FDA OKs New Rotavirus Vaccine

The double-blind, placebo-controlled phase III study included 15,183 healthy infants from 10 countries. They were randomly assigned to receive two oral doses of either the RIX4414 vaccine or a placebo.

The children were monitored until they were 2 years old. During that time, 32 of the 7,205 (0.4 percent) of children in the vaccine group had severe rotavirus gastroenteritis, compared with 161 of 7,081 (2.3 percent) of those in the placebo group.

Vaccine effectiveness was 80.5 percent to 82.1 percent against the wild-type G1 rotavirus strain, 77.5 percent against pooled non-G1 strains, and 80.5 percent against pooled non-G1 P(8) strains. Vaccine efficacy for hospital admissions for rotavirus gastroenteritis was 83 percent and admission for diarrhea of any cause was 39.3 percent.

The findings were published in the April 5 issue ofThe Lancet.

"Inclusion of this vaccine in routine pediatric immunization schedules can be expected to greatly reduce the burden of rotavirus disease worldwide," concluded Prof. Miguel O'Ryan, of the Institute of Biomedical Sciences at the University of Chile, and colleagues.

An accompanying commentary was written by Prof. Keith Grimwood of the Queensland Paediatric Infectious Disease Laboratory at Royal Children's Hospital and University of Queensland in Brisbane, Australia.

The World Health Organization, he wrote, "is awaiting efficacy data (on the vaccine) from low-income countries of Africa and Asia, where much greater strain diversity exists and where 413,000 rotavirus deaths occur every year compared with 15,000 in Latin America and 200 in Europe."

More information

The U.S. Centers for Disease Control and Prevention has more about rotavirus.

SOURCE: U.S. Food and Drug Administration, news release, April 3, 2008;The Lancet, news release, April 4, 2008