GSK Provides Update On Pandemic 2009 Influenza Vaccine

GlaxoSmithKline (GSK) has announced that approximately half a million people will receive its pandemic H1N1 vaccine, Pandemrix, as part of Government initiated vaccination programs across Europe, this week.

GSK also reported new results from a clinical trial assessing the use of Pandemrix in adults aged 18 to 85 years of age. The ongoing trail shows that after the first dose of adjuvanted vaccine, a strong immune response was demonstrated, inclusive of the over 60 age group. The adjuvanted vaccine in this trial contains the dose of H1N1 antigen (3.75µg) which is the EMEA approved final formulation.

The results show that 88% of the subjects between 61-70 years of age, and 86.7% of those over 70 years of age, demonstrated a response that was above the regulatory threshold of 1:40 seroprotection, which is considered indicative of protection. Results in the age group 18 – 60 years were similar to previously reported studies in that age group, with 97.5% of subjects reaching the 1:40 seroprotection level in this trial.

The study results suggested that the tolerability of the vaccine shown to be similar to that observed in the previously EMEA approved H5N1 adjuvanted vaccine.

Jean Stephenne, president of GSK Biologicals, said: “These results complete GSK’s first line results across key age groups. As previously shown in young children and adults under 60 years of age, these new data demonstrate the ability of the vaccine to induce a high immune response considered indicative of protection after one dose across a wide range of ages, including the elderly. These data are very important for those in government who need to continually assess new data in light of the current global public health challenge.”