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Immunization Concerns:Separating Fact from FictionSeparating Fact from Fiction

Nancy R. Kelly MD, MPHUT Southwestern Medical Center

OutlineOutline

Public health impact of vaccinesPublic health impact of vaccines

Vaccine schedules Vaccine schedules

School requirementsSchool requirements

ffVaccine refusalVaccine refusal

General vaccine concernsGeneral vaccine concerns

Common vaccineCommon vaccine--specific concernsspecific concerns

Reputable and notReputable and not--soso--reputable resourcesreputable resources

Public Health ImpactPublic Health ImpactVaccines are one of the greatest success stories Vaccines are one of the greatest success stories in modern medicine.in modern medicine.

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Recommendations Recommendations Advisory Committee for Advisory Committee for

Immunization Practices (ACIP)Immunization Practices (ACIP)

Recommendations Recommendations Advisory Committee for Advisory Committee for

Immunization Practices (ACIP)Immunization Practices (ACIP)

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Why Do Parents Refuse Why Do Parents Refuse Vaccines?Vaccines?

MisperceptionsMisperceptions–– Child not susceptible to diseaseChild not susceptible to disease

–– Disease not seriousDisease not serious

–– Vaccines don’t workVaccines don’t work

–– Vaccines not safeVaccines not safe

Parents don’t want to do anything that Parents don’t want to do anything that might harm their childmight harm their child

When Parents Refuse VaccinesWhen Parents Refuse Vaccines

Listen to their specific concernsListen to their specific concerns

Address parental concernsAddress parental concerns

Provide information from reputableProvide information from reputableProvide information from reputable Provide information from reputable sourcessources

Know websites and resources parents are Know websites and resources parents are usingusing

Help parents feel their decision to Help parents feel their decision to vaccinate is the right onevaccinate is the right one

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Puts individual child at risk of disease

Puts community at risk of disease

Problems with Vaccine Problems with Vaccine RefusalRefusal

outbreaks– 95% vaccination rate needed for “herd

immunity”

– Some individuals can’t get vaccinated or don’t respond to vaccine

General Vaccine Concerns

Concern

“I don’t think vaccines are safe. How are they tested and monitored?”

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Vaccine Safety Vaccine Safety -- LicensureLicensure

Vaccines must be FDA approved for use Vaccines must be FDA approved for use in the USin the US–– Process takes up to 10 years! Process takes up to 10 years! –– Animal studiesAnimal studies–– Human clinical trials Human clinical trials –– Review by FDA (studies, vaccine plant Review by FDA (studies, vaccine plant

inspection)inspection)–– Licensure by FDALicensure by FDA–– Monitoring of samples from each vaccine lotMonitoring of samples from each vaccine lot

Vaccine Safety Vaccine Safety -- MonitoringMonitoring

The Vaccine Adverse Event Reporting The Vaccine Adverse Event Reporting System (VAERS) System (VAERS)

–– National program of CDC and the FDANational program of CDC and the FDA

–– Monitors safety of vaccines after licensureMonitors safety of vaccines after licensure

–– Anyone can report a problem after a vaccineAnyone can report a problem after a vaccine

–– Method of detecting possible adverse effectsMethod of detecting possible adverse effects

–– Doesn’t prove vaccine caused problemDoesn’t prove vaccine caused problem

Vaccine Safety Vaccine Safety -- MonitoringMonitoring

Vaccine Safety DatalinkVaccine Safety Datalink–– Created by CDC Created by CDC

–– Partnerships with 8 large HMOsPartnerships with 8 large HMOs

–– Patients’ medical records used to analyze Patients’ medical records used to analyze vaccine related informationvaccine related information

–– 5.5 million people in WA, OR, CA, CO, MN, MA5.5 million people in WA, OR, CA, CO, MN, MA

–– Compare outcomes in vaccinated vs. Compare outcomes in vaccinated vs. unvaccinated childrenunvaccinated children

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ConcernConcern“Vaccines Don’t Work”“Vaccines Don’t Work”

If vaccines works so well, then why do If vaccines works so well, then why do vaccinevaccine--preventable diseases occur morepreventable diseases occur morevaccinevaccine--preventable diseases occur more preventable diseases occur more often in vaccinated people than often in vaccinated people than unvaccinated?unvaccinated?

100 college students living in dorm 100 college students living in dorm

95 vaccinated95 vaccinated 5 not vaccinated5 not vaccinated

MEASLES OUTBREAKMEASLES OUTBREAK

6/95 (6%) 6/95 (6%) 4/5 (80%)4/5 (80%)

get measlesget measles get measlesget measles

Unvaccinated people were 35 x more likely to get Unvaccinated people were 35 x more likely to get measles than vaccinated measles than vaccinated ((JAMAJAMA, July 1999), July 1999)

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ConcernConcern“ Vaccines aren’t Necessary”“ Vaccines aren’t Necessary”

Since almost everyone else is immunized, Since almost everyone else is immunized, and there is not much disease going and there is not much disease going around why doesaround why does mymy child have to bechild have to bearound, why does around, why does mymy child have to be child have to be immunized?immunized?

ConcernConcern“Vaccines aren’t Necessary”“Vaccines aren’t Necessary”

Three good reasons:Three good reasons:–– prevalent diseases (ex: prevalent diseases (ex: pertussispertussis) a child is at ) a child is at

high risk if not vaccinatedhigh risk if not vaccinated

less common diseases still present inless common diseases still present in–– less common diseases, still present in less common diseases, still present in environment (ex: environment (ex: measlesmeasles) outbreaks occur ) outbreaks occur when immunization rates decrease.when immunization rates decrease.

–– diseases eliminated from our country (diseases eliminated from our country (poliopolio), ), outbreaks still occur in other countries and outbreaks still occur in other countries and can cause disease in the US given increased can cause disease in the US given increased international travel.international travel.

ConcernConcern“Babies are Too Young to Get “Babies are Too Young to Get

Vaccinated”Vaccinated”

I would rather wait until my baby gets older I would rather wait until my baby gets older and stronger to give him his and stronger to give him his immunizationsimmunizationsimmunizations. immunizations.

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ConcernConcern“Babies are Too Young to Get “Babies are Too Young to Get

Vaccinated”Vaccinated”

Infants are vaccinated to protect them Infants are vaccinated to protect them from disease when they are most from disease when they are most

tibltiblsusceptiblesusceptible–– Pertussis Pertussis –– infects 8000/yr and kills 5infects 8000/yr and kills 5--10 in 10 in

the US, most under 1 year of agethe US, most under 1 year of age

–– Children < 2 at greatest risk for Haemophilus Children < 2 at greatest risk for Haemophilus influenza B (Hib) infectioninfluenza B (Hib) infection

ConcernConcern“Is it Better to be Naturally Infected “Is it Better to be Naturally Infected

than Immunized?”than Immunized?”Wouldn’t it be better for my child just to get Wouldn’t it be better for my child just to get natural disease rather than the vaccination natural disease rather than the vaccination and then have better immunity against that and then have better immunity against that disease?disease?disease? disease?

ConcernConcern“Is it Better to be Naturally Infected “Is it Better to be Naturally Infected

than Immunized?”than Immunized?”Natural infection causes better immunity than Natural infection causes better immunity than vaccination (exceptions: Hib, pneumococcal and vaccination (exceptions: Hib, pneumococcal and tetanus)tetanus)Vaccines require several dosesVaccines require several dosesVaccines require several doses Vaccines require several doses Trade off for better immunity is risk of morbidity Trade off for better immunity is risk of morbidity from natural infection from natural infection –– paralysis from polioparalysis from polio–– mental retardation from Hibmental retardation from Hib–– liver failure from hepatitis Bliver failure from hepatitis B–– deafness from mumpsdeafness from mumps–– pneumonia from Varicellapneumonia from Varicella

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ConcernConcernIllness and VaccinationIllness and Vaccination

My child has a cold and I don’t think she My child has a cold and I don’t think she should get her vaccinations today.should get her vaccinations today.

ConcernConcernIllness and VaccinationIllness and Vaccination

Mild illness NOT a contraindication to Mild illness NOT a contraindication to getting vaccinesgetting vaccines–– Represents a missed vaccine opportunityRepresents a missed vaccine opportunity

No increased risk of adverse effectsNo increased risk of adverse effects–– No increased risk of adverse effects No increased risk of adverse effects –– No evidence of decreased immune response No evidence of decreased immune response

Moderate or severe illness, with or without Moderate or severe illness, with or without fever is reason to delay vaccinesfever is reason to delay vaccines–– Evolving signs of illness may be confused Evolving signs of illness may be confused

with an adverse reaction to vaccinewith an adverse reaction to vaccine

ConcernConcern“Should I Use an ‘Alternate’ or “Should I Use an ‘Alternate’ or

‘Selective’ Immunization Schedule?”‘Selective’ Immunization Schedule?”

Alternate schedules Alternate schedules -- Delay vaccines Delay vaccines Selective schedules Selective schedules –– Defer some vaccines Defer some vaccines No evidence that vaccines given at age <2 No evidence that vaccines given at age <2 years are harmful to recipientyears are harmful to recipientSome of most serious childhood illnesses Some of most serious childhood illnesses attack children < 2 yearsattack children < 2 yearsNo evidence that giving multiple vaccines No evidence that giving multiple vaccines at one time is harmfulat one time is harmful

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VaccineVaccine--Specific ConcernsSpecific ConcernsVaccineVaccine--Specific ConcernsSpecific Concerns

What vaccine should be given to this What vaccine should be given to this newborn baby prior to discharge from the newborn baby prior to discharge from the hospital?hospital?

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ConcernConcern

““If I don’t have Hepatitis B, why should I immunize my baby at birth?

She will not be sexually active for yyears.”

Hepatitis B Hepatitis B –– Virus transmitted via blood or body fluidsVirus transmitted via blood or body fluids

–– causes liver disease causes liver disease

PersonPerson toto person spread can occur withperson spread can occur with

Hepatitis BHepatitis B

PersonPerson--toto--person spread can occur with person spread can occur with close close nonnon--sexualsexual contactcontact–– Virus can survive in environment >1 week Virus can survive in environment >1 week

–– Transmission can occur by sharing Transmission can occur by sharing washcloths, razors, toothbrusheswashcloths, razors, toothbrushes

–– Some people with hepatitis B don’t have Some people with hepatitis B don’t have symptoms but still can spread diseasesymptoms but still can spread disease

A healthy 2 month old girl is seen at the local A healthy 2 month old girl is seen at the local health department for her vaccinations. She health department for her vaccinations. She received hepatitis B vaccine at birth.received hepatitis B vaccine at birth.

What immunizations does she need today?What immunizations does she need today?

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ConcernConcern““I don’t want my baby to get I don’t want my baby to get

rotavirus vaccine. I heard it causes rotavirus vaccine. I heard it causes bloody diarrhea”bloody diarrhea”

Rotavirus – Causes vomiting and diarrhea

– Risk of dehydration in young

Intussusception – a condition in which one portion of the intestine telescopes into a nearby portion causing intestinal obstruction

ConcernConcernRotavirus Vaccine & IntussusceptionRotavirus Vaccine & Intussusception

RotashieldRotashield®® rotavirus vaccine tested in 10,054 rotavirus vaccine tested in 10,054 children before licensed in 1998children before licensed in 1998

Vaccine given to 1 million children (1998Vaccine given to 1 million children (1998 1999)1999)Vaccine given to 1 million children (1998Vaccine given to 1 million children (1998--1999)1999)

15 cases of intussusception in infants after 15 cases of intussusception in infants after receipt of vaccine reported to VAERSreceipt of vaccine reported to VAERS

Vaccine attributable risk ~ 1/11,000Vaccine attributable risk ~ 1/11,000

RotashieldRotashield®® taken off the market in 1999taken off the market in 1999

Example of how VAERS surveillance worksExample of how VAERS surveillance works

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New Rotavirus VaccineNew Rotavirus Vaccine

RotaTeqRotaTeq® ®

–– licensed in 2006 licensed in 2006 –– PrePre--licensure clinical trial >70,000 infantslicensure clinical trial >70,000 infants

PostPost licensure studieslicensure studies NO increased risk ofNO increased risk of–– PostPost--licensure studies licensure studies -- NO increased risk of NO increased risk of intussusceptionintussusception

–– Decreased need for hospitalization or ED visit by Decreased need for hospitalization or ED visit by 85%85%

Another New Rotavirus Another New Rotavirus VaccineVaccine

RotarixRotarix®®

–– licensed in 2008licensed in 2008

–– Requires only 2 dosesRequires only 2 doses

Recent data from studies in Mexico suggestRecent data from studies in Mexico suggest–– Recent data from studies in Mexico suggest Recent data from studies in Mexico suggest slight increased risk of intussusception after 1slight increased risk of intussusception after 1stst

dose (1/100,000)dose (1/100,000)

–– Risk of serious rotavirus disease > risk of Risk of serious rotavirus disease > risk of intussusceptionintussusception

–– Vaccine label changed to reflect slight increased Vaccine label changed to reflect slight increased riskrisk

ConcernConcern“I don’t want to get the flu shot “I don’t want to get the flu shot because it will make me sick.”because it will make me sick.”

Can the flu shot cause the flu in otherwise Can the flu shot cause the flu in otherwise healthy individuals?healthy individuals?healthy individuals?healthy individuals?

NO!NO!

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Influenza VaccineInfluenza Vaccine

InfluenzaInfluenza–– Contagious seasonal viral respiratory infectionContagious seasonal viral respiratory infection

Two Immunization MethodsTwo Immunization MethodsTwo Immunization MethodsTwo Immunization Methods–– InjectionInjection

Inactivated trivalent influenza vaccine (TIV)Inactivated trivalent influenza vaccine (TIV)

contains only noncontains only non--infectious virusinfectious virus

–– Nasal SprayNasal SprayLive attenuated influenza vaccine (LAIV)Live attenuated influenza vaccine (LAIV)

weakened virus can’t replicate in the lungsweakened virus can’t replicate in the lungs

Influenza VaccineInfluenza Vaccine

Is it possible to get the flu if you received an influenza vaccine?

YES !YES !

Vaccine strains may not match circulating viral strainsIndividuals may not mount adequate immune responseTakes ~ 2 weeks to mount a response

A healthy 11 year old girl comes to the health A healthy 11 year old girl comes to the health department for her vaccines. She has had department for her vaccines. She has had all the recommended vaccines through age all the recommended vaccines through age 4 years. 4 years.

What vaccines does she need today?What vaccines does she need today?

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ConcernConcern“I heard the Meningococcal Vaccine “I heard the Meningococcal Vaccine

Causes GuillainCauses Guillain--Barre”Barre”

Meningococcemia– Bacteria causes blood infection or meningitis

A i k– At risk– Children with immune-deficiencies– Healthy children < 1 yr and adolescents 15-18 yrs– Freshman living in college dorms

– Recommendations– MCV4 vaccine for healthy 11-12 year olds– Booster dose at 16 yrs

What is GuillainWhat is Guillain--Barre?Barre?

GuillainGuillain--BarrBarréé Syndrome (GBS) Syndrome (GBS) -- disorder disorder involving inflammatory deinvolving inflammatory de--myelination myelination

of of peripheral nerves, characterized by the peripheral nerves, characterized by the progressive, symmetrical weakness progressive, symmetrical weakness

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February 2008, > 15 million doses MCV4 February 2008, > 15 million doses MCV4 distributed.distributed.VAERS reports VAERS reports -- 26 cases of GBS within 6 wks of 26 cases of GBS within 6 wks of

ConcernConcernMeningococcemia Vaccine and Meningococcemia Vaccine and

GuillanGuillan--BarreBarre

ppvaccinationvaccinationInitial data Initial data -- possible small increased risk of GBSpossible small increased risk of GBSWarning added to vaccine information statementWarning added to vaccine information statementFurther research Further research -- 1.4 million patients studied and 1.4 million patients studied and NO cases of GBS within 6 wks of vaccinationNO cases of GBS within 6 wks of vaccinationwarning about GBS removed warning about GBS removed

ConcernConcern

“I don’t want my child to get the “I don’t want my child to get the MMR vaccine because I heard itMMR vaccine because I heard itMMR vaccine because I heard it MMR vaccine because I heard it

causes autism”causes autism”

MMR VaccineMeasles– Contagious respiratory infection

– 1/20 may develop pneumonia

– 1/1000 may die

MumpsMumps– Respiratory virus causing fever and swollen salivary

glands

– Can cause orchitis in older males, encephalitis

Rubella– Usually mild illness (fever and rash) in children

– Can cause birth defects if pregnant woman infected

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Concern Concern “Does MMR Cause Autism?”“Does MMR Cause Autism?”

“Wakefield Study” “Wakefield Study” –– Andrew Wakefield, British gastroenterologistAndrew Wakefield, British gastroenterologist

–– Published in Published in Lancet, 1998Lancet, 1998

–– suggested a connection between MMR suggested a connection between MMR vaccine, gastrointestinal symptoms, and autismvaccine, gastrointestinal symptoms, and autism

–– Study of 12 children with developmental delay Study of 12 children with developmental delay (8 with autism)(8 with autism)

Very small sample sizeVery small sample size

No control groupNo control group

–– Should study prevalence of autism in Should study prevalence of autism in vaccinated vs. unvaccinated childrenvaccinated vs. unvaccinated children

Wakefield Study Flaws

vaccinated vs. unvaccinated childrenvaccinated vs. unvaccinated children

Possible bias in data collectionPossible bias in data collection

–– Endoscopic and neuropsychological Endoscopic and neuropsychological assessments not blindedassessments not blinded

–– Data not collected systematically or Data not collected systematically or completelycompletely

In 2004, 10 of the 13 authors retracted the In 2004, 10 of the 13 authors retracted the study’s interpretationstudy’s interpretation

Wakefield Study

In February 2010, In February 2010, LancetLancet retracted the retracted the manuscriptmanuscript

In January 2011, In January 2011, British Medical JournalBritish Medical Journalclaimed study was fraudulentclaimed study was fraudulent

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The The LancetLancet RetractionRetraction

Study Found to be FraudulentStudy Found to be Fraudulent

The Damage…The Damage…Vaccination rates dropped Vaccination rates dropped

80% in UK in 200380% in UK in 2003--2004 (95% needed for 2004 (95% needed for herd immunity)herd immunity)

Measles epidemic in England and WalesMeasles epidemic in England and WalesMeasles epidemic in England and Wales Measles epidemic in England and Wales in 2008in 2008

Parental mistrust in vaccinesParental mistrust in vaccines

Resources spent on this rather than Resources spent on this rather than finding true cause of autismfinding true cause of autism

Mistrust in medical communityMistrust in medical community

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Why Did Parents Believe Why Did Parents Believe This?This?

Study in literature must be trueStudy in literature must be true

Signs of autism appear around the same Signs of autism appear around the same time children receive the MMR vaccine time children receive the MMR vaccine --

i i t t d l l ti hii i t t d l l ti himisinterpreted as causal relationshipmisinterpreted as causal relationship

The cause of autism is unknownThe cause of autism is unknown

MMR was something to blameMMR was something to blame

Media coverage /TV shows/celebrity Media coverage /TV shows/celebrity testimonialstestimonials

Re: Airing of television show “Eli Stone” in early 2008

No Evidence that No Evidence that MMR Causes AutismMMR Causes Autism

Numerous larger studies (> 23) found NO Numerous larger studies (> 23) found NO association between MMR vaccine and association between MMR vaccine and autismautism

1 year birthday video study 1 year birthday video study -- signs of signs of autism present prior to MMR autism present prior to MMR

In 2004, Institute of Medicine (IOM) In 2004, Institute of Medicine (IOM) concluded no association between MMR concluded no association between MMR vaccine and autism vaccine and autism

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Reputable and Reputable and NotNot--soso--Reputable Reputable

I i ti RI i ti RImmunization ResourcesImmunization Resources

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Reputable Vaccine ResourcesReputable Vaccine Resourceswww.cdc.govwww.cdc.gov Centers for Disease ControlCenters for Disease Controlwww.immunize.orgwww.immunize.org Immunization Action CoalitionImmunization Action Coalition11--800800--CDCCDC--INFO INFO Telephone advice re: vaccinesTelephone advice re: vaccinesnipinfo@cdc.govnipinfo@cdc.gov Email for vaccine questionsEmail for vaccine questionswww.cispimmunize.orgwww.cispimmunize.org Childhood Immunization Childhood Immunization

Support ProgramSupport Programwww hhs gov/nvpowww hhs gov/nvpo National Vaccine ProgramNational Vaccine Programwww.hhs.gov/nvpowww.hhs.gov/nvpo National Vaccine Program National Vaccine Program

OfficeOfficewww.immunizationinfo.orgwww.immunizationinfo.org National Network for National Network for

Immunization Information Immunization Information (NNii)(NNii)

www.michigan.gov/mdchwww.michigan.gov/mdch MI school shot requirementsMI school shot requirementswww.dshs.state.tx.uswww.dshs.state.tx.us TX school shot requirementsTX school shot requirements

Myers MG, Pineda D. “Myers MG, Pineda D. “Do Vaccines Cause That? A Guide for Do Vaccines Cause That? A Guide for Evaluating Vaccine Safety ConcernsEvaluating Vaccine Safety Concerns” 2008” 2008

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