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EU agency recommends first two H1N1 flu vaccines
Fri Sep 25, 2009 11:16am EDT
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By Ben Hirschler and Kate Kelland
LONDON (Reuters) - European healthcare regulators recommended two swine flu vaccines for approval on Friday, clearing the way for mass vaccination programs to start imminently.
Governments and manufacturers have been scrambling for vaccines to target the new H1N1 flu strain, ahead of a feared second wave of infection as the northern hemisphere heads into winter.
The European Medicines Agency (EMEA) said its expert committee on new drugs gave the go-ahead for the first H1N1 swine flu vaccines from GlaxoSmithKline and Novartis, called Pandemrix and Focetria.
The shots now only need final approval from European Commission, a move EMEA chief executive Thomas Lonngren said he expected to happen "very rapidly ... hopefully next week" as part of an accelerated regulation system for pandemic vaccines.
A third vaccine from Baxter, which had also been submitted under the fast-track "mock-up" procedure, did not get a green light, but the watchdog said it was still reviewing this and other applications.
A spokeswoman for Baxter said it expected to receive a positive opinion "within days."
Shares in Glaxo rose 1.7 percent by 1350 GMT, buoyed by the European green light.
"They weren't first out of the gate with the other players in the U.S. -- although they are confident of getting approval there -- so this has given them a bit of boost," said Navid Malik, an industry analyst at Matrix Corporate Capital.
Baxter stock added 1.2 percent, while Novartis was flat.
The World Health Organization (WHO) said on Thursday that drugmakers will only be able to produce enough H1N1 vaccine each year for half the planet -- around 3 billion doses per year -- meaning governments will have to decide who should get the limited supplies.
The WHO added that a single dose should be enough to give immunity to healthy adults and older children from the virus commonly known as swine flu, which was declared a pandemic in June.
TWO DOSES...FOR NOW
The EMEA, however, said it was currently recommending two doses be given, at an interval of three weeks, although it acknowledged preliminary data suggested one dose might suffice and this recommendation could be updated as new data comes in.
The London-based watchdog said it was confident the new vaccines were safe, despite being rushed through the approval process, adding manufacturers would have to carry out safety studies in 9,000 subjects for each vaccine after launch.
"Decades of experience with seasonal influenza vaccines indicate that insertion of a new strain in a vaccine should not substantially affect the safety or level of protection offered," the agency said in a statement. Continued...
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UPDATE 5-EU agency recommends first two H1N1 flu vaccines
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