Elsevier

Vaccine

Volume 28, Issue 43, 8 October 2010, Pages 7123-7129
Vaccine

Supporting new vaccine introduction decisions: Lessons learned from the Hib Initiative experience

https://doi.org/10.1016/j.vaccine.2010.07.028Get rights and content

Abstract

The introduction of Haemophilus influenzae type b (Hib) vaccine in developing countries has suffered from a long delay. Between 2005 and 2009, a surge in Hib vaccine adoption took place, particularly among GAVI-eligible countries. Several factors contributed to the increase in Hib vaccine adoption, including support provided by the Hib Initiative, a project funded by the GAVI Alliance in 2005 to accelerate evidence-informed decisions for use of Hib vaccine. This paper reviews the strategy adopted by the Hib Initiative and the lessons learned in the process, which provide a useful model to accelerate uptake of other new vaccines.

Introduction

The introduction of Hib vaccine into national immunization programs in developing countries has suffered from a long delay following vaccine licensure and availability in developed countries. The delay was attributed to multiple factors, including lack of data on burden of disease or vaccine impact, as well as inadequate supply, cost and financing limitations, and lack of political will [1]. By 2004, only a few developing countries had included Hib vaccines in their national immunization programs, despite various efforts by WHO and GAVI, and despite the high effectiveness of these vaccines and their documented impact. However, between 2005 and 2009, a significant surge in Hib vaccine adoption took place, with the number of GAVI-eligible countries that introduced or were approved to introduce Hib vaccine increasing from 19 of 75 (25%) in 2005, to 66 (92%) of 72 in 2009 [2].

In the early years of GAVI support, and in order to avoid the same delays that were observed with hepatitis B vaccine introduction, an assessment of the obstacles to Hib vaccine introduction led to corrective measures that contributed to accelerating Hib vaccine uptake. First, data from multiple studies, ranging from resource-intensive vaccine probe studies to rapid assessment of burden using the WHO Hib Rapid Assessment Tool (HibRAT) [3], indicated that Hib disease constituted a significant public health problem globally, and led to the revision in November 2006 of the WHO position statement [4]. This revised statement clearly recommending global use of Hib vaccine enabled all GAVI-eligible countries to apply for vaccine introduction without having to provide evidence of local burden, which had been an obstacle for some countries in GAVI phase I. Though data on local burden of disease is desirable, countries were encouraged to use data from neighboring countries, with similar population and socioeconomic characteristics, and global estimates. Second, as part of GAVI's phase II, new co-financing guidelines offered financial commitment until 2015 along with a small country co-payment, which helped alleviate countries’ concerns about ability to sustain the long-term program. Third, additional Hib vaccine formulations became available, including a fully liquid combination vaccine (DTP-HepB-Hib), and new manufacturers entered the market, thus decreasing concerns about limited supply and increasing hopes that the vaccine's price would decline with time. Finally, the advent of the Hib Initiative (HI) in 2005, at a critical time or a “tipping point” when all these favorable conditions came together, helped maximize their impact on Hib vaccine adoption. The HI was a 4-year project, initiated and funded by the GAVI Alliance in 2005, with the main objective of accelerating evidence-based decisions for Hib vaccine introduction in low-income countries. The HI was a consortium of academic and public health and institutions (Johns Hopkins Bloomberg School of Public Health, the London School of Hygiene and Tropical Medicine, the World Health Organization, and the Centers for Disease Control and Prevention). The consortium brought together a set of diverse skills in research and surveillance, communications and advocacy and policy-support, and utilized the global mandate of WHO and its network of regional and country offices to provide direct support to ministries of health. Building on lessons learned from the introduction of other vaccines, principally hepatitis B, the HI developed a strategic plan to address the key barriers for introduction. The plan focused on three areas that were determined critical to overcome the barriers for vaccine introduction—communications and advocacy, research and surveillance, and coordination of programmatic activities such as finance, supply and vaccine logistics. This paper reports on the experience and approach of the HI and the many lessons learned in implementing its strategy, hoping that these lessons will be useful for ongoing efforts to introduce other new vaccines.

Section snippets

Understanding the problem and designing strategies

The main objective of the HI communications strategy was to ensure that decision-makers and other stakeholders had timely access to evidence that was relevant and understandable, to inform decisions for Hib vaccine introduction. Early in the project, the HI determined what evidence was needed or perceived important for decision making. This was accomplished by discussions with WHO regional office staff; visiting countries considered to be strategically important for the region; conducting

Research and surveillance

By the time the HI started, a significant amount of data existed on Hib disease burden and vaccine efficacy and impact globally. It was also obvious that, except for economic analyses, most new studies could not be started and finished in time to affect the decision making process during the life of the HI project. Therefore, the research strategy of the HI mainly focused on addressing gaps in Hib knowledge, and supporting research and surveillance activities that could provide evidence and

Strategic coordination

The HI strived to develop a strong, focused and well coordinated team that built on the existing capacities of WHO and UNICEF at the global, regional and country level and supplement it with additional skills required to facilitate introduction of new vaccines in resource poor countries. The concerted action of all consortium members, along with the other partners, was crucial to address the various aspects relevant to decision making on vaccine introduction, including adequate financial

Conclusions

The Hib Initiative built on lessons learnt from the early efforts to accelerate the introduction of hepatitis B and Hib vaccines, but also added new lessons that may be useful for future initiatives. Some of these lessons learned may seem obvious principles of project management, or a matter of “common sense”, so what is really that helped the HI implement these principles to reach its goals? In addition to the right timing and the various factors discussed earlier, we believe it is a

Case studies

Case study 1: Involving child survival experts in Cambodia.

Lesson: Link Hib vaccine to the broader and more visible issue of child survival.

“Too often immunizations are considered a goal in themselves and not a means to achieve the goal of reducing child mortality.” Dr. Niklas Danielsson, Maternal and Child Health team leader, WHO, Cambodia.

In Cambodia, as in many Asian countries, Hib disease was not seen as an urgent public health issue by decision-makers. Cambodia's immunization program faced

Acknowledgments

We would like to acknowledge the contributions of the many colleagues whose efforts were crucial to the success of the project (listed alphabetically by organization): from the World Health Organization: Thomas Cherian, Rose Macauley, Taranda Manzila, Themba Mhlanga, Ezzeddine Mohsni, Liudmila Mosina, Mumba Mutale, Pem Namgyal, Deo Nshimirama, Jean-Marie Okwo-Bele, Manju Rani, Nadia Teleb and Patrick Zuber; from Johns Hopkins: Latia Brinkley, Judy Heck, Layla Lavasani, Jessica Shearer and James

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