REGIONAL COMMITTEE Sixtieth session Thimphu, Bhutan 31 August – 3 September 2007
Provisional Agenda item 14.1 SEA/RC60/12 13 July 2007
PROGRESS REPORTS REQUESTED BY MEMBER STATES: AVIAN AND PANDEMIC INFLUENZA PREPAREDNESS IN THE CONTEXT OF THE INTERNATIONAL HEALTH REGULATIONS (2005) Since November 2003, there have been 315 reported cases of human H5N1 infections with 191 deaths. In the South-East Asia Region, Thailand has had 25 reported cases with 17 deaths and Indonesia 101 human cases with 80 deaths. The H5N1 virus may be considered a pre-pandemic virus that could infect at least one billion people worldwide. Efforts to develop multisectoral pandemic preparedness plans and mobilize political and financial support in the Region are under way. Following-up on the Delhi Declaration on Avian Influenza Prevention and Control, WHO has assisted Member countries in developing National Influenza Pandemic Preparedness Plans (NIPPP), strengthening surveillance capacities in countries, building needed laboratories and developing technical guidelines for response, diagnosis and clinical management. It should be noted that this work also builds capacity for implementation of the International Health Regulations (IHR 2005). Several countries have received donor funding to support these efforts; another donor meeting, to be hosted by India will be held in December 2007. A recent issue involves production and availability of H5N1 and pandemic vaccines. Countries in the Region are concerned that they will not have access to commercially produced vaccines even though the virus used to develop these vaccines is from countries in the Region. WHO is assisting Member countries in the Region by helping to accredit at least two laboratories in the Region to identify the H5 virus. At the same time, WHO is coordinating international partnerships to support the production of pandemic vaccines in three countries of the Region. This is complemented by efforts to ensure an equitable and fair distribution of these vaccines, as needed by Member countries in the Region. This paper was submitted to the Joint Meeting of Heath Secretaries and the Consultative Committee for Programme Development and Management, held in the Regional Office from 2-6 July 2007 for its review.
The Joint Meeting made the following recommendations: Action by Member States (1) To strengthen veterinary public health as part of an integrated multi-sectoral pandemic preparedness plan. The human health sector should take an active role to prevent infection from poultry to human beings, and minimise case fatality. To apply non-pharmaceutical interventions such as risk communication and social distancing in addition to the use of vaccines and antiviral drugs during human pandemic phase. To develop guidelines on the major components of NIPPP and conduct training in order to build up capacity in the implementation of NIPPP. To develop/strengthen the core capacities as required by International Health Regulations (IHR) 2005 and the implementation of NIPPP, to cover capacities in both public and private sectors. To foster public and private partnership in a concerted effort in the implementation of NIPPP, including resource mobilization.
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Action by WHO-SEARO (1) To continue to support Member States in the Region in the implementation of NIPPP, capacity building and strengthening of the National Regulatory Authority (NRA) to ensure that influenza vaccination is part of the NIPPP. To operate the CSR unit in the Regional Office and two CSR sub-units in Delhi and Bangkok, including resource mobilization and stockpiling of antiviral, personal protection devices and pre-pandemic vaccines if available in future. To report the progress on the implementation of Avian and Pandemic Influenza preparedness in the context of IHR 2005 to the Sixty-first, Sixty-second, Sixtythird, Sixty-fourth and Sixty-fifth sessions of the Regional Committee.
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The paper is now submitted to the Sixtieth session of the Regional Committee for its consideration.
Contents Situation analysis......................................................................................................................... 1 Progress made so far ................................................................................................................... 1 Summary of activities .................................................................................................................. 2 Funding ...................................................................................................................................... 3 Recent controversial issues.......................................................................................................... 3 Action taken ............................................................................................................................... 3 Accreditation and virus sharing ............................................................................................3 Equitable access to vaccine..................................................................................................4 Gaps and challenges ................................................................................................................... 4
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Situation analysis 1. Since November 2003, avian influenza (AI) H5N1 outbreaks in birds have affected 60 countries across Asia, Europe, the Middle-East and Africa. In 2006 alone, 52 countries were affected in an unprecedented manner. So far, 5 countries of the South-East Asia Region have been affected by H5N1 outbreaks. 2. More than 220 million birds have been killed by the virus or culled to prevent further spread and the number keeps growing. 3. Recent genetic characterization of H5N1 strains involved in the current panzootic has demonstrated two distinct phylogenetic clades. Clade 1 viruses have circulated primarily in Cambodia, Thailand and Vietnam, and clade 2 viruses have circulated in China and Indonesia and have spread westward to the Middle East, Europe, and Africa. This may have implications in the transmissibility, clinical manifestation and severity of disease in human population, and in the emergence of a novel virus strain. 4. A majority of human H5N1 infection was due to direct contact with birds infected with the virus. To date, sustained person-to-person transmission has not been recognized, although probable person-to-person spread was identified in Thailand and among several family clusters in Indonesia. 5. As of 25 June 2007, a total of 315 human cases were reported from 12 countries worldwide with 191 deaths. Thailand reported 25 human cases with 17 deaths during 2004– 2006 whereas Indonesia reported 101 human cases with 80 deaths during 2005–2007 in the Region. The case fatality rate is higher than 50% per cent overall and about 85% presently in Indonesia. Almost 50% of global human cases and 66% of human deaths have been reported in Indonesia in the first six months of 2007. 6. H5N1 may be considered as a pre-pandemic virus. A global pandemic could infect at least one billion people and cause the death of between two to seven million. A modest pandemic lasting over one year might cause losses as high as 3% of Asia’s gross domestic product and 0.5% of the world’s GDP.
Progress made so far 7. There is considerable progress in the Region in the development of multisectoral pandemic preparedness plans in mobilizing political commitment and engaging various partners. A task force for follow-up of the ‘Delhi Declaration on Avian Influenza Prevention and Control’ has been actively involved in developing workplans on the basis of the following recommendations;
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Use assessment of National Influenza Pandemic Preparedness Plan (NIPPP) to develop a framework within which countries could build specific strategies for prevention and control of avian influenza. Define uniform standards to develop guidelines and protocols as appropriate and monitor their implementation for reducing the risk of Highly Pathogenic Avian Influenza (HPAI) infections to humans by appropriate control measures. Share available knowledge and expertise and also take leadership in surveillance and outbreak investigation, laboratory support, risk communication and research. Intensify efforts to make sufficient resources available to address this public health threat.
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Summary of activities 8. All countries in the Region have National Influenza Pandemic Preparedness Plans and are at various stages of implementing them. Assessment of NIPPP has been completed in eight countries and gaps have been identified. Inter-sectoral cooperation between the public health and animal health sectors has been developed and strengthened considerably. All countries need to further strengthen laboratory biosafety and human resource development for diagnosis of AI and influenza-like illness (ILI) and prepare Standard Operating Procedures for various activities such as quarantine, clinical case management and field investigation. Strengthening capacity in surveillance, alert and rapid response is crucial not only at the national level but also at peripheral levels. Member States have been updating their NIPPP after assessment of implementation status and availability of funding. 9. Similarly, national capacity to implement IHR (2005) has been assessed in eight countries and gaps have been identified. Some Member States have fairly developed core capacity and others are still in the process of developing such capacities. National IHR Focal Points have been identified in all Member States which need to be institutionalized. Development of a legal framework for implementation of IHR (2005), strengthening surveillance and response capacity at all levels, capacity building at points of entry and cross-border collaboration and communication will be key areas of activity in the next three years. Strengthening national capacities for implementation of IHR (2005) and NIPPP are complementary to each other. The first Regional Meeting on Implementation of IHR (2005) held in Male in April 2007 provided a framework for development of country workplans. 10. Sub-regional units of CSR have been established in Bangkok and New Delhi to provide prompt and efficient services in order to coordinate and strengthen surveillance and response for AI and Public Health Emergency of International Concern. Short courses in Field Epidemiology will be launched in 2007. 11. A series of regional and international workshops have been organized in order to strengthen alert, surveillance and response capacities as a part of avian and pandemic influenza preparedness. 12. Technical guidelines for surveillance and response, laboratory diagnosis, clinical case management and risk communication will be made available in 2007.
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13. Table-top exercises to test whether the strategies and activities contained in NIPPP would stand up to a real event have been conducted in eight countries. These exercises would help Member States to update and validate their NIPPP and to identify any major gaps in policies and procedures.
Funding 14. WHO and FAO are technically coordinating World Bank initiatives for funding AI country project in Member States. So far, agreement has been reached for Nepal (US$ 18.2 million), Bangladesh (US$ 37 million), Sri Lanka (US$ 7 million) and India (US$ 32 million). The World Bank has provided US$ 1.2 million through FAO to Myanmar on AI Prevention and Control. Bhutan is in the process of receiving US$ 1.6 million. Indonesia has received US$ 9.6 million for AI surveillance and response activities from AUSAID, USAID and CIDA and negotiations are continuing on US$ 24.9 million as a grant from JICA and EU. DPRK, Timor-Leste and Maldives have not yet received enough funds for AI activities. In addition, SEARO has received funding support from ADB, CAREID, USAID and USCDC. 15. The next ministerial and pledging conference on the international response to avian and pandemic influenza threats will be hosted by the Government of India and is planned to take place in December 2007.
Recent controversial issues 16. One of the main objectives of virus sharing is identification of a potential candidate vaccine strain for vaccine development and for profit-oriented vaccine producing companies to have access to shared virus by Member States. Some countries have questioned the existing Global Influenza Surveillance Network because there is no guarantee about access to pandemic vaccines in return for participating in the network. 17. There is a serious concern about equitable access and affordability to pandemic vaccines by a majority of Member States while virus-sharing and other benefits-sharing issues have not been settled. Intellectual property rights and patent rights have to be defined to ensure easy access and affordability to vaccine and technology. 18. Pre-pandemic or H5N1 vaccine production and stockpiling are the priorities of H5N1affected countries in Asia and Africa whereas other countries prefer to concentrate on pandemic vaccine production and stockpiling.
Action taken Accreditation and virus sharing 19. There are four H5 WHO Reference laboratories, with none in the South-East Asia Region. Since the Region is continuously facing H5N1 outbreaks, initiatives have been taken to accreditate at least two laboratories in the Region as reference laboratories by 2007.
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20. The success of the implementation of IHR (2005) greatly depends on the capacity to detect, verify, report AI outbreaks and virus sharing by Member States with WHO Collaborating Centres. Drawing up new Terms of References of the WHO Influenza Collaborating Centre Network, and its H5 Reference laboratories, for the sharing of influenza viruses will be crucial to address concerns raised by Member States. WHO is planning to organize an international meeting in Singapore in August 2007 to develop new Terms of Reference for WHO Collaborating Centres considering the resolution on the subject adopted by the 60th World Health Assembly.
Equitable access to vaccine 21. Existing manufacturing technology and capacity simply would not be able to supply enough vaccine to meet the global demand in the event of a pandemic. An ideal solution would enable more countries to produce vaccine locally (or regionally). WHO has been coordinating international partnership in establishing the know-how and the physical means for producing vaccines locally in six developing countries, three of which are in the South-East Asia Region. This would reduce competition for already scarce supplies and allow countries to obtain a degree of self-sufficiency. 22. WHO has been involved in the establishment of an international stockpile of vaccines for H5N1 and influenza viruses of pandemic potential. The 60th World Health Assembly in 2007 passed a resolution requesting WHO to formulate mechanisms and guidelines, in close consultation with Member States, aimed at ensuring fair and equitable distribution of pandemicinfluenza vaccines at affordable prices in the event of a pandemic in order to ensure timely availability of such vaccines to Member States in need.
Gaps and challenges (1) (2) (3) There are no accredited reference laboratories for diagnosis of H5N1 viruses in the Region. There is a lack of R&D for pre-pandemic vaccines and their production and stockpiling in the Region. There is a need for strengthening national capacity within a limited timeframe for implementation of IHR (2005) and to maintain transparency and timeliness in reporting of avian influenza outbreaks. Mobilization of substantial additional resources and international partnership are crucial for successful development of core capacities for implementation of IHR (2005) and pandemic preparedness.
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