SIXTY-SECOND WORLD HEALTH ASSEMBLY Provisional agenda item 12.1
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Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits Report by the Secretariat
1. In May 2007, the Sixtieth World Health Assembly adopted resolution WHA60.28 on Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits which, inter alia, requested the Director-General to report to the Sixty-first World Health Assembly, through the Executive Board, on progress made in implementing the resolution, including the work of the Intergovernmental Meeting. In May 2008, the Health Assembly noted the report submitted by the Secretariat,1 and in January 2009 the Executive Board noted a further report.2 2. In the period since the Intergovernmental Meeting held in November 2007, several activities have been undertaken to implement resolution WHA60.28.
INTERGOVERNMENTAL PROCESS 3. At the Intergovernmental Meeting session in November 2007, Member States adopted an Interim Statement3 calling for urgent implementation of two measures and requesting the Chair to convene an open-ended working group to carry work forward. The working group met in Geneva in April 2008 and focused on five issues, calling on the Chair to prepare a text, through the Bureau and in close consultation with Member States, for discussion at the resumption of the group’s meeting and the resumed Intergovernmental Meeting (Geneva, 8–13 December 2008). 4. The resumed open-ended working group considered the draft Chair’s text, and agreed that it be submitted to the resumed Intergovernmental Meeting as the basis for its work, before adjourning. Progress was made at the resumed Intergovernmental Meeting, notably through adoption of two texts: Guiding Principles for the development of terms of reference for WHO Network laboratories, and Terms of Reference for the Advisory Group.4 Nonetheless, consensus on the Chair’s text was not reached before the meeting was suspended. Before the Intergovernmental Meeting resumes on
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Document WHA61/2008/REC/3, summary records of the first and second meetings of Committee A. Document EB124/2009/REC/2, summary record of the first meeting, section 7. Document EB122/5, Annex 5. Document EB124/4 Add.1, Annex 1, Appendix 1 and 2.
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15 and 16 May 2009, the Chair and officers will facilitate informal consultations among Member States in order to find ways to resolve the remaining issues.
TRACEABILITY MECHANISIM 5. In the Interim Statement the Intergovernmental Meeting invited the Director-General to establish “a technical and feasible system as soon as possible within WHO to track all shared H5N1 and other potentially pandemic human viruses and the parts thereof”. During the two months between the suspension of the Intergovernmental Meeting in November 2007 and the opening of the 122nd session of the Executive Board (21–26 January 2008), the Secretariat devised and launched an interim influenza virus traceability system. The system was well received by the technical influenza community; in 2008 there were, on average, 10 000 page views a month on the virus tracking system web site. 6. The interim influenza virus traceability mechanism provides many of the features and information requested by Member States, notably information on all influenza A (H5N1) viruses and clinical specimens shared by Member States with WHO’s Global Influenza Surveillance Network since 24 November 2007, and tracking of all influenza A (H5N1) viruses that have been selected and developed under WHO’s aegis into candidate vaccine viruses using reverse genetics. The system also provides information on analysis results and progeny materials, if any, that have been generated. However, given the rapidity with which the interim system was developed, it suffers from certain deficiencies such as lack of linkages with other databases and redundant or cumbersome data-entry requirements. 7. In order to define the scope and identify critical technical parameters of an improved system, WHO convened a technical consultation (Ottawa, 24–26 September 2008), which brought together participants, with diverse backgrounds, to discuss the technical parameters and required features of the improved system with due reference to the mandate of the Intergovernmental Meeting. Two members of the Advisory Mechanism attended the meeting as observers and submitted a report of the proceedings directly to the Advisory Mechanism. 8. On the recommendation of the technical consultation in Ottawa, a small subgroup of participants and some additional experts formed a technical working group of experts and convened in Geneva to finalize the technical specifications of the system. 9. Based on the detailed specifications developed through these two consultative processes, the Secretariat issued a detailed Invitation for Contributions inviting interested parties to contribute complete software systems or discrete components that could enhance the Influenza Virus Traceability Mechanism. The terms and conditions for responding and those governing the acceptance of contributions by the Secretariat are contained in the Invitation for Contributions.
ADVISORY GROUP 10. The Director-General, in close consultation with Member States, appointed an Advisory Group of 18 members comprising internationally recognized policy-makers, public health experts and technical experts in the field of influenza, and based on equitable representation of WHO regions and affected countries.
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11. This Advisory Group advises the Director-General on strengthening the trust-based system needed to protect public health and undertake necessary monitoring and assessment of the system. The Advisory Group has met twice. At its first meeting (Geneva, 21 October 2008), it drafted provisional terms of reference and considered progress made on the development of the Influenza Virus Traceability Mechanism, notably through the report of the two members of the Advisory Group who attended the Ottawa technical consultation (see paragraph 7). In its second meeting (5 March 2009), the Advisory Group discussed the four preparatory documents to be submitted to the Intergovernmental Meeting at its resumed session in May and provided comments on them to the Secretariat.
INTERNATIONAL STOCKPILE OF H5N1 INFLUENZA VACCINES 12. Pursuant to resolution WHA60.28, the Secretariat undertook work towards establishing an international stockpile of vaccines for H5N1 or other influenza viruses of pandemic potential. In collaboration with a consulting group funded by the Bill & Melinda Gates Foundation, WHO developed several options for the stockpile, including associated costs and possible financing mechanisms. A detailed report on the findings was released in February 2009.1 13. During a meeting of experts and Member State representatives (Geneva, 4 March 2009), technical options for the design and financing of the international stockpile were discussed. Based on expert guidance, as well as the evidence and findings contained in the report,1 the Director-General considers that the optimal configuration for the international stockpile of H5N1 vaccines is as follows: • a short-term (three-to-five years) physical stockpile of donated vaccines that does not require replenishment • vaccine to be held in filled doses with ancillary supplies • the stockpile to be located in up to three cities, selected according to cost implications and other criteria which include, but are not limited to: − international air and cargo hubs (reliability of airport facilities and services in times of crisis) − geographical/regional balance − commitment of host country to ensure access and facilitate international deployment − demonstrated logistics infrastructure capacity (e.g. storage, handling and maintenance). The estimated present value cost of this option is US$ 70 million. The Director-General will consult with potential donors to secure in-kind and other donations to meet this estimated cost. 14. WHO will look to the guidance of the WHO Strategic Advisory Group of Experts on immunization and the specialized working group on H5N1 vaccines in order to consider and provide
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http://www.who.int/csr/disease/influenza/H5N1_Stockpile_Design_Feb2009.pdf.
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further recommendations on the use of H5N1 influenza vaccines in high-risk and priority groups (as defined in country plans) and the use of H5N1 vaccine that has been stockpiled but is reaching the end of its shelf-life. Meetings of the Strategic Advisory Group of Experts on immunization and its working group are scheduled for April 2009.
STRENGTHENING SURVEILLANCE AT THE ANIMAL–HUMAN INTERFACE 15. Collaboration between FAO, WHO, UNICEF and OIE is continuing, as exemplified by the Global Early Warning System for Major Animal Diseases, the Global Framework for Transboundary Animal Diseases, discussion related to the Mediterranean Zoonoses Control Programme, a recent jointly sponsored scientific meeting that brought together animal and human influenza scientists, and the Canadian International Development Agency-funded tripartite programmes on avian influenza. This collaboration has been strengthened as a result of joint responses to H5N1 disease in poultry and humans. There is now an acceptance that, in order to maintain the momentum in the response to H5N1 infection and increased preparedness for a pandemic of influenza, there should be a framework to enable a response to diseases at the human–animal interface, which includes human public health, and domestic and wildlife animal health using the concept of “One World, One Health” from the Wildlife Conservation Society 2004. A strategic framework for “One World, One Health” was presented to the Ministerial Meeting on Avian and Pandemic Influenza (Sharm-el-Sheikh, Egypt, 25 and 26 October 2008) by FAO, WHO, UNICEF, OIE, the World Bank and the United Nations System Influenza Coordinator. The success of the current response to avian influenza will help to promote a sustained response to avian influenza and other diseases which have a profound effect on human and animal health and the health of communities and economies. 16. The Executive Board at its 124th session noted an earlier version of this report.1
ACTION BY THE HEALTH ASSEMBLY 17. The Health Assembly is invited to note this report.
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See document EB124/2009/REC/3, summary record of the first meeting, section 7.
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