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Risky Business: Talking to Parents about Vaccines. NC Immunization Conference August 2011 Kristina Simeonsson, MD, MSPH Karin Hillenbrand, MD The Brody School of Medicine at ECU. Educational Objectives. Recognize factors that contribute to the controversy surrounding vaccines

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Risky business talking to parents about vaccines

Risky Business: Talking to Parents about Vaccines

NC Immunization Conference

August 2011

Kristina Simeonsson, MD, MSPH

Karin Hillenbrand, MDThe Brody School of Medicine at ECU


Educational objectives
Educational Objectives

  • Recognize factors that contribute to the controversy surrounding vaccines

  • Incorporate principles of “risk communication” when discussing immunization with parents

  • Identify the most common concerns parents have about vaccines

  • Develop an approach for counseling the vaccine-hesitant parent


Mmr vaccine gets a bad reputation
MMR Vaccine Gets a Bad Reputation

  • Wakefield “study” published in 1998

    • Case series of 8 children whose symptoms of autism appeared within one month of receiving MMR vaccine



Offit PA, Coffin SE; four separate pieces of dataVaccine 2003


Background parents
Background: Parents four separate pieces of data

  • Parents’ perceptions about the dangers of vaccines is key in their decision to have their child vaccinated

  • Lack of disease awareness prompts greater reluctance to accept adverse reactions

  • Consumerism is on the rise

  • Parents often trust information from the media, regardless of the source


Parental perspectives on vaccine
Parental Perspectives on Vaccine four separate pieces of data

Freed et al, Pediatrics 2010


Background providers
Background: Providers four separate pieces of data

  • Providers vary in their delivery of information about vaccines

    • may be uninformed, dismissive, disparaging

  • Providers may send mixed messages

    • invoke policies that conflict with our own science

      • thimerosal removed

    • publication of flawed studies

    • publication of popular parenting books


Wakefield study retracted
Wakefield Study Retracted four separate pieces of data

  • Case series was not consecutive

  • Data on timing of autistic features and gastrointestinal symptoms was altered

  • Study was funded by lawyers

  • Children were put through invasive procedures without appropriate consent


Background media
Background: Media four separate pieces of data

  • Increased access to information and misinformation

    • Volume of non-science-based material exceeds that from reliable sources

  • 24/7 news is a business industry

    • Controversy and bad news attract a larger audience

    • “Balanced coverage” can mean giving equal time to outlier views

  • Social networking

  • Celebrity science


Pertussis outbreak in chapel hill february 2009
Pertussis Outbreak in Chapel Hill four separate pieces of dataFebruary 2009

Cases Of Whooping Cough Plague Chapel Hill-Carrboro Schools

Whooping Cough Outbreaks Show Vaccine’s Limits


Mmr controversy in the united kingdom
MMR Controversy in the United Kingdom four separate pieces of data

More than 50% of parents interviewed believed that equal evidence existed for both sides of the debate

Less than 25% were aware that bulk of evidence favors supporters of the vaccine

Hargraves et al, Economics and Research Council, 2003


Refusal versus hesitancy
Refusal versus Hesitancy four separate pieces of data

  • Many parents express concerns about the safety of vaccines and should not automatically be categorized as being staunchly anti-vaccination


Parental report of level of trust of certain people for vaccine safety information
Parental Report of Level of Trust of Certain People for Vaccine Safety Information

Freed GL et al, Pediatrics 2011


Responding to parent concerns
Responding to Parent Concerns Vaccine Safety Information

  • Explore and address parental concerns

    • May need to discuss vaccines separately

  • Provide parents with risk and benefit information necessary to make an informed decision

  • Correct an misinformation or misperceptions that exist

    • 25% of parents falsely believe that the immune system could become weakened by too many vaccines

Diekema D and the Committee on Bioethics, Pediatrics 2005


Communication strategies
Communication Strategies Vaccine Safety Information

  • Improve communication skills of public and private health leaders

  • Present information in perspective

  • Avoid obfuscation

  • Admit gaps in knowledge

  • Be available and candid in answering questions

  • Invest in research on what is truly driving parents’ questions and concerns

Cooper LZ, Larson HJ, Katz SL. Pediatrics, 2008


Risk communication
Risk Communication Vaccine Safety Information

  • Developed from the need to find more effective ways to communicate health risks

  • Goal is to provide information about expected type and magnitude of an outcome from a behavior or exposure

  • The purpose of the message is to empower decision-making


Sandman s model of public perception of risk
Sandman’s Model of Public Perception of Risk Vaccine Safety Information

  • Hazard

    • Scientific estimation of mortality or morbidity

  • Outrage

    • Factors that make the public worried, angry, frightened or otherwise upset


Not all risks are created equal

Voluntary Vaccine Safety Information

Familiar

Natural origin

Adult

Understood benefit

Involuntary

Exotic

Manmade

Children

Questionable benefit

Not All Risks Are Created Equal

Crisis and Emergency Risk Communication

Centers for Disease Control and Prevention, September 2002


Principles of emergency risk communication
Principles of Emergency Risk Communication Vaccine Safety Information

  • Stop trying to allay panic

  • Emphasize there is a process in place

  • Don’t over reassure

  • Acknowledge uncertainty

  • Acknowledge people’s fears

  • Express wishes

  • Give people things to do

  • Acknowledge the shared misery

  • Give anticipatory guidance

  • Address dreaded “what if” questions

  • Be a role model and ask more of people

  • Be regretful

Crisis and Emergency Risk Communication

Centers for Disease Control and Prevention, September 2002


Principles of emergency risk communication1
Principles of Emergency Risk Communication Vaccine Safety Information

  • Stop trying to allay panic

  • Emphasize there is a process in place

  • Don’t over reassure

  • Acknowledge uncertainty

  • Acknowledge people’s fears

  • Express wishes

  • Give people things to do

  • Acknowledge the shared misery

  • Give anticipatory guidance

  • Address dreaded “what if” questions

  • Be a role model and ask more of people

  • Be regretful


Emphasize a process is in place
Emphasize a Process is in Place Vaccine Safety Information

  • There is a process to monitor vaccine safety.

    • pre- and post-licensure vaccine safety surveillance

      • Vaccine trials

      • Vaccine Safety Datalink

      • Vaccine Adverse Event Reporting System


Don t over reassure
Don’t Over Reassure Vaccine Safety Information

  • Speak openly and honestly about the side effects and risks of vaccines


Acknowledge uncertainty
Acknowledge Uncertainty Vaccine Safety Information

  • Offer what you know versus what you don’t know

    • We don’t know the cause(s) of autism

    • We do know multiple independent studies have shown no link between autism and MMR

    • We do know multiple independent studies have shown no link between thimerosal and autism


Acknowledge people s fears
Acknowledge People’s Fears Vaccine Safety Information

  • Even when fear is unjustified…

    • it doesn’t respond well to being ignored

    • It doesn’t respond well to criticism

    • It doesn’t respond well to statistics


Give people things to do
Give People Things to Do Vaccine Safety Information

  • Encourage parents to review educational material that you trust and agree to discuss at next visit

  • Provide references that are parent and provider friendly

  • Refer parents to websites that are parent and provider friendly


Give anticipatory guidance
Give Anticipatory Guidance Vaccine Safety Information

  • If you are aware of future negative outcomes, let people know what to expect

    • Risks of disease

    • Spread of disease to other vulnerable individuals

    • Possibility of isolation / quarantine during outbreaks


Be a role model and ask more of people
Be a Role Model and Ask More of People Vaccine Safety Information

  • May want to mention that you are up to date on your vaccines…

  • May want to mention that your children, grandchildren, nieces, nephews, etc. are vaccinated

  • Ask people to help you provide a community where children are safer from diseases


No benefit
No Benefit…? Vaccine Safety Information

  • Vaccines are a victim of their own success!

  • Never seen, rarely hear about

    • If we give a bunch of children vaccines, and no one catches anything, where’s the news in that?

  • Risk from disease is low

  • Risk of disease is low


Counseling parents
Counseling Parents Vaccine Safety Information

  • Vaccine Information Statements (VIS)

  • available from CDC,

  • Immunization Action Coalition


Do we still need vaccines
Do we still need vaccines? Vaccine Safety Information

  • common diseases: serious sequelae

    • pertussis, pneumococcus, chickenpox, hepatitis

  • rare but persistent disease: drop in vaccine coverage will cause resurgence

    • measles, mumps, rubella, H.flu type b, tetanus

  • disease eliminated from US: “only a plane ride away”

    • polio, diphtheria, (smallpox)


Too many vaccines
Too Many Vaccines? Vaccine Safety Information

  • in a national survey of parents:

    • 23% questioned the number of shots given to children

    • 25% were convinced vaccines weaken the immune system

Gellin BG, Maibach EW, Marcuse EK. Pediatrics. 2000.


Do multiple vaccines overwhelm the immune system
Do multiple vaccines overwhelm the immune system? Vaccine Safety Information

  • vaccine antigens are a very small subset of the environmental exposures for the immune system

  • ability to respond to extremely large numbers of distinct microbes

    • able to generate protective immune responses to multiple vaccines at once

  • vaccinated children get fewer infections (both vaccine-preventable and unrelated)


Are infants too young to get vaccines
Are infants too young to get vaccines? Vaccine Safety Information

  • newborns can mount an immune response from birth

  • serious diseases may affect young infants


Alternative and delayed schedules
Alternative and Delayed Schedules Vaccine Safety Information

  • Schedules designed to delay vaccine administration incur risks:

    • susceptible to disease for a longer time period

    • no evidence for benefit; unknown effect on efficacy

    • increased opportunities for known side effects

    • some single-ingredient vaccines not available

    • extra visits = extra time and cost


Isn t natural immunity better

YES... Vaccine Safety Information

immunity after disease follows a single infection; vaccine immunity may require several doses, and/or boosters

Isn’t natural immunity better?


Isn t natural immunity better1

…and NO Vaccine Safety Information

the cost is pain, discomfort and the potential for complications, disability, death

vaccines are one of the safest most effective disease prevention tools known

Isn’t natural immunity better?

  • worldwide most deaths from vaccine-preventable diseases occur in children with healthy immune systems

  • for some diseases immunity from vaccine is superior


What about my right to decide the law in north carolina
What about my right to decide? The Law in North Carolina Vaccine Safety Information

GS 130A-152(a): Every child in this state shall be immunized… Parent shall have the responsibility…

GS 130A-155(a): No child shall attend school, whether public, private, or religious, or a child care facility unless [immunized]…The principal or operator shall not permit the child to attend

GS 130A-155.1: No person shall attend college…unless [immunized]


School attendance
School Attendance Vaccine Safety Information

NCAC 41A .0401

  • Required vaccines

    • Diphtheria, tetanus, pertussis – 5 doses

      • Tdap: 6th grade; Td booster within 10 yrs: college

    • Polio – 4 doses

    • Measles, Mumps – 2 doses

    • Rubella – 1 dose

    • Varicella – 1 dose

    • Hepatitis B – 3 doses

    • H. influenzae B – 4 (3) doses


Exemptions
Exemptions Vaccine Safety Information

NCAC 41A .0401

Medical (NC 130A-156)

Religious (130A-157)

There is no exception to these requirements for the case of a personal belief or philosophy or a parent or guardian not founded upon a religious belief.


Medical exemption
Medical Exemption Vaccine Safety Information

  • permitted when a physician determines that an immunization may be harmful

  • must be written and signed by a NC licensed physician

  • must correspond to medical contraindications specified in NC Immunization rules, or receive an approved exception from the State Health Director

  • must maintain documentation in student’s permanent record


Religious exemption
Religious Exemption Vaccine Safety Information

  • “bona fide religious objection”

  • no form for requesting religious exemption in North Carolina

  • parent must provide a written, signed statement of the bona fide beliefs and their opposition to immunization in the student’s permanent record

    • not required to be notarized, signed by a religious leader, prepared by an attorney, or submitted to the state for review


Religious objection to vaccines
Religious Objection to Vaccines Vaccine Safety Information

  • Member of a religion that prohibits vaccination

    • Christian Science

  • Fetal tissues

    • some vaccines are made in human cell line cultures; some cell-line cultures originated from aborted fetal tissue obtained from legal therapeutic abortion in the 1960’s

  • Porcine additives

    • Islamic and Jewish law


Compulsory vs mandatory
Compulsory vs Mandatory Vaccine Safety Information

Offit. Deadly Choices. 2011

  • compulsory: people who refuse are forcibly vaccinated

    • right to refuse?

  • mandatory: people who refuse are denied social privileges (like attending school)

    • right to impose the risk on others?


Are vaccines safe
Are Vaccines Safe? Vaccine Safety Information

  • No vaccine (and no medication) is completely risk free

    • common mild side effects: pain, tenderness, redness

    • rare, serious side effects: anaphylaxis, thrombocytopenia

  • Act of commission or omission: active or passive role?

  • Because vaccines are given to healthy children, they must be as safe as possible:

    Benefit must clearly outweigh risk


Benefit vs risk hepatitis b
Benefit vs. Risk: Vaccine Safety InformationHepatitis B

  • Risk:

    • anaphylaxis: 1 in 600,000

    • no reported deaths

  • Benefit:

    • 5000 deaths/yr; 10,000 with cirrhosis or cancer

    • severe and fatal consequences more common in the young

    • 1 million people in US infected and asymptomatic

    • prior to vaccine, 18,000 children/yr in US caught Hepatitis B from someone other than their mothers


Benefit vs risk rotavirus
Benefit vs Risk: Rotavirus Vaccine Safety Information

  • Risk (RotaShield):

    • 1 million children vaccinated

    • 102 cases of intussusception: 1 in 10,000

    • 1 death

  • Benefit

    • US: 100,000 hospitalizations, 50-100 deaths/year

      • per million children: 16,000 hospitalizations, 5-10 deaths

    • most important cause of life-threatening diarrhea worldwide

      • >870,000 children under 5 years die each year


Change in risk benefit
Change in risk/benefit Vaccine Safety Information


Monitoring for safety
Monitoring for Safety Vaccine Safety Information

  • Pre-licensure testing

  • Post licensure monitoring

  • Lot testing

  • Vaccine Adverse Event Reporting System (VAERS)

  • Clinical Immunization Safety Assessment Centers (CISA)

  • Vaccine Safety Datalink (VSD)


Vaccines are not completely safe, but they are as safe as we can make them, far safer than most medications, and better than the diseases they prevent


Can vaccines cause chronic diseases like
Can vaccines cause chronic diseases like… can make them, far safer than most medications, and better than the diseases they prevent

  • infantile spasms? (pertussis)

  • autism? (measles/MMR)

  • diabetes? (Hib, BCG)

  • allergies and asthma? (pertussis, tetanus)

  • multiple sclerosis (Hep B, influenza, tetanus)

  • hemolytic anemia (DTP)

  • brain damage (polio, Hep B)

  • ITP (Hep B)

  • chronic arthritis (Hep B, Lyme)

  • SIDS? (Hep B, pertussis)


Vaccines and chronic disease
Vaccines and Chronic Disease can make them, far safer than most medications, and better than the diseases they prevent

  • Concerns arise because:

    • children receive many vaccines during the first 2 years

    • most children in the US are vaccinated

    • therefore most US children who develop chronic disease during childhood have received vaccines (often recently)

  • BUT:

    • sequence  consequence

    • not all potential associations have been studied but many have

    • multiple independent studies have shown no link between chronic disease and vaccines

    • no noted trend for an increase or decrease in a disease as vaccination increases or decreases over time


Mmr and autism
MMR and Autism can make them, far safer than most medications, and better than the diseases they prevent

Honda H, Shimizu Y, Rutter M. J Child Psych 2005.


Hepatitis b and sids
Hepatitis B and SIDS can make them, far safer than most medications, and better than the diseases they prevent


Refuting evidence
Refuting Evidence can make them, far safer than most medications, and better than the diseases they prevent

  • When disease follows vaccination, it occurs with a rate that can be predicted by chance alone

  • Cohort and case-control studies show no evidence of causality between vaccines and chronic disease

  • In some cases, vaccines are probably protective against these diseases

  • Practitioners must be aware of popular media, public health information, and changing recommendations, and have access to valid alternative sources of information for parents.


What about other ingredients in vaccines
What About Other Ingredients in Vaccines? can make them, far safer than most medications, and better than the diseases they prevent

  • preservatives

  • adjuvants

  • stabilizing additives

  • manufacturing residuals

    • antibiotics

    • formaldehyde

    • egg protein

    • yeast

  • Additives are present in very small amounts, but each is present for a reason


Preservatives thimerosal
Preservatives: thimerosal can make them, far safer than most medications, and better than the diseases they prevent

  • mercury-based preservative used since 1930’s

  • methylmercury is neurotoxic; vaccines contained ethylmercury

  • FDA modernization act of 1997: assess Hg content of all food and drugs

    • no distinction made between ethyl- and methylmercury

  • no adverse effects EVER attributed to vaccine thimerosal

  • except for some formulations of influenza, no routine pediatric vaccines in US now contain thimerosal


Adjuvants aluminum
Adjuvants: aluminum can make them, far safer than most medications, and better than the diseases they prevent

  • adjuvants enhance the immune response

  • aluminum salts only adjuvant in childhood vaccines in US

  • aluminum is ubiquitous in the environment: a major component of the earth’s crush, and found in air, food, and water.

    • breastmilk and formula contain aluminum

  • safety well established


Stabilizers gelatin
Stabilizers: gelatin can make them, far safer than most medications, and better than the diseases they prevent

  • stabilizers protect viruses from adverse conditions (freeze drying, heat)

  • all gelatin in vaccines is porcine

  • risk of allergic reaction

    • most common identifiable cause of acute hypersensitivity reaction to vaccines

    • extremely low, 1 in 2 million doses

    • history of allergy to foods containing gelatin is a contraindication to vaccines with gelatin


Antibiotics
Antibiotics can make them, far safer than most medications, and better than the diseases they prevent

  • antibiotics prevent bacterial contamination during manufacturing process

  • neomycin, polymyxin B, streptomycin, gentamicin; only neomycin is contained in vaccines in detectable quantities

    • never clearly found to cause allergic reaction to vaccination

    • reaction is delayed type hypersensitivity: SQ nodule


Formaldehyde
Formaldehyde can make them, far safer than most medications, and better than the diseases they prevent

  • used to detoxify, sterilize

  • essential metabolite for DNA synthesis, but known to damage DNA in high concentrations

  • all humans have detectable formaldehyde in blood

  • causes cancerous changes in cells in the lab; never shown to be a cause of cancer in man

  • diluted during manufacture, but residual amounts found in some vaccines

  • amount in vaccines considered safe


Egg protein
Egg Protein can make them, far safer than most medications, and better than the diseases they prevent

  • egg allergy occurs in 0.5% of all kids and 5% of atopic kids

  • influenza and yellow fever vaccines contain egg protein

    • if anaphylaxis to egg, vaccine is contraindicated

    • MMR does not contain egg


Yeast
Yeast can make them, far safer than most medications, and better than the diseases they prevent

  • Hepatitis B made in Baker’s yeast

  • anaphylaxis occurs rarely after HepB vaccination (1 in 600,000)

  • allergy to yeast not apparently the cause

    • IgE to yeast never found in a recipient


These are not in vaccines
These are can make them, far safer than most medications, and better than the diseases they preventNOT in vaccines...

Learn more about additives: vaccine.chop.edu.

antifreeze

aborted human fetus cells

chick embryos

monkey kidneys

fetal bovine serum


Sources for vaccine safety information
Sources for can make them, far safer than most medications, and better than the diseases they preventVaccine Safety Information

  • Vaccine Education Center – CHOP

    • vaccine.chop.edu

  • Institute for Vaccine Safety – Johns Hopkins

    • www.vaccinesafety.edu

  • Vaccine Safety and Adverse Events – CDC

    • www.cdc.gov/vaccinesafety/

  • Vaccine Safety Info for Families – AAP

    • www.aap.org/immunization/families/safety.html


An approach to the parent who refuses vaccines
An Approach to the Parent Who Refuses Vaccines… can make them, far safer than most medications, and better than the diseases they prevent

Listen

Acknowledge fears, and parents’ right to decide

Identify specific concerns, and provide a targeted, accurate response

State your recommendation clearly, but be nonconfrontational.

Avoid scientific lectures

Recommend valid websites and books


If parents still refuse
If parents still refuse? can make them, far safer than most medications, and better than the diseases they prevent

  • Voice respect for their opinion

  • Agree to readdress at future visits

  • Give some vaccines if you can

    • Document discussion in the healthcare record, and status in NCIR

  • Remember: All children deserve quality medical care


Summary
Summary can make them, far safer than most medications, and better than the diseases they prevent

  • Many parents have questions or concerns about childhood vaccines.

  • Most parents have great faith in their child’s provider

  • Most parents readily accept recommendations about vaccination

  • Most parents weigh risk and benefit, and determine that vaccines are right for their child and for society

  • When parents are concerned about vaccines, we must find out why and address their concerns


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