Ranking Vaccines A Prioritization Software Tool: Phase II: Prototype of a Decision-Support System (2013) / Chapter Skim
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1 Introduction: New Vaccines and SMART Vaccines
1 Introduction: New Vaccines and SMART Vaccines
Pages 13-24
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From page 13... ...
It is long and often arduous, and few appreciate the amount of work and resources that go toward producing and delivering what may seem to many like a trivial matter -- say, half a milliliter of fluid contained in a vaccine vial or ampoule. The process typically consumes hundreds of millions of dollars, and its success relies on the co-evolution of scientific understanding, regulatory environment and requirements, production technologies, public health needs, human resource management, and often an understanding of the culture of the intended recipients of vaccination (Rappuoli et al., 2011)
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From page 14... ...
In the 1980s vaccine discovery required a long time, while development periods were relatively short. More recently, the time involved in new vaccine discovery has shortened dramati cally due to the availability of various new technologies. However, in the meantime the regulatory requirements have lengthened the development timelines substantially. This results in longer times for vaccine licensure and significant increases in development costs.
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From page 15... ...
The situation has recently changed with the finding that the immunity created by the acellular vaccines appears to be not as long-lasting as the immunity from the whole cell vaccine. Now, with the shortcomings of the pertussis vaccines apparent, funding agencies are being asked to support research in the biology of pertussis, and regulatory agencies are being requested to find innovative ways to license new pertussis vaccines in the absence of efficacy trials.
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From page 16... ...
Decision making involves understanding the existing and emerging landscape of vaccine development, the real benefits that vaccination brings to society, and the limitations of the decision models available today. Sound decision making sometimes also involves persuading others; for example, a minister of health may need to convince the minister of finance about the value of a given vaccine (or a vaccination program)
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From page 17... ...
This software has been developed, keeping various stakeholders in mind, to provide a more consistent method for informing decisions and to offer an analytical base for reaching individual or collective decisions. Study Context and Scope A critical development in the realm of vaccine policy was the release of the 2010 National Vaccine Plan by the U.S.
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From page 18... ...
I. Improve global surveillance for vaccine-preventable diseases and strengthen global health information systems to monitor vaccine coverage, effectiveness, and safety. J. Support global introduction and availability of new and under utilized vaccines to prevent diseases of public health importance.
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From page 19... ...
involves the data architecture and software usability studies, with Step 3 efforts ultimately resulting in a catalogue of domestically and globally significant vaccine candidates. The committee has also expanded the datasets available for use with the software and evaluated three additional vaccine candidates for the United States and South Africa.
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From page 20... ...
Webinars, teleconferences, plenary talks, group discussions, and presentations were offered for a variety of audiences that included representatives from federal advisory groups, professional societies, policy groups, international governmental agencies, private industry, and philanthropic and trade organizations. The committee also organized an international stakeholder workshop to obtain additional feedback for
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From page 21... ...
The committee took the gathered feedback into account in its deliberations on refining the model, on informing the data collection for additional vaccine candidates, and on redesigning the software interface. Those efforts are detailed in Chapter 2.
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From page 22... ...
This report concludes with some strategic steps that the committee believes will greatly enhance the production of high quality datasets for use in SMART Vaccines.
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From page 23... ...
More likely, specialized assistants to decision makers will create or import relevant data and possibly even carry out preliminary analyses using weights specified by the decision maker. The current version of SMART Vaccines provides entry points into the software at appropriate points for each possible type of user, ranging from technical data specialists to final decision makers.
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From page 24... ...
decision makers in a wide range of constituencies: federal and private research groups, funders, vaccine manufacturers, purchasers of vaccines, regulators, and nongovernmental groups. SMART Vaccines offers a new framework that could help provide a new standard for decision making among various stakeholders in many circumstances such as decision making under opacity; prioritizing under constrained resources, complexities associated with globalization, economies, and health.
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