Full-Scale Anthrax Vaccine Program May Restart in October
By Jim Garamone
American Forces Press Service
WASHINGTON, Dec. 28, 2000 DoD officials expect the full- scale anthrax immunization program to restart in October 2001. Officials are confident that Bioport, the sole producer of the vaccine, will overcome problems and receive approval for their new facility.
"The producer of the vaccine has made some substantial progress in recent weeks," said Marine Maj. Gen. Randall West, senior adviser to the Secretary of Defense for Biological and Chemical Protection.
West said DoD has been speaking with the Food and Drug Administration, the Centers for Disease Control and others monitoring Bioport. "They and we have confidence that [Bioport is] going to achieve approval for new production and that will probably occur not later than the third quarter of the coming year," he said during an interview. This means full-scale vaccination would probably begin by October.
On November 28, DoD announced it was halting anthrax immunizations for service members bound for Korea. Currently, only service members and DoD civilians reporting for duty in Southwest Asia will receive the inoculations. In Korea, the vaccination program hasn't completely stopped but it has been slowed down, West said. "There are some vaccine supplies there that we will continue to use until they are gone," he said.
Officials made the decision because of the shortage of FDA- certified vaccine. The vaccine program will resume once tested and certified supplies of the vaccine start flowing.
Officials said service members and DoD civilians who have started the six-shot series will not have to start at ground zero when the program restarts. "Personnel that have had their shot protocols interrupted will not have to go back and start over. They will pick up where they left off," West said.
West said DoD is disappointed that it cannot provide vaccine to the total force right now. "We're trying to provide it in the area where we feel the threat is highest," he said. "There is, however, some additional supply available to a unit if they were deploying against an adversary that we knew to possess the capability and had reason to believe might use it."
The inoculation program has generated controversy. About 400 service members have refused the shots. As of Dec. 7, 2000, almost 2 million individual doses of the vaccine have been administered to 496,026 active and reserve service members. There were 1,326 reports of adverse reactions to the vaccine. Most were minor reactions at the shot site. A total of 52 required hospitalization. All returned to duty.
DoD ordered the inoculation program in 1996 with the first vaccines administered in March 1997.
The department is seeking a second source for biological warfare protection. "We don't want to be in a position where we have to rely on a sole-source, non-government producer in the future," West said. "We would like to have capabilities like that duplicated. We would like to have a facility where we can call all the shots and make all the decisions. So we are pursuing a government-owned production facility -- not just for anthrax but to include several other vaccines we would need in the future."
He said such a facility would not be operational for at least five to seven years.
For more information visit the program Web site at http://www.anthrax.osd.mil/.