GSK’s mock vaccine gets EU positive opinion
pharmafile | December 19, 2006 | News story | Research and Development |Â Â Â
GlaxoSmithKline Biological's mock pandemic flu vaccine has received a positive opinion from EU regulators.
Daronix is intended to protect against flu during an officially declared pandemic situation – once the virus strain has been identified. It is not expected to be used or stockpiled in its present form.
The race to produce vaccines against potential pandemic flu followed the rapid spread of the H5N1 or avian flu strain into Europe from Asia in 2005.
To date, avian flu has killed 153 people worldwide, but the greatest fear is that avian flu could combine with ordinary flu to create a new, far more deadly strain, which experts have said could kill between two and 50 million people, with many more millions hospitalised.
Researchers are unable to create a vaccine until they can identify any emerging new strain, which means the only preparation that can be made is to buy manufacturing capacity.
A mock flu vaccine mimics the future pandemic vaccine in terms of its composition and manufacturing method and contains a flu virus strain specifically chosen for a population that has never been exposed to it before. In the case of Daronix, the chosen strain has been derived from the one involved in recent outbreaks of avian flu.
The objective is to have a marketing authorisation in place that can be changed quickly in the event of a pandemic to include a vaccine with the virus strain responsible for the outbreak.
Jean Stephenne, president of GSK Biologicals, said: "Receiving this positive opinion is testament to the company's ongoing commitment to provide health authorities with concrete options against the threat of an influenza pandemic."
GSK is expected to file a second-generation avian flu vaccine to European regulators in the next few weeks. Currently in late-stage development, this vaccine utilises the company's novel adjuvant system technology and could be used as part of an immunisation programme, helping to protect the population in advance of a pandemic.
Stephenne added: "I believe, with the imminent filing of our second generation vaccine, GSK has brought two solid vaccine solutions to prepare for pandemic or proactive pre-pandemic vaccination."
