Recommendations

  • Additional passive protection studies with rabbits and monkeys including the transfer of animal and human sera are urgently needed to quantify the protective levels of antibody in vivo against different challenge doses of anthrax spores.

  • Additional active protection studies should be conducted or supported to develop data that describe the relationship between immunity and both specific and functional quantitative antibody levels, including studies of

    • the relationship between the vaccine dose and the resulting level of antibody in the blood of test animals that protects the animals from challenge;

    • the relationship between the level of antibody that protects animals from challenge and the level of antibody present in humans vaccinated by the regimen currently recommended for the licensed product; and

    • the vaccine dose that results in a level of antibody in the blood of human volunteers similar to that in the blood of the protected animals.

  • The Department of Defense should support efforts to standardize an assay for quantitation of antibody levels that can be used across laboratories carrying out research on anthrax vaccines.

  • The Department of Defense should pursue or support additional research with laboratory animals on the efficacy of AVA in combination with antibiotics administered following inhalational exposure to anthrax spores. Studies should focus on establishment of an appropriate duration for antibiotic prophylaxis after vaccine administration.

CHAPTER 5

Findings

  • The presence or absence of VAERS reports (or other case reports) cannot be considered in and of itself to provide adequate evidence of causal associations or its absence. Reports may suggest hypotheses for further investigation, but it must be borne in mind that many different factors beyond the presence of health symptoms can influence whether a report is filed.

  • Concerns of service members that reporting to VAERS is sometimes discouraged within the military setting have been responded to appropriately with reminders to physicians that DoD policy requires submission of a VAERS report for postvaccination health events that result in hospitalization or the loss of time from duty of more than 24 hours. Additional steps, however, are possible to facilitate reporting to VAERS, including improvements in the coding of health care visits that are potentially vaccine related.

  • The committee has reviewed the case materials and the methods applied by VAERS and AVEC to evaluate those materials and concurs with their conclusions that those materials present no signals of previously undescribed serious adverse reactions associated with exposure to AVA.

Recommendation

  • DoD should develop and implement a system to automate the generation of VAERS reports within the military health care system, using codes to identify from automated records those health care visits that are potentially vaccine related. Use of these codes should generate an automatic filing of a VAERS report that includes the specific diagnoses for the clinical event(s) that prompted the health



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