Vaccine Safety at CDC:

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• Vaccine Safety at CDC
• Immunization Program Perspective

Melinda Wharton, MD, MPH National Center for Immu
nization and Respiratory Diseases
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Immunization Program Perspective

• CDCs Advisory Committee on Immunization
  Practices makes vaccine recommendations
  
• Recommendations are implemented through both
  public and private sectors, affecting health of
  all children in the U.S.
  
• Vaccine safety is critical to public health

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The Cutter Incident

• April 25, 1955 Paralytic polio reported among
  children who had received inactivated polio
  vaccine
  
• April 28 CDCs Epidemic Intelligence Service
  mobilized as the Polio Surveillance Unit
  
• Two production pools of Cutter polio vaccine
  contained live polio virus

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The Cutter Incident and Vaccine Safety at CDC

• In face of uncertainty, importance of rapid
  response

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The Cutter Incident and Vaccine Safety at CDC

• In face of uncertainty, importance of rapid
  response
  
• National surveillance and multi-state field
  investigation are key tools

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RotaShield and Intussusception

• Late May Cases of intussusception among
  recipients of RotaShield reported to VAERS
  
• Early June CDC launches multi-state
  investigation
  
• Early July Preliminary data from multi-state
  investigation identifies additional cases among
  vaccinated children
  
• July 16, 1999 CDC suspends use of the vaccine

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The Cutter Incident and Vaccine Safety at CDC

• In face of uncertainty, importance of rapid
  response
  
• National surveillance and multi-state field
  investigation are key tools
  
• Public confidence is fragile, and once lost is
  difficult to regain

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Resuming Polio Vaccination, May 1955

• The nation, which mere weeks ago clamored with
  one voice for the Salk vaccine, now is skeptical.
  The faith of the reading, listening and watching
  public has been severely shaken. The delays in
  school inoculation programs, the starts and stops
  in vaccine production, the cloak-and-dagger
  meetings in Washington, the recurring rumors that
  Secy. Oveta Culp Hobby would resign all this
  had raised doubts. Nobody seems to be giving
  straight answers. It has the look of a
  cover-up.

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Current Organizational Structure

• February 2005 Immunization safety moved from
  the National Immunization Program
  
• Move separated risk assessment from risk
  management
  
• Immunization program continues to be responsible
  for immunization recommendations

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National Center for Immunization and Respiratory
Diseases

• Brings together most of the vaccine-preventable
  disease work of CDC into a new Center
  
• Laboratory, epidemiology, vaccine development
  work from NCID
  
• Epidemiology, global and domestic immunization
  program from NIP
  
• Hepatitis, HPV, travelers vaccines in other
  Centers

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Vaccine Safety and Immunization Programs

• Immunization programs affect the health of all
  children in the United States
  
• Good information on vaccine risks is critical

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Vaccine Safety and Immunization Programs

• Immunization programs affect the health of all
  children in the United States
  
• Good information on vaccine risks is critical
• The right answer

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Vaccine Safety and Immunization Programs

• Immunization programs affect the health of all
  children in the United States
  
• Good information on vaccine risks is critical
• The right answer
• Urgently obtained

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Vaccine Safety and Immunization Programs

• Immunization programs affect the health of all
  children in the United States
  
• Good information on vaccine risks is critical
• The right answer
• Urgently obtained
• Communicated clearly