Practical Approaches to Overcoming Vaccine Hesitancy

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1 Practical Approaches to Overcoming Vaccine Hesitancy Brought to you as a public health service by Sanofi Pasteur Inc. MKT /13 1

2 What Is Vaccine Hesitancy? Intent to skip or delay at least 1 of the vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) 1,2 Uncertainty as to whether a vaccine should be administered in accordance with the ACIP recommended immunization schedule 1,2 In spite of that uncertainty, some vaccine-hesitant parents will allow their children to be immunized anyway 2 Such parents are at risk for skipping or delaying other vaccines down the road 3 Steps that health care professionals (HCPs) can take to minimize the impact of vaccine hesitancy 4 : Establish trusting relationships with parents/patients Provide appropriate educational materials References: 1. Heller G, Roberts M. Turning the tide: addressing vaccine hesitancy and timely immunizations through a social marketing campaign. Presented at: 44th National Immunization Conference, Atlanta, Georgia, April 21, Abstract Opel DJ, et al. Hum Vaccines. 2011;7(4): Dempsey AF, et al. Pediatrics. 2011;128(5): Gust DA, et al. Pediatrics. 2008;122(4):

3 Vaccine Hesitancy: Not a New Problem Turn of the 19th century: Vaccination is introduced in the United States (US) : Massachusetts is the first state to make smallpox vaccination compulsory 1,2 1850s: US anti-vaccination movement arises in response to the proliferation of smallpox vaccination mandates 1,2 Activists object to regulations requiring submission to a procedure that involves discomfort and that might not be safe s: Smallpox re-emerges in the US, as a result of a decline in vaccination rates 1 Opposition to vaccination increases as new laws are passed and old ones to control smallpox are reinforced 1 References: 1. Omer SB, et al. N Engl J Med. 2009;360(19): Colgrove J. State of Immunity: The Politics of Vaccination in Twentieth-Century America. Berkeley, CA: University of California Press;

4 Impact of Non-medical Exemptions on Vaccination Rates Overall mean state-level rates of non-medical exemptions have increased; pace of that increase has accelerated 1-3 Vaccination coverage rates are lower in states with personal belief exemptions (PBEs) than in states permitting only religious exemptions 1,3 Children with non-medical exemptions tend to aggregate within schools and communities 2,4 Vaccine-preventable diseases tend to cluster in areas where exemption rates are highest 5-7 References: 1. Omer SB, et al. N Engl J Med. 2012;367(12): Omer SB, et al. N Engl J Med. 2009;360(19): Omer SB, et al. JAMA. 2006;296(14): Buttenheim A, et al. Am J Public Health. 2012;102(8):e59-e Feikin DR, et al. JAMA. 2000;284(24): Centers for Disease Control and Prevention (CDC). MMWR. 2008;57(8): Omer SB, et al. Am J Epidemiol. 2008;168(12):

5 High Incidence of Pertussis in States That Allow PBEs: US, 2012 a White check marks indicate states where the documented incidence of pertussis exceeded the national average during In 12 of 19 (63%) states permitting PBEs and 9 of 31 (29%) states not allowing PBEs, the documented incidence of pertussis was higher than average. 2 Allow medical exemptions only Allow religious exemptions but not PBEs Allow religious exemptions and PBEs a States shown in purple allow religious exemptions but not PBEs, whereas states shown in green allow both religious exemptions and PBEs. In Missouri, PBEs are permitted only for children in day care, preschool, and nursery school. 2,3 Map adapted from Harrington JW. 3 References: 1. CDC. Data on file (2012 Provisional Pertussis Surveillance Report), March MKT National Conference of State Legislatures. States with religious and philosophical exemptions from school immunization requirements. Accessed June 7, Harrington JW. Consultant Ped. 2011;10(11):S17-S21. 5

6 High Incidence of Measles in States That Allow PBEs: US, 2011 Red check marks indicate states that allow PBEs and had a high incidence of measles during ,2 Import-associated a Unknown source a Import-associated describes cases brought into the US from other countries; cases linked epidemiologically to importations of measles into the US; cases with virologic evidence suggesting recent importation; and cases linked to patients with virologic evidence of recent importation. Map reproduced from CDC. 1 References: 1. CDC. MMWR. 2012;61(15): National Conference of State Legislatures. States with religious and philosophical exemptions from school immunization requirements. Accessed June 7,

7 Factors That Contribute to Vaccine Hesitancy Increase in: Number of new vaccines for various diseases State-level school entry immunization mandates Continued success of vaccines in controlling diseases that parents/patients no longer remember and rarely see 1 Rise in consumerism, which has 2 : Encouraged parents/patients to shop around for an HCP and actively search for information about vaccines Eroded parents /patients trust in HCPs Spread of misinformation via mass media and the internet 3 Growing willingness to question the integrity of scientists, public health officials, and anyone else involved in formulating immunization policies 4 References: 1. Harrington JW. Consultant Ped. 2011;10(11):S17-S Timmermans S, Oh H. J Health Soc Behav. 2010;51(suppl):S94-S Opel DJ, et al. Arch Pediatr Adolesc Med. 2009;163(5): Colgrove J. State of Immunity: The Politics of Vaccination in Twentieth-Century America. Berkeley, CA: University of California Press;

8 Vaccine-Hesitant Parents Are Not All the Same 1 In a study by Gust and colleagues, 28% of parents had doubts about vaccination Concern about vaccine safety was a predictor of vaccine delay or refusal Parents with doubts about immunizations differ in their reasons for those doubts Reference: 1. Gust DA, et al. Pediatrics. 2008;122(4):

9 Types of Vaccine-Hesitant Parents 1,2 Uninformed but educable Want education to counter anti-vaccine information Misinformed but correctable Need information about vaccine benefits Well-read and open-minded Want to intelligently discuss pros and cons Strongly vaccine-hesitant Willing to listen but not likely to change their mind right away Strong-willed and committed against vaccines Want to sway the HCP to their line of thinking References: 1. Harrington JW. Consultant Ped. 2011;10(11):S17-S Halperin SA. Canadian J CME. 2000;12(1):

10 The ASK Approach for Effective Immunization Communication 1 Acknowledge the parent s/patient s concerns Ask for clarification to understand their needs; sometimes a simple fact is all that s needed to dispel a myth or misunderstanding Steer the conversation Refute the myth or misunderstanding with facts If the parent/patient is not already committed against vaccines, continue your conversation to identify additional obstacles Know your facts; be confident and prepared Recommend or provide reading material Refer the parent/patient to reliable internet resources Make your professional recommendation crystal clear Reference: 1. Morgana T, Pringle J. Approaches to families questioning vaccines the ASK approach for effective immunization communication. Presented at: 48th Annual Meeting of the Infectious Diseases Society of America, Vancouver, BC, October 23, Abstract

11 The CASE Framework for Conversations about Vaccines 1 Corroborate Acknowledge the parent s/patient s concern Find some point on which you and the parent/patient can agree Set the tone for a respectful conversation About me Talk about what you ve done to enhance your knowledge and expertise (eg, attended a conference) Science Describe what science has to say about the topic in question Explain and advise Offer your recommendation, based on the science Reference: 1. Singer A. Making the CASE for vaccine communication: a new model for talking to parents about vaccines. November Accessed June 7,

12 Tips for Handling Vaccine Hesitancy Take a (or another) deep breath Listen to the parents/patients Identify their questions or problems Make no assumptions Have a plan What is your practice philosophy? Will you see families who outright refuse all vaccines for their children? Tailor your advice to each individual parent/patient, based on his or her concerns 12

13 Tips for Handling Vaccine Hesitancy (cont) Document your discussion with the parent/patient Revisit the discussion at each subsequent visit Inform the parent/patient that you will be doing so For parents/patients who refuse, provide the Vaccine Information Statement and consider using a Refusal to Vaccinate form For unimmunized or partially immunized patients, flag the chart for the benefit of yourself and other HCPs, in the event that those patients require sick visits Be direct, clear, and authoritative with respect to your office s philosophy and policy vis-à-vis a parent s/patient s ongoing refusal to vaccinate Know the plan, and maintain a consistent approach within your practice 13

14 Concerns That Have Been Raised Regarding Vaccines Overloading of the immune system 1,2 Autism or other neurologic side effects 1 Mercury exposure and brain damage 1,3 Aluminum toxicity and brain damage 1,3 Formaldehyde injection 3 References: 1. Harrington JW. Consultant Ped. 2011;10(11):S17-S Offit PA, et al. Pediatrics. 2002;109(1): Offit PA, Jew RK. Pediatrics. 2003;112(6):

15 Concerns That Have Been Raised Regarding Vaccines Overloading of the immune system 1,2 Autism or other neurologic side effects 1 Mercury exposure and brain damage 1,3 Aluminum toxicity and brain damage 1,3 Formaldehyde injection 3 References: 1. Harrington JW. Consultant Ped. 2011;10(11):S17-S Offit PA, et al. Pediatrics. 2002;109(1): Offit PA, Jew RK. Pediatrics. 2003;112(6):

16 Key Facts About Multiple Vaccines and the Immune System An infant s immune system has the capacity to respond to thousands of antigens at any given time 1 Immune system is constantly replenished; it cannot be overloaded by the antigens (ie, proteins and polysaccharides) in vaccines 1 In fact, children are exposed to thousands of antigens every day (on toys, doorknobs, and playground equipment) 2 Although the number of recommended vaccines has increased over the years, children today typically receive fewer antigens than their parents did in the past 1,2 The response to multiple vaccines given during a single visit is similar to the response that occurs when individual vaccines are administered separately 1 References: 1. Offit PA, et al. Pediatrics. 2002;109(1): Harrington JW. Consultant Ped. 2011;10(11):S17-S21. 16

17 Concerns That Have Been Raised Regarding Vaccines Overloading of the immune system 1,2 Autism or other neurologic side effects 1 Mercury exposure and brain damage 1,3 Aluminum toxicity and brain damage 1,3 Formaldehyde injection 3 References: 1. Harrington JW. Consultant Ped. 2011;10(11):S17-S Offit PA, et al. Pediatrics. 2002;109(1): Offit PA, Jew RK. Pediatrics. 2003;112(6):

18 Debunking of the Link Between Vaccines and Neurologic Side Effects In 2010, The Lancet retracted the 1998 report alleging a link between vaccines and autism 1 Numerous studies have demonstrated that no such link exists Vaccines are given at around the same time that autism becomes apparent; however, they do not cause autism 2 To explain the difference between causal and temporal relations, use the analogy of the rooster that crows every morning The sun will rise whether or not the rooster crows Signs of autism in a child may predate a vaccination but not be noticed until after a particular vaccine has been given 2 The increased number of vaccines recommended for children has not resulted in a higher prevalence of neurodevelopmental problems 2-4 References: 1. Healy CM, Pickering LK. Pediatrics. 2011;127(suppl 1):S127-S Harrington JW. Consultant Ped. 2011;10(11):S17-S Institute of Medicine. The childhood immunization schedule and safety: stakeholder concerns, scientific evidence, and future studies. Washington, DC: National Academies Press; DeStefano F, et al. J Pediatrics Epub ahead of print. 18

19 Concerns That Have Been Raised Regarding Vaccines Overloading of the immune system 1,2 Autism or other neurologic side effects 1 Mercury exposure and brain damage 1,3 Aluminum toxicity and brain damage 1,3 Formaldehyde injection 3 References: 1. Harrington JW. Consultant Ped. 2011;10(11):S17-S Offit PA, et al. Pediatrics. 2002;109(1): Offit PA, Jew RK. Pediatrics. 2003;112(6):

20 Safety of Thimerosal and Aluminum Salts in Vaccines Thimerosal: a mercury-containing preservative that helps prevent bacterial or fungal contamination in vaccines 1 No scientific evidence that links thimerosal with autism 2 Symptoms of mercury poisoning differ from those of autism 3 Measles, mumps, and rubella vaccine never contained thimerosal or any other form of mercury 2 As a precautionary measure, thimerosal was removed from nearly all vaccines (the exception being multidose vials) in Yet the incidence of neurodevelopmental problems has continued to rise Aluminum salts: an adjuvant to enhance the immune response 2 Safety is well established 1,2 All infants are exposed to aluminum in the environment (eg, breast milk, infant formulas) 1 References: 1. Offit PA, Jew RK. Pediatrics. 2003;112(6): Harrington JW. Consultant Ped. 2011;10(11):S17-S Healy CM, Pickering LK. Pediatrics. 2011;127(suppl 1):S127-S

21 Concerns That Have Been Raised Regarding Vaccines Overloading of the immune system 1,2 Autism or other neurologic side effects 1 Mercury exposure and brain damage 1,3 Aluminum toxicity and brain damage 1,3 Formaldehyde injection 3 References: 1. Harrington JW. Consultant Ped. 2011;10(11):S17-S Offit PA, et al. Pediatrics. 2002;109(1): Offit PA, Jew RK. Pediatrics. 2003;112(6):

22 Key Facts About Formaldehyde 1 Is used to inactivate: Viruses that cause influenza and polio Tetanus and diphtheria toxins Is diluted during the manufacturing process Is required for the synthesis of thymidine, purines, and amino acids in all humans Quantity of formaldehyde found naturally in an infant s blood is 10-fold greater than that contained in any individual vaccine Reference: 1. Offit PA, Jew RK. Pediatrics. 2003;112(6):

23 Common Reasons for Vaccine Refusal on Religious Grounds God, not immunity, protects my child from illness The use of fetal cells in vaccine production is immoral The use of vaccines containing pork gelatin is wrong 23

24 God, not Immunity, Protects my Child from Illness Ask for clarification of that statement This will help you determine whether the parent s refusal of immunizations is indeed an act of faith If a parent states his or her religion specifically prohibits vaccination, a religious exemption may be in order a Such exemptions are often granted to members of the Christian Science and Amish faiths 1 Note: Amish religious doctrine does not specifically prohibit vaccination 2 Common non-religious reasons for vaccine hesitancy among the Amish: Concerns about vaccine safety and infant s ability to tolerate vaccines Idea that vaccination is not a priority Feeling that it s too difficult to travel to places where vaccinations are offered a Mississippi and West Virginia do not allow religious exemptions. References: 1. Calandrillo SP. Univ Mich J Law Reform. 2004;37(2): Wenger OK, et al. Pediatrics. 2011;128(1):

25 The Use of Fetal Cells in Vaccine Production is Immoral Cell lines derived from aborted fetal lung tissue were used to develop vaccines against diseases such as hepatitis A, polio, rubella, and varicella 1,2 Some Catholics may refuse vaccination in order to express their strong opposition to abortion 1 Others may believe that vaccination involves some form of cooperation with abortion 1 Bear in mind that the lung tissue for those cell lines was from 2 fetuses that were aborted during the 1960s 2 The cells used today are grown in culture 1 The Vatican supports use of all vaccines available at this time 2 Administration of those vaccines is morally justified because they: Avoid a serious risk Provide for the good of children and all who come in contact with them However, alternative vaccines should be used if and when they become available References: 1. Furton EJ. Ethics & Medics. 1999;24(3): Vatican Statement on Vaccines Derived from Aborted Human Fetuses. Accessed June 7,

26 The Use of Vaccines Containing Pork Gelatin is Wrong 1 Islam and Judaism accept vaccination According to Islamic legal scholars, it is permissible for observant Muslims to receive vaccines containing pork gelatin According to Orthodox Rabbi Abraham Adler, Jewish laws do allow receipt of non-oral products containing porcine ingredients Reference: 1. Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health. Religious Leaders Approval of Use of Vaccines Containing Porcine Gelatin. Accessed June 7,

27 Common Philosophical Objections to Vaccination Too much, too soon? Natural disease provides better immunity Most of the vaccine-preventable diseases don t even exist anymore My [fill in the blank] told me not to let you vaccinate my baby 27

28 Too Much, Too Soon? 1 Offer reassurance Vaccines do not overload the immune system Every day an infant encounters thousands of antigens (parts of germs that cause the immune system to fight disease) Explain why it s best to follow the recommended immunization schedule Goal: To ensure that the child is immune to diseases before he or she is most likely to be exposed The vaccines have been tested at the recommended ages, so we know they re safe, even in young children Reference: 1. CDC. The childhood immunization schedule. February Available at: Accessed June 7,

29 Natural Disease Provides Better Immunity Explain that: The cost of natural immunity can be severe 1 Fatal disease is not a risk worth taking Not vaccinating one s child puts his or her entire community at risk If possible, cite cases of disease from your own experience as an HCP Reference: 1. Offit PA, Moser CA. Pediatrics. 2009;123(1):e164-e

30 Most of the Vaccine-preventable Diseases Don t Even Exist Anymore Explain that once-prevalent vaccine-preventable diseases may return if high immunization rates are not maintained Give examples of recent outbreaks Invasive Haemophilus influenzae type b disease 1 : Minnesota in 2008 Measles 2 : California, Pennsylvania, and Washington in 2011 (as indicated on an earlier slide) If possible, cite cases of vaccine-preventable disease from your own experience as an HCP References: 1. CDC. MMWR. 2009;58(3): CDC. MMWR. 2012;61(15):

31 My [Fill in the Blank] Told Me not to Let You Vaccinate my Baby 1,2 Ask for clarification: What are the underlying concerns of the person who gave that advice? Offer your recommendation, based on facts Recommend or provide reading material Refer the parent to reliable resources References: 1. Morgana T, Pringle J. Approaches to families questioning vaccines the ASK approach for effective immunization communication. Presented at: 48th Annual Meeting of the Infectious Diseases Society of America, Vancouver, BC, October 23, Abstract Singer A. Making the CASE for vaccine communication: a new model for talking to parents about vaccines. November Accessed June 7,

32 Ways You Can Encourage Discussion With Vaccine-Hesitant Parents/Patients Help me understand how you came to that decision Help me understand your reasons for feeling that way What is it about vaccines that worries you? Share with me what you ve read Share with me what you ve heard about getting 2 or more shots at once 32

33 Helpful CDC and AAP Resources for HCPs CDC resources for vaccine conversations with parents: AAP webpage titled Communicating with Families: AAP webpage titled Parental Refusal to Vaccinate: Refusal to Vaccinate form AAP clinical report, titled Responding to Parental Refusals of Immunization of Children 1 Coding resources for vaccine refusal Sample office vaccine policy statement (for distribution to parents) Sample office poster Resources to answer questions Reference: 1. Diekema DS, Committee on Bioethics. Pediatrics. 2005;115(5):

34 Helpful Resources for Parents Vaccine Education Center at The Children s Hospital of Philadelphia: AAP s Childhood Immunization Support Program: Sanofi Pasteur s ImmYOUnity SM website: Vaccinate Your Baby: Offit PA, Bell LM. Vaccines: What Every Parent Should Know. New York, NY: IDG Books; 1999 Humiston SG, Good C. Vaccinating Your Child: Questions and Answers for the Concerned Parent. Atlanta, GA: Peachtree Publishers; 2000 Fisher MC. Immunizations & Infectious Diseases: An Informed Parent s Guide. Elk Grove Village, IL: AAP; 2005 Myers MG, Pineda D. Do Vaccines Cause That? A Guide for Evaluating Vaccine Safety Concerns. Galveston, TX: Immunizations for Public Health;

35 Additional Resources for HCPs and/or Parents Immunization Action Coalition: Immunization Education Program of the AAP s Pennsylvania chapter: Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health: National Association of Pediatric Nurse Practitioners: National Network for Immunization Information: Pediatric Infectious Diseases Society position statement on PBEs: 35

36 Backup 36

37 Evolution of Public Health Laws Concerning Vaccination 1905: Jacobson v Massachusetts establishes rights of states to pass and enforce vaccination laws : First philosophical exemption law is passed : Supreme Court finds school immunization laws constitutional s: Immunization laws are strengthened and strongly enforced : School immunization laws vary among states 3 50 states permit medical exemptions 48 states permit religious exemptions 19 states permit personal belief exemptions (PBEs) References: 1. Omer SB, et al. N Engl J Med. 2009;360(19): Dr. John Talarico, California Department of Public Health, personal communication, October 5, National Conference of State Legislatures. States with religious and philosophical exemptions from school immunization requirements. Accessed June 7,

38 More Childhood Vaccines But Fewer Antigens Number of Immunogenic Proteins and Polysaccharides Contained in Vaccines Over the Past 100 Years Vaccine Proteins Vaccine Proteins Vaccine Proteins Vaccine Proteins/ Polysaccharides Smallpox ~200 Smallpox ~200 Diphtheria 1 Diphtheria 1 TOTAL ~200 Diphtheria 1 Tetanus 1 Tetanus 1 WC = Whole-cell. Thanks to advances in technology, vaccines today contain fewer antigens. Even with more vaccines, the total immunologic load is much less. 1,2 Tetanus 1 WC pertussis ~3000 Acellular pertussis 2-5 WC pertussis ~3000 Polio 15 Polio 15 Polio 15 Measles 10 Measles 10 TOTAL ~3217 Mumps 9 Mumps 9 Reproduced with permission from Pediatrics. 2002;109(1): Copyright 2002 by the American Academy of Pediatrics. References: 1. Offit PA, et al. Pediatrics. 2002;109(1): CDC. Vaccines and How They Work. 4th ed. CDC, National Immunization Program, Immunization Services Division; Rubella 5 Rubella 5 TOTAL ~3041 Hib 2 Varicella 69 Pneumococcus 8 Hepatitis B 1 TOTAL

39 Time-based CPT a Billing Codes for Office Visits With Vaccine-Hesitant Parents When 50% or more of the visit is spent on counseling (as opposed to patient history or physical examination): Use if the visit lasts at least 25 minutes and less than 40 minutes Use if the visit lasts at least 40 minutes Keep in mind that time-based billing codes can be used only if the topics of counseling are well documented If a parent is already known to be vaccine-hesitant and is scheduling an appointment, be sure to: Give that parent a 30-minute slot Advise the staff to use a time-based billing code for that visit a CPT (Current Procedural Terminology) is a registered trademark of the American Medical Association. 39

40 Providing Parents With Accurate Information Most parents seek out information about vaccine safety from other people and from media outlets before taking their child to be immunized 1 Parents are increasingly using the internet to obtain vaccine information HCPs remain 1 of the most important sources of information and advice for parents making immunization decisions and can help build parental confidence in vaccines 1-3 Assisting HCPs in their efforts to communicate with parents about vaccines should remain a priority for national, state, and local immunization programs 2 References: 1. Kennedy A, et al. Health Affairs. 2011;30(6): Gust DA, et al. Pediatrics. 2008;122(4): Freed GL, et al. Pediatrics. 2011;127(suppl 1):S107-S

41 Vaccine Hesitancy and Suboptimal Immunization Rates Among Adults Coverage rates remain suboptimal for most vaccines that are routinely recommended for adults 1, National Foundation for Infectious Diseases telephone survey of 1013 adults 3 : 21% believe immunizations are optional for healthy adults 27% report refusing a vaccine offered to them by their HCP Primary reason for refusal is lack of concern about getting the disease Many parents even those whose children are fully vaccinated may hesitate to be vaccinated themselves Some are skeptical of the need for those immunizations Others harbor doubts about the safety and efficacy of 1 or more immunizations References: 1. CDC. MMWR. 2013;62(4): CDC. Flu vaccination coverage, United States, influenza season. Accessed June 7, National Foundation for Infectious Diseases Survey: Disconnect in What Doctors Think They Say About Vaccines and What Patients Hear. November Accessed June 7,

42 Sanofi Pasteur s ImmYOUnity SM Educational Campaign Helps answer questions about vaccines for family members of all ages Offers online and print material that HCPs can use to supplement discussions about vaccination with patients and parents 42

43 Infographics : A Simple Way to Understand and Share Key Facts Consumer-friendly, balanced, science-based information Website content that can be shared via social media and 43

44 How ImmYOUnity Can Help Public health departments, health systems, clinics, and others can link to from their own websites ImmYOUnity brochures can be disseminated to clinicians, patients, and parents Evolving campaign is open to input from HCPs and families to further support efforts to educate and immunize For more information, call VACCINE ( ), or contact a Sanofi Pasteur representative 44

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