-
- The second phase of
the Pentagon's anthrax vaccination
program will be delayed six months
to a year while the sole supplier of
the vaccine corrects deficiencies
in its newly renovated manufacturing
plant.
-
- BioPort Inc. of Lansing, Mich.,
needs certification from
the Food and Drug Administration before it can
send new batches of vaccine
to the Defense Department. But it failed to
meet FDA standards for the
manufacturing process during a November
inspection.
-
- Continuing efforts to meet those standards could add
$7 million
to $10 million to the program's cost and delay the program up
to a
year, said David Oliver Jr., principal deputy undersecretary of defense
for acquisition.
-
- Since the controversial vaccination program began about
two
years ago, inoculations for 383,000 active-duty and reserve service
members have begun. About 11,000 have completed the series of six shots,
administered over 18 months. Defense officials say "several
hundred"
service members have refused the shots because of
concerns about the manufacturer,
short- and long-term health effects,
and whether the vaccine will, in fact,
protect against anthrax, a
biological agent that defense officials regard
as one of the greatest
threats to U.S. forces.
-
- Eventually, the Defense Department plans to inoculate
all 2.4 million active and reserve troops. For now, however, it will
continue
to vaccinate only those going to Korea or the Persian Gulf, or
those who
have already begun the shots. Vaccinations for early
deployers, those who
would be among the first to be called up for a
contingency, were expected
to begin in January. But that portion of the
program has been delayed until
BioPort can ensure a continuous
supply.
-
- The FDA already has approved 430,000 doses of the vaccine
kept
at BioPort, which were manufactured before the renovation of the plant
took place. The Defense Department expects another 600,000 previously
manufactured
doses to be approved. The stock is expected to meet
demands of the immunization
program through the end of 2000.
-
- Another million doses
are in storage but defense officials
expect the plant to be certified
before they would need to use those, Oliver
said.
-
- BioPort purchased the anthrax
vaccine manufacturing facility
from the state of Michigan 15 months ago
and completely renovated it to
meet the Defense Department's
substantially increased need for the vaccine.
-
- In its recertification
inspection, the FDA examined such
issues as whether the facility could
reliably produce the vaccine, maintain
consistent potency, maintain
records in accordance with FDA standards,
and identify and prevent the
introduction of possible contaminants in the
manufacturing
process.
-
- "Frankly, it has been more difficult than either
the
department or BioPort expected to move from a small, state-regulated
production facility to a large, modern production facility that meets the
state-of-the-art FDA requirements," Dr. Sue Bailey, assistant
secretary
of defense for health affairs, said Dec. 13.
-
- "BioPort has
recently beefed up its management and
production teams. At the same
time, the department has augmented the team
that supervises this
program," she said.
-
- The FDA identified 30 problem areas. Among them:
-
- * The FDA could not
verify whether the company's parameters
for manufacturing temperatures,
stirring speed, refrigeration times and
holding times would guarantee
that each batch would be identical.
-
- * The company did not report
that it failed potency-test
results on some samples when using an
FDA-approved calculation method,
rather than an unapproved method
company officials thought was acceptable.
-
- * BioPort has not completely
demonstrated it can always
manufacture the vaccine without bacterial
contamination.
-
- * The company's internal procedures for reporting deviations
from the normal manufacturing process lacked a timeframe for concluding
investigations, and did not fully address when the deviation reports
should
be written.
-
- Robert Myers, BioPort's chief operating officer, said
he welcomes the federal oversight. BioPort is fully cooperating with the
FDA, he said.
-
- "We're working aggressively to resolve the issues
identified in the pre-approval inspection and any other concerns for the
renovated facility," Myers said.
-
- At least eight of the problems
the FDA found last month
were also cited in February 1998, around the
time the plant closed for
the much-needed renovation.
-
- The FDA frowns on
repeat problems, industry experts say.
-
- The deviations don't mean the
company didn't try to correct
the problems, Myers said, only that the
corrective action was insufficient
for the new inspection.
-
- Oliver noted that
some government tests have changed
since the new facility was built.
Therefore, new company procedures need
to be written, tested and
established.
-
- "Good manufacturing practices are always evolving
and it's
incumbent upon the manufacturer to stay abreast of any changes,"
Myers said.
-
- One critic of BioPort and the current vaccine who works
in the
biotech industry said the FDA observations reflect an inattention
to
rules.
-
- "It's one thing to have new observations,"
said
George Robertson, an Army Reserve colonel and an executive with a
Maryland biotech firm. "But it's altogether a different level of
noncompliance
to have repeat observations."
-
- Robertson worked on a possible
second-generation anthrax
vaccine developed at the U.S. Army Medical
Research Institute for Infectious
Disease at Fort Detrick, Md., in the
1990s.
-
- The
news that the Pentagon will spend up to $10 million
more on BioPort
comes just four months after it announced it was revising
its contract
with the company and would pay $24.1 million more for the
vaccine,
$18.7 million in advance.
-
- Defense officials said they and BioPort representatives
underestimated the cost of making the vaccine because Michigan was
subsidizing
the plant's costs.
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- Copyright 1999 Army Times
Publishing Company. All Rights
Reserved.
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