CDC says delay of Chiron flu vaccine not a
problem
Robert Roos 
Staff Writer
Aug 27, 2004 (CIDRAP News) – Close to half of the
nation's influenza vaccine doses will be shipped later than expected
this fall, but everyone who wants a flu shot should ultimately be
able to get it, federal health officials said today.
Chiron Corp. announced yesterday that it is delaying
release of its flu vaccine doses until early October because some
lots of vaccine didn’t meet sterility standards. The company said it
expects to ship 46 million to 48 million doses, down from the 50
million doses predicted previously.
But Julie Gerberding, MD, MPH, director of the Centers
for Disease Control and Prevention (CDC), said today the CDC still
expects that about 100 million doses of vaccine, more than ever
before, will be available this year.
"Those who are used to receiving their shot in early
October may not get it then," Gerberding said. But, "The bottom line
is that right now we're expecting to have enough flu vaccine so that
everybody who needs flu vaccine can have it. . . . For folks who are
trying to plan for their immunization, the best thing is to stay
tuned to messages from your local health officers and your
clinician."
The other flu vaccine manufacturers are expected to
deliver their product on schedule, Gerberding reported. Chiron and
Aventis Pasteur are each expected to produce roughly half of the
projected 100 million doses, while MedImmune is likely to supply
about 1.5 million doses of the intranasal vaccine FluMist, she said.
Chiron anticipates shipping 40 million doses in
October, and MedImmune also will deliver its doses in October,
according to Gerberding. After shipping a few doses this month,
Aventis anticipates delivering 15 million to 20 million doses in
September and the rest in October, she said.
"We're confident that we'll be able to get vaccination
programs started on time with the doses that we do have," Gerberding
commented.
Neither Chiron nor Gerberding revealed exactly what
caused the problem with the Chiron vaccine, produced in Liverpool,
England. The company announcement said "a small number of lots"
failed to meet sterility specifications. "While ongoing internal
investigations into the root cause of the variance indicate no
widespread issues with the manufacturing process, Chiron has delayed
releasing any Fluvirin doses until it has completed additional
release tests," the announcement said.
Gerberding said Chiron officials told her they "have
identified the problem, they're fixing it, and they're taking extra
steps to make sure they have a safe product before they ship it."
Chiron said its planned "late-season delivery" of 2
million Fluvirin doses for the CDC stockpile for the Vaccines for
Children program remains on schedule. Those doses are in addition to
the 46 million to 48 million produced for general distribution.
Gerberding said the vaccine lots affected by the
sterility problem don't include any pediatric vaccine. "We're not
expecting a decrease in total predicted doses available for children
at this time," she said.
In response to a question, she said Chiron's vaccine
production problems, to her knowledge, were not related to
thimerosal, a mercury compound used as a preservative in most flu
vaccine doses. The CDC predicted in May that 6 million to 8 million
doses of thimerosal-free flu vaccine would be produced this year for
people concerned about the preservative.
Gerberding said flu vaccine delays are nothing new.
"As recently as 2001 we had some shipments that were delayed until
October. . . . We've been here before, we've done this before, and
we've handled it."
The CDC, she noted, recommends flu vaccination for
people aged 50 and older, those who have a chronic medical condition
or weakened immunity, those who expect to be pregnant during the flu
season, children aged 6 to 23 months, healthcare workers, and people
in close contact with others in the foregoing categories.
See also:
Aug
26 Chiron news release
