Please login to the form below

Not currently logged in
Email:
Password:

GSK's Rotarix vaccine resumes use in US

The US Food and Drug Administration has recommended that inoculations with GSK's Rotarix resume, following concerns over contamination

The US Food and Drug Administration (FDA) has recommended that inoculations with GlaxoSmithKline(GSK)'s Rotarix resume, having given it the all-clear following concerns over contamination. The vaccine is designed to protect babies against rotavirus, a leading cause of severe diarrhoea – a major cause of death in developing countries.

The announcement follows an almost two-month pause in the rotavirus vaccine's use owing to the presence of porcine circovirus-1 (PCV-1) contamination.

In March, the FDA urged paediatricians to temporarily stop using the rotavirus vaccine after discovering that doses of it were contaminated with bits of an apparently benign pig virus. They suggested doctors use Merck's RotaTeq vaccine instead. 

On Friday (May 14, 2010), the agency reversed its decision, saying there is no evidence that porcine circovirus can infect or sicken humans.

In March, the European Medicines Agency (EMA) had also suggested that paediatricians should not use Rotarix, but it reversed this recommendation a few days later.

Merck's vaccine was introduced in 2006 and GSK's in 2008. GSK's oral vaccine has been used in millions of children worldwide, including one million in the US, with no signs of safety problems, health officials said.

17th May 2010

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
90TEN Healthcare

90TEN is an award-winning healthcare communications consultancy that puts people at the heart of everything we do. Our Life.Changing. campaigns...

Latest intelligence

The Challenges Of UX In Healthcare: Technology To Change Lives
Blue Latitude Health Director and Head of Customer Experience Elisa Del Galdo explores the latest digital healthcare trends and reveals the innovations changing the sector today....
It’s all about patient outcomes… right?
Lessons from history: a design thinking perspective...
Emma Walmsley 2
30 Women Leaders in UK Healthcare (part 3)
Continuing our special feature on Women Leaders in UK Healthcare...

Infographics