illnesses in vaccinees that may be misattributed as vaccine adverse reactions. It also is possible that unproven associations will be suggested as long-term adverse reactions of the smallpox vaccine, as has occurred with other vaccines. When it comes to the more difficult long-term problem of diseases such as multiple sclerosis and Guillain-Barré syndrome being potentially misattributed to the smallpox vaccine, there are currently no data systems to use for comparison. As with the swine influenza studies, observations of any long-term sequelae from individual observations of alert practitioners, or from VAERS, should be treated as signals and prompt more formal epidemiologic studies to refute or validate them. There also is the possibility, if and when the vaccination program is expanded in phase II, that cohort studies could be set up in the sites using the Vaccine Safety Datalink, a CDC system already in place to evaluate adverse results of childhood immunizations. The committee encourages CDC to utilize surveillance systems that already exist (e.g., health care utilization rates from the National Hospital Discharge Survey and the National Ambulatory Medical Care Survey) to determine baseline rates of disease and place the data that will be obtained from PVS and VAERS into perspective.

Establishment of a Data and Safety Monitoring Board (DSMB)

The committee also considered CDC’s plans for monitoring the safety of the smallpox vaccine. The committee briefly heard about plans for the establishment of a smallpox vaccine data and safety monitoring board, jointly operated between CDC and the Department of Defense (DoD) (Winkenwerder and Grabenstein, 2002). Since military vaccinations commenced soon after the President’s smallpox policy announcement on December 13, 2002, the military should already have some safety data available. Where possible, the committee encourages CDC to share with their state and local partners any data or lessons learned from the DoD smallpox vaccination experience thus far. The committee first describes what it perceives to be the special considerations for such a board involved in the pre-event smallpox vaccination program.

Such boards are most commonly referred to as data and safety monitoring boards (DSMBs) or data safety and quality monitoring boards (DSQMBs), although data monitoring committee also is a term of reference. DSMBs are defined in essence by their membership, their relationship to the clinical intervention being monitored, their rules of operation, and the scope of their responsibilities. There are, in fact, no hard and fast rules for these entities, but a standard of practice exists and is codified in particular by the rules used by the National Institutes of Health for their DSMBs. The common feature of all DSMBs is independence—real and perceived—sufficient to protect the privacy and safety of the participants.



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