  Daronrix, GlaxoSmithKline (GSK) Biologicals’ (London, UK, 

) first-generation, alum-adjuvanted,  inactivated, whole-virus candidate flu vaccine for one-time use in a pandemic  has received a positive opinion from Europe’s Committee for Medicinal Products  for Human Use. This is a first step in the preparation against a possible H5N1  pandemic.

GSK also announced that it is about to submit a second file  to the European regulatory authorities for another vaccine, a second-generation  H5N1 candidate vaccine. This vaccine, which is currently in late-stage  development, uses GSK’s novel proprietary adjuvant system technology. 

The new generation vaccine candidate has the added benefit  of requiring a substantially lower amount of antigen to raise a strong immune  response, and gives the ability to produce very large quantities of vaccines  for mass vaccination. Upon licensure, this second vaccine could potentially be used  as part of a proactive pre-pandemic vaccination campaign, helping to prepare  the human immune system in advance of a pandemic and give broad protection  against different H5N1 strains. 

News

Daronrix, GlaxoSmithKline (GSK) Biologicals' (London, UK, www.gsk.com) first-generation, alum-adjuvanted, inactivated, whole-virus candidate flu vaccine for one-time use in a pandemic has received a positive opinion from Europe's Committee for Medicinal Products for Human Use.