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Conclusions &
Recommendations
     24th IEAG

    March 2012
Context – a polio free India!
                                       2010*



  No WPV from any source since
        January 2011
  India is no longer an endemic
                  Last detected case January 2011


             country!


                                                * data as on 30 October 2010
But risks remain……
Questions to the IEAG
•   What are the challenges that India is likely to face in
    maintaining polio-free status?
•   What lessons from other countries can be applied in
    India to protect the programme gains?
•   What strategies should India follow in 2012-2014 to
    sustain polio-free status?
•   Is isolation of VDPVs a concern for India?
•   How should India plan for the polio endgame strategy?
Risks
• Importing WPV

• Development of cVDPVs
Lessons
• Its not over until its over
  everywhere

• 'The price of freedom is
  eternal vigilance'
Challenges
•   Maintaining immunity
•   Maintaining surveillance
•   Readiness to respond
•   Reducing risk
•   Building on polio
•   Preparing for the endgame
Maintaining immunity
Objectives of SIA strategy
• Maintain high levels of immunity
  especially in high risk areas and
  populations

• Protect against both WPV & VDPVs
Recommended SIA calendar, 2012




conducted                   planned




            NID with tOPV      SNID with bOPV
Recommended SIAs, 2013-14
2013                    NID with tOPV   SNID with bOPV




2014
Maintaining
surveillance
Surveillance performance indicators, last 6 months
     Non-polio AFP rate                  Stool collection rate




            14.3 AFP cases, Jan – Feb
               #                                    86%


                                        India
                                                Less than 60%
                                                60% to 69%
                                                70% to 79%
                                                80% and above
                                                No AFP case
Recommendations: Surveillance
• Expand environmental surveillance: Punjab & Gujarat

• Conduct planned field reviews & act on gaps
   – urgently address the issues identified in Andhra Pradesh

• Involve district / block level government staff in all
  components of AFP surveillance
   – response to AFP case reporting, sensitization of the existing
     reporting network, regular review of surveillance database etc

• Laboratory human and financial resources should be
  ensured to maintain high performance
Readiness to respond
Recommendations: Response

• The new state EPRPs should be reviewed and
  evaluated by GOI and partners by the end of
  April 2012
• National & state EPRPs should be updated at
  minimum annually
  – updates must include a full new risk analysis to
    inform risk mitigation measures.
• Conduct simulations of the emergency
  response plans at national and state levels
Recommendations: Planning for response
• State EPRPs must adequately address:
  – Plans for overcoming staff vacancies in high risk areas;
  – Systematic inclusion of high risk areas & populations for
    RI strengthening;
  – Timeline for harmonization of SIA and RI microplans in
    high risk areas;
  – Assignment of HR districts to Rapid Response Team
    members (RRT) for regular review of RI, SIA and
    emergency preparedness;
  – Assessment of communication risks and social mapping;

  – Identification of media spokesperson;
  – Plans for procurement of logistics and IEC materials for
    undertaking urgent mop-ups.
Reducing risk
Recommendations: Communications
• Maintain SMNet and other ground-level initiatives (e.g. through
  ASHA & Anganwari Workers) in traditional polio reservoirs and
  in newly emerging high-risk areas until risk is gone

• Appropriate social network research should be carried out in
  key high risk areas to inform programme actions

• Document and share experience & best practices, including
  elements of the SMNet, media engagement and utilization of
  data for identification, tracking and engagement of high-risk
  populations

• All communication efforts, including SMNet, at all levels adopt
  promotion of routine immunization as a primary message in all
  public communication
Recommendations: OPV supply
• All pre-qualified global OPV producers not yet licensed in India
  should be encouraged to apply for & complete the licensing process

• Considering the risks to vaccine supply DCGI should fast track the
  licensing process for already pre-qualified vaccines.

• GoI should continue to ensure a 50 million dose rolling emergency
  stock (40 million bOPV & 10 million tOPV) to enable rapid response

• GoI should plan for a 24 month time frame for OPV procurement

• To facilitate timely procurement of OPV for SIAs only
   – the standard vaccine shelf life can be reduced to 60%
   – the requirement for primary vaccine vial packaging indicating the product is not
     for sale be waivered (still required for secondary and outer packaging)
Reducing risk - importation

• Immunization of travellers at border crossing
  points should continue until there is no longer
  an epidemiological risk.
• Particular attention should continue to be paid
  to border populations to ensure that they are
  effectively covered by SIAs and routine
  immunization.
Reducing risk - VDPVs

• All detected VDPVs should continue to be
  thoroughly and rapidly investigated to determine
  risk of circulation

• Any evidence of circulation - mop-up response!
Building on polio
Where are we missing the maximum
               number of children?
                                                                                69% of partially and
                                                                                un-immunized
                                                                                children in 6 states:
                                                                                •Uttar Pradesh
                                                                                •Bihar
                                                                                •Madhya Pradesh,
                                                           Data not available

                                                           Below 5 %
                                                                                •Rajasthan
                                                           5 % - 10 %
                                                           >10 % - 25%
                                                                                •West Bengal
                                                           >25 %
                                                                                •Jharkhand



Source: CES 2009; Full immunization of children surveyed 12-23 months
2012-2013: Year of intensification of UIP
Recommendations: RI
• State EPRPs and Year of Intensification of UIP
  plans to be consolidated and operationalized
  – monitored timelines and milestones
  – focus on high risk and migrant populations
  – urban and peri-urban populations
• Focus on 239 high risk districts
• Conduct Immunization Weeks in in NE states, UP,
  Bihar, MP, Rajasthan, Gujarat and Jharkhand
• Priority to ensuring ANMs and MOs are present in
  HR areas in priority states
Recommendations:

• Surveillance for vaccine preventable diseases
  should be expanded based on the experience &
  structure of the AFP surveillance system


• The communications and operational experience of
  polio eradication should inform other disease
  control initiatives including measles elimination
Preparing for the
   endgame
Recent developments

•   SAGE Nov 2011: recommended that the endgame
    strategy be based on phased rather than simultaneous
    Sabin strain removal
•   WHO Executive Board Jan 2012: requested Director-
    General to develop comprehensive endgame strategy
    and timeline based on phased Sabin strain removal
•   SAGE Apr 2012: may consider an 'early switch' (by Apr
    2014), preceded by universal introduction of at least 1
    dose of IPV (ID or IM) at DPT3 contact.
IEAG Conclusion: 'Endgame'
Following the WHO Executive Board resolution of
  January 2012 endorsing eventual replacement
   of tOPV with bOPV globally, India should start
  preparing appropriate policies, esp. on the role
    of IPV, guided by and considering the global
             recommendations of SAGE.
Recommendations: 'Endgame' planning (1)

1. The national immunization programme should now
   begin incorporating into its planning:

  (a) an eventual tOPV-bOPV switch globally,
     potentially as early as April 2014, and

  (b) eventual cessation of all remaining bOPV globally
     at some point in the future (e.g. 2017-18 period).
Recommendations: 'Endgame' planning (2)

 1. This planning should include consideration of
    the introduction, in advance of a tOPV-bOPV
    switch, of at least one dose of IPV (e.g. at
    DPT3 contact), to boost population immunity
    thereby reducing the risk of a type 2 cVDPV
    emergence & the consequences of a potential
    cVPDV.
Polio Endgame Strategy-India,
                                   Potential Timeline                                                             tOPV-
                                                                                                                  bOPV
                                                                                                                  switch

                                                                                                           Polio
Last WPV                                                                                                certification
  case

     NID NID                              NID   NID                       NID   NID                        NID   NID
                                                                                           IPV intro?                    Post-
                                                                                                                         switch
                                                                                                                         VDPV
                                                Modelling, Research, Development                                         type 2
                                                                                                                         risk mgt.

       Certification standard surveillance, improved RI coverage
0
    J an Mar May      J ul   S ep Nov   J an Mar May    J ul   S ep Nov   J an Mar May   J ul   S ep Nov    J an Mar May


               2011                                   2012                            2013                        2014




                                                                                                             tOPV NID
Recommendations: 'Endgame' planning (3)
1. convene a small consultation with IEAG members in
   mid-2012, following the SAGE (April) and World
   Health Assembly (May), to facilitate national
   deliberations on the timing and IPV policy options
   for a tOPV-bOPV switch.

2. begin examining the programmatic and cost
   implications of adding at least 1 IPV dose to the
   routine EPI schedule (e.g. at the DPT3 contact) in
   advance of a global tOPV-bOPV switch.
Recommendations: 'Endgame' planning (3)
• include an examination of implications (pros/cons)
  of delivering IPV as a fractional (1/5th) dose intra-
  dermally (ID) vs. a full dose intramuscularly (IM).

• consolidate the considerable IPV study data already
  existing in India, including from licensing trials, to
  help inform policy options.

• finalize & start the planned trial to verify the
  immunogenicity & programmatic feasibility of a
  'bOPV + 1 dose of IPV (ID or IM)' routine schedule.
Recommendations: Research
1. implement the planned research agenda, giving
   priority to:
  (a) complete the mucosal immunity study,
  (b) conduct a new seroprevalence survey,
  (c) initiate the planned immunogenicity study with
     bOPV from multiple manufacturers, and
  (d) finalize the protocol for the trial to verify
     immunogenicity, programmatic feasibility of a
     'bOPV + 1 dose of IPV (ID or IM)' routine schedule.
Protecting the
 investment
GoI, partners, & donors
must maintain the human,
   material, & financial
  infrastructure of polio
 eradication until global
       certification

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Ieag conclusions and recommendations

  • 1. Conclusions & Recommendations 24th IEAG March 2012
  • 2. Context – a polio free India! 2010* No WPV from any source since January 2011 India is no longer an endemic Last detected case January 2011 country! * data as on 30 October 2010
  • 4. Questions to the IEAG • What are the challenges that India is likely to face in maintaining polio-free status? • What lessons from other countries can be applied in India to protect the programme gains? • What strategies should India follow in 2012-2014 to sustain polio-free status? • Is isolation of VDPVs a concern for India? • How should India plan for the polio endgame strategy?
  • 5. Risks • Importing WPV • Development of cVDPVs
  • 6. Lessons • Its not over until its over everywhere • 'The price of freedom is eternal vigilance'
  • 7. Challenges • Maintaining immunity • Maintaining surveillance • Readiness to respond • Reducing risk • Building on polio • Preparing for the endgame
  • 9. Objectives of SIA strategy • Maintain high levels of immunity especially in high risk areas and populations • Protect against both WPV & VDPVs
  • 10. Recommended SIA calendar, 2012 conducted planned NID with tOPV SNID with bOPV
  • 11. Recommended SIAs, 2013-14 2013 NID with tOPV SNID with bOPV 2014
  • 13. Surveillance performance indicators, last 6 months Non-polio AFP rate Stool collection rate 14.3 AFP cases, Jan – Feb # 86% India Less than 60% 60% to 69% 70% to 79% 80% and above No AFP case
  • 14. Recommendations: Surveillance • Expand environmental surveillance: Punjab & Gujarat • Conduct planned field reviews & act on gaps – urgently address the issues identified in Andhra Pradesh • Involve district / block level government staff in all components of AFP surveillance – response to AFP case reporting, sensitization of the existing reporting network, regular review of surveillance database etc • Laboratory human and financial resources should be ensured to maintain high performance
  • 16. Recommendations: Response • The new state EPRPs should be reviewed and evaluated by GOI and partners by the end of April 2012 • National & state EPRPs should be updated at minimum annually – updates must include a full new risk analysis to inform risk mitigation measures. • Conduct simulations of the emergency response plans at national and state levels
  • 17. Recommendations: Planning for response • State EPRPs must adequately address: – Plans for overcoming staff vacancies in high risk areas; – Systematic inclusion of high risk areas & populations for RI strengthening; – Timeline for harmonization of SIA and RI microplans in high risk areas; – Assignment of HR districts to Rapid Response Team members (RRT) for regular review of RI, SIA and emergency preparedness; – Assessment of communication risks and social mapping; – Identification of media spokesperson; – Plans for procurement of logistics and IEC materials for undertaking urgent mop-ups.
  • 19. Recommendations: Communications • Maintain SMNet and other ground-level initiatives (e.g. through ASHA & Anganwari Workers) in traditional polio reservoirs and in newly emerging high-risk areas until risk is gone • Appropriate social network research should be carried out in key high risk areas to inform programme actions • Document and share experience & best practices, including elements of the SMNet, media engagement and utilization of data for identification, tracking and engagement of high-risk populations • All communication efforts, including SMNet, at all levels adopt promotion of routine immunization as a primary message in all public communication
  • 20. Recommendations: OPV supply • All pre-qualified global OPV producers not yet licensed in India should be encouraged to apply for & complete the licensing process • Considering the risks to vaccine supply DCGI should fast track the licensing process for already pre-qualified vaccines. • GoI should continue to ensure a 50 million dose rolling emergency stock (40 million bOPV & 10 million tOPV) to enable rapid response • GoI should plan for a 24 month time frame for OPV procurement • To facilitate timely procurement of OPV for SIAs only – the standard vaccine shelf life can be reduced to 60% – the requirement for primary vaccine vial packaging indicating the product is not for sale be waivered (still required for secondary and outer packaging)
  • 21. Reducing risk - importation • Immunization of travellers at border crossing points should continue until there is no longer an epidemiological risk. • Particular attention should continue to be paid to border populations to ensure that they are effectively covered by SIAs and routine immunization.
  • 22. Reducing risk - VDPVs • All detected VDPVs should continue to be thoroughly and rapidly investigated to determine risk of circulation • Any evidence of circulation - mop-up response!
  • 24. Where are we missing the maximum number of children? 69% of partially and un-immunized children in 6 states: •Uttar Pradesh •Bihar •Madhya Pradesh, Data not available Below 5 % •Rajasthan 5 % - 10 % >10 % - 25% •West Bengal >25 % •Jharkhand Source: CES 2009; Full immunization of children surveyed 12-23 months
  • 25. 2012-2013: Year of intensification of UIP
  • 26. Recommendations: RI • State EPRPs and Year of Intensification of UIP plans to be consolidated and operationalized – monitored timelines and milestones – focus on high risk and migrant populations – urban and peri-urban populations • Focus on 239 high risk districts • Conduct Immunization Weeks in in NE states, UP, Bihar, MP, Rajasthan, Gujarat and Jharkhand • Priority to ensuring ANMs and MOs are present in HR areas in priority states
  • 27. Recommendations: • Surveillance for vaccine preventable diseases should be expanded based on the experience & structure of the AFP surveillance system • The communications and operational experience of polio eradication should inform other disease control initiatives including measles elimination
  • 28. Preparing for the endgame
  • 29. Recent developments • SAGE Nov 2011: recommended that the endgame strategy be based on phased rather than simultaneous Sabin strain removal • WHO Executive Board Jan 2012: requested Director- General to develop comprehensive endgame strategy and timeline based on phased Sabin strain removal • SAGE Apr 2012: may consider an 'early switch' (by Apr 2014), preceded by universal introduction of at least 1 dose of IPV (ID or IM) at DPT3 contact.
  • 30. IEAG Conclusion: 'Endgame' Following the WHO Executive Board resolution of January 2012 endorsing eventual replacement of tOPV with bOPV globally, India should start preparing appropriate policies, esp. on the role of IPV, guided by and considering the global recommendations of SAGE.
  • 31. Recommendations: 'Endgame' planning (1) 1. The national immunization programme should now begin incorporating into its planning: (a) an eventual tOPV-bOPV switch globally, potentially as early as April 2014, and (b) eventual cessation of all remaining bOPV globally at some point in the future (e.g. 2017-18 period).
  • 32. Recommendations: 'Endgame' planning (2) 1. This planning should include consideration of the introduction, in advance of a tOPV-bOPV switch, of at least one dose of IPV (e.g. at DPT3 contact), to boost population immunity thereby reducing the risk of a type 2 cVDPV emergence & the consequences of a potential cVPDV.
  • 33. Polio Endgame Strategy-India, Potential Timeline tOPV- bOPV switch Polio Last WPV certification case NID NID NID NID NID NID NID NID IPV intro? Post- switch VDPV Modelling, Research, Development type 2 risk mgt. Certification standard surveillance, improved RI coverage 0 J an Mar May J ul S ep Nov J an Mar May J ul S ep Nov J an Mar May J ul S ep Nov J an Mar May 2011 2012 2013 2014 tOPV NID
  • 34. Recommendations: 'Endgame' planning (3) 1. convene a small consultation with IEAG members in mid-2012, following the SAGE (April) and World Health Assembly (May), to facilitate national deliberations on the timing and IPV policy options for a tOPV-bOPV switch. 2. begin examining the programmatic and cost implications of adding at least 1 IPV dose to the routine EPI schedule (e.g. at the DPT3 contact) in advance of a global tOPV-bOPV switch.
  • 35. Recommendations: 'Endgame' planning (3) • include an examination of implications (pros/cons) of delivering IPV as a fractional (1/5th) dose intra- dermally (ID) vs. a full dose intramuscularly (IM). • consolidate the considerable IPV study data already existing in India, including from licensing trials, to help inform policy options. • finalize & start the planned trial to verify the immunogenicity & programmatic feasibility of a 'bOPV + 1 dose of IPV (ID or IM)' routine schedule.
  • 36. Recommendations: Research 1. implement the planned research agenda, giving priority to: (a) complete the mucosal immunity study, (b) conduct a new seroprevalence survey, (c) initiate the planned immunogenicity study with bOPV from multiple manufacturers, and (d) finalize the protocol for the trial to verify immunogenicity, programmatic feasibility of a 'bOPV + 1 dose of IPV (ID or IM)' routine schedule.
  • 38. GoI, partners, & donors must maintain the human, material, & financial infrastructure of polio eradication until global certification

Hinweis der Redaktion

  1. 22/03/12 Data in WHO HQ as of 30 Nov 2010
  2. CES national coverage