Congress wants answers about Anthrax; Delaware legislators maintain 'wait-and-see' stance

by Tom Eldred

Delaware State News

June 9, 2000

WASHINGTON - Concerns by members of Congress over the military's involuntary anthrax vaccination program surfaced this week as part of next year's defense authorization bill.

The measure was being debated Thursday before the full Senate.

The measure says further funding of the program should be halted until the Defense Department produces evidence that the Food and Drug Administration has approved the sole manufacturing source for the vaccine.

The bill also requires Secretary of Defense William Cohen to submit a report by February detailing plans and cost estimates for an alternate vaccine production facility in event the current supplier, BioPort Inc., of Lansing, Mich., fails to secure FDA approval or stops making the vaccine.

According to a congressional report released in February, BioPort has been cited repeatedly by the FDA for quality control deficiencies.

In March 1998 the plant was closed for $1.8 million in renovations and a $15 million expansion funded by the government, the report said. Vaccine production resumed in May 1999 but neither the facility nor any newly produced vaccine has received FDA approval.

A spokesperson for BioPort did not immediately return phone calls Thursday.

Secretary Cohen ordered all 2.4 million active duty and reserve military personnel to begin the 18-month long series of shots in 1998 in an effort to protect the troops from exposure to anthrax, which could be used as a deadly biological warfare agent.

The military reports approximately 600,000 personnel have received at least one inoculation and as many as 700 have reported adverse reactions.

Although the first phase of the six-shot program has been completed, the Senate Armed Services Committee noted the Pentagon has had to delay the second phase because BioPort has yet to secure full FDA approval of its facility and therefore must stockpile supplies of new vaccine.

The defense authorization bill follows on the heels of a May 16 letter to Mr. Cohen signed by 35 members of Congress. The letter called for an immediate halt to the inoculation program.

Delaware's three legislators - Sen. William V. Roth Jr., Rep. Michael N. Castle and Sen. Joseph R. Biden Jr. - are taking a wait-and-see attitude on the controversy.

"My top priorities are for the safety and well-being of our service men and women and the maintenance of a strong national defense," Sen. Biden said in a prepared statement.

"Anthrax is a very real threat to our forces around the world and it is our duty to do whatever we can to ensure they are protected from this deadly biological agent.''

The state's Democratic senator said he is "aware of the concerns that some have raised regarding potential side effects and (I) certainly do not dismiss or in any way diminish those concerns. At this point, I think it is imperative that we continue to monitor the program and thoroughly examine all scientific and medical information pertaining to the vaccination.''

The defense authorization bill, based on recommendations from the Senate Armed Services Committee, asks the Defense Department for a report on how the military would procure vaccine if the FDA "does not approve the release of the anthrax vaccine available from the current manufacturer or the current manufacturer terminates the production of anthrax vaccine permanently.''

The measure also directs Secretary Cohen to submit a report, no later than Feb. 1, 2001, on the process of acquiring "biological warfare defense vaccines'' for the Defense Department.

As part of that report, the secretary would be required to include a "complete design for an alternative site'' other than BioPort to produce the vaccine, together with estimated costs. The facility would be operated under government ownership by a private contractor.

Although not contained in the Senate authorization bill, the Armed Services Committee recommended Mr. Cohen "give strong consideration'' to the Pentagon's plans and cost estimates collected a decade ago for construction of a vaccine production facility at the Pine Bluff Arsenal in Pine Bluff, Ark.

"Given these issues, the committee believes a re-evaluation by the Department of Defense of the issues relating to the vaccine and development and production, and the merits of (a facility) at an alternate site are necessary at this time,'' the committee report said.

Sen. Roth said he's been watching the situation closely.

"I have heard from many Delawareans concerned about the anthrax vaccine,'' the Republican senator said. "I believe it is critical that this administration address these concerns, while still protecting our armed forces.

"Furthermore, I continue to urge any personnel having adverse reactions to the vaccine to report them, both to ensure they receive quick medical attention and so the Department of Defense can know the effects of the vaccine.''

Rep. Castle, while not directly involved with the Senate debate, said he wants to hear more about possibly making the vaccinations voluntary.

"The Congressional committee's recommendation to make this anthrax vaccination voluntary raises some serious questions that the Department of Defense should absolutely take into consideration,'' he said.

"The health of our military men and women should be the Defense Department's number one priority. It is vitally important that our soldiers are protected should they face biological warfare and it is our job to ensure they receive the safest and most effective vaccine available.''

The Senate is expected to act his week or early next week on the defense authorization bill. It will move next to appropriations and then be linked with similar legislation from the House for a final compromise version. The final measure will be submitted to President Clinton before Oct. 1 for his signature.

The final House version, passed Wednesday, makes no specific recommendations regarding the anthrax program.

Tom Eldred can be reached at 741-8212 or teldred@newszap.com.