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Expanded Program on Immunization: A Disease Control and Development Challenge

Robert Steinglass, MPH Immunization Team Leader Maternal and Child Survival Program - MCSP/USAID (JSI)

Presented February 10, 2016 Global Disease Control Programs & Policies

The Johns Hopkins Bloomberg School of Public Health

!  Evolution of the immunization program from a policy perspective

!  Policy initiatives !  Disease-specific approaches !  New vaccine introduction

Outline

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Evolution of the Immunization Program

Section A

WHO Advisory Committees on Immunization: Structure and Reporting (�Anatomical� View)

“Why do some global health initiatives receive priority from international and national political leaders whereas others receive little attention? To analyze this question we propose a framework consisting of four categories: the strength of the actors involved in the initiative, the power of the ideas they use to portray the issue, the nature of the political contexts in which they operate, and characteristics of the issue itself.”

—Shiffman & Smith, 2007

“Physiological” View of Policy Setting

The Public Health Challenge: Linking the Fears of the Rich with Needs of the Poor—Dr. Bill Foege

!  “Establishing global policy recommendations: the role of the Strategic Advisory Group of Experts on immunization.” Expert Review of Vaccines. 10(2), 2012.

!  The online platform for Taylor & Francis Group content (see Lecture page for Web site)

!  WHO position papers (published in the Weekly Epidemiological Record)

!  Strategic Advisory Group of Experts (SAGE) Web site

For Information on How WHO Sets Immunization Policies:

What’s New in Immunization?

!  Decade of Vaccine and Global Vaccine Action Plan

!  Moving from infancy to life course

!  Gavi new business strategy, 2016-2020

!  BMGF strategy for routine immunization in place

!  New vaccines exposing cracks in routine immunization system

!  Role for civil society organizations (CSOs) plus mechanism to engage them (Gavi constituency)

Some Current Policy-Related Conversations at Global Level (Incomplete!)

!  Measles regional elimination versus global eradication

!  Polio eradication: “end game,” “legacy/transition,” IPV intro, switch from tOPV to bOPV

!  Rubella vaccine introduction—preconditions?

!  LMIC and MIC access to new vaccine prices (+ graduation)

!  Transitioning from RED to “reaching every community” (REC)

!  “Vaccine hesitancy” (vs. “vaccination hesitancy”)

!  Investing HSS funds more directly in immunization

!  Penta3 coverage versus “Fully Immunized Coverage”

!  Presentation of vaccines (programmatic suitability)

!  Controlled temperature chain

!  New vaccine introductions—which ones?

Continued Evolution of the Immunization Program

Section B

Global Under- Five Mortality: Role of Vaccine Preventable Diseases (2008 Data)

Source: Black, R.E. at al. (Jun 5, 2010). Global, regional, and national causes of child mortality in 2008: a systematic analysis, Lancet. 375(9730): 1969-87. Epub 2010 May 11. * WHO/IVB estimates

!  “Estimated number of all deaths in children 1-59 months of age: 5.2 million. About 29% of deaths in children 1-59 months of age are vaccine preventable.” !  Global Immunization Data, October 2012, accessed June

12, 2013 from WHO Web site

Global Vaccination Trends (WHO, 2014)

Source: WHO/UNICEF coverage estimates 2013 revision. July 2014. Immunization Vaccines and Biologicals, (IVB). WHO. 194 WHO Member States 3

Global Vaccination Trends (WHO, 2014)

Source: WHO/UNICEF coverage estimates 2013 revision. July 2014. Immunization Vaccines and Biologicals, (IVB). WHO. 194 WHO Member States 4

!  Uganda reported immunization coverage

Example of Fluctuating Coverage at Country Level: DPT3 and Measles Coverage Rates, 1985–2010, Uganda

5 Source: WHO vaccine-preventable diseases: monitoring system 2011 global summary.

DTP3 Coverage for Lowest- and Highest-Wealth Quintiles, DHS Surveys in 21 African Countries, 2008–2014

!  Was potent vaccine administered safely and efficiently in a timely manner before exposure to disease?

Immunization Coverage Is Not Enough!

Image source: BASICS. (1996). 7

Enablers of Routine Immunization: Health Development Challenges

!  Accessibility (not enough!)

!  Availability

!  Affability

!  Awareness

!  Acceptability

!  Accountability

!  Affordability

A Cohesive Program Requires Many Components: A Development Approach

Source: BASICS. (1997). 9

Slide 20

Routine Immunization System

Life Cycle

Vaccination

Polio Eradication

NUV I Support other

health interventions

Family

Planni ng

New Vaccine Introduction

Section C

What Have Decision Makers Mostly Focused on before Introducing a New Vaccine?

!  Disease burden (incidence, mortality, morbidity, disability)

!  Vaccine efficacy, effectiveness

!  Vaccine safety, reactogenicity

!  Fits with existing immunization schedule (e.g., timeliness issues)

!  Simultaneous administration possible?

!  Combination with other antigens into single product possible?

!  Current and future price, stability, and security of vaccine market

!  Trade-offs with other investments

!  Immunogenicity

!  Expected health gains

!  Health care cost savings

!  Care-related productivity gains

!  Outbreak potential

!  Public perception of the disease

!  How to communicate about the disease/syndrome

!  Programmatic characteristics of competing products: !  Heat stability !  Storage temperature !  Number of doses per vial !  Wastage rate !  Storage volume !  Volume of waste for disposal !  Acceptability by health staff (e.g., number of injections on same day) !  Ease of use (preparation and administration) !  Volume of dose administered

But What Other Things Are Informed Decision Makers Increasingly Concerned About?

!  New vaccines can further reduce mortality, but they come with challenges !  Competing priorities compound decision making !  Cost-effectiveness questioned !  Longer-term mortgages which will come due !  More complex vaccines targeting disease syndromes—advocacy/communication

challenges !  Need for new delivery systems (e.g., schools) !  Practical introduction challenges (e.g., cold chain, logistics, more waste

management, training, multiple injections to child on same day)

New Vaccines …

challenges !  Need for new delivery systems (e.g., schools) !  Practical introduction challenges (e.g., cold chain, logistics, more waste

management, training, multiple injections to child on same day)

!  New vaccines require a well-functioning routine immunization program

New Vaccines …

Cumulative Value and Volume of Vaccines Used in Routine Childhood Immunization: Ethiopia

Source: Sabot, O., Yadav, P., Zaffran, M (2011). Maximizing every dose and dollar: The imperative of efficiency in vaccine delivery. National Bureau of Asian Research. 6

Vaccine Packaging: Size Matters! Newer Vaccines Were Bulky (More Compact Now)

Source: Optimize Project. 7

Vaccine Packaging: Size Matters! Newer Vaccines Were Bulky (More Compact Now)

Source: Optimize Project. 8

!  New vaccine in a typical fully-loaded district refrigerator at any given time can cost 20 times as much as the refrigerator itself

!  Preventive maintenance, timely repair, and replacement of malfunctioning cold chain equipment protects investments in expensive vaccines

Protect the Investment in Costly Vaccines!

Immunization Schedule Uptake Overview 1991–2013 of Introduction Status and 2014–2016 Projections

Source: WHO/IVB Database as of 18 October 2013 11

Age Groups Targeted to Receive Vaccines

System Requirements Are Growing

!  It is not unusual to find WHO or UNICEF and the national EPI Manager alone at the ICC table!

The Lonely Interagency Coordinating Committee (ICC) (or Equivalent) Table

Source: IMMUNIZATIONbasics/JSI, 2005 15

Challenges Facing Immunization

!  Increase/sustain coverage (beyond 80%) and quality with existing and new vaccines across wider age groups

!  Sustain reduced mortality from all vaccine-preventable diseases (and eradicate polio)

!  Assure functioning of immunization in context of changing health systems

!  Refocus on “vaccination” (not just “vaccines”) as a development challenge

!  Make room for broader range of disciplines to address all system components

!  Mobilize sustained/direct financing of routine immunization at national/district level

!  Use immunization as platform for other population-based interventions (e.g., routine integrated outreach)

!  Engage communities for joint identification and solving of problems, local ownership, and customized solutions

!  Engage civil society as allies, advocates, and service providers

!  Gain field experience for personal credibility at higher level !  Establish regular feedback loop to learn changing field needs !  Constantly scan horizon to identify necessary policy changes !  Understand what motivates persons and institutions !  Identify the levers of power/finance and line up allies !  Assemble and broadcast the evidence for policy proposals !  Ensure that proposed policy fits operationally with the program (e.g., supply, practice,

monitoring, etc.) !  Broaden policy discussion to include multiple disciplines !  Exercise excellent timing (seize the moment to make the sales pitch) !  Pick yourself up and try again!

!  “Never doubt that a small group of thoughtful, committed, citizens can change the world. Indeed, it is the only thing that ever has.” —Margaret Mead

Go Forth and Formulate Policy: A Primer

Let’s Make Every Child a VIP: Vaccinated, Immunized, and Protected

!  For more information, please visit the Maternal and Child Survival Program Web site (listed on lecture page)

!  This presentation was made possible by the generous support of the American people through the United States Agency for International Development (USAID), under the terms of the Cooperative Agreement AID-OAA-A-14-00028. The contents are the responsibility of the authors and do not necessarily reflect the views of USAID or the United States Government.

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!  twitter.com/MCSPglobal

Thank You