- LANSING, Mich. (UPI) - BioPort
Corp. could begin shipping anthrax vaccines to the military within a few
weeks now that the Food and Drug Administration has given conditional approval.
The production would be the first since 1998, when the former Michigan
Biologics Products Institute was sold by the state and renovations on the
production facility began.
The military, which owns all supplies of the vaccine in the United States,
plans to vaccinate all 2.4 million U.S. soldiers against anthrax for fear
several nations, including Iraq, have developed a weapons-grade version
of the deadly bacteria.
The government recently approved the use of 10,000 doses of vaccine made
recently by BioPort for people exposed to the pathogen from anthrax letters
sent to members of Congress.
Health and Human Services estimated some 3,000 congressional staff, postal
workers and others are eligible to receive the vaccine, along with additional
antibiotics because they were exposed to large numbers of anthrax spores.
While only animal studies are available, there is concern among medical
experts antibiotic treatment alone is not enough to kill all anthrax spores
in a person's system and that some spores can remain and cause infection
after antibiotic treatment ends.
BioPort is the only company with a contract to produce the anthrax vaccine
and the military has spent at least $126 million to acquire the doses.
The FDA prohibited any new vaccine from being produced at the facility
until BioPort fixed dozens of problems, some involving the quality of the
vaccine. A few relatively minor problems, mostly involving record keeping,
remain unresolved and the company must satisfy the FDA those problems are
being fixed before the conditional status will be lifted.
The 10,000 doses HHS purchased from the military were test doses made after
BioPort's renovations were complete but before FDA's approval of the facility.
They meet all FDA requirements.
"It's a very significant milestone for the company," BioPort
spokeswoman Brennen Root told Tuesday's Lansing State Journal. "Some
people say this is the finish line. We look at it as the beginning for
our company's future."
The FDA completed its final inspection of BioPort's facility Dec. 19, citing
seven deficiencies, some of which were fixed immediately.
The holdup now involves the Spokane, Wash., company, Hollister-Stier Laboratories,
which will be packaging the vaccine. The FDA found six deficiencies at
that operation.
About 500,000 troops already have received one dose of the vaccine. Anthrax
vaccination involves a series of six injections given over an 18-month
period.
In September 1998, BioPort bought the assets of the former Michigan Biologic
Products Institute. The company has its headquarters in Lansing and develops
and manufactures vaccines and plasma derivatives. The U.S. government is
the company's only customer for the anthrax vaccine.
Anthrax is an infectious disease that normally afflicts animals, especially
cattle and sheep. The spores can be produced in a dry form, which when
inhaled by humans can cause respiratory failure and death within a week.
Since anthrax is odorless, colorless and tasteless, those who have been
exposed may be unaware of the exposure and therefore unable to seek treatment
in a timely manner. For treatment to be effective, it has to be started
within 24 hours of exposure.
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