Our children will soon have to receive yet another vaccine on top of the cocktail they already get - and it's one that may cause convulsions and even death.
The Rotarix vaccine - designed to prevent the rotavirus infection that causes gastroenteritis - has just been approved by America's drug regulator, the Food and Drug Administration (FDA), even though a new study has discovered that it may increase the rate of convulsions and even pneumonia-related deaths.
The agency decided to approve the new vaccine because earlier studies from the manufacturer, GlaxoSmithKline, had not discovered any adverse effects. It has however asked the manufacturer to carry out a post-marketing safety study that involves 40,000 infants.
The most recent study, involving 31,673 infants, inadvertently discovered the possible link to increased rates of convulsions and deaths while it was assessing the new vaccine's risk of causing intussusception, or intestinal folding, which can lead to life-threatening intestinal blockage. The previous rotavirus vaccine was withdrawn from the market in 1999 because of its intussusception risk.
In earlier studies involving 24,000 infants, the new vaccine was found to cause only irritability, cough, runny nose, fever, and vomiting.
The new vaccine will be given to infants aged between six and 24 weeks.
(Source: FDA website)