This site is intended for health professionals only
Friday 24 May 2019
Share |

FDA declares Rotarix "safe to use"

US regulators have cleared a controversial diarrhoea vaccine three months after it was found to contain traces of an apparently benign pig virus.

The Food and Drug Administration (FDA) urged doctors against using GlaxoSmithKline's Rotarix after DNA traces of porcine circovirus were found in the product in March, suggesting Merck's RotaTeq be used as an alternative while the case was investigated.

Officials reversed the decision on Friday after a probe found the product posed no danger to humans.

The oral vaccine has been used in millions of children worldwide, including 1 million in the US, with no signs of safety problems, the FDA said.

The decision follows similar findings by the European Medicines Agency.

Rotavirus causes severe diarrhoea and is a leading child killer in developing countries.

Copyright Press Association 2010

Ads by Google

You are leaving

You are currently leaving the Nursing in Practice site. Are you sure you want to proceed?


Respect for nurses: Sign up to our e-petition TODAY

The Nursing in Practice Respect campaign is now live! Over the coming months, we're set to highlight the vital contribution and efforts of primary care and community care nurses throughout the UK.

As part of our campaign, Nursing in Practice is looking to call on parliament to set up a debate to celebrate the vital work that you do.



Calling all primary care nurses! 'Like' our Nursing in Practice Facebook page to enter our free draw to win a £25 M&S voucher