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BioPort Received Federal Approval Thursday
UPDATED: 9:40 a.m. EST February 1, 2002
The nation's sole manufacturer of an anthrax vaccine plans to produce and ship as many as 10 million doses of the drug to the U.S. military over the next two years.
BioPort gained federal approval Thursday to resume shipping the anthrax vaccine to the mililtary.
Lansing-based BioPort is the nation's only producer of the vaccine. The Food and Drug Administration said Thursday that BioPort's factory meets all requirements.
The FDA conducted a week-long inspection of BioPort's facilities in December. Shortly afterward, BioPort officials released the FDA's post-inspection report, which asked the company to make seven corrections before it is approved to ship the anthrax vaccine.
The company said that it was pleased with the results of the inspection and acted quickly to resolve four of the problems immediately following the visit.
BioPort produces a variety of vaccines for government and commercial use. But repeated failures to meet Food and Drug Administration guidelines prevented the company from making the anthrax vaccine for two years. The firm failed inspections in 1999 and 2000.
BioPort President Bob Kramer called Thursday "the biggest day in the company's history."
The Defense Department owns all of the vaccine that the company makes.
Federal officials said while the government doesn't recommend vaccinating the general public, having BioPort produce again is important in case civilians need to share the supply because of a bioterror attack.
BioPort will make and ship 2 million vaccine doses for the military this year, and between 3 million and 8 million next year.
Lansing-based BioPort is the nation's only producer of the vaccine. The Food and Drug Administration said Thursday that BioPort's factory meets all requirements.
The FDA conducted a week-long inspection of BioPort's facilities in December. Shortly afterward, BioPort officials released the FDA's post-inspection report, which asked the company to make seven corrections before it is approved to ship the anthrax vaccine.
The company said that it was pleased with the results of the inspection and acted quickly to resolve four of the problems immediately following the visit.
BioPort produces a variety of vaccines for government and commercial use. But repeated failures to meet Food and Drug Administration guidelines prevented the company from making the anthrax vaccine for two years. The firm failed inspections in 1999 and 2000.
BioPort President Bob Kramer called Thursday "the biggest day in the company's history."
The Defense Department owns all of the vaccine that the company makes.
Federal officials said while the government doesn't recommend vaccinating the general public, having BioPort produce again is important in case civilians need to share the supply because of a bioterror attack.
BioPort will make and ship 2 million vaccine doses for the military this year, and between 3 million and 8 million next year.Copyright 2002 by NewsNet5.com. The Associated Press contributed to this report. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
