Consensus Report

Protecting the Frontline in Biodefense Research: The Special Immunizations Program (2011)

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The U.S. Army's Special Immunizations Program is an important component of an overall biosafety program for laboratory workers at risk of exposure to hazardous pathogens. The program provides immunizations to scientists, laboratory technicians and other support staff who work with certain hazardous pathogens and toxins. Although first established to serve military personnel, the program was expanded through a cost-sharing agreement in 2004 to include other government and civilian workers, reflecting the expansion in biodefense research in recent years. This report examines issues related to the expansion of the Special Immunizations Program, considering the regulatory frameworks under which the vaccines are administered, how additional vaccines might be considered for inclusion in the Program, and factors that might influence the development and manufacturing of vaccines for the Special Immunizations Program.

Key Messages

  • Although the use of immunizations cannot substitute for careful adherence to all biosafety best practices, immunizations remain an important component of an overall biosafety program. Therefore, Special Immunizations Program investigational status vaccines should continue to be offered to laboratory workers on a voluntary basis, subject to risk assessments and informed consent.
  • Modification of the Special Immunizations Program by Federal agency stakeholders would help ensure that immunizations are readily available and accessible to all at-risk research workers, including those working on civilian, as well as, military projects.
  • In order to generate a specific list of pathogens for priority attention for inclusion in the Special Immunizations Program, a strategic review and systematic assessment on a pathogen-by-pathogen basis should be undertaken. The assessment should consider the characteristics of each pathogen and toxin and the characteristics of the threat posed by it, incorporating both military and civilian stakeholder perspectives. Regularly reviewing and assessing the vaccines included in the program would help ensure that the program reflects evolving civilian and military biodefense priorities.
  • Using licensed vaccines where available, and/or replacing older vaccines in the program with newer investigational vaccines that have substantially improved manufacturing, quality control, safety and immunogenicity profiles, would allow the Special Immunizations Program to offer the safest and most effective vaccines available. Because vaccines used in the Special Immunizations Program may have substantial value in a potential future national biodefense emergency, data on the safety and immunogenicity of these vaccines should be studied carefully.
  • As research on medical countermeasures continues, new vaccine products should be systematically incorporated into the Special Immunizations Program, and the removal of older or outdated products for similar applications should be considered. Products currently licensed for use in other countries, but not yet in the United States, could be used to fill gaps in the Special Immunizations Program inventory; to replace the older investigational products currently administered; and to expand the Special Immunizations Program to include vaccines against additional pathogens and toxins that reflect evolving national military and civilian medical countermeasures priorities.
  • To facilitate the development and licensure of Special Immunizations Program vaccines, the relevant regulatory authorities could explore new administrative and regulatory pathways. US government vaccine production and procurement plans should be designed to take full advantage of the Special Immunizations Program and to consider vaccines needed for the program.
  • If the Special Immunizations Program is to serve effectively as an immunization program for all at-risk researchers working with hazardous pathogens, the governance of the program should be revised to allow shared priority-setting and operational oversight by key civilian stakeholders, as well as military and other agencies. The revised system should build upon the wealth of Special Immunizations Program expertise available at U.S. Army Medical Research and Materiel Command.
  • Biodefense contracting and granting agencies should consider covering the cost of immunizing at-risk research workers, so that the cost is not borne solely by institutions working on government-supported programs. Although the committee supports the idea of central Special Immunizations Program administration, travel time and inconvenience would be reduced by establishing a small number of satellite clinic locations around the country.