GlaxoSmithKline Gets Positive Opinion on Pandemic Vaccine

January 24, 2007

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.

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. 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.