Michigan-based BioPort Corp., is the only laboratory in the United States authorized to produce an anthrax vaccine. BioPort produced the vaccine for US armed forces personnel under an exclusive contract with the Department of Defense. However, the private firm halted production of its anthrax vaccine in 1998 amid FDA concerns about the safety of its facilities. Last week, BioPort submitted the final materials necessary for a relicensing inspection of its renovated plant. The FDA has said it is encouraged by BioPort's efforts to improve its manufacturing process.
Once it has been relicensed, BioPort has said it would be prepared to supply the vaccine, currently reserved for the armed forces, to civilians too. BioPort could only take advantage of increased civilian demand for the vaccine once it had fulfilled its obligations to the Department of Defense and has produced enough vaccine.
In June this year, the Department of Defense curtailed its anthrax vaccination program as the vaccine started to run out. However, in a press release issued at the time, the department said BioPort could be ready to restart production of the anthrax vaccine by around the first quarter next year.
The FDA first approved manufacture of the anthrax vaccine in 1970.
BioPort gives answers to five questions. BioPort officials on Thursday gave written answers to the following questions, submitted by the North Lansing Community Association. Members of the group live near BioPort, the military's sole producer of anthrax vaccine. Residents have feared the plant could be a potential terrorist target.
What is the future availability of the anthrax vaccine for civilian use?
Currently, there is no vaccine for civilian use. There have been erroneous reports in the media claiming the BioPort Corp. "hasn't produced any vaccine." That is inaccurate. BioPort has been producing vaccine since 1999. Those considerable stockpiles of vaccine could be released for emergency military or civilian use under a directive from the FDA.
The future availability of licensed vaccine will be determined by the following factors: FDA approval of BioPort Corp.'s facility and vaccine-producing processes; fulfilling the obligations of our contract with the Department of Defense; directives from the Office of Homelad Security, the Defense Department, the Department of Health and Human Services, or another federal agency that would affect future manufacture and delivery of the vaccine.
Why the increased security at BioPort Corp.?
BioPort Corp. has increased its perimeter security using our own security personnel and members of the Michigan National Guard. Although BioPort has not received any threat, nor has any government agency contacted us regarding a specific threat, Gov. (John) Engler assigned National Guard personnel to BioPort on Oct. 1 as a precaution. We welcome the assistance from the National Guard and believe that the increased military presence serves as an additional deterrent to any unauthorized individual attempting to enter the facility.
What is the likelihood of a terrorist attack against BioPort?
The events of Sept. 11 have forever changed how we evaluate the risks to citizens of the United States. As scientists who work in the world of proabilities and statistics, we are uncomfortable claiming that the risk is zero. But we are confident in saying that the risk is nearly zero!
A terrorist attack is extremely unlikely, given BioPort's bolstered defense perimeter, the presence of the Michigan National Guard, President Bush's creation of the Office of Homeland Security, and the increased security measures that federal, state, and local governments have put in place. This should not be construed as complacency. We are continuing to upgrade our security procedures and remain in close contact with law enforcement and the military.
In the event of a terrorist attack, what is the likelihood of release of dangerous gases into the air?
We believe that the risk of a terrorist attack is extremely remote. If "dangerous gases" implies a breathable, airborne form of anthrax, we are confident that the statistical risk is zero.
What if an airplane crashed into the BioPort Corp. facility?
Certainly, given the beefed-up security of the nation's airspace since the tragedy of Sept. 11, this is a highly speculative, highly unlikely scenario. But simply put, nothing would happen beyond the physical damage caused by the crash itself.
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