GlaxoSmithKline’s bid to get the green light for its rotavirus vaccine has been boosted by a favourable recommendation from a US Food and Drug Administration panel.

The agency’s Vaccines and Related Biological Products Advisory Committee voted unanimously (12-0) in favour of GSK's data being adequate to support the efficacy of Rotarix in preventing rotavirus gastroenteritis in infants and 11-1 over the safety of the jab. The FDA does not have to follow the advice of the panel when it decides on final approval but it nearly always does.

If approved by the agency, Rotarix would allow for completion of the rotavirus vaccination series by four months of age, as it only requires two doses. This should help GSK’s jab make up ground in the USA on Merck & Co’s rival product Rotateq, which requires a three-dose course.

The positive recommendation followed a review of 11 clinical trials, involving over 75,000 children, of Rotarix which showed that the vaccine did not increase the risk of intussusception. The latter condition, which is twisting of the bowel, led to the recall of an earlier rotavirus vaccine, Wyeth’s Rotamune/RotaShield in 1999.

FDA medical officer Steven Rosenthal did note that there was a higher rate of pneumonia-related deaths and convulsions among vaccinated infants in one of the main studies. However, the overall death rate from any cause was similar between infants given the vaccine and those on placebo groups.

Ahead of the FDA advisory committee, GSK had noted that respiratory infections like pneumonia account for "dramatically greater numbers and proportions of infant deaths in Latin America, compared to the USA”. However the firm says it will conduct a post-marketing trial of Rotarix, which is already available insome 90 countries, to monitor potential side effects such as pneumonia, convulsions and also intussusception.

Rotavirus infects virtually every child worldwide by the age of five and is the leading cause of severe gastroenteritis in infants. In the USA each year, 2.7 million children younger than five years of age suffer from rotavirus disease, 55,000-70,000 children are hospitalised and 20-60 die.