LONDON, Feb 23 (bdnews24.com/Reuters) - European regulators have endorsed a second experimental bird flu vaccine for use in humans, from Swiss drugmaker Novartis AG.
The London-based European Medicines Agency said on Friday it recommended approval of Focetria for use in the event of a pandemic flu outbreak, such as one that could be caused by the H5N1 virus.
The move follows a similar endorsement in December of GlaxoSmithKline Plc's product Daronrix.
In both cases the products are 'mock-up' vaccines that could be used as the base for producing a shot to protect people if there is a pandemic triggered by bird flu.
They will have to be adapted to include the exact pandemic virus strain once a pandemic has officially been declared, making them unsuitable for stockpiling.
As such, Focetria and Daronrix represent just one approach in vaccine preparations.
Drug companies, including Novartis and Glaxo, are also working on second-generation vaccines against the H5N1 virus that causes bird flu, which could be used as part of a pre-pandemic vaccination campaign.
Novartis said Focetria would contain a special adjuvant, or additive, called MF59, which can boost the body's immune response and extend vaccine supplies by allowing for smaller amounts of viral antigens to be used in each dose.
The H5N1 avian flu virus mostly affects birds, but it can occasionally infect people and has killed more than 160 since late 2003.
Experts fear the virus will evolve just slightly into a form that people can easily catch and pass to one another, in which case the transmission rate would soar, causing a pandemic in which millions of people could die.
The European Medicine Agency's positive opinion on Focetria will now go to the European Commission, which has final responsibility for granting a license for new drugs and vaccines. Agency recommendations are normally endorsed by the Commission within two to three months.
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