By
Jennifer Larson, NurseZone feature
writer
More than
three months after a man died of inhalational anthrax in Florida, the U.S. Food
and Drug Administration gave clearance Jan. 31 to the one U.S. manufacturer of
the controversial anthrax vaccine to begin distribution of its licensed
treatment to the military.
Until now,
BioPort Corporation was unable to distribute its anthrax vaccine because its
laboratories were not deemed adequate by FDA standards. The FDA had cited
numerous deficiencies in the manufacturer’s labs, stalling production and
distribution.
The FDA
approved BioPort’s facility in Lansing, Michigan, Dec. 27 and inspected
another BioPort facility in Spokane, Washington, Jan. 7-10.
The U.S.
Department of Defense, which owns all the vaccine produced by BioPort, will
receive a total of 209,000 new doses of the vaccine. Each lot of vaccine will be
tested for purity, potency, identity and sterility before the FDA’s Center for
Biologics Evaluation and Research allows it to be released.
“This
vaccine meets FDA high standards for safety and efficacy,” said Health and
Human Services Secretary Tommy G. Thompson in a statement. “This product is a
critical component in our arsenal against bioterrorism.”
The
Department of Defense will continue to vaccinate designated special missions
units against anthrax and will review the possibility of expanding vaccination
for other members of the military forces, according to a statement released Jan.
31 by the department.
The
Centers for Disease Control and Prevention does not recommend vaccination
against anthrax for the general pubic. BioPort is reported to have no plans to
supply the vaccine to the public at the present.
However,
civilians may benefit from the $1.1 billion in federal funding that Thompson
plans to release to strengthen bioterrorism defense capabilities.
The funding will be provided in three parts, from the Centers for Disease
Control and Prevention, the Health Resources and Services Administration and the
HHS Office of Emergency Preparedness.
According
to HHS, states can immediately begin spending up to 20 percent of their
allotments to get started on preparedness measures. The remainder of the funds
will be released when a state’s plans have been received and approved.
Sources: U.S. Department of Defense, U.S. Department of
Health and Human Services, U.S. Food and Drug Administration.
Feb. 1, 2002. © 2002. NurseZone.com. All Rights Reserved.