1 / 29

National Vaccine Advisory Committee February 8-9, 2005

Polio Eradication -- Global Progress and Development of Post-Eradication Strategies: Implications for U.S. Stockpile and Outbreak Response Preparations. National Vaccine Advisory Committee February 8-9, 2005. Objectives of Session.

niyati
Download Presentation

National Vaccine Advisory Committee February 8-9, 2005

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Polio Eradication -- Global Progress and Development of Post-Eradication Strategies: Implications for U.S. Stockpile and Outbreak Response Preparations National Vaccine Advisory Committee February 8-9, 2005

  2. Objectives of Session • To provide update on polio eradication progress & plans for post-eradication era • To provide update on U.S. success in eliminating all forms of paralytic polio & status of U.S. polio vaccine stockpile • To elicit committee discussion re: key actions for U.S. stockpile

  3. (III)Elimination of Paralytic Poliomyelitis in U.S.A.

  4. Epidemiology of Polio – U.S.A. (I) • Routine childhood immunization program • IPV (1950s) & OPV (1960s) • Elimination of indigenous wild polio (1979) & imported wild polio (1993) • Adverse effects of oral polio vaccine • VAPP: average 9 cases / year • Accepted as necessary consequence of OPV use, to reduce risk of imported wild polio

  5. Paralytic Poliomyelitis and OPV licensing United States, 1960-1969 type 1 mOPV type 2 OPV type 3 mOPV VAPP Cases tOPV No. of Cases YEAR

  6. Paralytic Poliomyelitis, United States, 1980-1989 No. of Cases YEAR

  7. Epidemiology of Polio – U.S.A. (II) • Cessation of OPV in U.S. • Global polio eradication progress in 1990s: • Lower risk of imported wild poliovirus in USA • Changing benefit / risk ratio for OPV • VAPP = unacceptable risk • Transition to IPV: • Sequential IPV-OPV schedule (1997) • All IPV schedule (2000) • Last VAPP cases occurred in 1999

  8. Paralytic Polio Cases and OPV Doses DistributedUnited States, 1990-2003 IPV-OPV All-IPV OPV doses in millions VAPP cases Year

  9. Epidemiology of Polio – U.S.A. (III) • Post-OPV Cessation Era • High vaccination coverage maintained (2002 NIS) • High seroimmunity to all 3 serotypes after IPV-OPV or all-OPV schedules (urban areas) (Prevots et al.) • Paralytic Polio: Current & future risks • Source: Imported wild virus (primary) • Risk groups: • Under-vaccinated children in urban areas • Vaccine refusers in religious communities • Magnitude: very low but not zero

  10. Epidemiology of Polio – U.S.A. (Conclusion) • The U.S. has reached an important milestone – elimination of VAPP, through OPV cessation & transition to IPV. • A low risk of polio cases or outbreaks in the U.S. remains until the world is polio-free. • A polio vaccine stockpile, as approved, will help ensure an effective control of future outbreaks.

  11. (IV)U.S. Polio Vaccine Stockpile & Outbreak Response: Status, Issues & Future Directions

  12. Topics: IPV stockpile OPV stockpile Global collaboration State & local collaboration Sabin IPV Antiviral drug Order of presentation: NVAC/ACIP Report Current Status & Issues Future Directions Points for Discussion Outline

  13. U.S. Polio Vaccine Stockpile: IPV (I) • NVAC/ACIP report: • Projected / recommended = 8 million doses • Used alone / with OPV for outbreak control • Need for licensed, uncombined IPV • Current status & issues: • Current = ~4 million doses & holding • Might be difficult to get 8 million doses of uncombined IPV under current mechanism

  14. U.S. Polio Vaccine Stockpile: IPV (II) • Future directions • Continue efforts to develop uncombined IPV stockpile through Pediatric Vaccine Stockpile • Consider other options for IPV stockpile • Discussion points • How to maintain target supply of uncombined IPV long-term? • IPV stockpile: U.S. issue only or global one?

  15. U.S. Polio Vaccine Stockpile: OPV (I) • NVAC/ACIP report: • Access to & effective use of OPV in outbreak • Needed = 8 million doses (tOPV or each mOPV serotype) • Preferred type = mOPV, if available • Need to develop mechanism for use (IND vs other) • Current status & issues: • IND for OPV • Need to identify vaccine manufacturer and specific OPV product to continue

  16. U.S. Polio Vaccine Stockpile: OPV (II) • Future directions • Discuss regulatory options with FDA • Work with WHO & vaccine manufacturers re: mOPV • Develop IND & explore other emergency response use mechanisms • Discussion points • Proceed to mOPV stockpile without tOPV? • Are there other emergency response mechanisms to use?

  17. U.S. Polio Vaccine Stockpile: Global Collaboration (I) • NVAC/ACIP report: • CDC, FDA, WHO & other int’l partners • Finance, create & maintain global PVS • Guaranteed & immediate U.S. access • Current status & issues: • CDC & WHO staff – ongoing collaboration on stockpile & outbreak response • CDC will collaborate with FDA & other agencies – regulatory issues & mechanisms for use of vaccines

  18. U.S. Polio Vaccine Stockpile: Global Collaboration (II) • Future directions • Support WHO efforts to… • License mOPV & develop mOPV stockpile • Evaluate the safety of Sabin IPV (sIPV) • Assess potential use of antiviral drug • Determine appropriate global stockpile size, composition & regulation • Discussion points (sIPV & antiviral drug)

  19. U.S. Polio Vaccine Stockpile: State & Local Collaboration • NVAC/ACIP report: • Develop polio outbreak response plans • Current status & issues: • Outbreak response plan being drafted • Future directions / discussion • Involve CSTE, NACCHO & others in outbreak response plan development

  20. U.S. Polio Vaccine Stockpile: Sabin IPV • Global developments • Well outlined in Dr. Cochi’s presentation • Discussion points • Efficacy? Safety? Source? • Issues for potential licensure of sIPV in US for stockpile use? • Emergency use only (IND and/or other)?

  21. U.S. Polio Vaccine Stockpile: Antiviral Drug • Developments & issues • Outlined in Dr. Cochi’s talk • WHO-CDC-Private collaborative group • Exploring potential candidate antiviral drugs • Wider consideration: proposed NAS meeting • Discussion points • Support for NAS-sponsored meeting? • Potential to add as component of stockpile?

  22. U.S. Polio Vaccine Stockpile: Conclusions • U.S. stockpile: not yet a reality -- optimal size, composition & use • IPV stockpile: affected by economic issues • OPV stockpile: direction pending • Global developments re: mOPV • Regulatory issues / emergency use options • Potential products: evaluation / development • Sabin IPV, Antiviral Drug

  23. WHO David Heymann Bruce Aylward Roland Sutter Anna-Lea Jenny Harvard SPH & other Kim Thompson Rad Tebbens Marc Collett CDC Hamid Jafari Denise Johnson Linda Venczel Margie Watkins Nalinee Sangrujee Mark Pallansch Jane Seward Lorraine Alexander Kristin Kenyan Acknowledgements

  24. Thanks!

  25. U.S. Polio Vaccine Stockpile: Discussion (I) • IPV Stockpile: • How to maintain target supply of uncombined long-term? • IPV stockpile: U.S. issue only or global one? • OPV stockpile: • Proceed to mOPV stockpile without tOPV?

  26. U.S. Polio Vaccine Stockpile: Discussion (II) • Sabin IPV: • Efficacy? Safety? Source? • Issues for potential licensure of sIPV in US for stockpile use? • Emergency use only (IND or other)? • Antiviral drug: • Support for NAS-sponsored meeting? • Potential to add as component of stockpile?

  27. Extra slides

  28. Paralytic Poliomyelitis United States, 1951-1959 IPV licensed Poliomyelitis Cases * YEAR

  29. Paralytic Poliomyelitis United States, 1970-1979 No. of Cases YEAR

More Related