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An Occasional Series Exploring the Intersection of Vaccines, Ethics and Policy

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18 May 2012

Mind the Gaps (in the GVAP): Member States Should Defer on Endorsing the Global Vaccine Action Plan

By David R Curry, Executive Director, Center for Vaccine Ethics and Policy
http://centerforvaccineethicsandpolicy.wordpress.com/
[pdf version of this Viewpoint]

The collective effort undertaken by literally hundreds of members of the global vaccine and pubic health community over the last 18 months has been remarkable.

Fueled by some US$7 million in Gates Foundation funding(1) and significant in-kind support from many WHO departments, regions and other organizations, the resulting GVAP (Global Vaccine Action Plan) (2) has gone through numerous consultations and revisions over the last several months. The GVAP was posted last week as a 39-page document for consideration and proposed endorsement at next week’s 65th World Health Assembly (WHA) (3) in Geneva.

But there are five serious gaps in the GVAP that suggest member states might well defer on endorsement and recommend that the GVAP’s authoring body – the Decade of Vaccines Collaboration and its Secretariat – continue work and present a substantially more complete plan for consideration and endorsement at the 66th World Health Assembly in May 2013.

Gap 1: Governance and Accountability Framework
The Decade of Vaccines Collaboration leadership received clear counsel from the WHO Executive Board in January, 2012, and from SAGE (Strategic Advisory Group of Experts on Immunization) in February, 2012 on the need to develop and present a substantive accountability framework addressing governance and implementation oversight for the GVAP.

There is no such accountability or governance framework presented.  The GVAP limits itself to arguing that one is needed – one that “…identifies which stakeholders will be responsible for what actions, and articulates the process and responsibilities for monitoring and evaluating progress over the course of the Decade…” (4)

Later in the GVAP this gap is recognized to include “…more detailed roles and responsibilities for stakeholders, a complete set of indicators, the methodology and data sources for each indicator detailed and baselines established where required.”(5)  The GVAP draft does note that “…WHO will play a leadership role for the action plan as the normative lead agency in global health…” (6)

This does not an accountability framework make, and without one, endorsement is premature at best.

Gap 2: Funding Strategy to Address Projected US$18-20 billion implementation shortfall

The GVAP presents an analysis of costs and benefits associated with its key strategic objectives. The work behind this analysis broke new ground and is to be applauded, even with the constraints of limited data and sometimes questionable data quality.

The GVAP’s cost projections are limited to programming for 94 low- and lower-middle income countries, and do not factor in costs associated with seasonal influenza vaccine scale-up, improved surveillance systems, civil society engagement, technical agencies services, and some R&D costs.

Despite this gap in projected cost elements, the GVAP programs that are costed come in at between US$50 – 60 billion over the period to 2020, with an apparent shortfall of between US$18-20 billion in new funds to be raised from yet unidentified sources.( 7)

The plan states that this additional funding “…will require commitment from all stakeholders, with governments needing to continue making immunization a priority in resource allocation decisions; development partners needing to sustain and bolster access to funding for immunization in spite of competing priorities; and the entire community needing to continue efforts to reduce the cost of vaccine acquisition and immunization service delivery.”

Indeed. But a practical and plausible strategy to address this funding gap is not presented. This gap suggests that member state endorsement of the GVAP would not just be premature as argued above, but perhaps even fiscally irresponsible without such a financing strategy articulated.

Gap 3:  Aspiration Level and Coherence across Guiding Principles, Goals, Strategic Objectives, Indicators and Responsibilities
When Bill Gates announced the “decade of vaccines” and a pledge of US$10 billion to support it at the World Economic Forum in 2010, there was much hope for breakthroughs in aspiration and imagination in the eventual GVAP.

The gap between such hope and the GVAP now before the World Health Assembly is both alarming and disappointing. The Goals statement (8) underscores this, not because the goals are unimportant as stated, but that they lack any spark suggesting that the Decade of Vaccines will be more than an extension of straight line thinking from the ten decades preceding it:

Goals of the Decade of Vaccines (2011–2020)
- Achieve a world free of poliomyelitis
- Meet global and regional elimination targets
- Meet vaccination coverage targets in every region, country and community
- Develop and introduce new and improved vaccines and technologies
- Exceed the Millennium Development Goal 4 target for reducing child mortality

Moreover, the GVAP has the added burden of juggling “Six Guiding Principles” five “Goals of the Decade of Vaccines 2011-2015” “Six Strategic Objectives” – and indicators for each that in most cases lack aspiration, metrics or both.

The GVAP needs significantly better coherence among of these confusing framing rubrics, especially as the Decade of Vaccines Collaboration itself will dissolve itself as its grant period ends late in 2012, leaving no interpretive capability to untangle the GVAP’s intent.

Gap 4: Engagement of key immunization challenges beyond childhood vaccination
Childhood vaccination does and should enjoy a prominent place in the GVAP. But the GVAP’s vision and mission statements assert that scope of the Decade of Vaccines will address much more:

The vision for the Decade of Vaccines (2011–2020) is of a world in which all individuals and communities enjoy lives free from vaccine-preventable diseases. The mission of the Decade of Vaccines is to extend, by 2020 and beyond, the full benefit of immunization to all people, regardless of where they are born, who they are or where they live.

The GVAP does mention broader, global immunization challenges including “…disparities between countries, adolescent and adult immunization, and immunization during emergencies” but the treatment is limited to a few paragraphs in the context of “dimensions of equity.” 9 There is no substantive, practical or plausible plan language grounding these rather large areas of challenge.

Gap 5:  Engagement of core R&D issues and development priorities for new vaccines and new vaccine fields
Simply said, the GVAP does not come to grips with articulating the challenges, let alone provide practical strategies and solutions for this complex area of the decade ahead.

We suspect this is at least partly the result of basically excluding any industry input in the development of the GVAP (except limited industry association opportunity to comment).

This section of the plan concludes with the insight that:
“Concerted action among the research community, manufacturers, health professionals, programme managers, national immunization technical advisory groups, vaccine regulatory agencies and development partners will be needed to attain the full potential of research and development in the next decade. Methods and arguments for prioritization and allocation of scarce resources will have to be agreed upon by these groups, balancing the tensions between country-driven choices and the need for large-scale research efforts and markets in order to sustain development and commercialization.“ (10)

How could anyone disagree? The problem is that the framework for such concerted action and agreements is not addressed in the GVAP in plausible or actionable ways.

Beyond this, important emerging fields vaccinology that will make major health impacts in the decade ahead – such as therapeutic and behavioral vaccines – are given only passing mention. The lack of clarity about the vaccines landscape in 2020 and its implications for global public health is distressing.

In summary, the work done to date on the GAVP is to be applauded, but it was premature, at best, to present it for endorsement now.

Any one of the five gaps discussed above might be cause for the member states of the World Health Assembly to defer on endorsement of the current GVAP draft. Any one of these gaps might well justify a call for additional effort by the Decade of Vaccines Collaboration to work towards a plan that is coherent enough, complete enough and ambitious enough to deserve WHA endorsement, and to energize and guide us in the years ahead.

Note: The author was a member of a working group in the Decade of Vaccines Collaboration which developed the Global Vaccine Action Plan (GAVP) until February 2012.

(1) Gates Foundation grant to Institut de Salut Global Barcelona (February 2011) to support the Decade of Vaccines Secretariat   Amount: $7,015,922   Term: 1 year and 11 months http://www.gatesfoundation.org/Grants-2011/Pages/Institut-de-Salut-Global-Barcelona-OPP1029208.aspx

(2) A65/22  Draft global vaccine action plan
http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_22-en.pdf

(3) A65/1  Provisional agenda

(4) A65/22  global vaccine action plan, p. 8, Section 31
http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_22-en.pdf

(5) A65/22  global vaccine action plan, p. 30, Section 102
http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_22-en.pdf

(6) A65/22  global vaccine action plan, p. 30, Section 106
http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_22-en.pdf

(7) A65/22  global vaccine action plan, p. 28, Section 95
http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_22-en.pdf

(8) A65/22  global vaccine action plan, p. 8, Section 27
http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_22-en.pdf

(9) A65/22  global vaccine action plan, p. 15, Sections 52-55
http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_22-en.pdf

(10) A65/22  global vaccine action plan, p. 25, Section 88
http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_22-en.pdf