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Tetanus, Diphtheria and Polio Vaccine Administration

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Immunization Directive


Number:


Topic:

Administration of Pfizer-BioNTech COVID-19 Vaccine

Approved:


Reviewed:

Revised:



Procedure


Administer intramuscularly the Pfizer-BioNTech COVID-19 vaccine.

Involvement of a Delegated Controlled Act: Yes X No


Controlled Act #5: Administering a substance by injection or inhalation. This is a controlled act, which is in the scope of nursing practice. A member of the College of Nurses may perform a procedure within the controlled acts authorized to nursing if a physician, dentist, chiropodist, nurse practitioner or midwife orders it.


Controlled Act #8: Prescribing, dispensing, selling or compounding a drug as defined in the Drug and Pharmacies Regulation Act, or supervising the part of a pharmacy where such drugs are kept.



Delegation of the Controlled Act







Indications


Pfizer-BioNTech COVID-19 vaccine (COVID-19 mRNA vaccine) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 12 years of age and older.


Effective August 18, 2021 Ontario expanded eligibility to youth who are turning 12 in 2021 (youth born in 2009). Therefore, youth who have not yet had their 12th birthday but will by December 31, 2021 can receive Pfizer vaccine.


On September 29, 2021 Ontario is issued a preferential recommendation for the use of Pfizer-BioNTech COVID-19 vaccine over Moderna COVID-19 vaccine for individuals under 25 years of age due to an observed increase in pericarditis/myocarditis, though still rare, following vaccination with Moderna compared to Pfizer in the 18 to 24 year old age group.


It is recommended that those under 25 who received Moderna for their first dose receive Pfizer for their second dose. Should individuals aged 18- to 24-year-old wish to receive Moderna they can continue to do so with informed consent. The province will continue using the Pfizer vaccine for youth ages 12-17 (including those turning 12 in 2021).



Dosage and Administration:


Age

Dosage (mL)

Immunization Schedule

Minimum Interval

Authorized Interval

12 + years

0.3

2 dose

19 days

21 days


Everyone in Ontario turning 12 years of age in 2021 and older is now eligible to receive 2 doses of COVID-19 vaccine at the following provincially approved intervals:


Note: Pfizer vaccine can be administered at 21 days between doses based on product monograph. Provincial booking system and promotion are based on 28 days to be non-product specific.


According to the National Advisory Committee on Immunization (NACI) there is emerging evidence that a longer interval between the first and second doses of COVID-19 vaccines result in more robust and durable immune response and higher vaccine effectiveness. The interval between dose 1 and 2 for the current COVID-19 vaccines that appears to provide optimal protection while simultaneously minimizing the time at risk of infection due to having protection from only one dose is 8 weeks for mRNA vaccines. The choice to use a longer interval to optimize protection should be made considering the local transmission of SARS-CoV-2 and the degree of individual risk of exposure, such as for front line health care or other high-risk occupation, and whether a second dose is needed for earlier protection, such as to protect against an emerging variant.


The following groups are currently eligible for 3rd doses in Ontario:


Eligible Group

Interval

  • Individuals receiving active treatment (e.g., chemotherapy, targeted therapies, immunotherapy) for solid tumour or hematologic malignancies

  • Recipients of solid-organ transplant and taking immunosuppressive therapy

  • Recipients of chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)

  • Individuals with moderate to severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)

  • Those with stage 3 or advanced untreated HIV infection and those with acquired immunodeficiency syndrome

  • Those undergoing active treatment with the following categories of immunosuppressive therapies: anti-B cell therapies (monoclonal antibodies targeting CD19, CD20 and CD22), high-dose systemic corticosteroids (defined as prednisone equivalent of ≥ 2 mg/kg/day or 20 mg/day if weight > 10 kg, for ≥ 14 days), alkylating agents, antimetabolites, or tumor-necrosis factor (TNF) inhibitors and other biologic agents that are significantly immunosuppressive (refer to list of eligible medications in Addendum D)


At least two months (56 days) following their second dose


The Ontario recommended interval between the last dose of the initial primary series and the 3rd dose is at least 2 months (56 days). As per NACI, the minimum interval should be 28 days; however, an interval longer than the minimum 28 days between doses is likely to result in a better immune response. Exact timing should be decided with the treating provider to optimize the immune response from the vaccine series and minimize delays in management of the underlying condition.


  • Residents of seniors congregate settings including long-term care homes, retirement homes and elder care lodges

At least 6 months (168 days) following their second dose.


Note in Simcoe Muskoka, when LTCHs and RHomes were originally announced the province was using a 5-month interval. This interval can continue to be used for the remaining Rhomes booked for initial 3rd doses if they so choose.


The 6-month interval will be used for all other seniors congregate settings and for LTCH/Rhome residents going forward after initial 3rd dose campaign is completed.


  • Anyone 70 years of age or older (born in 1951)

At least 6 months (168 days) following their second dose

  • Indigenous people 16 years and older (born in 2005) and their household members

  • Health care workers who are 16 years and older (born in 2005)

  • Anyone who received a series of viral vector vaccine (2 doses of AstraZeneca/COVISHIELD or 1 dose of Jansen)


NACI recommends that, 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. 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. The previous dose should be counted, and the series need not be restarted.


For those receiving a 3rd dose, ideally the same product is used for all three doses. If different products were used for dose 1 and 2, ideally the same product used for dose 2 is used for dose 3. But ultimately vaccination should not be delayed and whatever vaccine is readily available should be offered.


*readily available = easily available at the time of vaccination without delay or vaccine wastage


Those who received AstraZeneca COVID-19 vaccine for their first dose, can choose to either receive a second dose of the AstraZeneca COVID-19 vaccine, or an mRNA COVID-19 vaccine (Pfizer or Moderna)


Booster doses are not recommended at this time for those under 16 years of age.


If an individual is later than their appropriate interval identified above to receive their 2nd dose, the vaccine should be given as soon as possible, and there is no need to restart the series.


Dose of mRNA Vaccine for Those who Received Non-Health Canada Approved Vaccines


Individuals who have received a 1 or 2-dose series of a COVID-19 vaccine that is not authorized for use by Health Canada should be offered 1 additional dose of mRNA vaccine. The minimum interval between the preceding dose and the additional dose should be 28 days.


If the individual has already received 3 doses of a non-Health Canada authorized COVID-19 vaccine at the appropriate interval, no additional doses are needed. Refer to Appendix A in the Ministry of Health COVID-19 Guidance for Individuals Vaccinated outside of Ontario/Canada for detailed schedules and recommendations.


Pfizer-BioNTech COVID-19 vaccine is to be administered intramuscularly in the deltoid muscle.


Nurses will store and handle the vaccine according to the instructions in the manufacture’s product monograph.


The vaccine comes as a frozen suspension in a multi-dose vial that requires thawing and dilution before administration.


Health Canada has authorized an update to the Pfizer-BioNTech COVID-19 Vaccine Product Monograph to allow a 3-month extension to the expiry date for all Pfizer-BioNTech COVID-19 vaccine vials with expiry dates of August 2021 through February 2022 printed on the vial and carton labels. Based on this authorization, cartons and vials of Pfizer-BioNTech COVID-19 vaccine with this expiry may remain in use for 3 months beyond the printed date as long as all approved storage conditions have been maintained.


Prior to dilution, the thawed suspension may contain white to off-white opaque particles. After dilution, the vaccine should be an off-white suspension. Do not administer if any particulate matter or discoloration is noted once diluted.


The contents of the vial must be diluted with 1.8 mL of sterile 0.9% sodium chloride. Pfizer will be providing Ontario with 10 mL plastic vials of sodium chloride that is to be used to dilute to the vaccine. Despite the 10 mL vial presentation of the diluent, the diluent is single use – once the 1.8 mL required is drawn from the diluent vial for adding to the antigen vial the diluent vial MUST be discarded. It cannot be used to dilute multiple vials of vaccine.


The diluent can be stored at room temperature.


Frozen Vials Prior to Use


The Pfizer-BioNTech COVID-19 vaccine is to be stored at ultra-low temperatures of -80°C to -60°C and protected from light, in the original packaging, until ready to use. Vials may also be stored at -25°C to -15°C for up to 2 weeks. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. Vials stored at -25°C to -15°C for up to 2 weeks may be returned one time to the recommended storage condition of -80°C to -60°C. Total cumulative time the vials are stored at -25°C to -15°C should be tracked and should not exceed 2 weeks.


Vials Prior to Dilution


The Pfizer-BioNTech COVID-19 vaccine may be thawed and stored at +2°C to +8°C for up to 31 days or at room temperature (up to 25°C) for no more than 2 hours. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Thawed vials can be handled in room light conditions.


Vials After Dilution


The Pfizer-BioNTech COVID-19 vaccine must be stored +2°C to +25°C and used within 6 hours from the time of dilution. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. After dilution, the vaccine vials can be handled in room light conditions.


Transport of Single Dose in Prefilled Syringe


While not recommended as routine practice, in exceptional circumstances (i.e. a few doses are needed to support the immunization and series completion of small numbers of individuals residing in congregate settings or for those who are home bound) single doses of Pfizer vaccine may be transported in a syringe. Refer to Addendum B for the procedure to follow in these circumstances.


Pooling of Vaccine from Up to 3 vials


As an interim measure during this time of limited COVID-19 vaccine, an additional dose of COVID-19 vaccine may be extracted from up to 3 vials of the same vaccine using aseptic technique. Refer to Addendum C.

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Contraindications


  1. Those who have had severe allergic reaction or anaphylaxis to a previous dose of COVID-19 mRNA vaccine or to any of its components (polyethylene glycol and, due to potential cross-reactivity, polysorbate) should not receive the mRNA COVID-19 vaccine in a community-based vaccine clinic. These people need an urgent referral to an allergist or immunologist to determine how/if they will complete their series.


For those who have had an allergic reaction within 4 hours and/or anaphylaxis that occurred with a vaccine or injectable medication that does not contain a component or cross-reacting component of mRNA COVID-19 vaccines, the vaccine can be given with an extended post-vaccination observation time of 30 minutes.


Those with a history of significant allergic reaction and/or anaphylaxis to any food, drug, venom, latex or other allergens not related to the mRNA COVID-19 vaccine can receive the vaccine with an extended post-vaccination observation time of 30 minutes.


  1. Pfizer-BioNTech COVID-19 Vaccine is contraindicated in those with an allergy to any component of the vaccine or an anaphylactic or other allergic reaction to a previous dose of this vaccine:


Vaccine

Vaccine Components

Contains Latex (Yes or No)

Pfizer-BioNTech COVID-19 Vaccine

  • nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2ALC-0315

  • ALC-0315 (4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis (2-hexyldecanoate)

  • ALC-0159 = 2-[(polyethylene glycol)-

2000]-N,N-ditetradecylacetamide

  • 1,2-distearoyl-sn-glycero-3-phosphocholine

  • Cholesterol

  • dibasic sodium phosphate dehydrate

  • monobasic potassium phosphate

  • potassium chloride

  • sodium chloride

  • sucrose

  • water for injection

No


  1. Pfizer-BioNTech COVID-19 vaccine should only be administered in SMDHU clinics to the following groups if they have consulted with their treating physician and it has been determined that the potential benefits of vaccination outweigh the potential risks:


  1. Individuals who experienced myocarditis and/or pericarditis after a first dose of an mRNA COVID-19 vaccine should wait to receive a second dose until more information is available.


In general, if a patient is 3 months post-chemotherapy and the cancer is in remission, or if immunosuppressive therapy has been discontinued for at least 3 months (6 months or more for anti-B cell antibodies), the person is no longer considered immunocompromised.


People living with HIV that are considered immunocompetent may be vaccinated. Those with stable Hep B and Hep C virus may also be vaccinated.


Pregnant individuals may choose to receive the vaccine at any time during their pregnancy. However, essential consideration should be made for those in the later stages of their pregnancy.

 

It is recommended, but not required, that pregnant individuals have discussion with their treating health care provider, or with a health care provider familiar with their pregnancy, that includes:


Breastfeeding women were excluded from the Phase III trials for COVID-19 vaccines available at present and as such there is no data on the safety of COVID-19 vaccines in lactating women or the effects of mRNA vaccines on the breastfed infant or milk production.

COVID-19 mRNA vaccines are not live vaccines, and based on their biologic mechanism of action, mRNA vaccines are not hypothesized to be a risk to the breastfeeding infant. For any individuals who are breastfeeding, the COVID-19 vaccine should be offered after recognizing the insufficiency of evidence for the use of COVID-19 vaccine in the breastfeeding population.


Persons with Autoimmune Conditions & Immunocompromised persons (due to disease or treatment) were excluded from the Phase III trials for COVID-19 vaccines available at present and as such there is currently no data on the safety of COVID-19 vaccines in these groups. These people (excluding those listed in 4 above who are required to consult with their training physician before receiving the vaccine) may choose to receive the vaccine and can do so under this directive provided the immunizer reviews with them the following:



Precautions & Other Important Information






Vaccination of those who may currently have SARS-CoV-2 infection is not known to have a detrimental effect on the illness. However, vaccination should be deferred in symptomatic individuals to avoid attributing any complications resulting from infection to being vaccine related.




Quality Assurance

The program managers will ensure that:


References


Product Monograph for (COMIRNATY™, Pfizer-BioNTech COVID-19 Vaccine [COVID-19 mRNA Vaccine], Revised September 16, 2021)


An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI): Recommendations on the use of COVID-19 Vaccine(s).

National Advisory Committee on Immunization. Interim Guidance on Booster COVID-19 Vaccine Doses in Canada. October 29, 2021.


National Advisory Committee on Immunization. Rapid Response Statement on Additional Dose of COVID-19 vaccine in immunocompromised individuals following a 1- or 2-dose primary series. July 22, 2021.


National Advisory Committee on Immunization. Rapid Response: Interchangeability of Authorized COVID-19 Vaccines. June 1, 2021.


Ontario Ministry of Health. COVID-19 Vaccination Recommendations for Special Populations. September 29, 2021.


Ontario Ministry of Health. COVID-19 What you need to know before your COVID-19 vaccine appointment.


Ontario Ministry of Health. COVID-19 Vaccine Storage and Handling Guidance – Revised June 24, 2021


Ontario Ministry of Health. COVID-19 Vaccine Administration – Revised October 20, 2021


SMDHU Policy LG0101 - Consent for Treatment – Revised September 2010

SMDHU Policy LG0104 - Delegated Controlled Acts – Revised August 25, 2010


SMDHU Policy GEN0105 – Directives & Standing Orders – Revised August 25, 2010


College of Nurses of Ontario (CNO), Practice Guideline, 41019, Directives Revised January 2018

https://www.cno.org/globalassets/docs/prac/41019_medicaldirectives.pdf


CNO, Practice Standard, 41007, Medication Revised January 2019

http://www.cno.org/docs/prac/41007_Medication.pdf


CNO, Practice Standard, 41071, Decisions about Procedures and Authorities Revised March 2018

https://www.cno.org/globalassets/docs/prac/41071_decisions.pdf


The College of Physicians and Surgeons Policy #5-12 - Delegation of Controlled Acts (revised Sept 2012)

https://www.cpso.on.ca/admin/CPSO/media/Documents/physician/polices-and-guidance/policies/delegation-of-controlled-acts.pdf


Educational Resources


http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php

Authorized to


All (insert staff’s designation) employed by (insert organization name), who have received the directive training and who have the following qualifications are authorized to administer these vaccines:




Authorization and Approval


The steps outlined in this directive, and training and resources available provide staff with the necessary knowledge and skills to safely, effectively and ethically administer this vaccine in a clinic setting.


Review/Revision History




Addendum A – the Administration of COVID-19 Vaccine to Residents of LTCHs & RHomes



Immunization of Residents at Facilities that are in Outbreak


COVID-19 vaccine can be offered to all residents, staff and essential caregivers:



COVID-19 vaccine will not be offered to:


Addendum B


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Addendum C


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Addendum D


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IMMPACT2 IMMUNIZATION REGISTRY DATA EXCHANGE SPECIFICATION OUTBOUND UNSOLICITED ORIGINAL
IMMUNIZATION CONSENT FORM WEST VIRGINIA LAW REQUIRES PARENTS TO
IMMUNIZATION REQUIREMENTS ALL IMMUNIZATIONS MUST MEET MASSACHUSETTS’S MINIMUM


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