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 MeetingFebruary 3-4, 2004

ACIP: NVAC:

Guthrie Birkhead MD MPHDirector, Center for Community HealthNew York State Department of HealthAlbany, NY

Fernando Guerra MDSan Antonio Metropolitan Health DistrictSan Antonio, TX

Samuel Katz MDWilburt C. Davison ProfessorDuke University Medical SchoolDurham, NC

Charles Helms MD PhD, ChairmanProfessor of MedicineUniversity of Iowa Hospitals and ClinicsIowa City, IA

John Modlin MDProfessor of Pediatrics and MedicineDartmouth Medical SchoolLebanon, NH

Alan Hinman MD MPHSenior Consultant Public Health ProgramsTask Force for Child Survival and Development

National Vaccine Program Office:

Bruce Gellin MD MPH National Vaccine Program OfficeWashington, DC

Centers for Disease Control and Prevention:

Lorraine Alexander, RN MPHJim Alexander MDVictor Caceres MD MPHSteve Cochi MD MPHRex EllingtonJohn Glasser PhDHamid Jafari MBBSCharles LeBaron MD

Food and Drug Administration:

Norman Baylor MDOffice of Vaccines Research and ReviewRockville, MD

Kevin MaloneTrudy Murphy MDWalter Orenstein MDIsmael Ortega PhDJane Seward MBBS MPHRoland Sutter MD MPHTMMargaret Watkins BSN MPHEddie 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.

RecommendationsChallenges 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.

RecommendationsChallenges 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.

RecommendationsChallenges 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.