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 Director, Center for Community Health New York State Department of Health Albany, NY Fernando Guerra MD San Antonio Metropolitan Health District San Antonio, TX Samuel Katz MD Wilburt C. Davison Professor Duke University Medical School Durham, NC Charles Helms MD PhD, Chairman Professor of Medicine University of Iowa Hospitals and Clinics Iowa City, IA John Modlin MD Professor of Pediatrics and Medicine Dartmouth Medical School Lebanon, NH Alan Hinman MD MPH Senior Consultant Public Health Programs Task Force for Child Survival and Development National Vaccine Program Office: Bruce Gellin MD MPH National Vaccine Program Office Washington, DC Centers for Disease Control and Prevention: Lorraine Alexander, RN MPH Jim Alexander MD Victor Caceres MD MPH Steve Cochi MD MPH Rex Ellington John Glasser PhD Hamid Jafari MBBS Charles LeBaron MD Food and Drug Administration: Norman Baylor MD Office of Vaccines Research and Review Rockville, MD Kevin Malone Trudy Murphy MD Walter Orenstein MD Ismael Ortega PhD Jane Seward MBBS MPH Roland Sutter MD MPHTM Margaret Watkins BSN MPH 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.