Global pharmaceutical company GlaxoSmithKline (GSK) is the first to get the go ahead for a wide spectrum vaccine to protect humans ahead of a possible future bird flu pandemic now that the European Commission (EC) is giving the drug giant approval today, Monday, to market its pre-pandemic vaccine Prepandrix in all 27 member states of the European Union (EU), according to various media reports.
Many experts believe it is only a matter of time before the deadly H5N1 bird flu virus, which currently humans can only catch from infected birds, mutates into a form that spreads easily from human to human and when it does so it will kill millions of people all over the world. The virus is now entrenched in the poultry populations of Asia, Africa and many parts of Europe, so the chances of this happening are greater than ever before.
Since 2003, according to laboratory confirmed cases reported to the the World Health Organization (WHO), the H5N1 bird flu virus has infected 382 humans worldwide of whom 241 have died, showing the high fatality rate of the virus.
According to the Telegraph, Chief executive of GSK, Jean-Pierre Garnier said that:
“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,” he added.
Although Prepandrix has only just received its first regulatory approval, countries such as the US, Switzerland and Finland have already started stockpiling the vaccine, sales of which last year topped 200 US dollars (102 million GB pounds). GSK said stockpiling means countries will be able to deal with an outbreak sooner rather than waiting for a vaccine to be developed for a particular strain.
Garnier said that:
“This drug represents one of the swing factors affecting us in 2008.”
“This is important for the company but it is more important in terms of global health,” he added. GSK has spent over 2 billion dollars in the last four years developing Prepandrix, which is given as two injections, three weeks apart.
While the new vaccine is based on the current version of the H5N1 virus, GSK said it is was flexible enough to cope with small mutations in the virus, giving it an advantage over most other flu vaccines being developed which become obsolete once the virus changes and then you have to wait six months for a new one to be made.
Garnier, said:
“For the first time the authorities are approving a pre-pandemic vaccine.”
“We have demonstrated that even if the H5N1 virus drifts to a different strain it is still effective,” he told the press, according to the Guardian.
The company said the vaccine could offer as much as 70 per cent protection or more, against a flu pandemic.
Some reports say that GSK is taking a chance in that if the H5N1 virus mutates into a human to human form it will not be very different from its current form, otherwise the vaccine will not be effective.
But Garnier said by giving their people the vaccine, governments were preparing their immune systems for a future pandemic. It was like getting fit for the Olympics, he said:
“It doesn’t mean you’re going to win the gold medal but if you train you’ll be a much better system.”
The idea is that governments will offer the bird flu jab at the same time as the seasonal flu jab.
Prepandrix, which has now passed all its clinical trials, is based on a blend of existing H5N1 strains from Vietnam and Indonesia, and once in the human body, the immune system learns to recognize them and make antibodies specifically against them.
Other governments have asked for more proof from their regulators of the effectiveness of the vaccine.
Garnier said GSK would be offering the vaccine to developing countries at a much reduced price.
Sources: Telegraph, Guardian, WHO.
Written by: Catharine Paddock, PhD