NEJM rotavirus studies: statement by PATH's Rotavirus Vaccine Program

Jan 4 2006

On Thursday, January 5, the New England Journal of Medicine published the results of two important clinical trials of rotavirus vaccines.

The studies demonstrated that rotavirus vaccines from both GlaxoSmithKline and Merck were highly efficacious and safe in the countries where these trials were conducted, including countries in Europe, and in North and South America. The results are extremely promising, and advocates for global child health should feel encouraged that interventions to prevent the most common cause of morbidity and mortality associated with diarrheal disease will soon be available.

However, an unanswered question is whether rotavirus vaccines will work as well in poor populations of Asia and Africa—where the burden of rotavirus is greatest—as it has in the mostly middle-income populations of Latin America. Historically, orally administered vaccines, of which rotavirus vaccine is one, have performed differently in different regions across the globe. PATH is working with GSK and Merck to answer that question by supporting clinical trials of these vaccines in Asia and Africa.

Each year an estimated 500,000 children die from the severe dehydration caused by rotavirus, over 80 percent of who live in the poorest regions of African and Asia where clinical trials have not yet been conducted. While the results from these two milestone clinical trials are very promising, much work remains to ensure that global and national decision-makers have information pertaining to the performance of these vaccines in the poorest countries in the world.

With support from the Global Alliance for Vaccines and Immunizations (GAVI) and The Vaccine Fund, and in partnership with the World Health Organization, the US Centers for Disease Control, and the vaccine manufacturers, PATH is designing and conducting clinical trials in Africa and Asia, with the aim of evaluating the potential of these vaccines to decrease the burden of rotavirus disease in these settings.

Beyond the clinical trial data, decision-makers need good information regarding the burden of rotavirus disease in their countries, as well as the relative value of introducing rotavirus vaccines compared to other possible public health interventions. Once again, PATH is involved in collecting and disseminating this kind of information. Taken together, this information will allow decision-makers at both the global and national levels to make the commitments necessary to ensure that these vaccines will be used in a sustainable fashion.

The editorial that accompanied these studies states that while the results of these studies are indeed promising, “The key question for the global community will be to determine whether these vaccines work equally well among the poorest children in the developing world.” PATH and its partners are answering that question.

www.path.org and www.rotavirusvaccine.org