Clinical Resource Folder Last revised: Dec 14/2021

12 Years and Older Immunizer Action to YES Answers to Standard Assessment Questions Question Have you ever felt faint or fainted after receiving a vaccine?

Immunizer Information

Follow Up Action If yes, suggest client lay down in Post Vaccination to receive vaccine In COVax – Enter Alert – history of fainting, lay down during vaccination

Allergies/Reactions Have you ever had an immediate /severe allergic reaction or anaphylaxis to a COVID-19 vaccine? Do you have a letter from the Allergist?

Looking for reaction to 1st dose of any COVID-19 vaccine - Pfizer, Moderna or AstraZeneca

If Yes, ask the next question about Allergist letter

Allergist letter required information: ▪ Client’s name ▪ Details, severity of the previous episodes, ▪ Confirmation that counselling was given, ▪ A vaccination care plan (including what parameters the community clinic should meet to provide safe vaccination administration). ▪ If a hospital setting is recommended for safe vaccine administration, it should clearly be indicated by the Allergist.

If No letter, do not administer, give client PPH letter for HCP to refer to Allergist. In COVax – enter an Alert - deferred, severe allergic reaction If Yes, review letter. If letter has all the required information, administer, client to wait 30 minutes In COVax – change Alert status from ‘Active’ to ‘Completed’ and upload Allergist letter If not all required information is in letter, do not administer, give PPH letter to return to Allergist. In COVax – enter Alert – refer back to Allergist

Have you had an allergic reaction within 4 hours of receiving a previous dose of a COVID-19 vaccine or any of components: ▪ polyethylene glycol (PEG) • polysorbate

PEG - in bowel prep for colonoscopy, laxatives, cough syrups, cosmetics, contact lens solutions, skin care products, in some food and drinks

Do you have a letter from the Allergist?

If No letter, do not administer either mRNA vaccine, give client PPH letter for HCP to refer to Allergist. In COVax – enter Alert and deferred, severe allergic reaction

Polysorbate – emulsifier in salad dressings, whipping cream, ice cream, cosmetics paints). Potential cross-reactive hypersensitivity with PEG, should not get either mRNA vaccine

If Yes, to PEG or Polysorbate ask the next question about Allergist letter

If Yes, review letter. If letter has all the required information, administer, client to wait 30 minutes In COVax – change Alert status from ‘Active’ to ‘Completed’ and upload Allergist letter If not all required information is in letter, do not administer, give PPH letter to return to Allergist. Or the component: ▪ tromethamine (in Moderna)

Tromethamine - component in contrast media, oral and parenteral medications

In COVax – enter Alert – refer back to Allergist If Yes to Tromethamine allergy and NO to PEG and/or polysorbate allergy - administer Pfizer

Have you ever had an allergic reaction/ anaphylaxis within 4 hours of a) any vaccine or injectable medication that does not contain a component of the COVID-19 vaccines? OR b) drug, food, venom, latex?

If Yes, administer, client to wait 30 minutes in Post-Vaccination

Revised 2021 11 25 (12 Years and Older Immunizer Action to YES Answer to SAQs)

12 Years and Older Immunizer Action to YES Answers to Standard Assessment Questions Myocarditis/ Pericarditis Have you been told by a physician that you have myocarditis/ pericarditis UNRELATED to COVID-19 vaccine? Are you still being followed by your clinical team regarding your previous myocarditis/ pericarditis? Have you been told by a physician that you have myocarditis/ pericarditis after your 1st or 2nd dose of COVID19 vaccine?

Did you have chest pain, after your 1st dose of COVID-19 vaccine Did you see a doctor for this chest pain? Are you having chest pain now?

Last Vaccine Have you had a vaccine in the last 14 days?

Looking for a historical diagnosis of Myocarditis: inflammation of the heart muscle Pericarditis: inflammation of lining around the heart

If Yes, ask the next question

If yes still being followed, do not administer, refer 12-17 to clinical team for recommendations If not being followed, administer In COVax – Enter Alert and deferred ongoing follow up for myocarditis Looking for a diagnosis related to COVID-19 vaccine If Yes to diagnosis, do not Myocarditis: inflammation of the heart muscle administer, client cannot receive a 2nd Pericarditis: inflammation of lining around the heart or 3rd dose until further direction from NACI or Province. A small # of cases have been reported in Canada and In COVax – deferred, diagnosis of internationally; Mostly in adolescents and younger adults myocarditis and/or pericarditis under 30 years of age; More frequently in males; Usually Diagnosing physician is responsible to within a week of 1st dose of vaccine submit an AEFI Ask additional questions to determine seriousness of chest If Yes or No, ask the next question pains (onset, duration, intensity, pre-existing conditions) Document in Clinical Notes What was advice of treating HCP? Record in Clinical Notes If Yes or No, ask the next question If in doubt, flag for Clinic Supervisor/ Clinical Lead to review and if needed to consult with MDs in MVP

If No, administer the vaccine If Yes, do not administer vaccine, refer to health care provider In COVax – Enter Alert and deferred, ongoing chest pain Post-Vaccination staff will complete an historical AEFI

NACI has determined that a precautionary approach is no longer necessary and states that COVID-19 vaccines may be administered with, or at any time before or after nonCOVID-19 vaccines consent

Medical Conditions Are you being treated for a bleeding disorder or taking blood thinners? Do you have allergic rhinitis, asthma, or eczema? Are you immunosuppressed due to disease or treatment of autoimmune disorder? Have you discussed receiving COVID-19 vaccine with your health care provider?

If Yes, administer after obtaining informed consent by reading the script for Co-Administration of Vaccines and In COVax - document in Clinical Notes

If Yes, administer, client to apply extra pressure and/or ice if bleeding occurs If Yes, administer, client to wait 30 minutes in Post-Vaccination.

Looking for Clients with Autoimmune Disorders Rheumatoid Arthritis, Type 1 Diabetes, Pernicious Anemia, Lupus, Myasthenia Gravis, Celiac, Graves, Addison’s, Crohn’s Diseases Clients receiving chemotherapy or stem cell, CAR-T, immune checkpoint inhibitors, monoclonal antibodies (e.g., rituximab) and other targeted agents (e.g. CD4/6 or PARP inhibitors)

Revised 2021 11 25 (12 Years and Older Immunizer Action to YES Answer to SAQs)

If Yes, administer vaccine, consulting with HCP is strongly advised but not required

5 – 11 Immunizer Action to YES Answers to Standard Assessment Questions DO NOT ADMINISTER Vaccine if SAQs are NOT answered reliably by parent/ legal guardian Question Have you ever felt faint or fainted after receiving a vaccine?

Immunizer Information

Follow Up Action If yes, suggest client lay down in Post Vaccination to receive vaccine In COVax – Enter Alert – history of fainting, lay down during vaccination

Allergies/Reactions Have you ever had an immediate Looking for reaction to 1st dose of If Yes, do not administer, ask the next question about /severe allergic reaction or any COVID-19 vaccine - Pfizer, Allergist letter. anaphylaxis to a COVID-19 vaccine? Moderna or AstraZeneca Do you have a Allergist letter required information: If no letter, do not administer, give client PPH letter for HCP to refer to letter from the ▪ Client’s name Allergist. Allergist? In COVax- Enter Alert and deferred, severe allergic reaction ▪ Details & severity of previous episode(s), ▪ Confirmation that counselling was given, ▪ A vaccination care plan (including what If yes, review Allergist letter. If letter has all the required information, parameters the community clinic should administer, client to wait 30 minutes. meet to provide safe vaccination In COVax – change Alert status from ‘Active’ to ‘Completed’ and upload administration). allergist letter. ▪ If a hospital setting is recommended for safe administration, it should clearly be If not all required information in letter, do not administer. Give PPH indicated by the Allergist. letter to client to return to Allergist. In COVax – Enter Alert and Allergist letter incomplete, referred back to Allergist Have you had an allergic reaction PEG - in bowel prep for colonoscopy, laxatives, cough If yes to any of the ingredients within 4 hours of receiving a previous syrups, cosmetics, contact lens solutions, skin care (PEG, polysorbate, or tromethamine), products, in some food and drinks dose of a COVID-19 vaccine or any of ask the next question about Allergist components: letter. Polysorbate – emulsifier in salad dressings, whipping ▪ polyethylene glycol (PEG) cream, ice cream, cosmetics paints). Potential cross-reactive hypersensitivity with PEG, should not get either mRNA • polysorbate vaccine ▪ tromethamine (in Moderna and Tromethamine (Tris) - component in contrast media, oral Paediatric Pfizer Orange label) and parenteral medications Do you have a If No letter, do not administer, give client PPH letter for HCP to refer to allergist. letter from the In COVax – Enter Alert and deferred, severe allergic reaction Allergist? If Yes, review letter - if letter has all required information administer, client to wait 30 minutes In COVax – change Alert status from ‘Active” to “Complete” and upload Allergist letter If letter does not have all required information, do not administer give PPH letter to client to return to Allergist. In CoVax – Enter Alert and Allergist letter incomplete, referred back to allergist Have you ever had an allergic reaction/ anaphylaxis within 4 hours of a) any vaccine or injectable medication that does not contain a component of the COVID-19 vaccines? OR b) drug, food, venom, latex? Revised 2021 11 25 Paediatric 5 – 11 years Immunizer Action to YES Answer to SAQs

If Yes, administer, client to wait 30 minutes in Post-Vaccination

5 – 11 Immunizer Action to YES Answers to Standard Assessment Questions DO NOT ADMINISTER Vaccine if SAQs are NOT answered reliably by parent/ legal guardian MYOCARDITIS/ PERICARDTIS Have you been told by a physician that you have myocarditis or pericarditis UNRELATED to the COVID-19 vaccine?

Are you still being followed by your clinical team regarding your previous myocarditis/ pericarditis?

Looking for a historical diagnosis of Myocarditis: inflammation of the heart muscle Pericarditis: inflammation of lining around the heart

If Yes, ask the next question about follow-up

Children who have a history of myocarditis unrelated to mRNA COVOID-19 vaccine should consult with their clinical team for individual considerations and recommendations If Yes still being followed, do not administer vaccine, refer to their clinical team for recommendations In COVax – Enter an Alert and deferred, ongoing follow up for myocarditis/ pericarditis If No, administer the vaccine (Not in Ministry document, no decision if required to bring a letter of clearance from cardiology saying OK to vaccinate)

If client returns to clinic with a letter from their treating clinical team recommending vaccination, consult Clinical Lead Last Vaccine Have you had a vaccine in the last 14 days?

NACI has determined that paediatric clients (5-11 years) cannot have vaccines administered within 14 days

Medical Conditions Are you being treated for a bleeding disorder or taking blood thinners? Do you have allergic rhinitis, asthma, or eczema? Are you Immunosuppressed due to disease or treatment? Have you talked with HCP about receiving the vaccine?

If Yes, do not administer Calculate date the client can return to receive vaccine In COVax – Enter Alert and deferred vaccine within 14 days

If Yes, administer, client to apply extra pressure and/or ice if bleeding occurs If Yes, administer, client to wait 30 minutes in Post-Vaccination.

Looking for Clients with Autoimmune Disorders Rheumatoid Arthritis, Type 1 Diabetes, Pernicious Anemia, Lupus, Myasthenia Gravis, Celiac, Graves, Addison’s, Crohn’s Diseases Clients receiving chemotherapy or stem cell, CAR-T, immune checkpoint inhibitors, monoclonal antibodies (e.g., rituximab) and other targeted agents (e.g. CD4/6 or PARP inhibitors)

Multisystem Inflammatory Syndrome in Children (MIS-C) Do you have a history of Children with a history of MIS-C unrelated to COVID-19 vaccine to be Multisystem Inflammatory deferred until clinically recovered or more than 90 days since the Syndrome in Children? diagnosis, whichever is longer Are you clinically recovered? If yes to clinically recovered, ask the next question

Has it been more than 90 days since diagnosis?

If Yes, administer vaccine, consultation is strongly recommended but not required

If yes, ask the next question

If no to clinically recovered, do not administer, Explain the 2 requirements for vaccination In COVax – Enter Alert and deferred MIS-C not clinically recovered TWO requirements that must be met before giving the vaccine. If yes to more than 90 days, 1. Must be at least 90 from diagnosis administer 2. Must have clinical recovery

Revised 2021 11 25 Paediatric 5 – 11 years Immunizer Action to YES Answer to SAQs

Decision Making Tool: MVP Clinics

Immunizers must ensure they have the knowledge, skill and judgement needed to administer vaccines and manage adverse events after immunization.

If you have any questions or concerns, consult with your supervisor Consider

Correct your workstation to ensure it is setup to meet health and safety standards before proceeding. Consult with Clinical Lead or Supervisor if assistance is needed

Consult with Clinical Lead and Supervisor to locate previous dose(s)

Environmental Check: Do you have all required supplies? Is the environment safe to enter? Do you have a clear safety plan?

NO

YES

Check with the client if this is their first, second or third dose. If client’s second or third dose, are the previous dose(s) recorded in COVAX?

NO

YES

Does the client meet the current eligibility requirements? Consult with Clinical Lead and Supervisor to confirm deferral of immunization

NO

YES

Are there any behavioral concerns for the client to be safely immunized? Consult Supervisor. Medical Directive Contraindications: A severe disruptive behavioral problem that would interfere with safely administering vaccine requires alternate practice setting.

NO

YES

Are there any barriers that prevent the client from understanding the SAQ questions? (E.g. Language barrier, cognitive considerations)

YES

NO

Are you able to use translation services to communicate appropriately with the client? Consult with your Clinical Lead & Supervisor for additional supports for communication

NO

Consult Clinical Lead and Supervisor. Defer immunization until client consent has been provided. If you cannot confirm the vaccine product is the correct vaccine, dose, needle size or the syringe is not attached securely consult Clinical Lead for follow up with Pre-Loading staff

If there are any concerns regarding engaging the safety, dispose of the needle directly into the sharp’s container.

Consider If client’s first dose is not in COVAX, check for duplicate accounts. Refer to IC WI C205 1st Dose NOT in COVax

Consider Correct interval between doses, age eligibility and correct vaccine brand based on age? Check for Alerts and Clinical Note Appropriate practice setting? (HCP vs PPH clinic e.g. History of allergic reaction

Consider Does the client have special needs, needle phobia or appear anxious or agitated? Is there a concern of needlestick injury to client or staff?

Consider Identify hearing or visual impairment and use alternate communication. Utilize translation services: Language line and translated SAQ questions. IC WI C070 Utilization of Translation Services at COVID-19 Immunization Clinics.doc (sharepoint.com).

YES Consider

Are there any contraindications to the client receiving the vaccine as outlined in the medical directive? If client does not meet Region of Peel criteria follow the steps as identified in ‘Immunizer’s Action to Yes Answers’ document. Consult Supervisor/Clinical Lead prior to deferral

Sharps Container: Is it closest to the client? Overfilled? Secured to prevent it from falling over? Do you have all your supplies? (Epi pen, etc.) Ensure safety assessment of practice setting

YES

NO

Utilize the SAQ Immunizer’s answers ‘Yes’ response document to ensure the client meets the medical directive criteria. This includes educating the client.

Consider Does the client provide verbal consent for the vaccine? (including vaccine brand)

NO

YES

Can you confirm the vaccine syringe is the correct vaccine and dose amount, correct needle size and the syringe is properly attached for immunization?

NO

YES Immunize Client

After immunization, can you safely engage the safety on the used needle?

NO

YES

Educate client on expected and reportable side effects (myo/ pericarditis symptoms) and how to seek appropriate medical attention after immunization.

Educate the client on determined wait time (1530 minutes) and monitor for adverse reactions after immunization

Explicit verbal consent is required from the client for both vaccine brand and to complete the dose vaccine series.

Consider Quality Check Vaccine syringe label and dose in syringe are correct: (0.3ml for Pfizer, 0.5ml for Moderna). Correct needle size (pediatric vs. adult) 25G X 1 inch vs. 25G X 5/8th . Needle is correctly secured to the syringe. One vaccine at a time for each Immunizer. Prime needle prior to immunization.

Consider To prevent needlestick injuries, the safety should be engaged with the thumb of the hand administering the injection.

Consider Do you have the knowledge, skill and judgement to respond to adverse events? Is your BLS certification valid (recert annualy?)

Used by immunizers when client has come in for second dose, however immunizer is unable to administer as there is an AEFI on record that has not be marked ‘Completed’.

Used by immunizers when clients have come in for their third dose, and meet the required criteria.

Dose 3

Version: October 1, 2021

‘Start Date’ is pre-populated. Do not enter ‘End Date’. Enter status as ‘Active’. Do not update status.

Standardized Comment: Client is allergic to [insert compound] in vaccine. Client permanently ineligible to receive COVID-19 vaccine.

Documentation

Ie. Approval verified by completed physician referral form, Dr. John Doe (CPSO #12345).

‘Start Date’ is pre-populated. Do not enter ‘End Date’. Enter status as ‘Active’. When client receives dose and investigation is complete, mark status as ‘Completed.’ Record an Alert Comment “Approval verified by OR , physician’s name and CPSO number.

Client will be advised when investigation is completed

If client is given a vaccine that is not their preferred vaccine, document in Clinical Notes and complete a Medication Error Incident Form. Standardized Comment: Client is unable to be administered another dose of vaccine at this time as AEFI Investigation has not yet been completed. Client advised to return when Investigation is completed.

Used by immunizers or registration Standardized Comment: Client has preference for [vaccine brand] Vaccine. Only [vaccine brand] should be administered to client if available and safe. staff to indicate when client has vaccine preference. ‘Start Date’ is pre-populated. Do not enter ‘End Date’. Enter status as ‘Active’. If client preference changes at any time, mark status as ‘Cancelled’ and create new Alert.

Used by immunizers when client is allergic to components of the vaccine (i.e. PEG, polysorbate) and is permanently ineligible to receive vaccine.

Definitions of Use

AEFI in Progress

Vaccine Preference

Permanently Ineligible

Approved Focus Statement

Documentation Functionality: Alert Record Type: Warning

❖ Refer to Screener/Registration and Immunizer/Post Registration Workflows on how to create an ‘Alert’ or a ‘Clinical Note.’ ❖ If more than one topic is discussed during a client interaction, two separate ‘Alerts’ or ‘Clinical Notes’ need to be created.

Note’ in COVax.

❖ Immunizers will use the approved Focus Statements in the ‘Alert Name’ field when entering an ‘Alert’ or DAR format when entering a ‘Clinical

GUIDANCE AND FOCUS STATEMENTS FOR ALERTS AND CLINICAL NOTES

Version: October 1, 2021

Please refer to the AEFI form on PHO website for a full list of adverse events

1. Anaphylaxis 2. Syncope with injury 3. Acute syncope requiring medical attention 4. Seizure 5. Convulsion 6. EMS call 7. Administration of Epinephrine 8. Skin allergy – generalized itching/ urticaria/swelling

Approved Focus Statement(s)

Record Type: AEFI

Definitions of Use

*Also create a ‘Client Incident’ Clinical Note

Used by post-immunization monitors or in-office PHNs to document when an AEFI has occurred post COVID19 vaccination.

Used by post-immunization monitors or in-office PHNs to document when an AEFI has occurred post COVID19 vaccination.

Documentation Functionality: Alert

If client has an AEFI ‘Alert,’ immunizer should ensure that ‘Alert’ status is ‘Completed’ and ‘Clinical Note’ has been reviewed prior to immunizing.

In-Office PHNs will: After investigation is completed, edit status to ‘Completed’ if applicable. Create ‘Clinical Note’ to document AEFI outcome and recommendations (i.e. directions on if second dose should be administered in PPH clinic).

Standardized Comment: AEFI investigation in progress, see clinical notes for details. ‘Start Date’ is pre-populated. Do not enter ‘End Date’. Enter status as ‘Active’.

Post-Immunization monitors to notify supervisor or delegate staff to input the following:

Documentation

Definitions of Use

*Also create an AEFI ‘Alert’ if an AEFI is submitted

Used by immunizer when an adverse event has occurred. It should also be used to document AEFI/adverse event details. As per IC WI C025 Management and Follow-up of incidents and Unusual Events.

Version: October 1, 2021

Client Incident & Adverse Effects

Medication Error

Do NOT use for clients that are allergic to components of the vaccine. An Alert should be created for those clients (see above). Used by immunizer to document when a medication error has occurred As per IC WI C180 Management And Follow Up Of Medications Errors In Covid-19 Immunization Clinics.

Refer to Medical Directive for deferral considerations.

‘YES’ Responses Used by immunizer to document and clarify ‘Yes’ responses to the Standard Assessment Questions prior to immunization. to the SAQ Questions Vaccine Deferral Used by immunizer to defer client if necessary. Immunizers must consult with the Clinic Supervisor before a deferral is made. Immunizers must also complete the ‘Important Information’ handout and provide to client.

Approved Focus Statement

Documentation Functionality: Clinical Note

When documenting a ‘Clinical Note’ immunizers should use the following DAR format: • D (data/assessment) • A (plan/intervention) • R (client response) (see Documentation of Client Services Provided By Peel Public Health Nurses for details).

Documentation

Used by immunizer to document any Out of Province doses. An Historical Dose should also be inputted by a Supervisor/Clinical Lead with Historical Dose capabilities.

Version: October 1, 2021

Document OOP Dose(s). Include following information if available: • Vaccine product • Lost # • Date of immunization • Province/Country of immunization For any Record of Vaccination that needed to be translated, indicate “Client reported...” prior to documenting information. Co-administration Used by immunizer to document consent for co-administration Standardized Comment: Client/ SDM was given of COVID-19 vaccine within days of receiving other vaccines required information on the risk of coadministration of COVID-19 vaccine within 14 days of having another vaccine administered and provided informed consent

OOP

Standardized Comment: Client and/or SDM informed of risks associated with Moderna vaccine in those under age 25. Client and/or SDM provided informed consent to receive Moderna vaccine.

Used by immunizer to indicate that Moderna Vaccine is being given to those who are under 25 years of age.

Moderna if 16mg/day) * methotrexate methylprednisolone (>16mg/day) * Metoject mycophenolate mofetil mycophenolic acid Myfortic 6-mercaptopurine (6-MP)

Decadron (>3mg/day) DepoMedrol (>6mg/day) dexamethasone (>3mg/day)

N

E

ocrelizumab Ocrevus ofatumumab Olumiant Orencia Ozanimod Otezla Ozanimod Otrexup

Enbrel Entyvio Envarsus PA Erelzi etanercept

F Fingolimod

G Gengraf Gilenya Golimumab Guselkumab Gengraf Gilenya golimumab

guselkumab

Neoral

O

P Pentasa Pentasa prednisone (>20mgm/day) Procytox Prograf Purinethol

R Rapamune Rasuvo Remicade Remsima Renflexis Rheumatrex Riabni Rinvoq risankizumab Rituxan rituximab Riximyo Ruxience

S Salazopyrin Sandimmune sarilumab secukinumab Siliq Simponi Sirolimus siponimod Skyrizi Solumedrol (>16mg/day) Stelara sulfasalzine

T tacrolimus Taltz Teriflunomide tocilizumab tofacitinib Tremfya Trexall Truxima

U upadacitinib ustekinumab V vedolizumab X Xeljanz Z Zeposia Not a comprehensive list. Ministry December 2, 2021 Version 4

AstraZeneca COVID-19 Vaccine / Vaxzevria / ChAdOx1-S / AZD122

3

United Kingdom

USA

Country Germany USA

if 26 or 27 days or more)

4-12 weeks (valid dose

days or more)

28 days (valid dose if 21

days or more)

Dose Interval 21 days (valid dose if 19

Series Recommendation for Additional Doses 2 doses 2 doses – with a dose interval of 19 days or more - no further doses If the last dose was received 18 days or less after the first dose mark 2nd dose as Invalid in COVax. Administer 1 dose of mRNA vaccine 60 days after the date of the last dose 1 dose- administer 1 dose of mRNA vaccine at 28 days dose interval 2 doses 2 doses - with a dose interval of 21 days or more – no further doses If the last dose was received 20 days or less after the first dose mark 2nd dose as Invalid in COVax. Administer 1 dose of mRNA vaccine 60 days after the date of the last dose 1 dose - administer 1 dose of mRNA vaccine at 28 days dose interval 2 doses 2 doses – with a dose interval of 26 or 27 days - no further doses IF the last dose was received 25 days or less after the first dose mark 2nd dose as Invalid in COVax. Administer 1 dose of mRNA vaccine 60 days after the date of the last dose 1 dose - administer 1 dose, of mRNA vaccine at 28 days dose interval

Reference: Ministry of Health, September 14, 2021, Version 2 COVID-19 Guidance for Individuals Vaccinated Outside of Ontario/Canada Revised – October 7, 2021

Moderna COVID-19 vaccine /Spikevax / mRNA-1273 / TAK/91

Vaccine Name Pfizer-BioNTech COVID-19 Vaccine/ Comirnaty/ BNT162B2 / Tozinameran

Calculate Dose Interval When determining the interval between dose 1 and dose 2, do not include the day on which dose 1 was administered and include the day on which dose 2 is administered. The day on which dose 1 is administered, considered as Day 0, then start your count on the next day. Example: Dose 1 was administered on September 1. September 1 is considered day 0. September 2 is considered day 1 and dose 2 can be administered on September 22 (Day 1 is September 2 + 21 days = September 22).

2

1

2 doses of a Health Canada approved vaccine or any combination of such vaccines, or 1 or 2 doses of a non-Health Canada approved vaccine followed by an additional dose (1) of a mRNA vaccine; or

 3 doses of a non-Health Canada approved vaccine NOTE: The WHO vaccine language has been removed from the dialogue





Definition of Fully Vaccinated - An individual is considered fully vaccinated, 14 days after the date of the last dose, if they have received:

Job Aid - COVID-19 Vaccine Platforms and Recommendations for Additional Doses

Epi VacCorona

Sinovac-CoronaVac / Ad5nCoV Sinopharm/Wuhan COVID-19 vaccine WIBP, Inactivated SARS-CoV-2 Vaccine (Vero cell) Covaxin / BBV152 SARS-CoV-2 Vaccine (Vero Cell) KoviVac QazCovid-in / QazVa COVIran - Barekat Sputnik V/ Gam-COVID-Vac Sputnik Light Ad5-nCoV / Convidecia Novavax /NVX-CoV2373 / CoVovax Abdala/ CIGB-66

8

9

21

20

11 12 13 14 15 16 17 18 19

10

7

Taiwan

India China Russia Kazakhstan Iran Russia Russia China USA Australia Cuba

China

China Uzbekistan Russia Turkmenistan China

China

USA

India

28 days

14 days

28 days 14 days 14 days 21 days 28 days 21 days N/A N/A 21 days

21 days

14 – 28 days

21 Days

30 days

21 – 28 days

N/A

if 26 or 27 days or more)

4-12 weeks (valid dose

3 doses - no further doses 1 or 2 doses - administer 1 dose of mRNA vaccine 3 doses- no further doses 1 or 2 doses - administer 1 dose of mRNA vaccine 1 or 2 doses - administer 1 dose of mRNA vaccine

1 or 2 doses - administer 1 dose of mRNA vaccine 1 or 2 doses - administer 1 dose of mRNA vaccine 1 or 2 doses - administer 1 dose of mRNA vaccine 1 or 2 doses - administer 1 dose of mRNA vaccine 1 or 2 doses - administer 1 dose of mRNA vaccine 1 or 2 doses - administer 1 dose of mRNA vaccine 1 dose -administer 1 dose of mRNA vaccine 1 dose - administer 1 dose of mRNA vaccine 1 or 2 doses - administer 1 dose of mRNA vaccine 3 doses 3 doses- no further doses 1 or 2 doses - administer 1 dose of mRNA vaccine 2 doses 1 or 2 doses - administer 1 dose of mRNA vaccine

2 doses 2 doses 2 doses 2 doses 2 doses 2 doses 1 dose 1 dose 2 doses

2 doses 1 or 2 doses - administer 1 dose of mRNA vaccine

2 doses 1 or 2 doses - administer 1 dose of mRNA vaccine

2 or 3 doses 2 or 3 doses 2 doses

2 doses 2 doses – with a dose interval of 26 or 27 days - no further doses IF the last dose was received 25 days or less after the first dose mark 2nd dose as Invalid in COVax. Administer 1 dose of mRNA vaccine 60 days after the date of the last dose 1 dose - administer 1 dose, of mRNA vaccine at 28 days dose interval 1 dose 1 dose - no further doses

Reference: Ministry of Health, September 14, 2021, Version 2 COVID-19 Guidance for Individuals Vaccinated Outside of Ontario/Canada Revised – October 7, 2021

MVC-COV1901

COVID-19 Janssen / JNJ78436735 /Ad26.COV2.S Sinopharm COVID-19 vaccine BIBP /BBIBP-CorV / Covilo RBD-Dimer /ZF2001 / ZIFIVAX

5

6

COVISHIELD/ ChAdOx1S.nCoV-19

4

Job Aid - COVID-19 Vaccine Platforms and Recommendations for Additional Doses

If yes, proceed with SAQ. If answered satisfactorily proceed with immunization, adult has signed consent form.

Ask, “Can you answer those questions?” health history questions about the client?

If yes, explain there are health history questions to be answered before vaccination.

Job Aid Obtaining Informed Consent for 5 to 11 Years 2021 11 25

SDM not contacted, do not administer vaccine. Explain cannot give vaccine until parent/ legal guardian is provides answers or consent. In COVax, enter Alert and or .

If no, explain “I need consent from your parent or legal guardian. Can I call that person for you?

In COVax, enter Alert and

If yes, “I need to talk to the person who signed the consent form to ask some health questions before I can give you the vaccine. Can I call that person for you?”

If yes, attempt to contact the SDM

SDM contacted, confirm identity and relationship to the client, explain need for health history questions before vaccination, ask SAQs, answer any questions about the vaccine, proceed with immunization, adult has signed consent form, and document encounter in proxy section and Clinical Notes.

If no, attempt to contact SDM.

SDM contacted, confirm identity and relationship to the client, explain reason for call:  need health history answers before vaccination, ask SAQs, answer any questions about the vaccine (client has signed consent form)  need informed consent, explain health history questions before vaccination, ask SAQs, answer any questions about the vaccine, obtain informed consent.  Proceed with vaccination and document encounter in Clinical Notes

Ask client, “Do you have a consent form that is signed by your parent or legal guardian?”

Client 5-11 Years is NOT Accompanied by an Adult

If no ask, “Do you have a consent form signed by the parent with decisionmaking responsibility or the legal guardian?”

Ask the adult, “Are you the parent with decision making responsibility or the legal guardian?”

SDM not contacted, do not administer the vaccine. Explain cannot proceed with vaccination until the parent/legal guardian is contacted to provide answers.

If yes, “Do you have any questions about the vaccine or information in the Immunization Prepackage available on the Region of Peel web?” If no, proceed to immunize If yes, answer questions and proceed to immunize

Client 5-11 years is Accompanied by an Adult NOT the SDM

Ask the adult, “Are you the parent with decision making responsibility or the legal guardian?”

Client 5-11 years is Accompanied by Parent with Decision Making Responsibility or Legal Guardian (SDM)

Immunizer Job Aid Obtaining Informed Consent for 5- to 11-Year-Old Clients

2 doses of a Health Canada approved vaccine or any combination of such vaccines, or 1 or 2 doses of a non-Health Canada approved vaccine followed by an additional dose (1) of a mRNA vaccine; or 3 doses of a non-Health Canada approved vaccine

Version Date: November 23, 2021

If they are not fully vaccinated and require another dose, assess whether client is able to receive another dose or restart the dosage series today based on dose interval. If client is eligible, check in client and complete registration process as outlined below.







An individual is considered fully vaccinated 14 days after the date of the last dose, if they have received:

The immunizer will then review the client’s ROV, input the historical dose and ROV, and assess whether the client is considered fully vaccinated in Ontario.

For all clients that are not found in the COVaxON system and their information is not previously added by DQ&R, registration staff will create the client profile. Registration staff will NOT enter historical doses, upload ROV, or check in the client.

Clients that reach out to Peel Public Health for any out of province dose documentation or additional doses will have their client profile created, and historical doses and Record of Vaccination (ROV) uploaded to the client profile by the Data Quality & Reporting (DQ&R) team. Once client is in clinic, registration staff will review information and check-in the client.

Refer to MVP Wi 190 Out of Province COVID-19 Vaccine Documentation and Additional Doses for more detail on the Out of Province Process

Out of Province Documentation and Additional Doses Process

Immunizer Job Aid – Out of Province and Additional Doses

Version Date: November 23, 2021

3) Select ‘Out of Province’

1) Locate client on COVax 2) Select ‘Document Historical Dose’ from drop-down on client profile

Follow the below steps to document the historical dose(s)

Entering Historical Dose

Version Date: November 23, 2021

5) Select appropriate Lot # from drop-down menu – if lot # unknown select the option for ‘Unspecified’

4) Select appropriate vaccine from drop-down menu – check Table to identify vaccine name, if cannot identify vaccine select the option ‘COVID-19 Unspecified’

Version Date: November 23, 2021

8) Review information provided to ensure accuracy

7) Enter details of historical dose. If client has a record of vaccination (ROV) select check-box at the bottom.

6) Collect ‘Consent for Data Collection’ in Ontario

Version Date: November 23, 2021

11) Upload the ROV into client profile under ‘Files’, can be done by taking a photo of ROV using surface pro.

10) A new DA # will populate

9) Select ‘Finish’

Version Date: November 23, 2021

4. If applicable check off Eligible for Next Dose box

3. Notify client that the dose received today will be documented for the Ministry of Health and check off Consent for Data Collection

2. Check off COVID-19 Assessment Complete

1. Click ‘Check-In’ located in the top right corner

Client Check-in

Client can now be Checked-in.

Version Date: November 23, 2021

Proceed with client Standard Assessment Questions, Immunization, Documentation, and Check-Out as per normal process. Refer to MVP WI 190 Out of Province COVID-19 Vaccine Documentation and Additional Doses for more detail on the role of the immunizer.

“Check-In” is completed for the client.

5. Click ‘Next’ and then ‘Finish’

If less than 8 weeks (56 days), read the Script to client about postponing 2nd dose Client prefers to follow product monograph dose interval. Read informed consent SCRIPT. If client consents, offer full dose Pfizer (0.3mL) 21 days after 1st dose

Offer full dose Pfizer (0.3mL)

25 years and older

25 years and older

Booster Dose

If client under 25 years old and prefers Moderna, read informed consent SCRIPT. If client consents, offer full dose Moderna (0.5mL)

Read informed consent SCRIPT Under 25 years old offer full dose Pfizer (0.3mL) Over 25 years old offer full dose Pfizer (0.3mL) or full dose Moderna (0.5mL)

Dose Interval 8 weeks (56 days) unless physician advises otherwise

Post-Transplant for Re-Vaccination

Residents in Congregate Settings/ HCWs/ Indigenous & Household/ Received 2 doses AZ or 1 dose Janssen Offer full dose Pfizer (0.3mL) or full If less than 8 weeks (56 days), read the Script to client about 50 years to 69 years dose Moderna (0.5mL) postponing 2nd dose Read informed consent SCRIPT Dose Interval 6 months (165-168 days) after 2nd dose Offer full dose Pfizer (0.3mL) or 1/2 dose Moderna (02.5mL) Read Script to client about 8-week Client prefers to follow product monograph. Read 70 years and older dose interval for 2nd dose informed consent SCRIPT. If client consents, offer full dose Read informed consent SCRIPT Pfizer (0.3mL) 21 days after 1st dose or full dose Moderna Dose Interval 6 months (165-168 days) after 2nd dose (0.5mL) 28 days after 1st dose Offer full dose Pfizer (0.3mL) or full dose Moderna (0.5mL)

Client prefers Moderna. Read informed consent SCRIPT. If client consents, offer full dose Moderna (0.5mL)

Read Script to client about booking 2nd dose at 8-week dose interval

Client prefers Moderna. Read informed consent SCRIPT. If client consents, offer full dose Moderna (0.5mL)

12 years old to 24 years old

12 years old to 24 years old

SDM prefers to follow product monograph dose interval. Read informed consent SCRIPT. If SDM consents, offer full dose Pfizer (0.2mL) 21 days after 1st dose 12 years and older

Dose interval 8-week (56 days) after 2nd dose. Read informed consent SCRIPT Under 25 years offer full dose Pfizer (0.3mL) Over 25 years offer full dose Pfizer (0.3mL) or Moderna (0.5mL) If client under 25 years old and prefers Moderna. Read informed consent SCRIPT. If client consents, offer a full dose Moderna (0.5mL)

If less than 8 weeks (56 days) dose interval, read Script to SDM about postponing 2nd dose

Obtain informed consent & SAQ answers. Offer full dose Pediatric Pfizer (0.2mL). Read Script to book 2nd dose at 8-week dose interval

3rd Dose 12 years and older Immunocompromised/ Prescribed Immunosuppressant Medications/ Dialysis

2nd Dose/ Interval

Age on the Day of Immunization

5 years old to 11 years and 5 years old to 11 years old 4 years old turning 5 years in 2021

1 Dose

st

8-week Dose Interval All Clients Information for all clients (adults, youth and pediatric) about the recommended 8-week interval between the first and second dose of mRNA vaccine. 1st Dose 1) The vaccine manufacturers, in their product monograph recommends specific time between the first and second dose. Pfizer states 21 days and Moderna 28 days. 2) There is emerging evidence that longer intervals between the first and second doses of COVID-19 vaccines result in a better immune response that lasts longer. 3) A longer interval may also result in a lower risk of myocarditis and/or pericarditis in children, adolescents, and young adults. 4) National Advisory Committee on Immunization (NACI) and the Ministry of Health strongly recommend that all individuals receive their second dose of the COVID-19 vaccine 8 weeks after their first dose for this reason. 5) Being aware of these reasons you may wish to schedule your second dose to met meet the recommended 8-week interval. 6) Do you have any further questions? 2nd Dose 1) The vaccine manufacturers, in their product monograph recommends specific time between the first and second dose. Pfizer states 21 days and Moderna 28 days. 2) There is emerging evidence that longer intervals between the first and second doses of COVID-19 vaccines result in a better immune response that lasts longer. 3) A longer interval may also result in a lower risk of myocarditis and/or pericarditis in children, adolescents, and young adults. 4) National Advisory Committee on Immunization (NACI) and the Ministry of Health strongly recommend that all individuals receive their second dose of the COVID-19 vaccine 8 weeks after their first dose for this reason. 5) Being aware of these reasons do you still wish to proceed to have your second dose under the 8-week interval? 6) Do you have any further questions?

November 26, 2021

Age appropriate Pfizer for 11 year old who got regular Pfizer for 1 st dose now to get Pediatric Pfizer for 2nd dose Information for parents and youth who received a full dose (30mcg) of Pfizer for dose 1 and are now receiving full dose (10mcg) of Pediatric Pfizer for dose 2 because they are still 11 years old on day of vaccination. 1) Health Canada has authorized the Pfizer pediatric formulation for use in children ages 5-11. 2) Some children age 11 did receive the 30mcg dose as their first dose, under Ontario’s extended eligibility (2009 birth year). 3) However, now with the availability of the pediatric formulation, we have a clearer recommendation based on the current age of the child on the day of vaccination. 4) The Ministry of Health recommends that “Children who are 11 years of age and received the 30mcg dose of the Pfizer vaccine as their first dose under Ontario’s extended eligibility (2009 birth year) are recommended to complete the vaccine series with the product authorized for their age at the time of the second dose (i.e., 10 mcg if 11 years, 30 mcg if 12 years)”. 5) Children have very good immune systems and very good responses to vaccinations in general 6) The preliminary study data showed that the pediatric 10 mcg dose provided: a. 90.7% protection against symptomatic COVID-19 b. no cases of myocarditis or pericarditis, and c. comparable amount neutralizing antibodies 7) In general, vaccines are given based on age, and not related to height, weight, or medical conditions so it is expected that an 11-year-old who is more adult-sized will still get a comparable benefit with the pediatric formulated age-appropriate dose Confirming Pediatric Doses Depending on Age Ages 4 turning 5 in 2021 5 – 11 at time of vaccination 11 turning 12 in 2021 (1st dose regular Pfizer)

November 26, 2021

Dose/ Vaccine Pediatric Pfizer (orange label) Pediatric Pfizer (orange label) Pediatric Pfizer (orange label)

Clinical Resource Folder Last revised: Dec 14/2021