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VIEWS: 4 PAGES: 13

									Needs and Recommendations for the United
    States Poliovirus Vaccine Stockpile



    Report of the Joint Working Group of the National
   Vaccine Advisory Committee (NVAC) and Advisory
     Committee on Immunization Practices (ACIP)

     National Vaccine Advisory Committee Meeting
                  February 3-4, 2004
ACIP:                                         NVAC:
Guthrie Birkhead MD MPH                       Fernando Guerra MD
Director, Center for Community Health         San Antonio Metropolitan Health District
New York State Department of Health           San Antonio, TX
Albany, NY
Samuel Katz MD                                Charles Helms MD PhD, Chairman
Wilburt C. Davison Professor                  Professor of Medicine
Duke University Medical School                University of Iowa Hospitals and Clinics
Durham, NC                                    Iowa City, IA
John Modlin MD                                Alan Hinman MD MPH
Professor of Pediatrics and Medicine          Senior Consultant Public Health Programs
Dartmouth Medical School                      Task Force for Child Survival and Development
Lebanon, NH
National Vaccine Program Office:              Food and Drug Administration:
Bruce Gellin MD MPH                           Norman Baylor MD
National Vaccine Program Office               Office of Vaccines Research and Review
Washington, DC                                Rockville, MD

Centers for Disease Control and Prevention:
Lorraine Alexander, RN MPH                    Kevin Malone
Jim Alexander MD                              Trudy Murphy MD
Victor Caceres MD MPH                         Walter Orenstein MD
Steve Cochi MD MPH                            Ismael Ortega PhD
Rex Ellington                                 Jane Seward MBBS MPH
John Glasser PhD                              Roland Sutter MD MPHTM
Hamid Jafari MBBS
                                              Margaret Watkins BSN MPH
Charles LeBaron MD
                                              Eddie Wilder
         Joint Working Group Process

• WG appointed February 2003

• Four subgroups formed:
   – 1. Rationale for poliovirus vaccine stockpile
   – 2. Characteristics of poliovirus vaccine stockpile
   – 3. Manufacturing issues for OPV
   – 4. Implementation of OPV IND

• Regular conference calls since May 2003
   – 8 WG calls
   – 10+ subgroup calls, including discussions with 2 OPV
     manufacturers and reviews of Decision Analysis Model

• Subgroup reports prepared and approved by WG

• Final report prepared from subgroup reports
   – Approved by WG January 23rd
                    Recommendations
                          IPV Stockpile
• The current projection of 8 million IPV doses appears adequate.

• If OPV stockpile unavailable, use IPV for outbreak response.

• If OPV stockpile available, use IPV outside the outbreak zone and
  use inside the outbreak zone when OPV is contraindicated/declined.

• Assure continued availability of non-combined IPV vaccines.


                         OPV Stockpile
• To be prudently prepared, the US should have access to a stockpile
  of OPV for use in the event of an outbreak.

• A quantity of 8 million tOPV doses or 8 million of each of the three
  mOPV types appears adequate.
                  Recommendations
       Challenges in Creating an OPV Stockpile:

                         Regulatory Issues
• Legislation enabling FDA certification of OPV used by international
  organizations (e.g. UNICEF, WHO) should be considered.

• Prepare an IND enabling establishment of an OPV stockpile for use in
  outbreaks.

• Prepare an Informed Consent process in advance of the need to
  administer OPV under an IND.
   – Build on recent national experience with vaccinia immunization.
   – Include information about Vaccine Injury Compensation Program
     coverage of OPV-related adverse events and availability of IPV.
              Recommendations
    Challenges in Creating an OPV Stockpile:

         Collaboration with International Partners
• CDC, FDA and HHS should work with WHO and other international
  partners to help finance, create, and maintain a global poliovirus
  vaccine stockpile that provides the US with immediate and
  guaranteed access to a portion of the OPV global stockpile available
  outside the US.

 Collaboration with State and Local Health Authorities
• CDC should work proactively with state and local health
  departments to develop polio outbreak response plans.

• The response plan should include an aggressive educational
  component that articulates the public health and individual benefits
  and risks of OPV and IPV.
   NVAC/ACIP Joint Working Group Report

• EXECUTIVE SUMMARY

• REPORT
   – Introduction
   – Background
   – Rationale for a Poliovirus Vaccine Stockpile
   – Characteristics of Poliovirus Vaccine Stockpile
   – Manufacturing Issues for a Poliovirus Vaccine Stockpile
   – Implementation Issues for a Poliovirus Vaccine Stockpile

• SUMMARY

• RECOMMENDATIONS

• APPENDIX I: DECISION ANALYSIS MODEL

• REFERENCES
                   NVAC/ACIP Joint
                 Working Group Charge:


• Provide rationale and recommendations for poliovirus vaccine(s) to
  be stockpiled.

• Determine optimal stockpile characteristics, assuming that the
  vaccine will be administered under FDA guidelines as an IND.

• Interview OPV manufacturers to understand their concerns and
  obtain their suggestions about developing a stockpile of OPV.

• Identify practical and regulatory issues expected when an
  unlicensed poliovirus vaccine is released as an IND.
                  Recommendations

                     OPV Stockpile




• Prudent preparedness requires that US should have
  access to a stockpile of OPV for use in the event of an
  outbreak.

• A quantity of 8 million tOPV doses or 8 million of each of
  the three mOPV types appears adequate.
              Recommendations
    Challenges in Creating an OPV Stockpile:

         Collaboration with International Partners
• CDC, FDA and HHS should work with WHO and other international
  partners to help finance, create, and maintain a global poliovirus
  vaccine stockpile that provides the US with immediate and
  guaranteed access to a portion of the OPV global stockpile available
  outside the US.
                      Recommendations

     Challenges in Creating an OPV Stockpile:
Collaboration with State and Local Health Authorities


  • CDC should work proactively with state and local health
    departments to develop polio outbreak response plans.

  • The response plan should include an aggressive educational
    component that articulates the public health and individual benefits
    and risks of OPV and IPV.
              Acknowledgements


• Lorraine Alexander RN MPH, Charley LeBaron MD and
  Trudy Murphy MD for excellent staff work and support.
• Pam Jenkins MD for work on Decision Analysis Model.
• Members for time and timeliness in getting comments
  back for reports.
• Non-member consultants who provided insight and
  suggestions.
• Participating poliovirus vaccine manufacturers who
  provided information and insight.

								
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