New England Journal of Medicine
Volume 360 – March 12, 2009 – Number 11
http://content.nejm.org/current.shtml

Perspectives
Global Health: Rotavirus Vaccines – Early Success, Remaining Questions
U. D. Parashar and R. I. Glass

[Final paragraphs]
“…Despite the promising early data from the United States, a key unanswered question is whether rotavirus vaccines will work equally well in the developing world, where they offer the greatest potential lifesaving benefits. Experience with previous candidate rotavirus vaccines, as well as vaccines against polio, cholera, and typhoid fever, has shown that the efficacy of live, oral vaccines can be impaired in developing countries. Several host and environmental factors – such as interference by maternal antibodies, concurrent administration of oral polio vaccine, prevalent viral and bacterial infections of the gut, and malnutrition – could affect the processing of vaccine in the infant gut and impair an infant’s ability to generate an effective immune response. For these reasons, the World Health Organization (WHO) has recommended evaluation of the efficacy of rotavirus vaccines in developing countries of Asia and Africa before issuing a recommendation for global vaccine use. Both RotaTeq and Rotarix are being tested in these regions, and the results of these trials are eagerly anticipated.

“If rotavirus vaccines demonstrate acceptable efficacy in developing countries and the WHO issues a global recommendation for their use, mechanisms for financing the introduction of the vaccines and securing a sustainable and affordable supply will be key to ensuring that they reach children in the poorest countries, where the vast majority of deaths from rotavirus occur. The Global Alliance for Vaccines and Immunization (GAVI) has already approved financial support for the purchase of rotavirus vaccines for eligible countries (those with a gross national income of less than $1,000 per capita) in Latin America and Europe, where vaccine efficacy has been proven, with a copayment for countries of 15 to 30 cents for a full vaccine series for each child. GAVI will decide whether to provide financial support for the purchase of rotavirus vaccine for countries in Asia and Africa after data from trials in these areas become available.

“With financial support and recommendations from the WHO and other international health organizations, the long wait for safe and effective vaccines to prevent deaths and severe disease from rotavirus diarrhea among children in the developing world may soon be over. In countries where these vaccines are currently being used as part of childhood immunization programs, their benefits are becoming readily apparent. In the United States, with increasing uptake of vaccine, we anticipate significant respite for children, parents, physicians, and health care facilities from the large burden of rotavirus disease in the current rotavirus season.”