US drugs board approves GSK's swine flu vaccine

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Glaxosmithkline received a further fillip to its growing swine flu vaccine sales yesterday when the Food and Drug Administration, the regulatory body in the United States, approved the group's treatment.

The nod paves the way for GSK to ship the 7.6 million doses of vaccine the US government has ordered.

The approval is subject to GSK providing further information about an outside contractor that fills the vials for the company, but GSK confirmed yesterday that it expects to provide the vaccine to the US by the end of the year.

A spokesperson for the group refused to comment, however, on how much the US government is paying for each dose, or, if as with the UK Government, the US is receiving a discount. GSK has disclosed that it is charging clients based on a sliding scale, from €7 a dose for developed countries, down to providing the World Health Organisation with 50 million free doses.

GSK's deal with the US is small relative to others it has secured. In the UK the group has agreed to share the supply of about 140 million doses with the US manufacturer Baxter. GSK has so far refused to comment on how the contract with the Government is split between the two companies.

The US deal is for GSK's unadjuvanted vaccine, a different treatment to Pandemrix, which contains an adjuvant – an added chemical that boosts the vaccine's efficacy – and which is largely being used in the UK. Last month, the group's chief executive, Andrew Witty, conceded that GSK would only be a "bit-part player in the US flu scenario". Nonetheless, GSK has taken worldwide orders for more than 440 million doses of Pandemrix.

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