Rotavirus Vaccines Proven Effective
According to the Centers for Disease Control and Prevention (CDC), globally more than 500,000 children die from rotavirus every year in the poorest countries of the world, but a new study shows the rotavirus vaccine can prevent many of these deaths.
Rotavirus vaccines can prevent almost half of the infections.
Dr. John Victor of the Seattle-based PATH non-profit development organization and colleagues have published their study results in the journal Lancet online.
The researchers conducted a multicenter double-blind, placebo-controlled trial in rural Matlab, Bangladesh, and urban and periurban Nha Trang, Vietnam. Infants aged 4—12 weeks without symptoms of gastrointestinal disorders were randomly assigned to receive three oral doses of pentavalent rotavirus vaccine 2 mL or placebo at around 6 weeks, 10 weeks, and 14 weeks of age, in conjunction with routine infant vaccines including oral poliovirus vaccine.
Episodes of gastroenteritis in infants who presented to study medical facilities were reported by clinical staff and from parent recollection. The primary endpoint was severe rotavirus gastroenteritis arising 14 days or more after the third dose of placebo or vaccine to end of study.
More than 2,000 babies aged one to three months got either three oral doses of the vaccine (1,017) or placebo (1,018). By the end of the study, there remained 991 infant in the vaccine group and 978 in the placebo group.
After two years, 38 vaccinated babies got severe rotavirus infections, compared to 71 babies that got placebo, making the vaccine 48% effective against severe disease.
Serious adverse events were experienced by 25 (2·5%) of infants in the vaccine group and 20 (2·0%) in the placebo group. The most frequent serious adverse event was pneumonia (vaccine 12 [1·2%]; placebo 15 [1·5%]).
Rotavirus vaccines made by GlaxoSmithKline and Merck and Sanofi Aventis are now part of the regular schedule for infants in the United States and other developed countries,
Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial; K Zaman PhD, Dang Duc Anh PhD, Dr John C Victor PhD, et al; The Lancet, Early Online Publication, 6 August 2010; doi:10.1016/S0140-6736(10)60755-6
Centers for Disease Control and Prevention