* GSK says U.S. delay not related to narcolepsy controversy
* Similar vaccine linked to sleeping disorder in Europe
LONDON, March 25 U.S. regulators have delayed
approval of an H5N1 bird flu vaccine from GlaxoSmithKline
, designed to be used in a pandemic.
A spokesman for Britain's biggest drugmaker said the delay
was not related to recent controversy over links between a
similar flu vaccine made by the company and narcolepsy.
Rather, the U.S. Food and Drug Administration (FDA) decided
it needed more time to assess the product "due to an
administrative matter that has recently been rectified", GSK
said in a statement on Monday.
"GSK and the FDA are actively working together to complete
the review in a timely manner," it added.
There is growing evidence of a link between GSK's earlier
H1N1 flu vaccine, Pandemrix, and an increase in narcolepsy cases
among children who received it in Europe - a fact which has
raised questions as to whether the FDA should approve the
similar H5N1 product.
Both vaccines contain AS03, a new adjuvant, or booster, that
turbo-charges the body's immune response to a vaccine.
A 14-member panel of advisers to the FDA voted unanimously
in November to recommend the H5N1 vaccine to protect against
bird flu. The panel considered early studies from Europe showing
an increase in the number of narcolepsy cases but concluded that
the potential benefit of the vaccine outweighed the risk.
Since then, however, new data, including study results from
Britain, suggest the scale and strength of the narcolepsy link
to Pandemrix during the 2009-10 H1N1 swine flu pandemic could be
greater than first thought.
Officials at the FDA were not immediately available to
comment on the case.