IOM: Safeguards are vital to smallpox program

Without protection, HCWs will decline vaccine

Add more safeguards to ensure that the smallpox vaccination program is as safe as possible, a federal panel of medical experts urged the Centers for Disease Control and Prevention (CDC) in Atlanta. The CDC should evaluate the program "at every step," including comparisons of safety data related to different implementation in different settings, the Institute of Medicine (IOM) panel said in its report, Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation.

The panel also recommended that hospitals stagger the vaccinations to lessen the impact on patient care of worker absences due to adverse reactions or administrative leave. "If the risk of smallpox disease [and thus the benefit of the vaccine] is truly very low, deliberation is key to assuring the safest program possible," the panel said. The IOM panel also said the CDC should take these steps:

  • Consider what criteria (such as higher than expected levels of adverse events) would trigger a reconsideration of vaccination recommendations.
  • Clarify the workers’ compensation protections and support other avenues of compensation for those suffering severe adverse reactions.
  • Add compensation information and other clarifications to the informed consent.
  • Evaluate Phase 1 of the program before moving to Phase 2 (with vaccination of other health care workers and emergency workers).
  • Conduct active surveillance of adverse reactions.
  • Ensure the independence of the Data Safety Monitoring Board.
  • Expand the training related to identification, treatment and reporting of adverse reactions.
  • Determine "as well as possible" the true costs of the program.

Greater protection for health care workers who suffer adverse reactions would lead to greater participation, the panel noted. "Without reimbursement for these losses, the committee fears that some, perhaps many, public health and health care workers will decline vaccination, thus undermining the effectiveness of the program’s implementation," the panel said. "Public health and health care workers who are considering vaccination need accurate information about the rights and protections that are available to them under their state’s workers’ compensation law."

(Editor’s note: To read the IOM report, go to: