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GSK's Rotarix set for approval meeting

The FDA is due to meet on Wednesday (February 20) to consider approving GlaxoSmithKline's rotavirus vaccine Rotarix.

The FDA is due to meet on Wednesday (February 20) to consider approving GlaxoSmithKline's (GSK) rotavirus vaccine Rotarix.

The oral vaccine for children is effective, but also associated with a higher risk of pneumonia-related deaths and other adverse reactions, according to documents posted by the US Food and Drug Administration (FDA).

The rotavirus infection causes severe infant diarrhoea that leads to hospitalisation.

FDA staff said its analysis of 11 studies revealed that in the largest trial, there was a statistically significant increase in deaths related to pneumonia compared with placebo.

The website says the drug is effective at preventing rotavirus-related gastroenteritis, but draws attention to the pneumonia-related deaths and convulsions.

The largest study involved around 63,000 children found that those given Rotarix had more convulsions. The study took place mainly in Latin America. GSK said that respiratory infections such as pneumonia account for a greater number of infant deaths in Latin America compared to the US.

GSK's vaccine was approved in the EU in March 2006.

2nd September 2008

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