October 6, 2000

DoD officials still feel strongly that the AVIP is necessary!

By Staff Sgt. Kathleen T. Rhem, USA
American Forces Press Service

WASHINGTON,-- DoD officials still feel strongly that the Anthrax Vaccine Immunization Program is necessary to protect U.S. forces, but they are examining different ways to acquire needed stocks of the vaccine.

“The department has moved toward alternative strategies for vaccine acquisition,” said Charles Cragin, deputy assistant secretary of defense for reserve affairs, while testifying before the House Government Reform Committee Oct. 3. “We realize that while the current vaccine is the most effective protection available against this lethal weapon, we must continually explore means to improve that protection.”

He said the department is working to reduce its reliance on BioPort Corp. as the only source of the vaccine approved by the Food and Drug Administration. “We are seeking to identify a second source for manufacturing the anthrax vaccine that can share the product license with BioPort,” he said, noting that DoD has received five “expressions of interest” thus far. The department will analyze the cost, schedule and technical feasibility of each of these.

“We admit (that the current) situation, where there is a single source of the anthrax vaccine, is not the most optimal position for the department,” said Anna Johnson-Winegar, acting assistant secretary of defense for health affairs.

DoD is also restricting further payments to BioPort to only those items “deemed allowable to comply with both good government fiscal practices and congressional direction,” Cragin said.

BioPort has been widely criticized for its failure to earn FDA approval to manufacture anthrax vaccine after retooling its plant and vaccine manufacturing process in 1998. Cragin stressed this poses no danger to service members, because vaccine being administered today comes from previously approved batches manufactured by the plant’s previous owner, the Michigan Department of Public Health.

It is the shortage of this previously approved vaccine that has caused DoD to scale back its vaccination schedule recently, he said.

DoD experts are also working to develop a completely different vaccine that would protect against several biological warfare agents. Cragin said the fiscal 2001 budget provides for research funds, but didn’t say when such research might be expected to yield results.

FDA official Mark Elengold explained the recent controversy over the discovery of squalene, a naturally occurring substance that boosts immune response, in certain batches of the anthrax vaccine. Both DoD and the FDA had previously contended there was no squalene in the vaccine, but more recent tests detected minute amounts.

Elengold explained that earlier tests could detect substances in parts per million, but the most recent tests are more sensitive, capable of detecting substances in parts per billion. The FDA found 10 to 20 parts per billion of squalene in lots of the anthrax vaccine that were administered to U.S. service members.

“These limits are so small that … until we developed this test, the answer would have been none,” Elengold said. He said the squalene levels likely occurred naturally because they were about one-millionth the amount that is safely put into certain other vaccines.

The House committee also heard extensive testimony from current and former members of the military who had either had health problems they believe stem from the vaccine or had left the service after refusing to take the vaccine. Marine Maj. Gen. Randall West, senior adviser to the deputy secretary for chemical and biological protection, rebutted this testimony.

“When you take a population of half a million people and give them vaccine, some of them are going to go on and get sick,” he said. “Eventually, all of us are going to die, but that doesn’t mean … that illness or that death was caused by the anthrax vaccine.”

He specifically referred to Kevin Edwards, an Army soldier who had testified earlier in the day. Edwards was diagnosed with Stephens Johnson Syndrome, a disfiguring disease that causes burns and often vision loss, usually associated with an allergic reaction to a medication.

West said experts at Brooke Army Medical Center, Fort Sam Houston, Texas, and Emory University in Atlanta had reviewed Edwards’ case and determined it was not related to the anthrax vaccine.

Questioned about the case of Air Force Senior Airman Thomas Collosimo, West admitted there are rare reactions to the vaccine and called the May 2000 incident unfortunate. “Occasionally, that happens,” he said. “It happens in very small numbers, and we wish it didn’t happen at all.”

Collosimo suffered severe reactions to the anthrax vaccine, including blackouts, dizziness and memory loss, and was sent from Hill Air Force Base, Utah, for treatment at Walter Reed Army Medical Center here.

West explained why it isn’t feasible for DoD to make the anthrax vaccination program optional for service members. “(In the event of an anthrax attack,) it would be very, very difficult to take care of the half of your force that wasn’t vaccinated,” he said. “And, it would keep the (other) half busy taking care of them when they could be fighting and winning on the battlefield.”

He also said it would be immoral not to use vaccine currently available, even while experts work to develop a better one.

“We don’t want to make anybody sick … , but I also don’t want to sit in front of you some day, after we send a force into harm’s way, have them run into an aerosolized anthrax exposure and explain to you why we had hundreds of thousands of deaths when we had protection available to keep them from dying.”

October 3, 2000

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."

Wyeth-Ayerst Pays $30 Million for FDA Violations

By Lauran Neergaard
The Associated Press

WASHINGTON (AP) - A major vaccine manufacturer agreed Tuesday to pay a $30 million fine for repeatedly violating federal drug-quality rules at two of its manufacturing plants, including a flu-shot factory whose temporary closure contributed to this year's delay in flu vaccine.

Wyeth-Ayerst Laboratories signed the consent decree with the Food and Drug Administration, which also requires the Pennsylvania-based company to take specific steps to improve quality at the plants on a preset schedule or face up to $5 million more in fines.

The FDA said it never found contaminated Wyeth products and is aware of no illnesses. It nevertheless called the manufacturing problems serious violations of rules meant to ensure that drugs and vaccines are sterile and of high quality.

The consent decree was prompted because Wyeth did not correct violations despite repeated FDA inspections, warnings and even the seizure last June of hundreds of doses of prescription drugs and vaccines made at one of the substandard plants, FDA said.

The factories are in Marietta, Pa., and Pearl River, N.Y. The violations dated back to 1995.

"Thirty million dollars is substantial money to us, no doubt about that. It is clear that FDA did regard these problems as problems that needed more attention and a faster pace than we achieved," said Dr. Bruce Burlington, Wyeth's senior vice president, who formerly worked at the FDA.

"We've been working hard on those problems," Burlington said. Among other steps, Wyeth hired outside quality consultants to tell FDA how the violations were being corrected; the federal agency also must reinspect the factories.

Among products made at the problem plants is flu vaccine.

Shipments of flu shots to doctors' offices are being delayed this fall, which has prompted federal officials to urge that the first available vaccine be given to elderly and chronically ill. The reason: All vaccine makers had trouble producing the right influenza strain, plus FDA-discovered manufacturing problems caused some companies temporarily to stop production.

All Wyeth's flu vaccine-related problems have been fixed and production restarted, Burlington said. Wyeth should begin shipping flu shots by midmonth and expects to have produced 24 million doses by the middle of December.

To guard against health problems, the FDA does not allow flu or other vaccines to be sold until samples have passed safety tests. "FDA is going to be closely monitoring the firm's compliance under the consent decree," said spokesman Lawrence Bachorik.

The consent decree is subject to federal court approval.