Report calls for changes to Army immunization program

A recent report by the National Research Council called for changes in the U.S. Army’s immunization program for laboratory scientists who work with deadly pathogens.

The NRC wants the vaccines to be made more available to civilian scientists and says civilian federal agencies should be given a greater role in setting policies and priorities, including determining which vaccines should be offered, according to CIDRAP News.

Currently, the Army’s Special Immunizations Program provides both licensed and investigational unlicensed vaccines to military and civilian researchers working with deadly pathogens. It is based out of the U.S. Army Medical Research Institute for Infectious Diseases at Ft. Detrick, Maryland.

Initially, the program was intended to serve only military personnel, but in 2004, it was expanded to include civilian researchers as well. The NRC said that it has failed to anticipate the needs of researchers beyond those in the military, particularly those who are involved in civilian biodefense countermeasures and public health research.

When the program was expanded in 2004, expectations put the number of participants at between 1,000 to 5,000, but the number of enrolled remained at around 600. The NRC said that the cost of the program to its participants could be to blame.

The program costs about $10,000 to $15,000 per person per year, plus the cost of travel to Ft. Detrick to actually be vaccinated, CIDRAP News reports.

The NRC suggests that the cost for the program be included in contracts and grants that the government awards to institutions that work on biodefense research projects. Furthermore, it suggests the creation of satellite clinics to reduce travel costs.

The program also does not offer vaccines against agents that are of interest to biodefense researchers, according to the NRC. The vaccines offered primarily reflect those that have historically fit the needs of the Department of Defense research programs.

The SIP currently offers unlicensed vaccines against botulism, three forms of equine encephalitis, Rift Valley fever, Q fever and tularemia. It offers licensed vaccines for anthrax, hepatitis B, Japanese encephalitis, rabies, smallpox and yellow fever.

The NRC suggests that the U.S. Department of Health and Human Services and the U.S. Department of Agriculture, as well as the DOD, be included in regular assessments of the vaccines included and the status of new vaccines, CIDRAP News reports.

"However, as currently structured and managed, the program appears to lack a coordinated civilian and military perspective on policy, management, and funding. Revising the governance of the [SIP] would help develop processes for shared priority-setting and operational oversight by key stakeholders from civilian as well as military agencies," the report says, according to CIDRAP News.

Additionally, the report recommends that the U.S. Food and Drug Administration explore new administrative and regulatory pathways to aid in the development and licensing of vaccines that could be used by the SIP.

The Biomedical Advanced Research and Development authority, part of HHS, requested the report’s preparation.