The US Food and Drug Administration approved Merck's Rotateq (rotavirus vaccine, live, oral, pentavalent), the only vaccine available in the US to prevent rotavirus gastroenteritis, a leading cause of severe diarrhoea in infants and young children. Rotateq is an oral, three-dose vaccine given to infants between the ages of six to 32 weeks.

"Virtually all children will experience rotavirus. While some children experience mild symptoms of rotavirus, infection can be severe and lead to dehydration that can be fatal," said Paul Offit, chief of infectious diseases, The Children's Hospital of Philadelphia and co-inventor of the vaccine.

"The FDA approval of this vaccine is exciting for paediatricians because they will now have a way to help protect infants from rotavirus. For the many people who have worked on the research and development of this vaccine for nearly 20 years, to see that effort result in the availability of a vaccine to prevent this common and unpredictable disease is something to be proud of," added Offit.

Rotateq can be given during the current routine well baby visits at two, four, and six months of age. It is ready-to-use without re-formulation or mixing and is the only oral vaccine approved for use in infants in the US. The Advisory Committee on Immunization Practices (ACIP) is expected to decide whether Rotateq should be added to the current paediatric immunisation schedule of recommended vaccines later this month, claims the company release.

Rotateq is a pentavalent vaccine that targets the strains of rotavirus responsible for more than 90 per cent of rotavirus disease in the US. Among children under five in the United States, it is estimated that 2.7 million episodes of rotavirus gastroenteritis occur each year, leading to approximately 250,000 emergency room (ER) visits and up to 70,000 hospitalisations.

The FDA approval of Rotateq is based on data from Merck's Phase III clinical trials of more than 70,000 infants, including the Rotavirus Efficacy and Safety Trial (REST), one of the largest pre-licensure vaccine clinical trials ever conducted.