Occupational Health Program: Vaccine Information

Commercial vaccines should be made available to workers to provide protection against infectious agents to which they may be occupationally exposed. Current, applicable vaccine information statements must be provided whenever a vaccine is administered. Each worker’s immunization history should be evaluated for completeness and currency at the time of employment and re-evaluated when the individual is assigned job responsibilities with a new biohazard.

At present time, the following vaccines are available for Tier 1 BSAT:

• Francisella tularensis
• Variola major virus
• Variola minor virus
• Bacillus anthracis

The vaccines for smallpox (vaccinia vaccine) and anthrax are FDA licensed. The vaccines for tularemia are available through U.S. Food and Drug Administration (FDA) investigational new drug (IND) protocols. If indicated by risk assessment, the IND vaccines may be made available on a voluntary basis under FDA research protocols with informed consent.

The Anthrax vaccine is recommended by the U.S. Department of Health and Human Services’ (HHS) Advisory Committee for Immunization Practices (ACIP) for groups at risk for repeated exposures to B. anthracis spores. Five groups at risk for repeated exposure include:

• Laboratory personnel handling environmental specimens (especially powders) and performing confirmatory testing for anthracis in the U.S. Laboratory Response Network (LRN).
• Workers who will be making repeated entries into known anthracis-spore-contaminated areas.
• Workers in other settings in which repeated exposure to aerosolized anthracis spores might occur.

Laboratory workers using standard Biosafety Level 2 practices in the routine processing of clinical samples or environmental swabs are not considered by ACIP to be at increased risk for exposure to B. anthracis spores. (For persons not at risk for repeated exposures to aerosolized B. anthracis spores through their occupation, pre-exposure vaccination against anthrax is not recommended).

Currently no vaccine is available for immunization of laboratory personnel working with botulinum toxin or cultures of botulinum neurotoxin producing species of Clostridium. Although administered under an FDA IND since 1965, CDC discontinued distribution of the Pentavalent (ABCDE) Botulinum Toxoid vaccine in 2011 due to decline in potency and CDC observed increase in moderate local reactions. An equine- based heptavalent (A, B, C, D, E, F, and G) antitoxin is available through a CDC-sponsored FDA IND for treatment of individuals with symptoms consistent with botulism. Health-care providers for exposed laboratory personnel should consult their state health department epidemiologist to determine if use of Heptavalent botulism antitoxin is warranted.

When occupational exposure to highly pathogenic agents is possible and no commercial vaccine is available, it may be appropriate to immunize workers using vaccines or immune serum preparations that are investigational, or for which the specific indication constitutes an off-label use. Use of investigational products, or of licensed products for off-label indications must be accompanied by adequate informed consent outlining the limited availability of information on safety and efficacy. Use of investigational products should occur through IND protocols providing safety oversight by both the FDA and appropriate institutional human subjects research protection committees. Recommendation of investigational products, as well as commercial vaccines that are less efficacious, associated with high rates of local or systemic reactions, or that produce increasingly severe reactions with repeated use, should be considered carefully.

The healthcare provider in OHP should design medical support services in consultation with representatives from the entity’s institutional environmental health and safety program and the principal investigators. Workers should be fully informed of the available medical support services and encouraged to utilize them.