Bioinformatics Institute of India: Pharma Department

GSK Issues Statement On FDA's Warning Against Rotavirus

Galaxo Smith Kline(GSK) has notified regulatory authorities of the presence of material from a virus called PCV-1 in its oral rotavirus vaccine, Roatrix. PCV-1 does not multiply in humans and is not known to cause illness in humans. It is found in everyday meat products and is frequently eaten with no resulting disease or illness.

The material was first detected following work done by a research team in the US using a novel technique for looking for viruses and then confirmed by additional tests conducted by GSK.

Having reviewed the information and data submitted by Glaxo Smith Kline, as well as information available regarding PCV-1 from the world's literature, the EMA and the WHO will also be issuing statements confirming the positive balance of benefits and risks of the vaccine despite the presence of the material from PCV-1 and have not recommended any change to the way that healthcare practioners in Europe and the dveloping world use Rotarix. The US FDA similarly has issued a statement confirming that there is no evidence that this finding poses a safety risk based on the exellent safety profile of Rotarix and evidences that PCV-1 is a known virus that does not multiply in humans and is and is not known to cause iullness in humans.

Roatarix has been produced according to US FDA standards reviewed and approved for US licensure in 2008. This notwithstanding, the US FDA is recommending that US clinicians and public health professionals temporarily suspended the use of Rotarix as a precautionary measure.