* FDA approves unadjuvanted H1N1 pandemic vaccine
* Glaxo plans to ship all 7.6 mln doses in December
* Vaccine will contribute small amount to U.S. needs
(Adds details, background)
NEW YORK, Nov 10 GlaxoSmithKline Plc (GSK.L)
has won U.S. marketing approval to sell an unadjuvanted H1N1
swine vaccine, allowing it to ship relatively modest amounts of
scarce vaccine to the United States next month.
The British company said on Tuesday the Food and Drug
Administration had approved a modified version of its FluLaval
seasonal flu vaccine containing the new H1N1 strain.
The green light clears the way for it to fill a order for
7.6 million doses from the U.S. government.
Glaxo is one of the world's largest manufacturers of flu
vaccines, along with Sanofi-Aventis SA (SASY.PA) and Novartis
But it is not a big source of swine flu vaccine for the
United States, since its main H1N1 vaccine Pandemrix contains
an adjuvant, or additive, and is not being used here.
The company's chief executive, Andrew Witty, told reporters
last month that it would be only a "bit-part player in the U.S.
The 7.6 million doses of Glaxo's unadjuvanted vaccine,
which is being manufactured in Canada, is just a small fraction
of the 250 million doses ordered by the U.S. government.
Glaxo said it expected to start shipping its vaccine in
December and complete deliveries by the end of the year.
Worldwide, Glaxo has taken orders for more than 440 million
doses of its adjuvanted Pandemrix H1N1 vacccine.
(Reporting by Ben Hirschler; Editing Bernard Orr)