Accelerating Implementation of Underutilized Vaccines: The Hib Initiative National Immunization Conference March 7, 2007 Rana A. Hajjeh, MD

Outline – why are we still talking about Hib disease Hib disease Global Status Obstacles for Hib vaccine introduction in developing countries The Hib Initiative: strategic approach and rationale Progress and lessons learned

Decline of Hib meningitis following introduction of Hib conjugate vaccines, children <5 yrs, U.S.— Source: Adams WG, JAMA mo 2 mo

Hib Disease – Children <5 years old Meningitis –Hib: the leading cause of bacterial meningitis –Mortality: 20-60% of hospitalized patients –Permanent long term sequelae: 15-35% Pneumonia –In several studies, Hib accounted for over 20% of severe pneumonia –Mortality: 2-20% Resistance to first line antibiotics increasing worldwide

Source: WHO 2005 World Health Report Pneumonia causes almost 1 in 5 child deaths The leading cause of infectious death in children <5 years of age Hib accounts for 20% of severe pneumonia in most studies in developing countries Under-nutrition ( underlying cause ) 53%

GAVI-- Global Alliance for Vaccines and Immunizations

Hib Vaccine Status, 2004– <10% of children in GAVI eligible countries had access to Hib vaccine (17 countries) YesNo Hib in EPI GAVI/VF Support Source: WHO/IVB database

Why are children with the greatest need the last to receive these vaccines? Lack of awareness Uncertainty about disease burden and vaccine impact Concern about cost and sustainability Concern about supply Focus on other priorities

The Hib Initiative - Mission “ To expedite and sustain evidence-informed decisions at the global, regional and country levels regarding the use of Hib vaccination to prevent childhood meningitis and pneumonia”

Generally, it has taken over 20 years for more widespread adoption 50% coverage* 33% coverage* 10% coverage * *Coverage estimates based on 3 doses for children in 72 GAVI eligible countries June 2006 coverage Target June 2009

Strategic Approach “ The significant problems we face cannot be solved at the same level we were at when we created them” (Einstein) Evidence- informed decisions

Burden of Disease Issues

Incidence of Hib meningitis in children < 5 yrs of age, worldwide (pre-vaccine era) Source: WHO, literature review, 2002 In many parts of the world, there is consistent evidence that Hib meningitis is a significant problem

The Gambia: Incidence of Hib meningitis in children under 5 yrs of age cases per 100,000 per year Source: Adegbola et al., Lancet 2005; 366: Hib Trial National Immunization Program

Hib invasive disease incidence in Kilifi, Kenya decreased from 66 to 7.6 /100,000 in children < 5 years Hib vaccine introduction Source: Cowgill et al., JAMA, 8/05

Mongolia - Incidence of Hib Meningitis Cases and Deaths per 100,000 Children < 5 (MOH) Episodes/ 100,000 children < 5

“In view of their demonstrated safety and efficacy, Hib conjugate vaccines should be included in all routine infant immunization programmes. Lack of local surveillance data should not delay the introduction of the vaccines, especially in countries where regional evidence indicates a high burden of disease.” WER 24 Nov, 2006 WHO Revised Position Paper on Hib Vaccine, Nov. 06

Impact of Revised WHO position paper Supports the GAVI/Hib Initiative mandate in expediting evidence-based decision making re: Hib vaccine introduction Shifts focus from conducting more burden of disease studies, to assessing other pieces of evidence: Financial sustainability, Program needs, other public health priorities

Communication Activities Highlighting major events & publications Regional materials Focused country advocacy Media outreach Website Increase awareness re: pneumonia

Hib Vaccine decision making – At the “tipping point”- New Hopes, New Challenges FOCUS On Hib WHO revised position paper GAVI financing guidelines Additional vaccine available Recent UNICEF tender

New GAVI financing policies Co-payTerms Poorest ($1000 GNI/capita, LDC) $0.23 Fixed co-payment through 2010 Intermediate ($1000 GNI/ capita, not LDC) $0.38 Fixed co-payment through 2010 Least Poor (>$1000 GNI/capita) $0.43 Gradually increasing co- payment through 2010 Fragile States $0.15 Fixed co-pay, flexible financing through 2010

Additional Benefits of Hib Vaccine Value of vaccines (Bloom & Weston, World Economics, 2005) : –Lives saved –Improved outcomes (less disability –Reduced medical costs –Improved productivity and economic benefit Help achieve MDG 4 1

Pentavalent DTP-Hep B- Hib Manufacturers – Stage of Development Clinical Trials Source: GAVI – Commissioned Boston Consulting Group Study 2005 Sales and Marketing Production Licensing/ Regulatory 1 liquid-lyo 1 all liquid 1 two-vial liquid Ph II/IIIPh I 3 liquid-lyo 1 all liquid 1 liquid-lyo 7 additional manufacturers have products in development or plan to develop Expected presentation: Manufacturers:

Stopping the vicious cycle Limited supply Higher price Uncertain demand 3) Higher prices keep developing countries uncertain about demand and donors uncertain about financing needs 1)Uncertainty about demand in developing countries has kept industry from investing in capacity 2) Limited vaccine supply keeps prices relatively high

Global Coordination – All Stakeholders A coordinated approach from various stakeholders builds stronger support and more sustainable decisions WHO UNICEF Researchers Policy Makers Others Pediatric Association Community leaders /parents? Healthcare providers

Progress/Impact Indicators 1. % countries that introduce Hib vaccine or receive approval in regions with well documented disease burden, by yr: (started with 16/49) –Goal, by June 2007: 21 of 49 countries –To date: 24/49 (introduced or approved) 2. % of countries that make a decision about Hib introduction, in regions where disease burden data is needed (defined as inclusion in cMYP/ applying to GAVI or rec. by a functional advisory group), by 2009: –Asia:10 of 15 (66%; 1/15); to date: 8/15 (SriLanka, Mongolia, Pakistan, Bangladesh, Bhutan, Nepal, Indonesia, Vietnam) –CEE/NIS: 5 of 10 (50%; started 0/10): to date: 5 0f 10 (Ukr, Alb, Bos/Hrz introduced, in cMYP: Kyr, Mol, Uzb))

10 Largest Birth Cohorts Total GAVI Phase 2 countries: 83.4 million

Lessons learned (again…) No assumptions Need to put burden in context of other important child health priorities/ vaccine as part strategy to reduce pneumonia mortality/ child survival package and impact on MDG4 Existing data not always accessible, need to develop materials for country- level use to present to decision makers Need to answer questions re: financing and supply (anticipated availability, …) together with relevant partners Challenge current perceptions: why not increase fiscal budget for health? Messages from all partners should be consistent No “standard process” for decision making - work closely with country Identify local champions and know your target audience

Where am I? You’re 30 metres above the ground in a balloon You must be a researcher Yes. How did you know? Because what you told me is absolutely correct but completely useless You must be a policy maker Yes, how did you know? Because you don’t know where you are or where you’re going, and now you’re blaming me….

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MDGs – Reduce Child (<5) Mortality by 66% by 2015 (MDG4) "We will have time to reach the Millennium Development Goals – worldwide and in most, or even all, individual countries – but only if we break with business as usual. We cannot win overnight. Success will require sustained action across the entire decade between now and the deadline. ……………………………………………………. And we must more than double global development assistance over the next few years. Nothing less will help to achieve the Goals." Kofi A. Annan

Hib vaccine is part of a package of interventions The Lancet Child Survival Series II July 5, 2003 * Pneumo and rota vaccines are now estimated to prevent 8% and 5% respectively