Covid-19 Vaccine – Mrna Pfizer – Ultra Frozen Vaccine Implementation Date: December 16, 2020

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    CULCULCAN The Final Synthesis - isbn 978-0-9939480-0-8 Staff Member

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    CULCULCAN, Dec 24, 2020
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  2. CULCULCAN

    CULCULCAN The Final Synthesis - isbn 978-0-9939480-0-8 Staff Member

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    COVID-19 Vaccine Pfizer Alberta Immunization Policy | Biological Products ©2020 Government of Alberta | Published: December 14, 2020 |

    Page 1 of 5 COVID-19 Vaccine – mRNA Pfizer – Ultra frozen Vaccine Implementation Date: December 16, 2020 This policy is evergreen and will be updated as new information becomes available. Please consult the Product Monograph1 for further information about the vaccine. COVID-19 mRNA Vaccine (Ultra Frozen Vaccine) Manufacturer Pfizer-BioNTech Licensed use 16 years of age and older Composition/Platform Vaccine Type  mRNA (new technology) – nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S)  Formulated in lipid nanoparticles (LNPs)  No adjuvants or preservatives Indications for use of provincially funded vaccine This vaccine is being offered in a phased approach. Please follow operational guidelines to assess eligibility. Dose 0.3 mL Route  Intramuscular injection in the deltoid muscle. (Vastus lateralis can be used as an alternate if required.) Schedule 2 doses1  Dose 1: day 0  Dose 2: day 21 - 28 Notes:  Minimum spacing between doses is 19 days  Recommended spacing between doses is 21-28 days 2  If administration of the second dose of is delayed, the second dose should be provided as soon as possible. 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.2 Contraindications  Known severe hypersensitivity to any component of the vaccine. o 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, laxatives, cough syrup, cosmetics, skin products and some food and drinks.  Anaphylaxis to previous dose of COVID-19 mRNA vaccine. COVID-19 Vaccine Pfizer Alberta Immunization Policy | Biological Products ©2020 Government of Alberta | Published: December 14, 2020 |

    Page 2 of 5 Precautions  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.2,4  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. 1  Administration should be postponed in individuals suffering from acute severe febrile illness.1,2  Timing of administration and potential interference between COVID-19 vaccine and monoclonal products are currently unknown and expert clinical opinion should be sought on a case-by-case basis.  COVID-19 vaccine should not be offered to populations who are immunosuppressed due to disease or treatment or those with an auto-immune disorder until further evidence is available as there is a lack of evidence on efficacy and safety in this group. o However, a complete series of COVID-19 vaccine may be offered in consultation with the individual’s physician to individuals in the eligible group in this population if a risk assessment deems that the benefits outweigh the potential risks for the individual, and if informed consent includes discussion about the absence of evidence on the use of COVID-19 vaccine in this population.2 Possible reactions Very Common (≥1/10)1  injection-site pain, fatigue, chills, fever, headache, arthralgia, myalgia Common (≤1/100 to<1/10)1  redness or swelling at injection site, vomiting, diarrhea Uncommon (≥1/1000 to <1/100)1  lymphadenopathy Pregnancy • The safety and efficacy of Pfizer-BioNTech COVID-19 Vaccine in pregnant women have not yet been established.1 • Vaccine should not be offered to individuals who are pregnant until after completion of pregnancy.2 • However, a complete series of COVID-19 vaccine may be offered in consultation with the individual’s physician to pregnant individuals in the eligible group if a risk assessment deems that the benefits outweigh the potential risks for the individual and the fetus, and if informed consent includes discussion about the absence of evidence on the use of COVID-19 vaccine in this population.2 Lactation  It is unknown whether Pfizer-BioNTech COVID-19 Vaccine is excreted in human milk. A risk to the newborns/infants cannot be excluded.2  COVID-19 vaccine should not be offered to individuals who are breastfeeding.  However, a complete series of COVID-19 vaccine may be offered in consultation with an individual’s physician to individuals in the eligible group who are breastfeeding if a risk assessment deems that the benefits outweigh the potential risks for the individual and the infant, and if informed consent includes discussion about the absence of evidence on the use of COVID-19 vaccine in this population.2 Interchangeability  Currently, no data exists on the interchangeability of COVID-19 vaccines.2  The vaccine series should be completed with the same COVID-19 vaccine product.2 COVID-19 Vaccine Pfizer Alberta Immunization Policy | Biological Products ©2020 Government of Alberta | Published: December 14, 2020 |

    Page 3 of 5 Administration with Other 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 and COVID-19 vaccine adverse events without potential confounding from adverse events following other vaccines.2  If a COVID-19 vaccine is inadvertently administered at the same time as another vaccine, neither dose should be repeated.2  In the absence of evidence, it would be prudent to wait for a period of at least 28 days between the administration of the complete two-dose schedule of COVID19 vaccine and the administration of another vaccine (except in the case where another vaccine is required for post-exposure prophylaxis). 2  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 administrating a COVID19 vaccine.2 Appearance  Frozen - white to off-white solution. 1  Thawed – may contain white to off-white opaque particles.1  Thawed and reconstituted – off-white solution with no visible particulates.1 Storage and Handling  Can be stored in a freezer between -80°C to -60°C storage for up to 6 months. 1  If 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.  Prior to dilution, thawed vials can be stored: 1 o in the refrigerator at 2°C to 8°C for up to 5 days, or o at room temperature (up to 25°C) for no more than 2 hours. Do not refreeze.  After thawing and mixing with 0.9% sodium chloride diluent, the vaccine can be stored at 2°C to 25°C for up to 6 hours. 1  During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 1  After dilution, the vaccine vials can be handled in room light conditions.1 Packaging Vaccine  5 doses per vial  975 doses per package o Tray is 229 mm long, 229 mm wide, 40 mm high  Cannot be re-packaged Diluent  Diluent is provided in 10 mL plastic vials (latex-free, preservative-free).  Packaged in cartons of 25 vials and can be stored at room temperature.  Diluent is single use. Once the 1.8 mL required is drawn from the diluent vial and added to the antigen vial, the diluent vial MUST be discarded. It cannot be used to dilute multiple vials of vaccine. Non-medicinal Ingredients Lipid nanoparticles (these help the mRNA enter the cell):  ALC-0315 = (4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis(2- hexyldecanoate)  ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide COVID-19 Vaccine Pfizer Alberta Immunization Policy | Biological Products ©2020 Government of Alberta | Published: December 14, 2020 |

    Page 4 of 5 Other Lipids: (provide structural integrity of the nanoparticles)  1,2-distearoyl-sn-glycero-3-phosphocholine  cholesterol Salts: (help maintain the vaccine pH)  bibasic sodium phosphate dihydrate  monobasic potassium phosphate  potassium chloride  sodium chloride Other:  sucrose (protects the nanoparticles when frozen)  water for injection Preparation/ Reconstitution The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial contains a frozen suspension that does not contain preservative and must be thawed and diluted prior to administration. Thaw vaccine before use: 1 The frozen vial contains 0.45 mL and will need to be thawed before dilution.  Vials may be thawed in the refrigerator (2°C to 8°C) or at room temperature (up to 25°C). o Thaw for 30 minutes at room temperature. (Vials at room temperature must be diluted within 2 hours.) o Thaw for 3 hours in the refrigerator; and allow the vial to come to room temperature before dilution. Dilute before use: 1 1. Before dilution, invert gently 10 times to mix. Do not shake. 2. Dilution with sterile 0.9% Sodium Chloride Injection is required. (Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent.) 3. Cleanse the vial stopper with a single-use antiseptic swab. 4. Add 1.8 mL of 0.9% Sodium Chloride Injection, into the Pfizer-BioNTech COVID19 Vaccine vial using a needle 21-gauge or narrower. o Diluent is single use. Once the 1.8 mL required is drawn from the diluent vial and added to the antigen vial, the diluent vial MUST be discarded. It cannot be used to dilute multiple vials of vaccine. 5. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. o This is to prevent any vaccine loss through spraying out due to higher pressure. 6. Gently invert the vial again 10 times to mix. Do not shake. 7. Inspect the vial to confirm there are no particulates and no discoloration is observed. 8. Record the date and time of dilution on the Pfizer-BioNTech COVID-19 Vaccine vial label. 9. Store between +2°C to +25°C. 10. Discard any unused vaccine 6 hours after dilution. Notes: Pre-loading vaccine into syringes is not supported. The immunizing health practitioner must draw up the vaccine dose at the time of administration. Program Notes Licensed for use in Canada December 9, 2020 See www.CVDvaccine.ca for additional information. COVID-19 Vaccine Pfizer Alberta Immunization Policy | Biological Products ©2020 Government of Alberta | Published: December 14, 2020 |

    Page 5 of 5 References 1 Pfizer-BioNTech. (2020 December 9). COVID-19 mRNA Vaccine, Suspension for Intramuscular Injection Product Monograph. https://covid-vaccine.canada.ca/info/pdf/pfizer-biontech-covid-19-vaccine-pm1-en.pdf 2 National Advisory Committee on Immunization. (2020). Recommendations on the use of COVID-19 Vaccine(s). 3 Pfizer Training Resources. 2020 December 8, 4 Health Canada. Recalls and safey alerts. (2020 December 12) Pfizer-BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergies. https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74543aeng.php
     
    CULCULCAN, Dec 24, 2020
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  3. CULCULCAN

    CULCULCAN The Final Synthesis - isbn 978-0-9939480-0-8 Staff Member

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    CULCULCAN, Dec 26, 2020
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