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

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Red Health

Red Health was formed in 2007 to bring something fresh to the healthcare PR world. Our approach was simple –...

Latest intelligence

“Fake News” and Credibility in Medical Publishing
Natalie Yeadon from Impetus Digital shares her thoughts on fighting fake news in Pharma and healthcare....
Delivering true value: what does it mean for KAM in cancer care?
Lisa Alderson, Business Development Director at Wilmington Healthcare, explores the challenges that pharma’s KAM teams face in engaging with the NHS and how they must evolve...
Pharma M&A
Pharma funding and M&A in 2020
Why pharma M&A has continually bucked the trend...

Infographics