ABSTRACT
Vaccine research in developing countries has not been immune to controversy. A series of clinical trials demonstrated that the tetravalent rhesus rotavirus (RRV-TV) vaccine prevented serious rotavirus diarrhea in developed countries, (4) as well as in developing countries (5). After being approved by the U.S. Food and Drug Administration, it was recommended for universal use in the United States. Once widespread vaccination in the United States was underway, and 1.5 million doses were given, however, a transient association between RRV-TV vaccination and intussusception was observed. In October 1999, while the definitive studies to prove this association were under way, the vaccine manufacturer voluntarily withdrew the RRV-TV vaccine from the U.S. market. This led to the dispute as to whether research with the vaccine should (or could) continue in developing countries (6). Even though many considered the much greater benefit of rotavirus vaccines in developing countries to outweigh the risks, concerns about a double standard (or appearances thereof) effectively ended further testing. In the wake of the controversy, developing countries would have to wait another seven years for new rotavirus vaccines to be developed (7).
