GSK's Prepandrix approved by EC, first European pre-pandemic flu vacc

The European Commission has approved UK drug major GlaxoSmithKline's H5N1 adjuvanted vaccine, Prepandrix, making it the first company to obtain a European licence for a pre-pandemic vaccine.

This novel approach to vaccination offers the 27 members of the European Union the potential to protect their population in advance of an officially-declared outbreak of bird flu in humans rather than relying on traditional vaccines, which are made from the strain of the influenza circulating in the population but involve a delay of four to six months after the onset due to long manufacturing lead times.

Earlier this year (Marketletter March 3), the European Medicines Agency (EMEA) recommended the authorization of GSK's first-in-class pre-pandemic vaccine and, although the product has only now received regulatory clearance, advance sales as part of EU government stockpiling efforts earned GSK $200.0 million last year.