GSK files influenza vaccine for review

GlaxoSmithKline (GSK) has announced that it has filed its novel H5N1 split antigen pre-pandemic influenza vaccine for review by the Committee for Medicinal Products for Human Use (CHMP) in Europe. CHMP has accepted this filing.

The vaccine filed for review uses the company’s proprietary adjuvant system and delivers 3.8 micrograms of antigen to obtain a seroprotective response from the person injected.

Results of a clinical study in Belgian indicated that administration of two such doses of antigen 21 days apart resulted in this response in over 80 per cent of patients, surpassing target levels laid out by regulatory authorities.

Jean Stephenne, president of GSK Biologicals, commented that the filing of this vaccine was a key landmark in the company’s vaccine development programme for pandemic preparedness.

“I believe the rapidity with which immunogenicity and safety data has been generated resulting in this filing pays tribute to our ongoing commitment to provide, in as short a timeframe as possible, credible options against the threat of an influenza pandemic,” he said.

He added that such a vaccine could potentially offer a cross-protective response as part of a campaign of pre-pandemic vaccinations to make available early protection for citizens against the pandemic influenza virus.

Earlier this month, GSK announced that it had been awarded a contract US Department of Health and Human Services for the development of flu vaccines for pre-pandemic and pandemic situations.