# Presentation: 405825

## 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

## Slide 2

| 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

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## 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**.**

## Slide 7

## 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.