Vaccines for the 21st Century A Tool for Decisionmaking (2000) / Chapter Skim
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Observations
Observations
Pages 123-132
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From page 123... ...
In the course of developing and illustrating this model, the committee discussed general issues related to the funding of research, neglected opportunities for vaccine R&D, the qualitative judgments integral to this modeling exercise, and vaccine program concerns. The committee thus closes this report with a series of observations that it hopes are considered as seriously as the analytic model that was the focus of the project.
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From page 124... ...
The role of hepatitis B virus in liver cancer was recognized in 1985, but the current report includes many more examples of vaccine-preventable infections as causes of chronic conditions; for example, hepatitis C virus infection and liver damage, including cancer, Helicobacter pylori infection and gastric ulcers and cancers; and human papillomavirus infection and cervical cancer. Furthermore, scientific studies are emerging indicating a role for infectious agents in the pathogenesis of coronary artery disease and in a predisposition to asthma.
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From page 125... ...
Private philanthropic organizations such as the Rockefeller Foundation, the Burroughs Wellcome Fund, and the Josiah Macy Foundation also support basic and applied R&D related to vaccines. Although private industry supports basic research, the most important role it plays is to assume the costs of applied R&D.
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From page 126... ...
Examples of these discussed by the committee include the financial burdens of pilot production and the high costs of the complex clinical trials required by FDA to demonstrate efficacy as well as safety. Although the committee did not study in detail the relationship between public and private research on vaccines, it is clear that improvements can be made to foster collaboration when market forces cannot guarantee that a for-prof~t vaccine manufacturer will risk an investment in the development and manufacture of a particular vaccine or a particular type of vaccines.
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From page 127... ...
There are many diseases of great importance to other countries that do not currently pose a significant burden on domestic health. However, policymakers in this country should factor these diseases and the international burden to health into their decisionmaking for both parochial considerations related to the potential threat to the United States from new and emerging infections, as well as the altruistic considerations involved in aiding other countries.
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From page 128... ...
Vaccine manufacturers and other researchers interested in the use of vaccines directed against group B streptococcus and other infectious agents believe that some form of legal protection from lawsuits is imperative before these vaccines can be developed and licensed. The rationale for the immunization of pregnant women as a crucial strategy for reducing the rates of morbidity and mortality from group B streptococcus in both mothers and
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From page 129... ...
The committee struggled with applying the health utility index in its QALY calculations, but in the end, it noticed remarkable inter- and intraperson consistency in the values obtained for similar health states. The committee expects and encourages continued research on this and other measures of health status.
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From page 130... ...
The committee hopes that the Federal government and state governments, the medical community, the public, and vaccine manufacturers carefully think about rational approaches to combination vaccines and vaccination schedules. Furthermore, noninjection routes of delivery (for example, oral, intranasal, or cutaneous routes of delivery)
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From page 131... ...
Vaccines, like other public health successes, such as clean water, fluoridation for the prevention of caries, and food safety measures are victims of their own success: people forget how dangerous vaccine-preventable diseases can be and become complacent. This false sense of security strikes individuals, communities, health care providers, and policymakers.
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