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
Wilmington Healthcare

A heritage to envy Wilmington Healthcare brings together the data intelligence specialisms of Binley’s, NHiS, Wellards and HSJ to create...

Latest intelligence

Report: Achieving launch excellence in the challenging healthcare markets of today
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...
What is blockchain and why should i care - Richard Springham
Four Health - Emerging Technologies The power of blockchain lies in the fact it can prove that a unique event occurred at a certain time with out the need to...
NHS medicines optimisation milestone
Steve How, Paul Midgley and Oli Hudson, of the Wilmington Healthcare Consulting Team, explore the implications of Adalimumab’s recent European patent expiry...

Infographics