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 manufactured by GlaxoSmithKline (GSK) 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 are excited about the prospect that interventions to prevent the most common cause of morbidity and mortality associated with diarrheal disease will soon be available. 

While these study results are encouraging, 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 they have in the mostly middle-income populations of Latin America. In collaboration with GSK and Merck, PATH is planning and conducting clinical trials in poor populations in sub-Saharan Africa and Asia to evaluate the vaccines' performance in these settings. In addition to co-sponsoring these clinical trials, PATH and its partners at the US Centers for Disease Control and Prevention and the World Health Organization continue to collect and disseminate important information about the burden of rotavirus disease in poor countries and the cost-effectiveness of rotavirus vaccines. Together, this evidence will allow decision-makers at both the national and global levels to build a foundation for future efforts toward rotavirus vaccine introduction.

We welcome these milestone study results and look forward to moving ahead with our clinical trial agenda and advocacy activities aimed at bringing rotavirus vaccines to the world's most vulnerable children.

To read PATH's complete statement on the recent studies, visit http://www.rotavirus.org/documents/NEJMstatement.pdf.

Full text of the studies, along with an accompanying editorial by Drs. Roger Glass and Umesh Parashar, may be viewed on the journal's website by clicking the following links:

The Promise of New Rotavirus Vaccines (editorial)

Safety and Efficacy of an Attenuated Vaccine against Severe Rotavirus Gastroenteritis

Safety and Efficacy of a Pentavalent Human-Bovine (WC3) Reassortant Rotavirus Vaccine