In
the 2004 flu season, Chiron cut its production of flu vaccine doses
for the U.S. market by almost half--due to quality control issues
at its plant in Liverpool, England. With the 2005 flu season rapidly
approaching, it appears the company will again produce fewer doses
than originally planned, due to stringent work procedures and "strained"
workers.
But Chiron's problems don't stop there ...
The company announced that problems at another manufacturing facility
in Marburg, Germany will prevent the production of its Begrivac
flu vaccine for European markets as well.
A Resurfaced Problem
It seems quality tests have again discovered sterility problems
for Chiron, this time in Germany.
Expected manufacturing of the Bergrivac vaccine has been reduced
by some two-thirds (from 12 million to 4 million doses), disabling
Chiron from supplying the vaccine to Germany and the United Kingdom
for the coming flu season.
The dilemma raises concerns regarding whether the company will
be able to resolve its manufacturing tribulations in time to provide
the United States with the flu vaccine it needs. Food and Drug Administration
(FDA) scientists are currently in the midst of conducting an inspection
that will determine if Chiron will be allowed to sell its flu vaccine
in the United States this fall.
Assistance from Elsewhere
Though aside from Chiron, the United States has a few flu vaccine
providers up its sleeve:
-
Sanofi-Pasteur expects to produce as many as 60 million doses.
Moreover, a new $150 million Sanofi-Pasteur factory--designed
to boost the nation's precarious vaccine supply--is projected
to be ready for production for the 2009 flu season.
-
MedImmune, also licensed to sell flu vaccine in the United
States, may provide up to 3 million doses.
-
And if GlaxoSmithKline's application is approved by the FDA,
the company could tack on 10 million more doses.
USA
Today July 21, 2005
San
Diego Union-Tribune July 20, 2005
