Polio Eradication -- Global Progress and Development of Post-Eradication Strategies: Implications for U.S. Stockpile and Outbreak Response Preparations

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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

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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

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

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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
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Paralytic Poliomyelitis, United States, 1980-1989

No. of Cases
YEAR
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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

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

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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.

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

• 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

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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

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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?

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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

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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?

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U.S. Polio Vaccine Stockpile Global
Collaboration (I)

• NVAC/ACIP report
• CDC, FDA, WHO other intl 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

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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)

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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

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U.S. Polio Vaccine Stockpile Sabin IPV

• Global developments
• Well outlined in Dr. Cochis presentation
• Discussion points
• Efficacy? Safety? Source?
• Issues for potential licensure of sIPV in US for
  stockpile use?
• Emergency use only (IND and/or other)?

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U.S. Polio Vaccine Stockpile Antiviral Drug

• Developments issues
• Outlined in Dr. Cochis 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?

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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

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Acknowledgements

• 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

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Thanks!
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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?

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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?

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Extra slides
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Paralytic Poliomyelitis United States, 1951-1959
IPV licensed
Poliomyelitis Cases

YEAR
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Paralytic Poliomyelitis United States, 1970-1979

No. of Cases
YEAR