GSK announces positive decision on flu vaccine

GlaxoSmithKline (GSK) has announced that its first-generation alum-adjuvanted inactivated whole virus candidate flu vaccine, Daronix, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Union

The vaccine is designed for use following the official declaration of a flu pandemic by the European Union or World Health Organisation.

Following the receipt of this positive opinion, GSK will submit a further file to the authorities for its second-generation H5N1 vaccine candidate using the company’s innovative adjuvant system technology.

Jean Stephenne, president of the vaccines division of GSK, said: “Receiving this positive opinion today from the CHMP is testament to the company’s ongoing commitment to provide health authorities with concrete options against the threat of an influenza pandemic.”

He added that this decision, in conjunction to the company’s forthcoming filing of another vaccine, the company would deliver two vaccines in preparation of a flu pandemic or for vaccinating populations prior to a pandemic.

In November, the company joined with the Department of Health and Human Services and Centres for Disease Control and Prevention in the US for their first National Influenza Vaccination Week.

The campaign aimed to raise awareness of the need for flu vaccinations to combat seasonal influenza.