Joseph Domachowske, MD

Professor of Pediatrics, Microbiology and Immunology

Golisano Children’s Hospital

SUNY Upstate Medical University

Syracuse NY

Vaccine Champions:

Addressing Immunization and HPV Vaccine

Hesitancy Head-on

Disclosures

• Consultant and/or grant recipient from:

– Pfizer

– Merck

– GlaxoSmithKline

– Sanofi Pasteur

– Medimmune

– Novartis

• I will not be discussing specific vaccine

brands

Learning Objectives

• Discuss burden of vaccine hesitancy on society

• Understand parental reasons for vaccine refusal

• Discuss management of vaccine hesitancy or

refusal in the office

• Describe information resources for counseling

vaccine hesitant parents

Vaccine mis-information is easy to find • Books, parenting magazines

– How to Legally Refuse Vaccinations. Get this Life-Saving Report - FREE!

• Anti-vaccination internet sites – National Vaccine Information Center at http://www.909shot.com

• Billboards, television, other social media

Pediatrician’s Experience

• Within a 12-month period, 85% of

pediatricians report encountering a parent

who refused or delayed one or more

vaccines

• 54% report encountering a parent who

refused all vaccines • http://www.aap.org/immunization/pediatricians/pdf/RefusaltoVaccinate.pdf

Who is Vaccine Delayed?

• >1% of the birth cohort of USA is under vaccinated due to parental concern

• Unvaccinated children

– Ready access to health care, Caucasian, married mothers with college education, and a household income >$75,000

• Under vaccinated children

– African American, those with difficulty accessing health care, resource poor, inner city, single mother without college education.

Pediatrics. 2004:114.e16, Pediatrics.2004;114:187-195

Vaccine hesitancy is not a new problem

• Vaccination introduced in the US at the turn of 19th century

• First smallpox vaccination law passed 1809

• 1850s anti-vaccination movements arises

• Vaccine use declines, smallpox re-emerges in the 1870s

• New laws passed and reinforcement of old ones to control smallpox resulted in increased opposition to vaccination

Evolution of Public Health Laws

• 1905: Jacobson vs. Massachusetts establishes a right of the state to pass and enforce vaccination laws

• First philosophical exemption law passed 1910

• 1922: the Supreme Court finds public school immunization laws constitutional

• 1970s: Strong enforcement of immunization laws

• 2013: School based immunization laws – 50 states permit medical exemptions

– 18 states permit philosophical/personal belief exemptions (PBEs)

– 48 states permit religious exemptions

Vaccination Exemptions by State

http://www.vaccinesafety.edu/cc-exem.htm

Impact of Exemptions on Vaccination Rates

• Mean state-wide rates of non-medical exemptions have slowly risen over the last decade

• States with PBEs have lower statewide vaccination coverage rates

• Vaccine preventable diseases have been shown to cluster in areas where exemption rates are highest

• Michigan is a good example

Relative locations of pertussis space-time clusters (1993–2004) and exemptions spatial

clusters (1991–2004) in Michigan.

Omer S B et al. Am. J. Epidemiol. 2008;168:1389-1396

American Journal of Epidemiology © The Author 2008. Published by the Johns Hopkins

Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail:

journals.permissions@oxfordjournals.org.

19 States have a documeted pertussis incidence higher than the national average of 11.6/100,000 (as of 11/23/12)

http://www.cdc.gov/pertussis/outbreaks.html

Wisconsin 93.4 Alaska 28.6 Idaho 13.1

Minnesota 78.1 North Dakota 25.6 Pennsylvania 12.9

Vermont 66.1 Oregon 22.1 Missouri 12.3

Washington 64.3 Kansas 21.9

Iowa 47.5 New Hampshire 15.7

Maine 45.6 Colorado 15.2

Montana 44.3 Arizona 13.5

New Mexico 31.0 Illinois 13.5

12/19 (63%) of these

states allow PBE

Vaccination Exemptions by State

N=30

N= 2

N=18

12/18 (67%) PBE states have higher pertussis rates than the national average

7/30 (23%) non-PBE states have higher pertussis rates than the national average

Reasons For Vaccine Hesitancy

• Safety concerns

• Philosophical objections

• Religious objections

Parental Reasons For Refusing

Vaccines

• In one study 28% of parents had concerns

about vaccination

• Vaccine safety concern was a predictor for

delay or vaccine refusal

• Parents who exhibit doubts about

immunizations are not all the same

Pediatrics 2008;122:718–725

How are we doing with the teens?

• Fewer school requirements

– 35 states require Tdap

– 12 states require conjugate meningococcal

vaccine

– 1 state, plus DC require 3 doses of HPV

vaccine (females only)

Robust uptake of Tdap and MCV-4 both approved and recommended in 2005

Percentage of teens immunized:

Tdap MCV-4

2008 40.8 41.8

2009 55.6 54.2

2010 69.0 63.4

2011 78.2 70.5

As expected, rates are best where where school requirements exist

What about HPV vaccine?

• Approved and recommended universally for

females in 2006, approved in males 2009

• Expanded universal recommendation for

males in 2011

• So, we have had more than 6 years to

immunize females, and almost 2 years to

immunize males

• How are we doing?

0

10

20

30

40

50

60

70

80

90

100

2009 2010 2011

females

males

3-dose coverage of HPV vaccine,

U.S., according to the National Immunization Survey

Per

cent

vac

cinat

ed Healthy People 2020 goal

Why is it more difficult to

communicate and execute this

recommendation than for

any other vaccine?

Some common concerns

• Is it safe?

– Doesn’t it make kids faint?

– I’ve heard about the deaths.

• Is it necessary?

– My child is not sexually active

– It may ‘allow’ my child to become sexually

active

– I’m not sure my religious leaders would

approve

Ongoing Safety Surveillance for qHPV vaccine

Ongoing Safety Surveillance for qHPV vaccine

Religions and Vaccines

• Christian Scientists refuse vaccination

• In Pakistan and Afghanistan, the Taliban

have issued fatwa's opposing vaccination

• Islam and Judaism accept vaccination

• The Vatican supports use of all vaccines

• Amish communities will generally accept

vaccination, particularly during an outbreak

but have low rates of coverage

What about philosophical

objections:

• ‘I don’t believe in it’

• Natural disease provides better immunity

• My (fill in the blank) told me not to let you

vaccinate my teen

• Some families are ‘absolute’ conscientious

objectors

Approaches to the vaccine reluctant

and hesitant in the office • Document your discussion with the parent

– At times it is appropriate to engage the teen!

• Revisit the discussion at each subsequent visit. Inform the family that you will be doing so

– Remind the teen that at age 18, this becomes their decision

• For parents and teens who refuse, provide the VIS, and consider using the the vaccine refusal form

• Be direct, clear and authoritative on your office philosophy and policy for ongoing refusal to vaccinate. Know the plan, and maintain a practice-wide consistent approach

AAP Site http://www2.aap.org/immunization/pediatricians/refusaltovaccinate.html

• AAP refusal to vaccinate form

• AAP clinical report

• Coding resources for vaccine refusal

• Sample office policy letter to parents

• Sample office poster

• Resources to answer questions

• Many others

Handling Vaccine Hesitancy

• First: Take (another) deep breath

– Listen to the parent and the teen

– Identify THEIR question or problem

– Make no assumptions

• Second: Have a plan

– What is your practice philosophy?

• Third: Advise parents and teens based on

their concerns

Different Parent Types

• Believer parent

• Relaxed parent

• Cautious parent

• Conscientious objector parent

Believer Parent

• Lowest information

• Highest commitment to vaccination

• Completes childhood series

• May ask about safety and side effects

• Stress that benefits outweigh the risks

• Provide reading materials

Relaxed Parent

• Low to moderate information needed

• Highest commitment to vaccination

• Completes childhood series

• Less likely to ask questions

• May need to probe for unanswered questions

• Stress that benefits outweigh the risks

• Provide reading materials

Cautious Parent

• High information needs

• High emotional involvement with child

• Rigid thought patterns

• Moderate to low commitment to vaccination

• Believe disease protection is necessary

• May pick and choose some vaccines over

others, or may prefer spreading out vaccines

Cautious Parent - Encourage

Discussion

• “Tell me how you made your choice”

• “Tell me why you feel that way”

• “Tell me what worries you”

• “Tell me what you know”

• “Tell me what you know about getting more

than one shot at a time”

Cautious Parent

• Present a balanced view

• Emphasize benefits of vaccination

• Stress risks of disease and serious

complications

• Answer factual questions with authority

– If you don’t know, don’t guess– they may

already know the answer

• Recommend or provide reading materials

and internet resources

Conscientious Objector Parent

• Low or no information needs

• These parents are FIRM about not vaccinating

• Studies show that they are unlikely to change

their minds

Conscientious Objector Parent

• Best practice points

– Confirmation: Is your decision firm?

– Are you aware that a decision not to immunize

is a decision to accept the risks and

consequences of disease?

– Provide the practice philosophy

Conscientious Objector Parent

• Important information to provide

– Depending on state law, some vaccines are required whether the family has philosophical objections or not. Home school is an option.

– In other states, during an outbreak, the child may be excluded from school/daycare for days to months

– Keep child home if sick to protect others

– Concerned about infectious illness and going to doctor?

– Are you willing to receive any vaccine information?

– Your decision will be noted in your child’s file

The A-S-K Approach For

Effective Immunization

Communication

• A Acknowledge

• S Steer the conversation

• K Knowledge – know your facts!

IDSA 2010; Morgana and Pringle

Acknowledge

– Acknowledge the parental concerns

– Ask for clarification to understand their needs

• Sometimes a simple fact is all that is needed to

dispel a misunderstanding

• Sometimes a common myth has been perpetuated

Steer The Conversation

– Refute the myth or misunderstanding with facts

– Continue your conversation to identify

additional obstacles (close your conversation if

parent is a conscientious objector)

Knowledge

• Know your facts! Be confident and prepared

• Provide further knowledge as necessary

• Provide further reading material and internet resources

• Make your professional recommendation crystal clear

Provider Resources for Vaccine

Conversations with Parents • AAP’s Childhood Immunization Support Program (CISP)

www.cispimmunize.org

• The Immunization Education Program (IEP) of the Pennsylvania Chapter of the American Academy of Pediatrics http://www.paiep.org/

• The Immunization Action Coalition (IAC) www.immunize.org/reports/

• Centers for Disease Control and Prevention (CDC) National Immunization Program http://www.cdc.gov/vaccines/hcp.htm

• National Network of Immunization Information (NNii)www.immunizationinfo.org

• Vaccine Education Center at Children’s Hospital of Philadelphia www.vaccine.chop.edu

• Institute for Vaccine Safety, Johns Hopkins University www.vaccinesafety.edu

• The Canadian Coalition for Immunization Awareness and Promotion (CCIAP) http://immunize.cpha.ca/en/default.aspx

Resources for Parents • AAP’s Childhood Immunization Support Program (CISP)

• Why Should I Immunize My Child?www.cispimmunize.org/fam/why.html

• The Immunization Education Program (IEP) of the Pennsylvania Chapter of the American Academy of Pediatrics http://www.paiep.org/

• Centers for Disease Control and Prevention National Immunization Program http://www.cdc.gov/vaccines/spec-grps/parents.htm

• National Network of Immunization Information (NNii).www.immunizationinfo.org

• Vaccine Education Center at Children’s Hospital of Philadelphia www.vaccine.chop.edu

• Institute for Vaccine Safety, Johns Hopkins University www.vaccinesafety.edu

• The Canadian Coalition for Immunization Awareness and Promotion (CCIAP) http://immunize.cpha.ca/en/default.aspx

• Vaccinate Your Baby www.vaccinateyourbaby.org

Books for Parents

• 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 and Infectious Diseases: An Informed Parent’s Guide. Elk Grove Village, IL: American Academy of Pediatrics; 2005

• Myers, MG and Pineda D. Do Vaccines Cause That? A Guide for Evaluating Vaccine Safety Concerns. Immunizations for Public Health. 2008

DEPARTMENT OF HEALTH DIVISION OF EPIDEMIOLOGY, ENVIRONMENTAL AND OCCUPATIONAL HEALTH

PO BOX 369 TRENTON, N.J. 08625-0369

www.nj.gov/health

January 9, 2013

Dear School Administrators, In the November 2012 Annual Immunization Status Report mailing, the New Jersey Department of Health (DOH), provided an update based on a more permissive Advisory Committee on Immunization Practices (ACIP) recommendation for administering influenza vaccine to persons with egg allergies, i.e., per ACIP, most patients who report an egg allergy can safely receive flu vaccine. The DOH has received numerous inquiries from school health officials and parents regarding vaccination of persons with egg allergies. The current ACIP recommendation includes an algorithm for healthcare providers to manage patients with egg allergies. Since egg allergies range in severity, school health officials may find it difficult to determine the validity of influenza vaccine medical exemptions. Medical exemptions must be written in accordance with N.J.A.C. 8:57-4.3 which stipulates that a written statement must be provided from a physician licensed to practice medicine or osteopathy or an advanced practice nurse indicating that an immunization is medically contraindicated for a specific period of time, and the reason(s) for the medical contraindication, based upon valid medical reasons as enumerated by the ACIP. After careful consideration, the DOH has made a decision to continue to accept egg allergy as a valid medical contraindication for the 2012-2013 school year. In other words, if the physician/APN’s written medical exemption states that the child has an egg allergy and cannot receive flu vaccine for that reason, we would encourage schools to accept this as a valid exemption. DOH will continue to evaluate the feasibility of implementing this ACIP recommendation in the future. In the interim, we continue to encourage healthcare providers to follow ACIP’s guidelines and screening protocols to determine whether their patient can receive flu vaccine. For the complete ACIP 2012-2013 influenza recommendations, please visit http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6132a3.htm?s_cid=mm6132a3 . The DOH apologizes for any inconvenience this may have caused and appreciate your continued patience and cooperation. Please access the DOH, Vaccine Preventable Disease Program website for additional information on NJ’s immunization requirements and frequently asked questions http://www.nj.gov/health/cd/imm.shtml. Should you require further assistance, please contact the Vaccine Preventable Disease Program at (609) 826-4861. Sincerely,

Barbara Montana, MD, MPH, FACP Medical Director Communicable Disease Service

Revised 1/9/13

CHRIS CHRISTIE Governor

KIM GUADAGNO Lt. Governor

MARY E. O’DOWD, M.P.H. Commissioner

For more information visit www.iom.edu/childimmunizationschedule

The Childhood Immunization Schedule and SafetyStakeholder Concerns, Scientific Evidence, and Future Studies

Vaccines are among the most effective and safe public health interven-tions to prevent serious disease and death. Because of the success of vaccines, most Americans have no firsthand experience with such devastating illnesses as polio or diphtheria. Widespread immunizations have resulted in a decline in vaccine-preventable diseases. Health care providers who vaccinate young children follow a schedule prepared by the U.S. Advisory Committee on Immunization Practices (ACIP). The current recommended U.S. childhood immunization schedule is timed to protect children from 14 pathogens by inoculating them at the time in their lives when they are most vulnerable to disease. Under the current schedule, which applies to children younger than 6, children may receive as many as 24 immunizations by their second birthday and may receive up to five injections during a single doctor’s visit. Technological advances have reduced the num-ber of antigens—that is, inactivated or dead viruses and bacteria, or altered bacterial toxins that cause disease and infection—in vaccines. New vaccines undergo rigorous testing prior to approval by the Food and Drug Administra-tion (FDA). However, like all medicines and medical interventions, vaccines carry some risk. Some parents’ attitudes toward the childhood immunization schedule have shifted, driven largely by concerns about potential side effects from vac-cines. In light of this, the Department of Health and Human Services (HHS) asked the Institute of Medicine (IOM) to identify research approaches, meth-odologies, and study designs that could address questions about the safety of the current childhood immunization schedule. The IOM committee’s report, The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Sci-entific Evidence, and Future Studies, summarizes its findings.

The current recommended U.S. childhood immunization schedule is timed to protect children from

14 pathogens by inoculating them at the time in their lives when they are most vulnerable to disease.

REPORT BRIEF JANUARY 2013

2

The Current Schedule

Newly approved vaccines are tested within the context of the existing ACIP-recommended schedule and are reviewed by clinical researchers who weigh the new vaccine’s benefits against its possible risks. Before the ACIP recommends add-ing a new vaccine to the immunization schedule, it reviews comprehensive data about that vac-cine’s safety and efficacy in clinical trials, injuries and deaths caused by the disease the vaccine is designed to combat, and the feasibility of adding the new vaccine into the existing schedule, among other factors. Every year, the Centers for Disease Control and Prevention (CDC) issues guidance on immu-nization use and schedules for children (birth to age 6), adolescents (ages 7 through 18), and adults, based on these ACIP recommendations.

Stakeholder Concerns

In the course of its work, the IOM committee solicited feedback from a diverse group of stake-holders, including researchers; advocacy groups; federal agencies and advisory committees; the general public, including parents; the health care system and providers; international organiza-tions; the media; nongovernmental organizations; philanthropic organizations; and vaccine-related industries, distributors, and private investors. More than 90 percent of children entering kindergarten have been immunized with most recommended vaccines in accordance with the ACIP-recommended schedule, according to an analysis of U.S. data. Still, parents, providers, and public health officials agree that there has been insufficient communication between providers and parents about vaccine safety concerns. A number of concerned parents say the sched-ule is too “crowded” and have requested flexibil-ity, such as delaying one or more immunizations or having fewer shots per visit. Some parents have rejected the vaccines outright, arguing that the potential harm of their child suffering a side effect from the vaccine outweighs the well-documented

benefits of immunizations preventing serious dis-ease. Other parents delay or decline immuniza-tions due to worries that family history, the child’s premature birth, or an underlying medical condi-tion may make them more vulnerable to compli-cations. Some simply distrust the federal govern-ment’s decisions about the safety and benefits of childhood immunizations. While parents generally worry about chil-dren’s health and well-being, and their concerns about immunization safety can be viewed in that context, delaying or declining vaccination has led to outbreaks of such vaccine-preventable diseases as measles and whooping cough that may jeopar-dize public health, particularly for people who are under-immunized or who were never immunized. States with policies that make it easy to exempt children from immunizations were associated with a 90 percent higher incidence of whooping cough in 2011.

No Evidence of Safety Concerns

Upon reviewing stakeholder concerns and sci-entific literature regarding the entire childhood immunization schedule, the IOM committee finds no evidence that the schedule is unsafe. The com-mittee’s review did not reveal an evidence base suggesting that the U.S. childhood immuniza-tion schedule is linked to autoimmune diseases, asthma, hypersensitivity, seizures, child develop-mental disorders, learning or developmental dis-orders, or attention deficit or disruptive disorders. Existing mechanisms to detect safety sig-nals—including three major surveillance systems of FDA-approved products maintained by the CDC and a supplemental vaccine safety monitor-ing initiative by the FDA—provide further confi-dence that the current childhood immunization schedule is safe. Despite the reassuring available evidence, the committee calls for continued study of the immu-nization schedule using existing data systems. Answering research questions of the most importance to stakeholders could be done through

3

that monitors potentially rare and serious side effects after vaccines are marketed, is the best available system for studying the U.S. immuniza-tion schedule. VSD data represent more than 9 million children and adults—roughly 3 percent of the U.S. population—and include medical details, such as the diagnoses and procedures associated with outpatient, inpatient, and urgent care vis-its. For this reason, the committee concludes that the VSD is currently the best available system for studying the childhood immunization schedule. The committee notes one potential limitation of the VSD: children who are immunized with alternative vaccination schedules may differ in meaningful ways from children who adhere to the schedule, and these differences could make it difficult to tease out health differences that are attributable to the immunization schedule. In order to bridge such data gaps, the VSD sys-tem could be modified to enable new analyses of important questions, participants could be asked additional questions, and medical records could be reviewed. The federal government also should continue to build on this component of its robust vaccine safety net by enhancing the quality of VSD’s demographic information and including more diversity in its study populations.

Conclusion

Since the late 1970s, IOM committees have con-ducted more than 60 studies of vaccine safety, attesting to society’s sustained interest in safely

Upon reviewing stakeholder concerns and scientific literature regarding the entire childhood immunization schedule, the IOM committee finds no evidence that the schedule is unsafe.

a variety of methods. The committee does not endorse conducting a new randomized controlled clinical trial that would compare the health out-comes of unvaccinated children with their fully immunized peers. Although this is the strongest study design type, ethical concerns prohibit this study, as unvaccinated individuals and commu-nities intentionally would be left vulnerable to morbidity and mortality. While stakeholder con-cerns should be one, but not the only, element that drives continued searches for scientific evidence, the committee writes that these concerns alone, absent epidemiological or biological plausibility of potential safety problems, do not warrant fur-ther study. A new observational study, a complex under-taking that also would require a considerable investment, would be less likely than a random-ized controlled clinical trial to conclusively reveal differences in health outcomes between children who are fully immunized and unimmunized chil-dren. Fewer than 1 percent of Americans refuse all immunizations. Enrolling sufficient numbers of unvaccinated children and matching them with vaccinated children of the same age, gender, eth-nicity, and geographic location—a necessary step to rule out chance findings—would be prohibi-tively difficult and time-consuming. The IOM committee finds analysis using exist-ing databases to be the most feasible approach to studying the safety of the childhood immuniza-tion schedule. It concludes that the Vaccine Safety Datalink (VSD), a collaborative effort between the CDC and nine managed care organizations

The Institute of Medicine serves as adviser to the nation to improve health. Established in 1970 under the charter of the National Academy of Sciences,

the Institute of Medicine provides independent, objective, evidence-based advice to policy makers, health professionals, the private sector, and the public.

Copyright 2013 by the National Academy of Sciences. All rights reserved.

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Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule

Karen Helsing Study Director

Suzanne Landi Research Associate

Chelsea Frakes Research Assistant

Rose Marie MartinezSenior Director, Board on Population Health and Public Health Practice

Study Staff

Study Sponsor

Department of Health and Human Services

Ada Sue Hinshaw (Chair) Uniformed Services University of the Health Sciences, Bethesda, MD

Tomás J. Aragón San Francisco Department of Public Health, CA

Alfred Berg University of Washington School of Medicine, Seattle

Stephen L. Buka Brown University, Providence, RI

R. Alta Charo University of Wisconsin Law School, Madison (until August 2012)

Gerry Fairbrother AcademyHealth, Washington, DC

Elena Fuentes-Afflick University of California, San Francisco

Sidney M. Gospe, Jr. University of Washington School of Medicine, Seattle

Paul A. Greenberger Northwestern University Feinberg School of Medicine, Chicago, IL

Daniel F. Heitjan University of Pennsylvania Perelman School of Medicine, Philadelphia

Annette C. Leland Independent, Washington, DC

Pejman Rohani University of Michigan, Ann Arbor

Lainie Friedman Ross University of Chicago, IL

Pauline A. Thomas New Jersey Medical School, Newark

vaccinating populations from preventable disease. This committee’s report is unique in that it is the first to attempt to examine the entire childhood immunization schedule as it exists today. In this most comprehensive examination of the immunization schedule to date, the IOM commit-tee uncovered no evidence of major safety concerns associated with adherence to the childhood immu-nization schedule, which should help to reassure a diverse group of stakeholders. Indeed, rather than exposing children to harm, following the complete childhood immunization schedule is strongly asso-ciated with reducing vaccine-preventable diseases. As scientific advances continue and new vac-cines are developed, the childhood immunization schedule may grow even more complex. Looking to the future, the IOM supports HHS’s efforts to ensure that stakeholders are more fully involved in addressing benefits and concerns regarding the safety of the childhood immunization schedule. f