Saskatchewan Immunization Manual Chapter 10 – Biological Products September 2021 TABLE OF CONTENTS 1. Refer to SIM, Chapter 5, Immunization Schedules, Section 2.1, Minimum Intervals for Specific Vaccine Series for minimum interval scheduling. 2. Please note that websites are provided for non-publicly funded vaccines in Saskatchewan. All biological product monographs can be found in the Drug Product Database on the Health Canada website at: http://webprod3.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp. The Ministry of Health does not endorse products or manufacturer websites. 3. Post-exposure contact immunoprophylaxis management falls under the direction of a Medical Health Officer as per the Saskatchewan Communicable Disease Control Manual, available at: http://www.ehealthsask.ca/services/manuals/Pages/CDCManual.aspx . 1.0 ACTIVE IMMUNIZING AGENTS • Cholera – E. coli Vaccine (Chol-Ecol-O) o DUKORAL® • COVID – 19 o AstraZeneca/COVISHIELD o MODERNA o PFIZER • Third and Fourth COVID-19 Dose Recommendations for Travellers • Provision of COVID-19 Vaccine Booster Doses to Select Populations • Diphtheria-Tetanus-acellular Pertussis-Polio-Haemophilus influenzae type b Adsorbed Vaccine (DTaP- IPV-Hib) o INFANRIX™-IPV/Hib o PEDIACEL® • Diphtheria-Tetanus-acellular Pertussis-Hepatitis B-Polio-Haemophilus influenzae type b Adsorbed Vaccine (DTaP-HB-IPV-Hib) o INFANRIX™-hexa • Haemophilus influenzae type b Conjugate Vaccine (Hib) o Act-HIB ® o HIBERIX® • Hepatitis A Vaccine (HA) Indications • Hepatitis A Vaccine (HA) o Avaxim™ and Avaxim™ Pediatric o Havrix® 1440 and Havrix® 720 Junior o Vaqta® • Hepatitis A and B Vaccine Combined Vaccine (HAHB) o Twinrix™ and Twinrix Junior™ • Hepatitis A and Typhoid Vaccine (HA-Typh-I) o ViVAXIM® • Hepatitis B (HB) Vaccine Indications • Hepatitis B Vaccine - Immigrant Populations Ineligibility List • Hepatitis B Re-Vaccination Assessment Algorithm • Hepatitis B Series Completion Recommendations for Children 11-15 Years Old • Hepatitis B Vaccine Series Completion Scenarios • Hepatitis B Vaccine (HB) o ENGERIX®-B o RECOMBIVAX HB® • Herpes Zoster Vaccine o Shingrix™ (RZV) o ZOSTAVAX® II (LZV) Saskatchewan Immunization Manual Chapter 10 – Biological Products August 2021 • Human Papillomavirus Vaccine o CERVARIX™ (HPV-2) o GARDASIL®9 (HPV-9) • Influenza Vaccine o AFLURIA TETRA o FLUCELVAX® QUAD o FLULAVAL TETRA o FLUMIST QUADRIVALENT o FLUZONE® QUADRIVALENT o FLUZONE® HIGH DOSE QUADRIVALENT o INFLUVAC® TETRA • Japanese Encephalitis Vaccine (JE) o IXIARO™ • Measles-Mumps-Rubella Vaccine (MMR) o MMRII™ o PRIORIX™ • Measles-Mumps-Rubella-Varicella Vaccine (MMRV) o PRIORIX-Tetra™ o ProQuad™ • Meningococcal Conjugate C Vaccine (Men-C-C) o MENJUGATE™ Liquid o Neis Vac-C® • Meningococcal Conjugate ACYW-135 Vaccine (Men-C-ACYW-135) o Menactra® o Menveo™ o NIMENRIX™ • Multicomponent Meningococcal B Vaccine o BEXSERO® (MenB 4C) o Trumenba™ (MenB bivalent) • Pneumococcal Conjugate Vaccine o SYNFLORIX™ (Pneu-C-10) o Prevnar® 13 (Pneu-C-13) • Pneumococcal Polysaccharide Vaccine (Pneu-P-23) o PNEUMOVAX® 23 • Poliomyelitis Vaccine (Inactivated) (IPV) o IMOVAX® Polio • Rabies Vaccine (Rab) (Post-exposure prophylaxis) o IMOVAX® Rabies [Human Diploid Cell Vaccine (HDCV)] o RabAvert® [Purified Chick Embryo Cell Vaccine (PCECV)] • Rotavirus Vaccine o Rotarix™ (Rot-1) o RotaTeq® (Rot-5) Saskatchewan Immunization Manual Chapter 10 – Biological Products June 2020 • Tetanus-Diphtheria Adsorbed Vaccine (Td) o Td Adsorbed™ • Tetanus-Diphtheria-acellular Pertussis Vaccine (Tdap) o ADACEL® o BOOSTRIX™ • Tetanus-Diphtheria-acellular Pertussis-Inactivated Poliomyelitis Vaccine (Tdap-IPV) o ADACEL®-Polio o BOOSTRIX®-Polio™ • Typhoid Vaccine (Typh-I) (Salmonella Typhi Vi Capsular Polysaccharide) o Typhim Vi® • Typhoid Vaccine (Typh-O) (Live Oral Attenuated Ty 21a) o Vivotif® • Typhoid Vaccine (Typh-I) (Salmonella Typhi Vi Capsular Polysaccharide) o Typherix® • Varicella Vaccine (Var) o VARILRIX® o Varivax III™ • Yellow Fever Vaccine (YF) o YF-Vax™ 2.0 DIAGNOSTIC, PASSIVE IMMUNIZING AND ANTITOXIN AGENTS • Purified (tuberculosis) Protein Derivative (PPD) (Mantoux) o Tubersol® • Immune Globulin Preparation Injection Site, Needle Length and Total Site Volume per Age Group • Botulism Immune Globulin o BabyBIG • Hepatitis B Immune Globulin (HBIg) TM o HepaGam B o HyperHEP B™ S/D • Immune Globulin (Ig - Intramuscular) o GamaSTAN™ S/D • Rabies Immune Globulin (RabIg) o HYPERRAB™ S/D o IMOGAM® o KamRAB™ • Tetanus Immune Globulin (TIg) o HYPERTET™ S/D • Varicella Zoster Immune Globulin (VarIg) o VariZIG™ • Botulism Antitoxin (BAT) o Botulism Antitoxin • Diphtheria Antitoxin (DAT) o Diphtheria Antitoxin Saskatchewan Immunization Manual Chapter 10 – Biological Products April 2012 THIS CHAPTER MEETS THE FOLLOWING IMMUNIZATION COMPETENCIES FOR HEALTH PROFESSIONALS (PHAC, 2008): http://www.phac-aspc.gc.ca/im/pdf/ichp-cips-eng.pdf #4: The Types of Immunizing Agents and Their Composition ♦ Competency: Applies the knowledge of the components and properties of immunizing agents as needed for safe and effective practice. #8: Administration of Immunizing Agents ♦ Competency: Prepares and administers immunization agents correctly. #11: Populations Requiring Special Considerations ♦ Competency: Recognizes and responds to the unique immunization needs of certain population groups Saskatchewan Immunization Manual Chapter 10 – Biological Products August 2021 Cholera - E.coli (Chol-Ecol-O) [Non-publicly funded] DUKORAL® (Valneva Canada. 2020 product monograph available at: https://www.valneva.ca) Saskatchewan Immunization Manual Chapter 10 – Biological Products 2021-09-07 Page 1 of 5 COVID-19 Vaccine – AstraZeneca/COVISHIELD (Licensed for use in Canada February 26, 2021) Product monographs: AstraZeneca: https://covid-vaccine.canada.ca/info/pdf/astrazeneca-covid-19-vaccine-pm-en.pdf COVISHIELD: https://covid-vaccine.canada.ca/info/pdf/covishield-pm-en.pdf Recombinant Viral Vector Vaccine (Refrigerated Vaccine) Manufacturer AstraZeneca COVID-19 Vaccine: AstraZeneca COVISHIELD COVID-19 Vaccine: Serum Institute of India Licensed use Licensed for 18 years of age. Composition/Platform • Recombinant adenovirus vector encoding the viral spike glycoprotein Vaccine Type, Efficacy • Efficacy 62% after 2 doses in adults 18-64 years old • The interval between the first and second dose of the AstraZeneca/ COVISHIELD vaccine may impact efficacy of the vaccine, with lower efficacy if the interval is less than 12 weeks. • No adjuvants, preservatives, or antibiotics. Indications for use of • This vaccine is being offered in a phased approach. Please follow operational guidelines to provincially funded assess eligibility. vaccine Dose 0.5 mL Route • Intramuscular injection (IM) Schedule 2 doses • Dose 1: day 0 • Dose 2: minimum interval of 28 days (4 weeks). o NOTE: mRNA vaccine given at least 28 days later is preferred as the second dose for those who received AZ or COVISHIELD as their first dose, resulting in increased immunogenicity. • Refer to Third and Fourth COVID-19 Dose Recommendations for Travellers in this chapter. • As of September 7, 2021 the following people are eligible for an additional ‘booster dose’ • Transplant recipients (including solid organ, islet cell, tissue and hematopoietic stem cell transplants). • Recipients of stable, active treatment (chemotherapy, targeted therapies, immunotherapy) for malignant hematologic disorders • Recipients of an anti-CD20 agent (e.g. rituximab, ocrelizumab, ofatumumab). • Long-term care home and personal care home residents • For further details, refer to the Ministry of Health’s COVID – 19 Vaccine Contraindications and Precautions Background Document found in the COVID-19 Immunization Manual. Contraindications • Known severe hypersensitivity to any component of the vaccine. • One non-medicinal ingredient in the vaccine known to cause type 1 hypersensitivity reactions is polysorbate 80. The potential allergen may be found medical preparations (e.g., vitamin oils, tablets, and anticancer agents), cosmetics. • Anaphylaxis to previous dose of viral vector or mRNA COVID-19 vaccine. • History of capillary leak syndrome (CLS). • Thrombosis associated with lupus anticoagulant (thrombotic anti-phospholipid syndrome (APS)). • Major venous or arterial thrombosis with thrombocytopenia following a viral vector COVID-19 vaccine. • Individuals with a previous history of Heparin Induced Thrombocytopenia (HIT). (HIT antibody lingering might interfere with lab assay to detect VIPIT/VITT antibody and complicate management). • VITT: The reaction typically occurs 4 to 28 days, but may occur up to 42 days after Saskatchewan Immunization Manual Chapter 10 – Biological Products 2021-09-07 Page 2 of 5 vaccination. The number of people who are affected following immunization with this vaccine is about one out of every 26,000 to one out of every 100,000 persons after the first dose and about one out of every 600,000 persons after the second dose. The case fatality rate of VITT ranges between 20 and 50%. Precautions • Previous history of Cerebral Sinus Venous Thrombosis (CVST) with thrombocytopenia - should only receive a viral vector COVID-19 vaccine if the potential benefits outweigh the potential risks. An alternate COVID-19 vaccine should be offered. Thrombocytopenia and bleeding disorders • 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. Concurrent Illness • Administration