First pre-pandemic vaccine approved to help protect against bird flu pandemic

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

GSK’s pre-pandemic vaccine has been shown to provide a strong and persistent immune response against a broad range of H5N1 strains of the virus. “This vaccine marks a significant step in the world’s ability to cope with an influenza pandemic. It is testament to GSK’s commitment to help prevent the devastating effects of this potential public health crisis,” said Jean-Pierre Garnier, CEO, GSK.

According to the World Health Organization (WHO), vaccines are the most important intervention for preventing influenza and reducing its health consequences during a pandemic. There are currently two types of vaccines potentially available to governments – a pandemic vaccine and a pre-pandemic vaccine.

Pandemic vaccines are produced as soon as a pandemic influenza is declared, using the specific pandemic strain. However, due to long manufacturing lead times, these vaccines will 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 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 immunization with such stockpiled pre-pandemic vaccines in advance or at the onset of a pandemic is the most effective strategy for protecting entire populations. This is particularly significant in Asia, where 75% of human deaths due to H5N1 infections have been reported and where an increasing number of infections continue to be seen.

To date, the WHO has reported 382 human cases of H5N1 or bird flu infections from 14 countries resulting in 241 deaths. Public health experts fear that this virus may evolve into a strain that is easily transmitted between people, triggering a worldwide pandemic. Influenza pandemics are global outbreaks that involve viruses to which humans have little or no immunity. H5N1 is one such flu virus strain.

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

GSK is committed to support governments and health authorities around the world in planning to respond to a global influenza pandemic prior to its outbreak and in the event one is officially declared. It has previously announced its intention to donate 50 million doses of its pre-pandemic vaccine to the WHO in support of its stockpile initiative, which can be distributed to the world’s poorest countries at short notice by the WHO. GSK supports this proactive strategy of worldwide stockpiling of H5N1 pre-pandemic vaccine which may be able to save millions of lives by protecting some of the most vulnerable populations in the world at the outbreak of a pandemic.