Rotavirus Vaccines — Early Success, Remaining Questions

Abstract

In 2006, the results of pivotal clinical trials of two new rotavirus vaccines — RotaTeq (Merck) and Rotarix (GlaxoSmithKline) — were published, and high efficacy (85 to 98%) against severe rotavirus diarrhea was reported for both products.^1,2 Perhaps even more important, neither vaccine was associated with intussusception, an adverse effect that had led to the withdrawal of another rotavirus vaccine — RotaShield, made by Wyeth–Lederle — from the U.S. market in 1999. The rapid resurgence of rotavirus vaccines after the abrupt and devastating setback associated with the withdrawal of RotaShield was remarkable, reflecting the commitment of the public health community and the vaccine industry to preventing this most common cause of severe diarrhea in children. In the United States, rotavirus causes an estimated 3 million cases of diarrhea each year; medical attention is sought for more than 500,000 children, and 60,000 to 70,000 are hospitalized. In the developing world, the disease kills more than half a million children annually. Both vaccines have been recommended for routine immunization of U.S. infants (RotaTeq in February 2006 and Rotarix in June 2008) and have also been introduced in the routine immunization programs of several countries in Latin America and Europe, and in Australia.