Dr Arlene King, Director, Public Health Agency of Canada, Ottawa, Ontario K1A OK9, Canada
19 October 2007
WHO HQ, Geneva, Switzerland
INITIATIVE FOR VACCINE RESEARCH (IVR) & GLOBAL INFLUENZA PROGRAM (GIP)
Immunization, Vaccines and Biologicals
World Health Organization
All populations in all countries are expected to be susceptible to infection with a pandemic influenza virus. (why would they say that?)
Progress since May 2006 in implementing GAP strategies
Presentations and discussions held during the meeting served to review activities contributing to the implementation of the GAP.
Major progress has been made by the vaccine industry in developing H5N1 vaccine formulations, which will allow substantial antigen sparing in case of a pandemic. Indeed, three multinationals have shown appropriate immunogenicity of vaccine candidates containing as little as 3.8 to 7.5 ug HA, formulated with proprietary adjuvants.
The Group agreed upon the following key issues:
1) The overarching goal of the GAP to increase influenza vaccine production needs can be
characterized by several concurring issues: a) development of creative financial strategies; b) building a strong marketing campaign; c) relying on lessons learned from previous vaccine-preventable disease control, elimination, or eradication campaigns, i.e. polio; and d) incorporating lateral thinking to leverage sister UN organizations and partners such as the United Nations Children’s Fund (UNICEF), the Global Alliance for Vaccines and Immunization (GAVI) and others. In particular, GAVI should be approached as a source of financial assistance. In addition, the establishment of a financing mechanism such as the Pan American Health Organization (PAHO) Revolving Fund should be explored as a solution to reduce seasonal influenza vaccine prices.
2) The GAP business plan provides a global framework for increasing vaccine production capacity for influenza vaccines. Implementation of the GAP should also result in strengthening of surveillance, as well as providing an opportunity for improving the performance of national immunization programmes.
Indeed, it may improve the world’s ability to conduct mass vaccination campaigns and represents an opportunity to strengthen vaccine regulatory systems.
As the kind of strategy contained in the GAP business plan has never been pursued, the Group noted that there were obvious risks. A major risk factor is the underlying assumption that there will in fact be a pandemic. If there is not a pandemic within the next five years, there may be loss of interest and
political awareness, and other public health needs may shift investment away from pandemic
influenza. Therefore, it is critical to identify the best possible strategy to maintain political commitment
and WHO is working with partners (UNICEF) and donors to mitigate this risk. The Advisory Group appreciated that the business plan was developed by independent consultants following discussions with country representatives and other stakeholders to achieve buy-in by the international community, and to prevent the GAP from being considered a bureaucrat-driven solution.
3) In the context of GAP approaches 2 and 3, there is a need to develop reproducible assays to
evaluate immunogenicity of influenza vaccines and to establish adequate correlates of protection. The efficacy of potential cross-reactive vaccine candidates to induce broad-spectrum protection should continue to be addressed in a critical manner. Stockpiling of potential H5N1 viruses should be assessed with caution; use of this may be justified in the absence of optimally matched and approved vaccine during the early phases of an influenza pandemic. WHO, Member States, and other stakeholders are currently establishing criteria, guidelines for use, maintenance issues, operational, and ethical issues of a WHO international influenza pandemic vaccine stockpile
From a marketing and financial perspective, the right engine to achieve this plan has to be selected based on a financial perspective. It will be critical to choose the right channel, which may include hosting the GAP under the umbrella of the implementation of international health regulations, as a global health security issue, or under health system strengthening. The business plan should work towards alignment with other organizations, harmonization of strategies with donors and maintenance of commitment of stakeholders/donors to avoid donor fatigue.
The Advisory Group suggested focusing on the following priorities over the coming months:
1) The main priorities for WHO for the year 2008 should be to choose the appropriate spin to be placed on the business plan in association with the right marketing strategy. WHO also needs to establish a detailed operational plan and to define financial resources i.e. donors, countries, and other stakeholders. Leveraging the GAP with twin programmes from sister agencies or other stakeholders, as well as making sure that the need for increasing influenza vaccine production capacity is addressed in the political arena are key priorities.
2) Additional priorities include:
– Maintaining global commitment through information, communication, and educational activities.
– Addressing any potential liability issues associated with the business plan.
The Canadian govt. has shielded the manufacturers from liability in the case of side affects or death from the vaccine. Why?
It certainly looks like a scam folks! Before you take the vaccine do your own research.