FDA warning on use of Rotarix vaccine

“FDA has carefully reviewed the available data on the presence of DNA from PCV1 in Rotarix. The agency,through its own laboratory studies,has confirmed its presence in the vaccine,” it says.

Adding that till the time it gathers additional information to present it to its expert advisory committee,FDA recommends that clinicians and public health professionals temporarily suspend the use of Rotarix.

Given to children below the age of six months until eight months,the warning,according to doctors in India,is important as private practitioners here widely administer Rotarix to children.

“The vaccine is widely used in clinical practice and there are studies of its efficacy. FDA has an authority to completely withdraw the product from the market,but if it is not banning it then there is no need to panic. However,there is a need for further trials to get into the depth of it,” said Dr Sunil Mehra,a senior pediatrician.

Rotavirus disease causes over 500,000 infant deaths across the world each year; an estimated one lakh children die in India every year of the virus.

This is not the first time that questions have been raised over Rotarix. The vaccine has been withdrawn from the US market once earlier.

“In the initial trial itself,rotavirus had caused intestinal inflammation. It was,therefore,stopped. It has come to the market again but the effectiveness of the vaccine and its cost benefit still remains limited. In India,the vaccine is still new and its long-term effects can be seen only in decades to come,” said Dr Sanjeev Bagai,CEO and senior consultant pediatrician,Batra Hospital and Medical Research Centre.

Those using the vaccine vouch for it but the warning has nonetheless made them cautious. “In pre-term babies,the vaccine may lead to passing of blood stools but even those incidences are very low. The vaccine has proved to be efficacious and in the past few years the incidences of rotavirus disease too have gone down,” said Dr Dr Satvinder Kapoor,consultant, Max Hospital,Pitampura.

The FDA will now convene an expert advisory panel in four to six weeks to make further recommendations.