OPV Cessation Guidelines

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Guaranteeing our InvestmentOutcomes of the Ad
Hoc Advisory Committee on Polio Eradication
(AACPE)
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Circulating vaccine-derived polioviruses
(cVDPVs) China, 2004
Polio outbreak 2 cases
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Clinical and laboratory surveillance network for
acute flaccid paralysis
















































































































































Specialised Reference Laboratory
Regional Reference Laboratory

National/ Sub-national Laboratory

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Circulating vaccine-derived polioviruses
(cVDPVs) 2000 - 2004
Hispaniola 2000 22 cases
China 2004 2 cases
Philippines 2001 3 cases
Madagascar 2002 4 cases
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Vaccine-associated paralytic polio (VAPP)

• VAPP polio occurring in vaccine recipients or
  contacts
• Temporal association with immunization
• Greatest risk in those receiving first dose of
  OPV
• Generally healthy, very small percentage
  immunodeficient
• Overall risk 2-4 VAPP cases/million birth
  cohort 250-500 cases per year

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Summary of iVDPV long-term excretion cases
known to WHO

• 24 iVDPVs, including 22 long term excretors
• 2 currently known to excrete
• 7 type 1, 16 type 2, 1 type 3
• cases have been from Europe (9), USA (7), Japan
  (1), Argentina (1), Kuwait (1), Taiwan (1), Iran
  (1), Ireland/Zimbabwe (1), Thailand (1), Peru (1)

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Vaccine-associated risks to polio eradication
Frequency Annual Evolution Risk
to date burden over time
cVDPV 1 per year 10 increases VAPP
2-4/million birth cohort 250-500 stable iVDPV
24 identified lt1 under study since
1963
IPV sites 1 accident (1990s) lt1 decreases with
containment lab accident 1
investigation NK decreases with
containment deliberate 0
NK unknown
based on current understanding
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Timing of OPV cessation
'As soon as possible after interruption of wild
poliovirus transmission globally, to take
advantage of high population immunity
surveillance sensitivity.' Expert Consultation on
Vaccine-derived Polioviruses (VDPVs), Sept
2003, Geneva

• '3-5 years after interruption of wild poliovirus'
• Advisory Group on Polio Eradication
• Sept 2004, Geneva

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Conditionalities for OPV Cessation

• Appropriate containment of all polioviruses.
• Global surveillance notification capacity.
• Coordinated cessation of OPV.
• 'Post OPV' immunization policy in place.
• Vaccine stockpile response mechanism.

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Schematic Main Risks Timeline

• Main Risk
• Years after last wild poliovirus

0
1
2
4
5
3
Routine immunization campaigns, Continued AFP
surveillance
Vaccine stockpile, Continued AFP surveillance
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AACPE Recommendations

• 1. The synchronized cessation of OPV, the
  containment of polioviruses, and the
  establishment/use of a vaccine stockpile should
  be submitted to the WHA to achieve a global
  consensus on cessation of OPV.

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AACPE Recommendations

• 2. The draft National Guidelines for OPV
  Cessation should be tested with selected national
  health policy makers so that the revised version
  can be finalized for WHO Member States by
  mid-2005.

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AACPE Recommendations

• 3. The framework for a vaccine stockpile (size,
  composition, operation) should be available by
  mid-2005. Full, front-loaded financing for the
  stockpile should be sought urgently to allow WHO
  to engage vaccine manufacturers in its
  development while sufficient production capacity
  is still available.

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Potential WHA Resolutions

• OPV Cessation consensus on globally coordinated
  OPV cessation as key goal of the eradication
  initiative.
• Containment (future handling of polioviruses)
  consensus on need for safe storage at secure
  biosafety levels for Sabin, vaccine-derived
  wild polioviruses after OPV cessation.
• Outbreak Response (reintroduction of
  polioviruses) consensus on the need for vaccine
  stockpile and international controls, mechanism
  for responding to polio outbreak should one occur.

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Next Steps

• Sep 04 'Ad Hoc Advisory Committee'
• Nov 04 Pilot and further revise National
  Guidelines
• Jan 05 WHA Executive Board consideration 1st
  rev OPV cessation, containment, stockpiles
• May 05 World Health Assembly information item
• Sep 05/06 WHO Regional Committees information
  items

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Smallpox Eradication certified 1980
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HIV first identified 1981
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Polio Eradication seize the opportunity
while window of opportunity is open

• Interrupt transmission by end of 2005
• Guarantee the investment