GlaxoSmithKline (GSK plc) announced that the European Commission has granted a marketing authorisation for its H5N1 adjuvanted pre-pandemic vaccine, Prepandrix, in all 27 EU member states. GSK is the first company to obtain a European licence for a pre-pandemic vaccine, thereby offering European governments the potential for protecting their population in advance or at the onset of an officially declared influenza pandemic.

"This vaccine marks a significant step in the world's ability to cope with an influenza pandemic. It is testament to GSK scientists who have pioneered the approach to pre-pandemic vaccination, demonstrating our commitment to doing everything we can to help prevent the devastating effects of a pandemic and play our part in averting this potential public health crisis," said Jean-Pierre Garnier, CEO, GlaxoSmithKline.

According to the World Health Organisation (WHO), vaccines are the most important intervention for preventing influenza and reducing its health consequences during a pandemic. There are two vaccine-based approaches that could be used in the event of a pandemic vaccine and a pre-pandemic vaccine.

Pandemic vaccines are produced as soon as a pandemic is declared, using the specific pandemic influenza strain. These vaccines will however, due to long manufacturing lead times, only be available four to six months after the onset of a pandemic, which will likely be too late for many of the victims of the first pandemic wave.

A pre-pandemic vaccine is produced in advance of a pandemic. Such a vaccine is based on the currently circulating avian H5N1 influenza virus likely to cause a pandemic and has the ability to raise immune protection against potential drift H5N1 strains. Pre-pandemic vaccines therefore play a critical role in pandemic preparedness planning, with experts citing that immunisation with such stockpiled vaccines in advance or at the onset of a pandemic is the most effective strategy for protecting entire populations.

"Pre-pandemic vaccination is an important strategy for addressing the current threat of a pandemic posed by H5N1," said Jean Stéphenne, President and General Manager GSK Biologicals. "GSK welcomes the EU approval for Prepandrix and remains committed to actively work with governments on their pandemic preparedness plans to help protect against the potentially devastating impact of a pandemic".

GSKs pre-pandemic H5N1 vaccine is formulated with a novel proprietary adjuvant system, which is designed to achieve a high immune response at a low dose of antigen which is long-lasting and active against a broad range of H5N1 strains.