FDA says illnesses show no links to anthrax vaccine
Associated Press
WASHINGTON -- Despite more than 1,500 reports of adverse reactions, "no clear patterns" have emerged in any illness said to be related to the anthrax vaccine being given to the military, the Food and Drug Administration told Congress on Tuesday.
Mark Elengold, a deputy director at the FDA, made the declaration after a string of witnesses at a four-hour congressional hearing, some in tears, blamed the vaccine for a variety of diseases or the deaths of loved ones.
"I took the anthrax shot healthy and am now ill," Thomas Colosimo, a senior airman, said. He chronicled a series of adverse reactions to four shots, including severe weight loss and losses of consciousness.
Another witness, Nancy Rugo of Spokane, Wash., blamed the vaccine for the death of her sister, Sgt. Sandra Larson.
Barbara Dunn of Ionia, Mich., widow of a civilian employee of the only manufacturer of the vaccine, blamed the serum for husband Richard Dunn's death in July.
And a Navy seaman based on Okinawa, Petty Officer 3rd Class David M. Ponder, declared his right to refuse the vaccine.
The FDA's Elengold acknowledged that the squalene molecule linked in a recent Tulane University report to Gulf War illnesses has been found in the anthrax vaccine, but he said it was in quantities no greater than might occur naturally in the body.
At the Pentagon, spokesman Kenneth Bacon said the FDA assured the Pentagon that squalene was not added to the anthrax vaccine but was present as a naturally occurring substance.
"We don't know if those lots were administered to the troops," he said.
Pentagon witnesses at the hearing reiterated the decision to continue requiring anthrax inoculations for all soldiers in the Persian Gulf area and Korea, despite vaccine shortages.
Previously, all military personnel were required to get the shots and some face court-martial for refusing.
Elengold said the government-run Vaccine Adverse Event Reporting System has received 1,561 reports of problems after anthrax shots, including 76 serious cases, since 1990. The vaccine also is given to civilians who work with animals.
About 2 million doses have been administered, including more than 1.9 million to military personnel since the Pentagon's mandatory program began. A full course to guard against anthrax requires six shots.
"There are no clear patterns emerging at this time," Elengold said. "The reports on anthrax vaccine received thus far do not raise any specific concerns about the safety of the vaccine."
A panel of Pentagon witnesses echoed that assurance.
Reading a joint statement, Charles Cragin, the principal deputy defense undersecretary, said one or more doses have been administered to 447,000 service members, with 442 refusing to obey a direct order to take the vaccine.
Two years of intensive study of complaints have identified "no unexpected events and no disease syndromes associated with the anthrax vaccine," he said.
Rep. Dan Burton, R-Ind., House Government Reform Committee chairman, pledged further hearings to push the military into either abandoning the program or making it voluntary.
Burton also warned the Pentagon against coercing military personnel to prevent them from reporting adverse reactions. He offered confidentiality to any service members who come forward.
"The Defense Department is giving this investigational vaccine without informed consent," he said. "Doing research on our troops without their knowledge or permission is wrong."
WASHINGTON -- Despite more than 1,500 reports of adverse reactions, "no clear patterns" have emerged in any illness said to be related to the anthrax vaccine being given to the military, the Food and Drug Administration told Congress on Tuesday.
Mark Elengold, a deputy director at the FDA, made the declaration after a string of witnesses at a four-hour congressional hearing, some in tears, blamed the vaccine for a variety of diseases or the deaths of loved ones.
"I took the anthrax shot healthy and am now ill," Thomas Colosimo, a senior airman, said. He chronicled a series of adverse reactions to four shots, including severe weight loss and losses of consciousness.
Another witness, Nancy Rugo of Spokane, Wash., blamed the vaccine for the death of her sister, Sgt. Sandra Larson.
Barbara Dunn of Ionia, Mich., widow of a civilian employee of the only manufacturer of the vaccine, blamed the serum for husband Richard Dunn's death in July.
And a Navy seaman based on Okinawa, Petty Officer 3rd Class David M. Ponder, declared his right to refuse the vaccine.
The FDA's Elengold acknowledged that the squalene molecule linked in a recent Tulane University report to Gulf War illnesses has been found in the anthrax vaccine, but he said it was in quantities no greater than might occur naturally in the body.
At the Pentagon, spokesman Kenneth Bacon said the FDA assured the Pentagon that squalene was not added to the anthrax vaccine but was present as a naturally occurring substance.
"We don't know if those lots were administered to the troops," he said.
Pentagon witnesses at the hearing reiterated the decision to continue requiring anthrax inoculations for all soldiers in the Persian Gulf area and Korea, despite vaccine shortages.
Previously, all military personnel were required to get the shots and some face court-martial for refusing.
Elengold said the government-run Vaccine Adverse Event Reporting System has received 1,561 reports of problems after anthrax shots, including 76 serious cases, since 1990. The vaccine also is given to civilians who work with animals.
About 2 million doses have been administered, including more than 1.9 million to military personnel since the Pentagon's mandatory program began. A full course to guard against anthrax requires six shots.
"There are no clear patterns emerging at this time," Elengold said. "The reports on anthrax vaccine received thus far do not raise any specific concerns about the safety of the vaccine."
A panel of Pentagon witnesses echoed that assurance.
Reading a joint statement, Charles Cragin, the principal deputy defense undersecretary, said one or more doses have been administered to 447,000 service members, with 442 refusing to obey a direct order to take the vaccine.
Two years of intensive study of complaints have identified "no unexpected events and no disease syndromes associated with the anthrax vaccine," he said.
Rep. Dan Burton, R-Ind., House Government Reform Committee chairman, pledged further hearings to push the military into either abandoning the program or making it voluntary.
Burton also warned the Pentagon against coercing military personnel to prevent them from reporting adverse reactions. He offered confidentiality to any service members who come forward.
"The Defense Department is giving this investigational vaccine without informed consent," he said. "Doing research on our troops without their knowledge or permission is wrong."
