Selected research from leading health care experts whose findings have a direct bearing on public policies effecting medical progress. Research is chosen based on its quality and relevance by the Medical Progress Today editorial staff.

Selected Research

The Promise of New Rotavirus Vaccines
Umesh D. Parashar, M.B., B.S., Roger I. Glass, M.D., Ph.D., New England Journal of Medicine, 1-5-06

Two new rotavirus vaccines, one from Merck and one from GlaxoSmithKline, have shown enormous promise in reducing deaths from this disease in developing nations, where it kills half a million children every year.

This issue of the Journal includes reports on the promising results of large clinical trials of two new rotavirus vaccines whose manufacturers moved ahead with trials despite the many challenges and risks. The two new products, Rotateq from Merck and Rotarix from GlaxoSmithKline, are both live oral vaccines intended to be given to infants at the same time as their immunizations for diphtheria, pertussis, and tetanus, but they differ in their approaches, strains, and formulations. …
Despite these differences, both vaccines demonstrate an impressive efficacy profile. The slight differences in observed efficacy against severe rotavirus disease (85 percent for Rotarix and 98 percent for Rotateq) might well be explained by differences in the classification of disease severity and the populations studied. GlaxoSmithKline conducted its trials primarily among infants of poor and middle-income families in Latin America, whereas the Merck vaccine was tested in the United States and Finland. A particularly exciting finding of great importance to public health (and to the economic burden of disease) was the magnitude of the reduction in hospitalizations for diarrhea of any cause, a decrease that was greater than expected given the number of diagnosed cases of rotavirus.

Both of these studies are available for free on the Journal’s Web site. The tragedy, however, remains that an effective rotavirus vaccine was withdrawn from the market in 1999, after the discovery of a rare, but very dangerous adverse effect (1 in 10,000 vaccinations). In the interim, hundreds of thousands of children have died waiting for a “safer” vaccine.

Project FDA.
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