6.12 Draft global vaccine action plan: update

Secretariat note

The Board is invited to review an information document that highlights progress in developing the Decade of Vaccines draft action plan, including the draft vision statement, and details of the four work streams in the action plan, in preparation for a substantive review by the Sixty-fifth World Health Assembly.

Document EB130/21:  Draft global vaccine action plan: update

Watchers' notes of EB discussion

 Draft of the global vaccine action plan: update (EB 130/21, EB 130/Conf.Paper No.1, EB 130/Conf.Paper No.1 Add.1, EB 130/Conf.Paper No.6 and EB 130/Conf.Paper No.14)

The discussion on vaccines focused on a general issue - the development of the global vaccine action plan - and two specific draft resolutions: the “World Immunization Week” and another one called “Towards eradication of measles”.

Both resolutions were released very late, respectively on January 16th and January 18th; the first one was proposed by Barbados and requests Member States to designate the last week of April as World Immunization Week.

The second one was proposed by Ecuador on behalf of the Union of South American Nations (UNASUR) and, among other requests, urges Member States to establish a time frame for the eradication of measles.  

Concerning the global vaccine action plan, many Member States (i.e. US and Japan) recognized the importance of this agenda item for global public health and for the achievement of the related MGDs. However, some concerns were raised on several issues.

Japan requested the Secretariat to assess how the global vaccine action plan will coordinate with already existing programmes on immunization in order to avoid duplication especially at the field level.  

Estonia, on behalf of EU, reminded the importance of the rational use of immunization and called WHO to play a crucial role in norms setting and technical support within the Decade of Vaccine (DoV) Collaboration.

On the same way, France asked for more information on the WHO relationship with GAVI alliance and the other partners of the DoV Collaboration. France and US requested also clarification on the establishment of a “vaccine access forum” and its operational implications.

Timor-Leste raised an interesting point by saying that despite huge achievements, immunization coverage remains still low in some countries due to limited financial support. Therefore, they asked the Secretariat to include in the report detailed information about immunization coverage and its linkage with economic situation of different countries.

China highlighted the importance of promoting technology transfer in order to facilitate local production of vaccines at country level.  The last point that deserves to be mentioned is the US statement on the use of the words “access to” and “use of” vaccines. In its opinion access to vaccine is not sufficient and the delegate pushed to add the word “use of” into the document thus slightly reducing the meaning of immunization to a consumable good.

The People’s Health Movement presented a statement in which civil society urged Member States to carefully consider how conflicts of interest will be tackled in the “vaccine access forum” since it will include stakeholders with commercial mindsets that might rival public health goals. Moreover the statement affirmed that immunization programmes should not be seen as a substitute to the broader range of public health measures, such as access to primary health care services, health education and the availability of safe drinking water and sanitation.

The Assistant DG (Family, women’s and children’s health) took the floor answering that further clarifications on Member States requests will be given after the special session of the Strategic Advisory Group of Experts (SAGE) on immunization that will be held next February in Geneva. Addressing the France concern, she affirmed that “up to now the DoV collaboration has been an extremely positive one and we are working hand in hand with all the partners of the DoV collaboration”. Concerning the resolution on measles proposed by Ecuador, Estonia and Ecuador itself asked for the inclusion of the vaccination for measles in the draft global vaccine action plan.

US among others asked to replace the word “eradication” with the word “elimination” in the text of the resolution because the goal of eradication is still not achievable. After this amendment the resolution was adopted.

The resolution “World Immunization Week” obtained wide support since it could be a window opportunity. However Thailand sharply drew the attention on the risk that the private sector could take advantage of this event to market indiscriminately its products suggesting that the best option is to promote only basic and evidence-based immunization programmes 

PHM Comments

The document summarizes progress in the development of the global vaccine action plan and is divided into five main chapters and twenty nine paragraphs.

First chapter: THE GLOBAL VACCINE ACTION PLAN – AN IMMUNIZATION AGENDA FOR THE DECADE OF VACCINES.

This chapter mentions the Decade of Vaccines and provides some basic information about the context, the development and the aims of the global vaccine action plan.

According to the document, the global vaccine action plan was initially discussed by the Sixty-fourth World Health Assembly in 2011 as part of the progress report on the implementation of the Global Immunization Vision and Strategy (Document A64/14: The Global Immunization Vision and Strategy 2006–2015 was the first-ever 10-year framework for fully realizing the potential of immunization in controlling morbidity and mortality from vaccine-preventable diseases. By 2010, the strategy had successfully become the global rallying point and had been adopted by many countries as an overarching strategic framework for immunization. As such, it has been used for the creation of regional immunization strategies and by many countries to draw up comprehensive multi-year national plans for immunization. Several companion documents and action plans have been developed by WHO and UNICEF in collaboration with other partners in order to implement the strategies in the framework.).

Such a report included a description of the start of the collaborative process to develop a global vaccine action plan that builds on the success of the Global Immunization Vision and Strategy. According to Document A64/14, WHO, UNICEF, the Bill & Melinda Gates Foundation and other partners are beginning a 12-month collaborative process to draft together a global vaccine action plan for consideration by the Sixty-fifth World Health Assembly. Such a plan should enable greater coordination between all stakeholders, outline the steps necessary to achieve the vision and goals outlined above, and identify gaps that must be filled in order to realize the potential of vaccines by 2020 and beyond.

Moreover, according to the Secretariat report, the action plan will include a clear process to define an accountability framework , arrived at through a comprehensive global, regional, and in-country consultation process but the terms of reference of the mentioned process are not explicit and clear.

This collaborative process currently runs under the umbrella of the Decade of Vaccines Collaboration, that can be defined as a public-private venture in which WHO and UNICEF work together with the Bill and Melinda Gates Foundation and other partners with the aim of enhancing coordination across the global community by creating a global vaccine action plan that outlines the steps necessary to achieve the vision outlined above. The global vaccine action plan will also identify the financial resources needed and articulate a set of measures for assessing progress¹.

Although the first time reference is the Sixty-fourth World Health Assembly in 2011, the idea of a decade of vaccines comes from far away in terms of time and space.

In 2000, Microsoft founder Bill Gates and his wife Melinda launched at the World Economic Forum a global campaign to deliver vaccines and immunizations to fight disease in the developing world, namely the Global Alliance for Vaccines and Immunisation (the GAVI Alliance).

Ten years later, the history repeats itself. In January 2010 Bill Gates, speaking at the World Economic Forum Annual Meeting in Davos, said the world “must make this the decade of vaccines” and announced that his foundation will commit US$ 10 billion over the next 10 years to help research, develop and deliver vaccines for the world’s poorest countries². This was the biggest single commitment that the Gates Foundation had ever announced.

Few months later, in December 2010, WHO, UNICEF, the National Institute of Allergy and Infectious Disease (NIAD) and the Bill and Melinda Gates Foundation announced the establishment of a collaboration to increase coordination across the international vaccine community and create a Global Vaccine Action Plan. The collaboration, called Decade of Vaccines Collaboration (DoV Collaboration), works independently and outside the WHO framework and has its own structure that includes a Leadership Council to provide oversight for the planning effort, a Steering Committee that holds the primary responsibility for developing the action plan, an International Advisory Committee to assist the Leadership Council in evaluating the action plan, and a Secretariat for administrative support.

Only after the creation of the DoV Collaboration the idea of a global vaccine action plan officially arrived at the Sixty-fourth World Health Assembly for being discussed.

There are few points that deserve to be analyzed and discussed.

First of all, the Decade of Vaccine Collaboration as public-private venture actually runs outside the WHO framework. At the same time Dr. Margaret Chan, WHO Director General, has been brought into the Leadership Council and the whole WHO is called to discuss and support, through the mentioned documents, the global vaccine action plan.

In light of these connections, there might be an overlap between the WHO role and competencies and the Decade of Vaccines Collaboration’s aims that make difficult to understand who is actually leading the process. Moreover, the appearance of the Collaboration as a new actor in the global health field undermines the WHO position and contributes to shift the global health governance from the public to the private sector.

Furthermore, the field of vaccines is a very sensitive one. In 2009, after the declaration of the influenza pandemic, WHO has been questioned about conflicts of interest among the scientists who advised its pandemic planning, and about the transparency of the science underlying its advice to governments³. At that time WHO took advice from experts who had declarable financial and research ties with pharmaceutical companies producing antivirals and influenza vaccines.

This previous episode authorizes to raise some questions about the process ownership: who wrote the current document, who defined the road-map and the aims of the Collaboration as well as of the global action plan and which is the role WHO can play in protecting the public health and in ensuring an independent and evidence-based advice? In other words, it is crucial to understand who is really leading the process and which interests have come into play.

Finally, it is important to understand who, once the plan of action will be implemented, will decide which new vaccines have to be produced and according to which evaluations and priorities; who will decide where and why the new vaccines will be introduced. By answering these questions, it will be easier to unveil the undisclosed interests and better define the economical and political implications of such a decisions.

Second chapter: CONTEXT AND INTRODUCTION

This chapter is an overview of the current state of the art.

Paragraph 4 draws the attention on the remarkable progress made in immunization over the last 10 years by saying that many countries have added new antigens in their national immunization programme – contributing to a dramatic reduction in the mortality of children under the age of five. From a technical perspective it would be fundamental to know which are the new antigens that have been introduced, providing some strong evidence on their efficacy in preventing the disease and being more precise about the reduction of mortality by explaining for how long the decrease has been sustained. Otherwise it is impossible to affirm that the benefits in terms of health are due to immunization programmes.

In paragraph 5 it is stated that vaccine-preventable diseases remain the major cause of mortality and morbility without providing any additional data to support this affirmation. According to the latest epidemiological data, it is fair to ask whether vaccine-preventable diseases are really the major cause of mortality in countries where children suffer from a lack of clear water, healthy food, access to health care services and adequate life conditions.

The last paragraph (6) presents some of the opportunities and challenges of the coming decade. While it is stated that the economic benefits of immunization will contribute to overall growth, once again, no data are gathered in order to understand the real economic impact of an enhanced immunization coverage. In the following line, the increasing availability of information is seen as an opportunity in boosting public demand for immunization. Taking into account that potential conflicts of interests might be present, it should be known who will provide information and, above all, which information will be gathered and who or what will benefit from these opportunities and these information.

Among the challenges, the funding-gap, the sustainability of contributions and the competing interesting in the contests of struggling economies. In fact, from a public health perspective it is fundamental to plan actions according to priorities even more in a period of economic and financial crisis and the introduction of new vaccines as well as an expansion of the current immunization programmes might not be a priority in the agenda settings.

Third chapter: A VISION OF SUCCESS AT THE END OF THE DECADE

This chapter describes the goals that will be achieved in the next decade and the principles that will guide this process.

In this paragraph there are some points that deserve to be analyzed. First of all, the tone of the statement is quite propagandistic. Immunization is described as a component of the right to the highest attainable level of health and as a core component of primary health care and a pivotal component of health systems.

It is recognized that effective vaccine delivery requires well functioning health systems; however, it is less recognized that an excessive focus on immunization might also have negative consequences, decreasing the availability and quality of health care and draining human and financial resources from other programmes. Furthermore, in a Primary Health Care perspective, there is no mention of other lower cost strategies in order to improve the health of the population and of the important role that actions on social determinants of health can play in achieving desired outcomes.

Fourth chapter: REQUIRED ACTIONS

This chapter describes some required actions:

Individuals and communities understand and demand immunization

Paragraph 9 draws attention on the fact that improvements in coverage and programme sustainability are possible if individuals and communities understand the benefits of immunization, and demand it, both as their right, and as their responsibility.

The concept of right to immunization, responsibility and participation are used inappropriately. It is stated that once individuals and communities are aware of their rights to immunization and of the benefits of these programmes, they will definitely participate in immunization activities. It is not recognized the possibility for individuals to refuse the vaccination after being informed. Moreover, the proposed strategy also lacks any reference to the active inclusion of communities in the process.

Paragraph 10 is dedicated to communication issues and states that it is necessary to improve the linkages between technical experts and advocates so that they are better able to find the most appropriate form of communications for each social context in order to determine the most effective strategies for delivering these messages and stimulating demand learning also from commercial and public marketing efforts.

If the objective is to stimulate public demand for immunization, is it still possible to talk about information in order to let people do their free and informed choices or should we rather talk about propaganda?

Finally, paragraph 11 calls for the participation of civil society organizations in the implementation of these strategies. As usual, no clear distinction is made between public interest organizations and commercial interest organizations.

Equity drives the integration of immunization programmes into broader health systems

Paragraph 12 reaffirms the economic benefits of immunization stating that in the coming decade people will be able to lead healthier and more productive lives. Once again, no data are provided in order to understand the real impact of an enhanced immunization coverage. It is positive that the necessity to extend the benefits of immunization not only to infants but also to other target groups like adolescents and adults is recognized. However, it has to be recognized that the extension of vaccination might represent an inviting opportunity for industry to increase its market share.

Paragraph 13 states that data are needed to inform the design, implementation and monitoring of comprehensive national immunization programmes. Investments are therefore needed to maintain and strengthen disease surveillance systems, post-marketing surveillance for adverse events and the conduct of epidemiological studies to document vaccination impact and monitor changes in disease trends.

Once again it is not clear who will decide which new vaccines have to be produced and according to which evaluations and priorities. WHO should have the responsibility to make sure that such fundamental questions are being answered. Furthermore, in this chapter there is no recognition that national priorities are different. The introduction of new vaccines should be subject to detailed needs assessment studies, cost-benefit analyses and public health impact assessments which recognize the specific circumstances of each country. WHO should assist member states in undertaking such studies where appropriate⁴.

Paragraph 14 calls again for the participation of civil society organizations and scientific community in the implementation of these strategies and in advocating for the prioritization of immunization. However, it is not taken into account the possible conflict of interest of experts and organizations who have financial and research ties with pharmaceutical companies producing vaccines.

Achieve sustainable long-term financing and quality vaccine supply

Chapter 16 introduces the establishment of a “vaccine access forum” that could improve communication and coordination among countries, public sector organizations and vaccine manufacturers. However, there are significant risks associated with this proposal: how conflicts of interests will be dealt with if this forum will include stakeholders with commercial interests that can be in conflict with the goals of public health?

Chapter 17 deals with the funding strategies. The two financing mechanisms proposed are the International Finance Facility for Immunization (IFFIm) and the Advance Market Commitments (AMCs).

Sustainability is certainly a key criterion in the financing of immunization programs, however there are still some open questions regarding the strategies proposed. For example, concerning the AMCs, it should be asked if it is possible to manage it in a fair, transparent and accountable way. Which will be the criteria to decide which vaccines will be funded through the AMC mechanism? Who will establish these criteria? Moreover, there is no mention of the negative impact that the Trade Related aspects of Intellectual Property Rights (TRIPS) Agreement have on the affordability of vaccines.

Maximize the benefits of immunization through global research and development efforts

This paragraph deals with research and development of new and improved vaccines. Concerning research, it should be asked who will decide which are the new vaccines that have to be produced and according to which evaluations and priorities these decisions will be taken. Concerning innovation in vaccine development (in fields such as adjuvants) it should be asked who should monitor these aspects. Indeed there has been a great deal of discussion about the possible negative effects of the use of adjuvants to improve the immunogenicity of vaccines against the 2009 H1N1 pandemic influenza. Maybe a committee of independent experts should be created on order to monitor these decisions.

Countries commit to immunization as a priority

This paragraph states that country ownership is crucial to the long-term sustainability of immunization programmes. These actions rely on governments committing to immunization as a priority and on civil society organizations advocating for the prioritization of immunization. A key role in this process will also be played by the National Immunization Technical Advisory Group – a body of national experts that supports and advises the health ministry on all technical and scientific topics related to vaccines and immunization.

Once again, no mention is made of possible conflict of interests of members of these groups. Experts with conflict of interests should disclose all circumstances that could give rise to a potential conflict of interest and should be excluded from decision making process.