censed product AVA. The vaccination plan was to be phased in gradually, starting with service members judged most likely to encounter the threat. The first vaccinations under DoD’s Anthrax Vaccine Immunization Program (AVIP) took place in March 1998. As more members of the military received the mandatory vaccine doses, some raised concerns about the safety and efficacy of the vaccine being administered.

Because of the importance of protecting service personnel from potential acts of biological warfare using B. anthracis, and because of concern among troops and their families about adverse events possibly associated with the anthrax vaccine, the U.S. Congress has also been interested in the anthrax vaccine and the DoD immunization policy. In its appropriations for the Department of Health and Human Services for fiscal year 2000, Congress provided funding for CDC to carry out a research program on vaccines used against biological agents. The request is found in Box 1-1 below.

As it began planning a research program to respond to this mandate, CDC sought the input of the Institute of Medicine (IOM) regarding its developing plan. CDC contracted with IOM to establish an expert panel to review the completeness and appropriateness of the CDC anthrax vaccine safety and efficacy research program. The committee’s Statement of Task is found in Box 1-2.

BOX 1-1 Congressional Request for CDC Anthrax Vaccine Research, FY 2000–1

Public Law 106-113 provided fiscal year 2000 funding

“to the Centers for Disease Control and Prevention (CDC) for a collaborative effort to study the safety and efficacy of vaccines used against biological agents. The study would address: (1) the risk factors for adverse events, including differences in rates of adverse events between men and women; (2) determining immunological correlates of protection and documenting vaccine efficacy; and (3) optimizing the vaccination schedule and administration to assure efficacy while minimizing the number of doses required and the occurrence of adverse events. It is intended that NIH, CDC, and the Department of Defense will fully cooperate in this effort.”

The excerpt of Public Law 106-113 above is the language that formed the basis of the contract for this project. In the succeeding year, Congress made additional comments as follows in the House–Senate conference report that was generated in conjunction with fiscal year 2001 appropriations legislation, with fiscal year 2001 funding provided by Public Law 106-554.

“Regarding the anthrax study, the conferees understand that clinical studies will be greatly facilitated by the establishment of the Vaccine Healthcare Center Network, with the first site at Walter Reed Army Medical Center. This Network will facilitate data collection, standardization of the anthrax immunization, training and general data collection for this project.”

BOX 1-2 Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program Statement of Task

This committee will advise the Centers for Disease Control and Prevention (CDC) on the completeness and appropriateness of the CDC plan to respond to the Congressional mandate to study the safety and efficacy of anthrax vaccine, addressing: (1) risk factors for adverse reactions, including gender differences; (2) determining immunologic correlates of protection and documenting vaccine efficacy; (3) optimizing the vaccination schedule and routes of administration to assure efficacy while minimizing the number of doses required and the occurrence of adverse events. The CDC, the National Institutes of Health (NIH), and the Department of Defense (DOD) are directed by Congress to collaborate and cooperate fully in this effort.



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