Minutes of IEAG Meeting
25th Meeting of the India Expert Advisory Group for Polio Eradication (IEAG)
Delhi, India, 3 May 2013
Conclusions and Recommendations
The twenty-fifth meeting of the India Expert Advisory Group (IEAG) was convened on 3 May 2013 in Delhi, with the following objectives:
- To review progress on polio eradication since the twenty-fourth meeting of the IEAG in March 2012;
- To make recommendations on strategies to ensure the maintenance of polio-free status in India.
- To make recommendations on polio vaccination strategies during the post-eradication phase.
The meeting was co-chaired by Mr. K. Desiraju, Secretary (Health and Family Welfare), Ministry of Health and Family Welfare, Government of India, and Dr. Jagadish Deshpande, Director, Enterovirus Research Centre (ICMR), Mumbai. A list of IEAG members and the special invitees that attended the meeting is annexed. The IEAG was pleased to have the participation of Dr. Jagdish Prasad, Director General Health Services, Ms. Anuradha Gupta, Additional Secretary& Mission Director, NRHM, Dr. Rakesh Kumar, Joint Secretary, MoHFW, Government of India and representatives from the States of Bihar, Uttar Pradesh (UP) and West Bengal. In addition, core partner agencies (WHO, Rotary International, UNICEF, and CDC) were represented as were the Bill and Melinda Gates Foundation, USAID, CORE, and DFID.
The IEAG met in the context of three major developments for India and globally:
India has now been free of polio for more than 24 months and the South East Asian Region has begun the process of certifying polio-free status;
Poliovirus circulation is rapidly declining globally; to date, in 2013 only 3 countries have reported cases, and case numbers are less than half for the same period in 2012, itself the lowest year on record; the only country with wild poliovirus type 3 during the past 12 months being Nigeria.
Post-eradication policy issues for immunization aimed at keeping the world polio-free are assuming increasing importance.
The IEAG was posed the following questions by the Government of India:
- Is the proposed number and scope of supplementary immunization activities (SIAs) in 2013-2014 sufficient to maintain high population immunity? What is the number and scope of SIAs that should be planned for 2015?
- Is the emergency preparedness in the country adequate to respond rapidly and effectively to the importation of wild poliovirus or emergence of circulating vaccine-derived polioviruses (cVDPVs)?
- Is poliovirus surveillance in India good enough to rapidly detect poliovirus circulation/importation?
- What additional steps should India take to mitigate the risk of importations?
- What are the next steps to finalize the timing of the inactivated polio vaccine (IPV) dose in the routine immunization schedule in India?
- Are there other operational assessments required to optimize the switch from trivalent oral polio vaccine (tOPV) to bivalent OPV (bOPV) and IPV introduction?
- Are the proposed research studies sufficient to mitigate risks due to potential gaps in bOPV supply for routine immunization (RI) and for IPV supply requirements for post-switch boosting?
- Are the areas that the polio network is currently supporting in routine immunization appropriate? Are there any additional areas that the programme should be looking at to support broader immunization goals?
- How does the IEAG recommend transitioning the polio human resources and skills to benefit other programmes, while maintaining a thorough response capacity for polio?
India has not reported any case of confirmed polio due to wild poliovirus (WPV) for more than 24 months; the last confirmed case due to the WPV had onset on13 January 2011. One case due to vaccine-derived poliovirus (VDPV) has been detected each in 2012 and 2013. There is no evidence that any of these VDPVs were circulating or had any relationship with the circulating VDPVs (cVDPVs) detected in 2009 and 2010 in India. Since the last WPV case, an extremely high standard of surveillance quality has been maintained, along with a sustained high level of population immunity. The continued strong oversight and support to the polio eradication effort, in the absence of poliovirus circulation, reflects great credit on the Union and State governments for their strong commitment to completing eradication, including through the provision of substantial financial resources, implementation of previous IEAG recommendations and, most importantly, identifying and addressing programme weaknesses, and reaching high risk areas and populations with high quality immunization and surveillance activities. The challenge for India now is to remain polio-free until the global eradication of all circulating wild polioviruses.
The risks to India’s polio-free status remain the same as at the time of the 24th meeting of the IEAG, namely:
- International importation of wild poliovirus. As noted previously, the most significant risk is the importation of wild poliovirus from remaining countries with endemic circulation. Despite the reduction in WPV transmission globally, the endemic zones of Pakistan, Afghanistan, and Nigeria continue to constitute a risk. Additionally, the possibility of outbreaks in non-endemic countries leading to spread that threatens India cannot be discounted.
- The development of circulating vaccine-derived polioviruses (cVDPVs). Although no circulating VDPVs have been detected in India since 2010, experience demonstrates that cVDPVs (particularly cVDPV type 2) can develop if there are pockets of the population with very low immunity against polioviruses type 2. The regular use of tOPV in national campaigns in the past 3 years has reduced the risk of type 2 cVDPV emergence in India, but some level of risk remains.
IEAG Conclusions and Recommendations
The questions posed to the IEAG fall essentially into four groups; first is the issue of maintaining high levels of population immunity; second is the capacity to reduce the risk of importation, and to detect and respond to importations of wild poliovirus or outbreaks of cVDPVs; third is the development of post-eradication immunization policy; and fourth is maximizing the impact of polio eradication on broader immunization goals in India. The recommendations below aim to answer the questions posed to the IEAG by the Government of India and to outline the strategies and activities needed to mitigate the risks outlined above.
Annual serological surveys tracking the immunity levels of children in the highest risk areas of UP and Bihar show that the current regime of supplementary immunization activities, coupled with improvements in routine immunization in these areas, have led to the achievement and maintenance of high levels of immunity against all three poliovirus serotypes. The IEAG, therefore, continues to believe that both supplementary immunization and enhanced routine immunization are needed to maintain high population immunity against polioviruses until global eradication is achieved, to minimize the impact of any WPV importation, and to ensure that cVDPVs do not develop.
OPV Supplementary Immunization Activities (SIAs) Schedule
The IEAG recommended the following for the period from May 2013-2015.
Polio SIAs for the remainder of 2013:
- As per current national plans, three large-scale SNIDs with bOPV, targeting all of UP, Bihar, Delhi and associated high-risk areas of Haryana, Rajasthan, and Uttarakhand, and migrant/ high-risk areas in Maharashtra, Punjab, Gujarat, Jharkhand, and West Bengal.
Polio SIAs in 2014:
- As per previous IEAG recommendations, two NIDs with tOPV in all areas in the 1st quarter of 2014
Three SNIDs with bOPV, ideally one in each of quarters 2, 3, and 4 of 2014 targeting all of UP, Bihar, Delhi, and associated high-risk areas of Haryana, Rajasthan, and Uttarakhand, and migrant/ high-risk areas in Maharashtra, Punjab, Gujarat, Jharkhand, and West Bengal .
Polio SIAs 2015:2 NIDs+2/3 SNIDs
- Two NIDs with tOPV in all areas in the 1st quarter of 2014
- Two to three SNIDs with bOPV (depending on global epidemiology) targeting all of UP, Bihar, Delhi, and associated high-risk areas of Haryana, Rajasthan, and Uttarakhand, and migrant/ high-risk areas in Maharashtra, Punjab, Gujarat, Jharkhand, and West Bengal.
The timing of sub-national rounds should be at the discretion of the national programme and based on operational and epidemiological considerations.
Quality of supplementary immunization activities
It is absolutely essential that the current high quality of the Polio SIAs (Pulse Polio campaigns) be maintained to obtain the maximum possible benefit of SIAs on population immunity. State Governments should ensure that full attention is paid to maintaining the highest possible quality of SIA rounds, and quality should continue to be closely monitored and tracked at district, state, and national level.
Serological surveys to determine immunity levels:
The programme should continue annual seroprevalence surveys in selected areas and populations to provide information on immunity to inform national immunization strategies.
Detecting and responding to importations and outbreaks
The IEAG believes that the Acute Flaccid Paralysis (AFP) surveillance and laboratory system is performing at a very high standard and is adequate to provide early detection of importations and outbreaks. The IEAG also believes that the emergency response system put in place by Union and State Governments is currently adequate to generate a rapid and effective response. The main risk to maintaining the quality and effectiveness of surveillance and emergency response systems is complacency and the waning of a high state of alert over time.
Surveillance and laboratory
- An extremely high level of vigilance must be maintained through to global certification of eradication, and through to cessation of use of oral poliovirus vaccines; this requires ensuring that adequate financial and human resources and attention are devoted to the surveillance and laboratory systems by the Government of India and partners.
- The IEAG noted and endorsed the plan to expand environmental surveillance to Gujarat.
- Regular field reviews of surveillance should continue to be conducted on a rotational basis and with particular attention to high-risk areas as determined by epidemiological, surveillance or immunization indicators. The recommendations of these reviews should continue to be acted upon by the state governments to address surveillance gaps and summaries of actions presented to future IEAG meetings.
- Identify causes of AFP other than polio by reviewing the findings of the National Expert Review Committee for case classification and all available information on the non-polio AFP cases. This could help facilitate health system interventions for addressing these causes.
- All detected VDPVs should continue to be thoroughly investigated to determine any risk of circulation, and appropriate actions taken based on investigation findings.
- The IEAG re-emphasized previous recommendations that any circulating poliovirus detected, regardless of source, anywhere in the country should be considered a public health emergency and responded to by multiple high-quality mop-up vaccination campaigns.
- The Emergency Preparedness and Response Plans (EPRPs) at national and state levels should be updated at a minimum annually; the update should include a full new risk analysis to inform risk mitigation measures.
- A simulation exercise (‘tabletop exercise’) for the emergency response plans at national and selected state levels should be conducted annually to maintain readiness and sharpness of response.
- As per previous IEAG recommendation, the Union Government should ensure a rolling stock of 40 million doses of bOPV and 10 million doses of OPV to enable response to any wild poliovirus or vaccine-derived poliovirus detection.
Reducing risks of importation
- Immunization of travelers at land border crossing points from neighboring countries is the most significant risk reduction strategy and 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.
- The Government of India should strongly promote the current WHO polio immunization recommendations for travelers to and from endemic or infected areas.
- The issue of immunization requirements for travelers from endemic areas should be re-visited in late 2014 in light of epidemiological developments and discussions on the International Health Regulations.
While the IEAG was not asked specifically about the certification process, presentations referring to that process were made. Given the critical importance of India’s input to the certification process in the region and globally, and the imminence of the Regional Certification Commission’s consideration of the region’s status, the IEAG recommended:
- The national programme should urgently proceed with the inventory of laboratories in India to ensure that certification requirements can be met
- The parallel active search process should be fast-tracked to rapidly identify those laboratories most likely to be holding poliovirus and ensure their status is known; it must be ensured that the fast track process includes all Indian vaccine suppliers and their associated facilities, and any other relevant private sector facilities
- Given the complexity of Phase 1 of the containment process (the inventory process), the national programme should consider destroying or securing relevant WPV stocks as the inventory is implemented (i.e. commence implementation of Phase 2).
Post-eradication policy and preparing for the endgame
With the preparations of the South-East Asian Region for regional certification of polio-free status early in 2014, the polio endgame planning for the post-eradication era in India and the region is therefore now a priority. This planning revolves around the sequential removal of oral poliovirus vaccines from routine use, the introduction of inactivated polio vaccine as a risk mitigation strategy prior to this process, and the eventual documentation of the absence of any live poliovirus outside appropriately contained facilities.
Planning for the tOPV/bOPV switch
The national immunization programme should incorporate into its planning the switch from tOPV to bOPV for routine and supplementary immunization, potentially in 2016, and the eventual cessation of use of bOPV at some point in the future. This will require assessment of vaccine needs and licensed supplies for bOPV.
IPV introduction process
The ICMR expert group should study the proposal for a routine single intramuscular dose of IPV at the DPT3 contact in order to facilitate introduction in 2015 in advance of the global tOPV/bOPV switch, and should finalize recommendations on the subject by the end of July 2013, taking into account the findings of the SAGE Polio Working Group meeting in June 2013.
Mitigating the risk of vaccine supply gaps
- The planned bOPV licensing study should be initiated immediately with all bOPV products, to improve the security of supply and potential impact on the price of vaccines for planning for the tOPV/bOPV switch.
- In order to ensure that a full range of strategy options for boosting with IPV have been explored and are available, an IPV boosting study should be conducted to compare the intramuscular versus intradermal delivery route.
The Government of India and partners should carry out a cold chain assessment within the next 12 months taking into consideration the requirements for all new vaccine introductions including IPV.
Building on Polio Eradication
The IEAG appreciated the clearly laid out plan for using polio networks and experience to support the improvement of routine immunization as part of the Government’s Year of Intensification of Immunization and considers the areas of work outlined in the plan to be very appropriate. Substantial progress has already been made in these areas of work, in particular with the institutionalization of State and District Immunization Task Forces for immunization, in the incorporation of high risk communities into routine immunization micro plans, building capacity of frontline workers on routine immunization and in the development of integrated communications strategies and use of the communications network to promote immunization. However, further work needs to be done to maximize the benefit of the polio infrastructure and experience for broader immunization goals. The achievements of the Government and partners in establishing the structures and skills necessary to eradicate polio from India is widely respected and rightly regarded as a model of how public health programmes can reach extremely high standards even under very difficult circumstances; it will be crucial to maintaining these structures and skills through to global certification and the transition period beyond.
Strengthening Routine immunization
The IEAG endorsed the plans for using the polio network and experience to strengthen routine immunization, with a particular focus on high-risk areas and groups, and urged the Government of India to extend the period of intensification of routine immunization beyond 2013.
Broadening the impact
- The current process of systematically planning inputs to routine immunization intensification should be broadened to include other immunization goals, for example, measles and other disease control goals, cold chain strengthening, and new vaccines introduction, which have also been a focus of polio programme support.
- A practical review of the impact of polio network support to broader immunization goals, particularly intensifying routine immunization, should be carried out in Q4 2013 to inform future plans and strategies; this review should not only aim to identify areas of work that have been successful or unsuccessful in impacting on broader immunization goals, but also to identify additional opportunities for synergies with polio.
- Without overloading the AFP surveillance system, and taking into account the high demands being made in the lead up to certification, surveillance for vaccine-preventable diseases should continue to be expanded based on the experience and structure of the AFP surveillance system.
- Noting the polio Social Mobilization Network’s contribution to promoting RI awareness, areas of priority for the network should include interpersonal communication by field staff (including ASHAs and AWWs) to mobilize families of missed children and dropouts, and confidence-building measures among the community in the event of an AEFI. SMNet strategies and approaches should be extended to RI-priority states to generate demand, mobilize the most underserved and help reach out to every child with life-saving vaccines.
Maintaining the capacity of the polio network
The IEAG urged the Government of India, partners, and donors, to invest in maintaining the human, material, and financial infrastructure of polio eradication until the process of eradication of all poliovirus globally, and the implementation of post-eradication immunization policy is completed.
- Mr. Keshav Desiraju, Secretary, (H & FW) MoHFW, Govt. of India
- Dr. Jagadish Deshpande, Director, Enterovirus Research Centre, ICMR, Mumbai
- Ms. Anuradha Gupta, Additional Secretary & Mission Director, MoHFW, Govt. of India
- Dr. Jagdish Prasad, DGHS, MoHFW, Govt of India
- Dr. Rakesh Kumar, Joint Secretary (RCH), MoHFW, Govt of India
- Prof A K Dutta, Consultant Paediatrician, UP
- Dr. R N Srivastava, Consultant Paediatrician, New Delhi
- Dr. Harish Chellani, Consultant Paediatrician and Associate Professor, Safdarjung Hospital, New Delhi
- Prof Sanjay Chaturvedi, Prof. Community Medicine, UCMS, Delhi
- Prof Ashok Mishra, Deptt of PSM, Gwalior Medical College, MP
- Dr. Devendra Taneja, Director, Professor of Community Medicine, Maulana Azad Medical College, Delhi
- Dr. Vipin Vashishtha, National Convener, IAP Advisory Committee on Vaccines & Immunization Practices (on behalf of Dr. C P Bansal, President, IAP)
- Dr. Shashi Khare, Additional Director, NCDC, Delhi
- Mr. Deepak Kapur, Chairman, Rotary International
- Dr. Ambujam Nair Kapoor, Deputy Director General, ICMR, Delhi
- Dr. Bruce Aylward, Assistant Director-General, WHO-Geneva
- Dr. Steve Cochi, Senior Advisor, Global Immunization Division, CDC, Atlanta
- Dr. Henri van den Hombergh, Senior Health Advisor Immunization, UNICEF-New York
- Mr. Carl Tinstman, Public Health Consultant, Geneva
- Dr. Ajay Khera, Dy. Commissioner (CH & I), MoHFW, Govt of India.
- Dr. Nata Menabde, WHO Representative to India
- Mr. Louis Georges Arsenault, Country Representative, UNICEF
- Dr. Hamid Jafari, Director (a.i.) WHO-Geneva
- Shri Vyas Ji, Principal Secretary (Health & FW), Department of Health, Bihar
- Mr. Pravir Kumar, Principal Secretary (Medical, Health & FW), Uttar Pradesh
- Mr. Satish Chandra Tiwari, Principal Secretary (Health & FW), West Bengal
- Dr. Pradeep Haldar, Dy. Commissioner (Immunization), MoHFW, Govt of India
- Dr. M K Aggarwal, Dy. Commissioner (UIP), MoHFW, Govt of India
- Dr. Sunil Bahl, Dy. Project Manager (Technical), WHO-India (NPSP)
- Mr. Lieven Desomer, UNICEF, India
- Dr. Roma Solomon, Director, CGPP India
- Dr. N K Arora, INCLEN Trust, India
- Dr. Anindya Sekhar Bose, Vaccines & Immunization, BMGF
- Ms. Nancy Godfrey, USAID
- Mr. Sanjay Kapur, USAID
- Ms. Rashmi Kukreja, DFID
- Dr. Monica Chaturvedi, ITSU, PHFI
- Dr. Prem Singh, ITSU, PHFI