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FDA Attempts to Quell Growing Fear of Flu Vaccine
Shortage, Again
Oct. 18, 2005 With growing concern about another
shortage of flu vaccine this year, the FDA issued a statement that it
anticipates the production of more vaccine than last year. Yesterday,
Chiron, the flu producer whose shutdown caused last years problem, said
its U.S. flu vaccine deliveries will fall short of targets less than
18 million doses of the 18 to 26 million projected.
Chief Executive Howard Pien said the shortage is
due to production problems at its British manufacturing plant the one
closed last year. Chiron, however, is one of four producers being used
by the U.S. this year.
Flu shots have been delayed in many part of the
country and one reason, health workers say, was an effort by
manufacturers to release vaccine incrementally, as the U.S. Centers for
Disease Control and Prevention suggested. The CDC strategy was to ensure
that the vaccine, which the government approves batch by batch, was
distributed equitably across the country.
Many say the CDC plan was wrong. Producers and
distributors should have been encouraged to ship first to those who take
care of high-risk people
"A tremendous amount of work by FDA, MHRA, and the
firm has brought us to the point that will allow Chiron to distribute
influenza vaccine for this flu season," said Dr. Jesse Goodman, Director
of FDA's Center for Biologics Evaluation and Research. "However, as with
all influenza vaccine manufacturers, Chiron's influenza vaccine must
undergo safety testing and lot release evaluation before it can be
released to the market."
FDA is committed to working with all of the
influenza vaccine manufacturers to expedite product lot release and
availability of vaccine. While occasional spot shortages may occur as
manufacturers complete their final testing, we expect these shortages to
resolve as vaccine continues to be released to health care providers and
others who administer the vaccine.
There are four manufacturers distributing influenza
vaccine this year: Sanofi Pasteur, Inc., MedImmune Vaccines, Inc.,
GlaxoSmithKline Biologicals, and Chiron. FDA has been actively working
with them to ensure an adequate, safe, and effective supply of vaccine.
As part of this overall effort, the Agency has had close interactions
with the Medicines and Healthcare Products Regulatory Agency (MHRA, the
U.K. regulatory authority) and Chiron, as the company has worked to
correct the problems that led to its license suspension by MHRA.
Influenza season may begin as early as October and
run through May. The best time to get vaccinated is in October or
November, but getting vaccinating in December or later still can be
beneficial.
For more information on influenza and influenza
vaccine Click Here
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