Session II –  Panel: Evidence: Practice, Policy and Ethical Challenges to 202X

Moderator: Art Caplan, Penn Center for Bioethics
Susan Ellenberg, Penn Medicine
Developing Evidence on Vaccine Safety
[slides: Global Vaccines 202X_Ellenberg ]
[video: here ]

Josh Cohen, Tufts Medical Center
The Outlook for Cost-Effectiveness Analysis
[slides: Global Vaccines 202X_Cohen]
[video: here ]

Lisa Prosser, University of Michigan
Cost-effectiveness Analysis and Vaccine Policy
[slides: Global Vaccines 202X_Prosser]
[video: here ]

Jon Andrus, PAHO
New Vaccines in Developing Countries: Evidence, Practice, Policy, and Challenges
[slides: Global Vaccines 202X_Andrus ]
[video: Part I, Part II ]

Robert Field, Drexel University
Evidence-Based Decision Making for Vaccines: The Need for Ethical Grounding
[slides: Global Vaccines 202X_Field ]
[video: Part I, Part II ]

[return to agenda]

Session Abstract
Clearly, evidence-based decision processes supporting vaccine recommendations and deployment will grow in importance globally over the “decade of vaccines” and beyond: Data collection, analytics and decision-support around vaccine efficacy, safety, post-marketing surveillance, long-term outcomes, cost-effectiveness, economic impact and more will certainly evolve in sophistication and utility in the years ahead: Indeed, that evolution will be critical to better grounding public health decision-making around immunization and saving lives:

As economic and budgetary pressures in developed and developing economies continue to weigh on the introduction of existing and new vaccines into national schedules, evidence will be the bulwark for grounding and defending the enabling recommendations:

Equally, “evidence” in the sense above depends on ethical and policy underpinnings which, for the most part, have been only marginally engaged by the bioethics and policy communities.

This session will focus on the current state and future directions for evidence, its role in policy and decision-making, and with a focus on access, equity and ethical considerations.


New England Journal of Medicine
April 7, 2011  Vol. 364 No. 14
Determining the Value of Drugs — The Evolving British Experience
Ruth R. Faden, Ph.D., M.P.H., and Kalipso Chalkidou, M.D., Ph.D.
N Engl J Med 2011; 364:1289-1291April 7, 2011



PAHO Pro Vac

Andrus et al.
A Model for Enhancing Evidence-Based Capacity to Make Informed Policy Decisions on the Introduction of New Va ccines in the Americas: PAHO’s ProVa c Initiative
Public Health Reports / November–December 2007 / Volume 122
Andrus et al. 2007

Jauregui et al.
Strengthening the technical capacity at country-level to make informed policy decisions on new vaccine introduction: Lessons learned by PAHO’s ProVac Initiative
Vaccine, 2010 (article in press version supplied by PAHO)
Jauregui et al 2010

Burns et al.
Descriptive analysis of immunization policy decision making in the Americas
Pan Am J Public Health 26(5), 2009
Descriptive analysis current decision making process


PLoS Medicine
(Accessed 24 January 2010)

Meeting the Demand for Results and Accountability: A Call for Action on Health Data from Eight Global Health Agencies
Margaret Chan, Michel Kazatchkine, Julian Lob-Levyt, Thoraya Obaid, Julian Schweizer, Michel Sidibe, Ann Veneman, Tadataka Yamada Essay, published 26 Jan 2010

[Initial paragraph and selected text]
“Recent substantial increases in international attention to health have been accompanied by demands for statistics that accurately track health progress and performance, evaluate the impact of health programs and policies, and increase accountability at country and global levels. The use of results-based financing mechanisms by major global donors has created further demand for timely and reliable data for decision-making. In addition, there is increasing country demand for data in the context of health sector strategic plans, including in countries that have established International Health Partnership (IHP+) compacts. In spite of recognized efforts by programs and countries, the ability to respond to this demand is constrained by limited data availability, quality, and use. Many developing countries have limitations that hamper the production of data of sufficient quality and timeliness to permit regular tracking of progress made in scaling up and strengthening health systems. Data gaps span across the range of input, output, outcome, and impact indicators. New ways of working and a more systematic approach by all partners are needed to better monitor and evaluate progress and performance. We believe that this global public good is a necessary foundation to improve health investments and programs and accelerate progress towards the Millennium Development Goals (MDGs) and other major international health goals…”

Eight agencies working in global health – Bill & Melinda Gates Foundation; GAVI; Global Fund to Fight AIDS, Tuberculosis & Malaria; UNAIDS; UNFPA; UNICEF; World Bank, and the World Health Organization – “…agree that it is critical to strengthen the five key data sources and capacity for analysis, synthesis, validation, and use of health data in countries. This should enable countries to better monitor and evaluate their own progress and performance and, secondarily, allow them to respond to the increased emphasis on results and accountability. The eight agencies propose four global actions to support these country goals:”

– Increase Levels and Efficiency of Investments in Health Information
– Develop a Common Data Architecture
– Strengthen Performance Monitoring and Evaluation
– Increase Data Access and Use

Perspectives, Editorials, Comment Pieces
“Legislating against Use of Cost-Effectiveness Information”
P.J. Neumann, M.C. Weinstein
New England Journal of Medicine
NEJM_Neumann et al_Legislating Against CE Information_2010_363-1495-1497

“The Right to Health as the Unheralded Narrative of Health Care Reform”
E.A. Friedman, E.Y. Adashi
JAMA, December 15, 2010 – Vol 304, No. 23
JAMA-2010-Friedman-ACA and Right to Health_2639-40

Special Reports
“Preventive Services Without Cost Sharing…Will the benefits outweigh the costs?”
Health Policy Brief: Health Affairs, Dec 28, 2010
RWJ_HealthPolicyBrief_Preventive Services_28 Dec 2010

Journal Articles
“The role of economic information in decision-making by ACIP”
Dempsey et al
Vaccine 26 (2008) 5389-5392
Vaccine_Demsey et al_Role of Economic Information ACIP_26(2008)5389-5392

Bibliography: Vaccines and Economic Evaluation: QALYs, CEAs and more…
D.R. Curry
January 2011
CVEP_ACIP-Healthcare Reform Symposium_ Bibliography_12 Jan 2011

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