoring of all symptoms vaccine recipients may experience.

o This will occur via the Canadian National Vaccine Safety Network (CANVAS) and the AHS Provincial AEFI Team.

https://canvas-covid.ca/

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• Clinical immunization questions should first be directed to your site lead. You may be asked to contact [email protected]

• Process and operational questions should be directed to your Site Lead

Questions?

mailto:[email protected]

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References

1. Alberta Health, Health System Accountability and Performance Division, Alberta Vaccine Storage and Handling Policy for Provincially Funded Vaccine (2019 April).

2. Alberta Health, Health System Accountability and Performance Division, Alberta Vaccine Storage and Handling Policy for COVID-19 Vaccine (2021 June 15).

3. Alberta Health, Public Health and Compliance, COVID-19 Vaccine – AstraZeneca/COVISHIELD Vaccine. Alberta Immunization Policy (2021 June 14).

4. Alberta Health, Public Health and Compliance, COVID-19 Vaccine – mRNA Moderna frozen Vaccine. Alberta Immunization Policy (2021 June 16).

5. Alberta Health, Public Health and Compliance, COVID-19 Vaccine – mRNA Pfizer-Ultra frozen Vaccine. Alberta Immunization Policy (2021 June 16).

6. Alberta Health Services, Nursing Professional Practice (NPP), Health Professions Strategy & Practice (HPSP); Pharmacy Services (2021 June 1): Operations Guide Requirements & Considerations for Implementing COVID-19 Vaccine Preparation Stations.

7. Alberta Health Services. Population Public and Indigenous Health, Infection Prevention and Control and Workplace Health and Safety. (2018 July). Guidelines for Outbreak Prevention, Control and Management in Acute Care and Facility Living Sites.

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References

8. AstraZeneca/Verity Pharmaceuticals Inc, (Updated 2021 April 23). AstraZeneca and COVISHIELD COVID-19 vaccine, Solution for Intramuscular Injection Product Monograph. https://covid-vaccine.canada.ca/info/pdf/astrazeneca-covid-19-vaccine-pm-en.pdf

9. AstraZeneca/Verity Pharmaceuticals Inc. (2021 March 31). Important Safety Information on AstraZeneca COVID-19 Vaccine and COVISHIELD: Risk of Thrombosis with Thrombocytopenia. https://covid-vaccine.canada.ca/info/pdf/astrazeneca-covid-19-vaccine-letter.pdf

10. Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. Hamborsky J, Kroger A, Wolfe S, eds. 13th ed. Washington D.C. Public Health Foundation 2015.

11. Centers for Disease Control and Prevention. (2021 April 28) Information about COVID-19 Vaccines for People who are Pregnant or Breastfeeding. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html

12. Health Canada. (2021 April 14). Health Canada provides update on safety review of AstraZeneca and COVISHIELD COVID-19 vaccines. https://www.canada.ca/en/health-canada/news/2021/04/health-canada-provides-update-on-safety-review-of-astrazeneca-and-covishield-covid-19-vaccines.html

13. Health Canada. Health Products and Food Branch Inspectorate. (2011 April 28) Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUI-0069). http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0069-eng.php

https://covid-vaccine.canada.ca/info/pdf/astrazeneca-covid-19-vaccine-pm-en.pdfhttps://covid-vaccine.canada.ca/info/pdf/astrazeneca-covid-19-vaccine-letter.pdfhttps://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.htmlhttps://www.canada.ca/en/health-canada/news/2021/04/health-canada-provides-update-on-safety-review-of-astrazeneca-and-covishield-covid-19-vaccines.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0069-eng.php

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References

14. Health Canada. Statement. (2021 May 19). Health Canada authorizes more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine. https://www.canada.ca/en/health-canada/news/2021/05/health-canada-authorizes-more-flexible-storage-conditions-for-pfizer-biontech-covid-19-vaccine.html

15. Moderna (2021 June 9) Moderna COVID-19 Vaccine, mRNA-1273 SARS-CoV-2 vaccine, Suspension for intramuscular injection: Product Monograph. https://covid-vaccine.canada.ca/info/pdf/moderna-covid-19-vaccine-pm1.pdf

16. National Advisory Committee on Immunization. Canadian immunization guide (Evergreen Edition). Ottawa, ON: Public Health Agency of Canada. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php

17. National Advisory Committee on Immunization. (2021 March 3). NACI Rapid Response: Extended dose intervals for COVID-19 vaccines to optimize early vaccine rollut and popuplation protection in Canada. https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/rapid-response-extended-dose-intervals-covid-19-vaccines-early-rollout-population-protection.html

18. National Advisory Committee on Immunization. (2021 May 28). Recommendations on the use of COVID-19 Vaccines. https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-covid-19-vaccines.html

19. National Advisory Committee on Immunization (2021 March 29). NACI Rapid Response: Recommended use of AstraZeneca COVID-19 vaccine in younger adults. https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/rapid-response-recommended-use-astrazeneca-covid-19-vaccine-younger-adults.html

https://www.canada.ca/en/health-canada/news/2021/05/health-canada-authorizes-more-flexible-storage-conditions-for-pfizer-biontech-covid-19-vaccine.htmlhttps://covid-vaccine.canada.ca/info/pdf/moderna-covid-19-vaccine-pm1.pdfhttp://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.phphttps://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/rapid-response-extended-dose-intervals-covid-19-vaccines-early-rollout-population-protection.htmlhttps://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-covid-19-vaccines.htmlhttps://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/rapid-response-recommended-use-astrazeneca-covid-19-vaccine-younger-adults.html

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2020-2021 COVID-19 Immunization OrientationObjectiveIntroductionWhat is COVID-19?What are COVID-19 Variant Strains?How is COVID-19 Spread?COVID-19 InfectivityCOVID-19 Signs and SymptomsHow Serious is COVID-19?Treatment of COVID-19Universal COVID-19 Immunization ProgramVaccine Efficacy & EffectivenessCOVID-19 Vaccines Available in AlbertaWhat are Viral Vector COVID-19 Vaccines?What are mRNA COVID-19 Vaccines?Vaccine Storage and Handling PrinciplesVaccine Storage and Handling PrinciplesVaccine Storage and Handling PrinciplesAstraZeneca/COVISHIELD Vaccine Efficacy AstraZeneca/COVISHIELD �Vaccine Summary AstraZeneca/COVISHIELD �Vaccine StorageAstraZeneca/COVISHIELD Vaccine ReactionsViral Vector COVID-19 Vaccine Rare EventsSlide Number 24Slide Number 25Pfizer mRNA Vaccine Efficacy & Effectiveness Pfizer mRNA COVID-19�Vaccine SummaryPfizer mRNA COVID-19 Vaccine ReactionsPfizer mRNA COVID-19 �Vaccine StoragePfizer mRNA Vaccine – ManagementPfizer mRNA Vaccine – Preparation Pfizer mRNA Vaccine – Preparation Pfizer mRNA Vaccine – Preparation Slide Number 34Moderna mRNA Vaccine Efficacy & Effectiveness �Moderna mRNA COVID-19 �Vaccine Summary �Moderna mRNA COVID-19 Vaccine Reactions �Moderna mRNA COVID-19 �Vaccine Storage Moderna mRNA Vaccine Management Moderna mRNA Vaccine – Preparation Moderna mRNA Vaccine – PreparationmRNA COVID-19 Vaccine TransportmRNA COVID-19 Vaccine Transport Viral Vector COVID-19 Vaccine Transport COVID-19 Vaccine – ContraindicationsCOVID-19 Vaccine – ContraindicationsCOVID-19 Vaccine – PrecautionsCOVID-19 Vaccine – Other ConsiderationsCOVID-19 Vaccine – Other ConsiderationsPregnancyPregnancyBreastfeeding Immunocompromised & Auto-Immune Disorders Immunocompromised & Auto-Immune DisordersCOVID-19 Vaccine Schedule ExceptionsRationale: COVID-19 Vaccine Schedule Exceptions Interchangeability & Interruption Interchangeability & InterruptionCOVID-19 Vaccine & Other Vaccine ProductsSlide Number 60Fit to Immunize AssessmentInformed Consent COVID-19 Vaccine Administration COVID-19 Vaccine AdministrationIntramuscular InjectionsLimb IntegrityIntramuscular InjectionsInfection Prevention & Control (IPC)Commitment to ComfortCommitment to Comfort – 5 Core PrinciplesAnaphylaxisCOVID-19 Vaccine RecordingCOVID-19 Vaccine Recording��Return Visit – Second Dose ��Return Visit – Second Dose ��Reason Codes�Slide Number 77Slide Number 78Adverse Events Following Immunization ReportingAdverse Events Following Immunization ReportingAdverse Events Following Immunization Reporting Active Surveillance Questions?References References References References