IOM suggests CDC include children, elderly in studies of anthrax vaccine

Oct 29, 2002 (CIDRAP News) The Centers for Disease Control and Prevention (CDC) should make a few changes in its congressionally required research program on the anthrax vaccine, including studying use of the vaccine in children and the elderly, the Institute of Medicine (IOM) said in a recent report.

An IOM committee that was assigned to review the program concluded that it "provides a generally complete and appropriate response to the congressional mandate," according to the report summary. The report, titled "An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program," was released Oct 15.

Congress ordered the CDC in 1999 to conduct research to identify the risk factors for vaccine-related adverse events, immunologic correlates of protection, and ways to improve the vaccination schedule and route of administration to reduce adverse events while maintaining efficacy. Congress acted after a number of military personnel who were vaccinated under a program started in 1998 complained about adverse reactions to the six-shot series. The CDC asked the IOM to evaluate its research program.

The IOM committee endorsed the design of the CDC's clinical trial focusing on the vaccination schedule, the route of inoculation, and risk factors for adverse events. The CDC's studies on vaccine efficacy and immunologic correlates of protection in nonhuman primates also were called satisfactory.

The committee said the anthrax attacks in 2001"confirmed the urgency of CDC's planned research and revealed the need for other studies." The panel recommended additional animal studies to examine the efficacy of the vaccine when given after exposure to anthrax spores and to determine how long post exposure antibiotics should be given after vaccination." Also needed are studies of the use of AVA (and any future anthrax vaccine) in vulnerable populations, including children, the elderly, and persons with chronic illnesses," the report states. "Such studies should reflect the findings from the clinical trial on the optimal route of inoculation and number of vaccine doses."

The committee also called for studies on passive protection, protection against different doses of anthrax spores, and ways to link military healthcare data with other data resources to help investigate the risk of adverse events occurring years after vaccination.

Further, the report recommends that the CDC assign one senior scientist to manage the whole research program. "In addition to setting priorities and guiding strategic planning for the research program, a clearly defined leader can facilitate appropriate responses as circumstances change and new opportunities arise," the report states. It also recommends the use of an external scientific advisory committee.

The 15-member IOM committee was chaired by Philip S. Brachman, a professor in the department of international health at Emory University in Atlanta.