What Immunization Providers Need to Know about Vaccine Safety and Talking to Concerned Parents

Overview of Presentation

Overview of the U.S. vaccine safety system
Updates on a

Vaccine Safety

When the vaccine is under development, studies are done

What Do VAERS Reports Mean?

VAERS has led to early identification of

How Do We Decide What We Are Going to Worry About?

Consistent

A Faster Approach to Vaccine Safety Studies

Alternative to traditional post-licensure vaccine

Meningococcal Conjugate Vaccine and Guillain-Barré Syndrome

VAERS: 24 confirmed reports among vaccine

Timing of Onset of GBS following Meningococcal Conjugate Vaccine

Onset intervals 2-33

Update on Safety of Varicella Vaccine

Varicella vaccine strain can establish

Establishment of VZV Latency in Sensory-Nerve Ganglia

Kimberlin D, Whitley R. N

Herpes Zoster among Recipients of Varicella Vaccine

VAERS: 981 reports of

Judicial Watch Investigates Side-Effects of HPV Vaccine

Wed, 05/14/2008 - 14:05 —

Adverse Events and HPV Vaccine: Summary

Over 21 million doses distributed
As of

Reports of Death Following HPV Vaccine

20 U.S. death reports; unable to

Syncope (Fainting) following HPV Vaccine

Increased reporting of syncope among vaccinees
Although usually

General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization

Intussusception and RotaTeq®

9.1 million doses distributed (March 2006- August 31, 2007)*
VAERS:

Adverse Reactions Following MMRV and MMR+V

Fever is more common in the

Temporal Distribution of Seizures after MMRV Vaccination

Days Post-MMRV Vaccine

Number of Seizures

(2/06-9/07, after

Thimerosal and Autism: What Does the Science Show?

Ecologic studies: autism does not

Children Receiving Autism Services by Quarter, California, 2002-2007

California Department of Developmental

Vaccines and Autism, Still

MMR and autism (1998)
Thimerosal and autism (2001)
Simultaneous administration

Vaccines and Autism: Context

Heuristics and biases
Distrust of government
Unanswered questions about autism

“Why doesn’t CDC study autism rates in unvaccinated children?”

Almost all children

Number of Vaccines in the Routine Childhood and Adolescent Immunization Schedule

1985

1995

2006

Measles
Rubella
Mumps
Diphtheria
Tetanus
Pertussis
Polio
Hib

Recommended Schedule for Persons Aged 0-6 Years, U.S.

Current Parent Concerns

Focus groups with first time mothers in 3 cities:

What Parents Are Concerned About (2008)

It is painful for children to

Why Do We Give Vaccines at the Ages We Do?

To provide

Advisory Committee on Immunization Practices

Evidence-based recommendations based on:
Licensed indications and schedule
Burden

Missed Opportunities

Definition: Healthcare encounter in which a child is eligible to

Safety and Efficacy Issues Potentially Associated with the Schedule

Data generally available

Outpatient Visits for Fever by Day after Vaccine at Northern California

Data on Simultaneous Administration for a Licensed Vaccine: ROTARIX

484 healthy infants

The Science of Studying More than One Thing at a Time

Rapid

Other Issues

Recommendations and requirements – should everything that is recommended be

Is Our Immunization Schedule “One Size Fits All”?

Contraindications and precautions do

SMEI and “Vaccine Encephalopathy”

Epileptic encephalopathies, without other specific cause identified, with

What Determines Credibility? Low Concern Settings

All other factors
15-20%

Competence/
Expertise
80-85%

Randall Hyer, NIC, 2005

What Determines Credibility? High Concern Settings

All other factors
15-20%

Competence/
Expertise
15-20%

Honesty/openness
15-20%

Listening/caring/
Empathy
50%

Randall Hyer, NIC, 2005

Measles Cases Reported to CDC/NCIRD January 1 to July 11, 2008

Invasive H. influenzae type B disease -- Minnesota, 2008

5 cases of

Where That Leaves Us

When we do more than one thing at