The US Food and Drug Administration (FDA) recommended doctors to temporarily stop using GlaxoSmithKline’s Rotarix vaccine for rotavirus immunisation in the US.
"FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunisation in the United States while the agency learns more about components of an extraneous virus detected in the vaccine," the US drug regulator said.
While the temporary suspension is based on findings of an independent US academic research team, the regulator said there was "no evidence at this time that this finding poses a safety risk".
| DOSE FOR TROUBLE # Advice on Rotarix based only on academic team’s findings # Detected no known safety risks in Rotarix so far # USFDA to convene an expert committee in 4-6 weeks on Rotarix |
The US FDA will convene an expert advisory committee in four to six weeks and make additional recommendations on the use of rotavirus vaccines, it said.
Rotarix had global sales of $440 million last year, up 50 per cent from 2008.
GlaxoSmithkline sells Rotarix in India as well, with sales of around $270 million, industry sources said.
Shares of GlaxoSmithKline Pharmaceuticals closed the day at Rs 1,745 on the National Stock Exchange, up 0.53 per cent from Monday.
