The Children's Vaccine Initiative Continuing Activities (1995) / Chapter Skim
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PROVING VACCINE EFFICACY: THE CHALLENGE OF DEVELOPING-COUNTRY FIELD TRIALS
PROVING VACCINE EFFICACY: THE CHALLENGE OF DEVELOPING-COUNTRY FIELD TRIALS
Pages 14-19
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PROVING VACCINE EFFICACY: THE CHALLENGE OF DEVELOPING-COUNTRY FIELD TRIALS20 Accurate diagnosis is essential for understanding the extent and basis of pneumonia infections. Yet, the three traditional methods for diagnosing bacterial pneumonia utilizing blood culture, lung aspirates, and sputum culture are far 19 Emil Gotschlich.
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Finally, accurate diagnosis of pneumonia would have a direct, positive impact on the conduct of D r ARI vaccine studies (Box 3~. BOX 3 Impact of Accurate Diagnosis of Bacterial Pneumonia on Vaccine Trials · Increased ability to evaluate efficacy against nonbacteramic disease · Improved ability to evaluate population-based impact · Potentially reduced diagnostic bias in case-control studies · Potentially improved information on vaccine formulation · Decreased sample size for prospective randomized controlled trials SOURCE: Broome, 1994.
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Because it does not require vaccination records to provide useful information, surveillance may prove more useful in the developing-world setting than the case-control paradigm. A recent postlicensure Hib trial in Chile illustrates another way developing or transitional countries can obtain useful information about vaccine effectiveness without investing in traditional double-blind, placebo-controlled studies.
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In the case of pneumococcal vaccines, a group of experts convened by the World Health Organization in 1993 agreed that a phase III randomized controlled trial was essential for a manufacturer to get usable efficacy data on a pneumococcal vaccine, while developing countries had a legitimate interest in conducting phase IV studies to obtain information on effectiveness.22 Still, many feel there is no substitute for a randomized controlled trial to determine whether a pneumococcal vaccine reduces both mortality and the proportion of individuals hospitalized with pneumonia (and perhaps ALRI)
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.23 Vaccine makers themselves may push for more than one randomized study to obtain pivotal trial-quality data.24 Indeed, there may be some benefit in conducting identically designed efficacy trials in many parts of the world at once, as was done with typhoid vaccine in the 1 960s.25 The Public-/Private-Sector Interfaced The interface between the public and private sectors is different at each point along the vaccine R&D pipeline. Similarly, the sources of funding, the forces driving the system, accountability, and risks associated with R&D vary according to the perspective of the participant (Table 2~.
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In the case of human vaccines, three-quarters of current revenues come from just two regions of the world: Europe and the United States.27 Much of the remaining money now made from vaccine sales is sheltered in several large markets like those of Japan and China that are virtually closed to the outside world. Vaccine purchased by the Pan American Health Organization and UNICEF accounts for roughly 5 percent of worldwide vaccine revenues.
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