Tetravalent rotavirus vaccine

OBJECTIVE: TO review the clinical efficacy, safety, and pharmacoeconomic da ta about the use of rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) in infants and children. DATA SOURCES: A MEDLINE search (January 1990-December 1998) was conducted t o identify all publications on the RRV-TV vaccine including pharmacology, c linical trials, adverse effects, and pharmacoeconomics in infants and child ren. Bibliographies of articles were also used. STUDY SELECTION: All randomized and placebo-controlled clinical efficacy tr ials were reviewed. Additionally, pharmacoeconomic studies focusing on the potential impact on healthcare costs were chosen fur review, DATA SYNTHESIS: Rotavirus-induced gastroenteritis is a significant problem in developed and developing countries, Various forms of a rotavirus vaccine have been studied worldwide. The tetravalent. vaccine appears to have simi lar efficacy in developed and developing countries. It seems to be most eff ective against the most severe forms of gastroenteritis, with an 80% overal l efficacy rate. This vaccine is well tolerated; the most common adverse ef fect is fever after the first dose, Pharmacoeconomic studies indicate that although the vaccine may be only moderately effective against less severe g astroenteritis, over $1 billion annually could potentially be saved in the US with its universal use. CONCLUSIONS: The new rotavirus vaccine is effective in preventing and reduc ing the incidence of rotavirus-induced gastroenteritis. The morbidity, mort ality, and healthcare costs from this disease may be reduced if this vaccin e is provided to children worldwide.