.
Christopher Shays, Connecticut
Chairman
Room B-372 Rayburn Building
Washington, D.C. 20515
Tel: 202 225-2548
Fax: 202 225-2382
NEWS RELEASE
For Immediate Release
Contact: Robert Newman
April 26, 1999
(202) 225-2548
(Washington, DC) -- Congressman Christopher Shays (R-CT), Chairman of the Subcommittee on National Security, Veterans Affairs, and International Relations, will convene an oversight hearing April 29 to continue examination of the Department of Defense's (DoD's) Anthrax Vaccine Immunization Program (AVIP) for all military personnel. The hearing was announced today by Congressman Dan Burton (R-IN), Chairman of the Committee on Government Reform.
"In this second hearing on anthrax, the Subcommittee will focus on the safety of the vaccine and its effectiveness against aerosolized biological weapons attack," said Chairman Shays. "We need to be sure use of this vaccine is based on more than old data and wishful thinking."
The hearing will convene April 29, at 10 a.m., room 2247 of the Rayburn building in Washington, DC. Among the witnesses will be representatives from the General Accounting Office (GAO), FDA, DoD, the vaccine manufacturer, and individuals who have received the vaccine.
The Food and Drug Administration (FDA) first approved the vaccine as safe for civilian use against incidental infection in 1970. However, questions have been raised about the vaccine's effectiveness against massive doses of weaponized anthrax anticipated in an intentional biological warfare attack. Subsequent FDA review of studies concluded the vaccine was effective against cutaneous (through skin) exposure. Data from human and animal tests were insufficient to support a finding of efficacy with regard to airborne anthrax spores.
The only FDA-approved vaccine manufacturer, the Michigan Biologics Products Institute (MBPI), has been cited repeatedly by the FDA for quality control deficiencies and good manufacturing practice violations. In March 1997, the FDA warned that steps would be taken to revoke production licenses, including anthrax vaccine, unless immediate actions were taken to correct longstanding deficiencies. MBPI was acquired by the BioPort Corporation in 1998. In March 1998 the plant was closed for $1.8 million in renovations and a $15 million expansion funded by DoD. Vaccine production is not expected to resume before late 1999.
DoD plans to inoculate all 2.4 million active duty personnel against anthrax at an estimated cost of $130 million. The immunization series calls for six injections of the "killed bacteria" vaccine over a period of 18 months, followed by annual booster shots. Vaccinations began in March 1998.
There have been no systematic, long-term studies on anthrax vaccine health effects, if any. Due to poor record keeping, DoD was unable to conduct broad follow-up studies on the 150,000 U.S. troops who received the vaccine in the Gulf War. Some have suggested that the vaccine, alone or in combination with other substances, may play a role in Gulf War veterans' illnesses.
In May 1998, Chairman Shays requested a GAO review of the safety and efficacy of the vaccine and the significance of FDA-reported deficience at the manufacturing plant. Preliminary results of that study will be discussed at the hearing.
"There is very limited data to support DoD's conclusion the vaccine is safe in the long term or effective against airborne concentrations," Shays said. "Since the anthrax immunization program is mandatory, we should know far more that we do about the health impact on our nation's armed forces."
The Subcommittee on National Security, Veterans Affairs, and International Relations has oversight responsibilities over those departments and agencies of government responsible for national security, veterans affairs, and international relations, including all efforts to combat terrorism and intelligence gathering activities.
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Anthrax (II): Safety and Efficacy of the Mandatory Vaccine April 29, 1999
WITNESS LIST
Kwai Chan, Director
National Security and International Affairs Division General Accounting Office
(GAO)
Dr. Katherine Zoon, Director
Center for Biologics Evaluation and Research Food and Drug Administration
(FDA)
Gen. Eddie Cain
Joint Program Manager for Biological Defense Department of Defense
Dr. Robert Myers
Chief Operating Officer BioPort Corporation
Dr. Meryl Nass
Physician Freeport, Maine
David Churchill
Albion, Michigan
Randy Martin
Eaton Rapids, Michigan
Roberta Groll
Battle Creek Michigan
Michael Shepard
Savannah, Georgia
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