Please login to the form below

Not currently logged in
Email:
Password:

GSK's Rotarix set for approval meeting

The FDA is due to meet on Wednesday (February 20) to consider approving GlaxoSmithKline's rotavirus vaccine Rotarix.

The FDA is due to meet on Wednesday (February 20) to consider approving GlaxoSmithKline's (GSK) rotavirus vaccine Rotarix.

The oral vaccine for children is effective, but also associated with a higher risk of pneumonia-related deaths and other adverse reactions, according to documents posted by the US Food and Drug Administration (FDA).

The rotavirus infection causes severe infant diarrhoea that leads to hospitalisation.

FDA staff said its analysis of 11 studies revealed that in the largest trial, there was a statistically significant increase in deaths related to pneumonia compared with placebo.

The website says the drug is effective at preventing rotavirus-related gastroenteritis, but draws attention to the pneumonia-related deaths and convulsions.

The largest study involved around 63,000 children found that those given Rotarix had more convulsions. The study took place mainly in Latin America. GSK said that respiratory infections such as pneumonia account for a greater number of infant deaths in Latin America compared to the US.

GSK's vaccine was approved in the EU in March 2006.

2nd September 2008

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

patients
Retaining reader value in plain language summaries of clinical studies
Balancing the risk of misinterpretation with the public’s ability to understand simplified plain-language summaries...
Can we talk about the ego-bias and chemicals influencing your target audience’s behaviour?
Over the Summer, the Page & Page team became fascinated by two books on this very subject. Two books from one author, Dean Burnett, an eminent neuroscientist, lecturing at Cardiff...
Paris
Making Europe a leader in bioscience: boosting trust and opening minds
A vision of Paris as Europe’s leading hub for life sciences innovation...

Infographics