Immunization Communication Tool

1 In the last 50 yearsimmunization hassaved more lives thanany other REFERENCEI mmunizationCommunication ToolFor ImmunizersImmunizationCommunication ToolThis document is a project of the British ColumbiaImmunization Committee Professional EducationWorking Group (PEWG)AUTHORSANDREA DERBAN,RN,BSN(First Nations and Inuit Health Branch)JESSICA HARPER,RN,BScN, CCHN(C) (BC Centre for Disease Control)SHAILA JIWA,RN,BScN, MScPPH(BC Centre for Disease Control)JAMIE PRINGLE,RN(c),BSN, MSc(A) (Vancouver Coastal Health)CHELSEA HAINES,RN,BScN(ImmunizeBC)ACKNOWLEDGEMEN TSIAN ROE, BComm(BC Centre for Disease Control)BRITTANY DEETER,RN,MSN(BC Centre for Disease Control)Thank you to all the Public Health Nurses who provided feedback onthe first edition of the Immunization Communication Communication Working Group: A Working Group of the BC Immunization SubcommitteeAUTHORSANDREA DERBAN,RN,BSN(BC Centre for Disease Control)LISA JARVOS,RN,BSN(Fraser Health)MYRNA KLEIN,RN,BSN(Vancouver Island Health)TAMSIN MORGANA, , RN, BSN, (Vancouver Coastal Health) JAMIE PRINGLE,RN(c),BSN, MSc(A) (Vancouver Coastal Health)ACKNOWLEDGEMENTSDONNA MCNEIL,RN,BSN(Vancouver Island Health)IAN ROE, (BC Centre for Disease Control)JOANNE SMREK,RN,BSN(Interior Health)MARGOT SMYTHE,RN,BSN(Vancouver Coastal Health) JILL WALKER,RN,BSN(Northern Health)BC HealthFiles Immunization Working Group2013 CONTRIBUTORS2008 CONTRIBUTORS 2014 BCIC PEWG.

2 All rights in this tool are of actual BC Immunization A S K Approach A framework for Immunization communicationHealth care providers have an essential role to providethe public with evidence based information regardingimmunization. This ensures the continuous success ofimmunization following approach providesa systematic method to answer difficult immunizationquestions and helps to enhance Immunization communi-cation between health care providers and the at: Are vaccines safe?YESV accines are safe, effective and necessary, with hugebenefits to children s health all through their lives. 2 Vaccines are among the safest tools of modern medicine. InCanada, serious side effects occur very rarely. For example, theestimated annual reported rate of anaphylaxis ranges to reports per 1,000,000 doses of vaccine distributedin Canada. The vast majority of side effects from vaccines areminor and temporary, such as a sore arm or mild vaccines are usually given to healthy people, especiallychildren, tolerance for adverse events following immuniza-tion is this reason, we have multiple overlappingsystems that review adverse events to ensure vaccine to Section How is vaccine safety monitored inCanada?

3 Many unfounded claims have been made about the dangersof vaccination by anti-vaccination activists, celebritiesand rogue scientists. However, the claims have not held upto scientific scrutiny. Despite this, these ideas have beenpopularized in the lay press and have made their way tothe internet. As a result, well-meaning parents, influencedby negative things they hear and read, are refusing to havetheir children are safe, effective and necessary, with hugebenefits to children s health all through their lives. 2 According to the Public Health Agency of Canada, in the last50 years, Immunization has saved more lives in Canada thanany other health in Canada are effective and safe much safer thanthe diseases they prevent. Vaccine-preventable diseases canlead to pneumonia, deafness, brain damage, heart problems,blindness, paralysis and carry a risk of life-long disabilityor may have questions about the risks associated withimmunization.

4 Immunization , like other medical procedures,carries some risk, but this risk is very small. The risk fromvaccine-preventable disease is much greater. It is important todiscuss the risks and benefits with your health care health officials take vaccine safety concerns veryseriously. For this reason, we have multiple overlappingsystems that review the different components involvedwith vaccine safety. The benefits of Immunization aresubstantial and well to Section How is vaccine safety monitored inCanada?IT S JUST LIKEYour risk of being struck by to the National Weather Service, the riskof being struck by lightning in a given year is about1 in 1,000,000. About the same risk of experiencinganaphylaxis after administration of a not to focus on the wrong risk!1: VACCINE SAFETYC linical Evidence Client Knowledge[ 1 ]1 VaccineSafety[ 2 ] How are vaccines approved in Canada?

5 1: VACCINE SAFETYHEALTHCANADAIt can take up to 10 years or longer to develop and receive approval for a vaccine Vaccine Development and ApprovalLab StudiesStep 1 Step 1 Immunogenicity - immune response needed to prevent disease Challenge studies in animal models Safety studies - no toxicities that would prevent their use in peopleS Step 2 Immunogenicity Local/systemic reactionsS 3 Step 3S 3 Step 3 Biologics and Genetic Therapies Directorate (BGTD):Canadian Approval of VaccineAntigen Research Epidemiology of a DiseaseInfectious AgentS Step 3 Optimal dose/schedule in target populationSafety assessmentEfficacy in target populations Safety assessmentAnimal StudiesHuman Studies10 100 Human Studies50 500 Human Studies300 30,000 Pre-ClinicalClinical Phase IClinical Phase IIClinical Phase IIIA pproval of Product Monograph Health professional informationScientific informationConsumer information Inspection of Manufacturing Facilities Laboratory Analysis of Vaccine SafetyPurityPotency [ 3 ] How are vaccines approved in Canada?

6 1: VACCINE SAFETYB iologics and Genetic Therapies Directorate (BGTD) The BGTD of Health Canada is the regulatory authorityresponsible for establishing the safety, efficacy and qualityof all biologics for human use, including in place to ensure vaccine safety:1. Before approval, the BGTD has regulatory processes to ensurethat lab and clinical studies provide evidence of productsafety and meet the highest standards of Before and after approval, the BGTD also has regulatoryprocesses to ensure the highest quality of manufacturingis used to produce Vaccine manufacturing facilities are inspected and givena license by Every new lot of vaccines produced has to be cleared byregulators before approval to sell in Canada. 5. Regulators and public health authorities continuouslymonitor vaccines after they have been approved to detectany previously unrecognized safety safety is an international concern.

7 Information onpossible safety concerns is communicated very rapidly amongdifferent and Genetic Therapies Directorate (BGTD) The BGTD of Health Canada is the national body that regu-lates the safety and effectiveness of vaccines are released to the public, they go throughmany phases of evaluation. This process may take manyyears because of the time that is needed to gather thescientific information necessary to ensure a vaccine is safeand following are steps the BGTD has in place to ensurevaccine safety:1. Vaccines are only approved after they are proven to be safeand Vaccine manufacturing facilities are inspected and givenapproval by the Every new lot of vaccines produced has to be cleared bythe BGTD before approval to sell in Canada. 4. The BGTD and public health authorities continuouslymonitor vaccines after they have been approved to detectany previously unrecognized safety Evidence Client KnowledgeEXAMPLEOn November 2, 2012 there was a voluntaryrecall of GSK Infanrix Hexa : GlaxoSmithKline, in consultation with Health Canada,would like to inform you of its decision to voluntarilyrecall one Lot (A21CB242A) of Infanrix Hexa vaccineas a result of detection of contamination in the environ-ment where material used to make the recall vaccinehad been placed.

8 No contamination was found in thevaccine. The recall was a precautionary measure. No contamination was found in the vaccine. No reported adverse events appeared to be linkedto the reasons for to Endnote How is vaccine safety monitored in Canada?1: VACCINE SAFETY[ 4 ]Ensuring vaccine safety is vitally Canada, there is active and passive surveillance and SurveillanceIMPACT, Immunization Monitoring Program ACTive, is apediatric hospital -based national active surveillance networkfor adverse events in children following Immunization ,vaccine failures, and selected infectious diseases that are,or will be, complements existing national surveillance systems,supports public health action, informs policy dialoguewith Federal, Provincial, Territorial and other nationalstakeholders, and assists in meeting Canada s internationalcommitments for vaccine safety monitoring and SurveillanceCAEFISS, Canadian Adverse Events Following ImmunizationSurveillance System, is a voluntary reporting system in whichAEFI reports collected by provincial and/or territorial publichealth authorities are forwarded for collation.

9 The nationalCAEFISS database is overseen by the Public Health Agencyof Canada s Vaccine Safety Section within the Surveillanceand Outbreak Response Division of the Centre forImmunization and Respiratory Infectious Diseases. Whilereporting nationally is voluntary, several provinces andterritories have laws requiring that healthcare professionalsreport AEFI (Ontario, Quebec, Saskatchewan, Manitoba,Nova Scotia, and New Brunswick).10 Ensuring vaccine safety is vitally Canada, there is active and passive surveillance and SurveillanceIMPACT, Immunization Monitoring Program ACTive, is apediatric hospital -based national active surveillance networkfor adverse events in children following Immunization , vaccinefailures and selected infectious diseases that are, or will be, events can best be thought ofas unfavorable effects following vaccination. Passive SurveillanceCAEFISS,Canadian Adverse Events Following ImmunizationSurveillance System, is a reporting system in which parentsvoluntarily report to their health care providers any adverseevents following Immunization .

10 Each report is reviewed bya medical health officer and the information is sent to thePublic Health Agency of Canada for further reporting of adverse events following immunizationhelps certain governmental agencies monitor vaccine safetyfor Evidence Client How is vaccine safety monitored in Canada?1: VACCINE SAFETY[ 5 ]Alberta Children s HospitalCalgary, AltaStollery Children s HospitalEdmonton, AltaWinnipeg Children s HospitalWinnipeg, ManThe hospital forSick ChildrenToronto, OntMontreal Children s HospitalMontreal, QueEastern Health Janeway Child Health and Rehabilitation CentreSt. John s, NfldIWK HealthCentreHalifax, , QueChildren s hospital ofEastern OntarioOttawa, OntRoyal University HospitalSaskatoon,SaskCentre Mere-Enfantdu QuebecQuebec, QueBC Children s HospitalVancouver, BCIMPACTC entresAcrossCanadaImmunization Monitoring Program ACTiveThese nurses then forward reports of adverse eventsfollowing Immunization (AEFI) to the Vaccine SafetyUnit at the Immunization Division of the Public HealthAgency of Canada (PHAC).