vaccination program (vaccination offered to all health care workers, firefighters, law enforcement, and emergency workers) may be more difficult. Since vaccinees in this category may not be members of a particular smallpox response team, and there may not be enough vaccination site care monitors available to contact and follow up with each of these vaccinees (let alone conduct “take” readings and monitor their vaccination sites on a daily basis), the ability of the Active Surveillance System to determine a confirmed outcome on each of these vaccinees currently is uncertain.

Accordingly, it also will be more difficult to collect data on common adverse reactions and vaccinees’ experiences following smallpox vaccination. Because of the much larger number of vaccinees that will be included in the recently expanded vaccination program, there may not be enough vaccination site care monitors available to monitor vaccinees on a daily basis. If monitors are not designated or available to follow all of these vaccinees, and consequently, no data are entered into HSVMS for these vaccinees, valuable data could be lost. This could hinder the ability to evaluate the vaccination program on a national scale, since this expansion of the program would provide the majority of the sample size needed for significant results in an evaluation.

Collection of data on serious adverse events, common adverse events, and vaccinees’ experiences following smallpox vaccination is important not only for “phase I” but also for any expansion of the program. Only with larger sample sizes can significant results be obtained from the data. In order to assure the continued integrity and safety of the expanded vaccination program, the committee recommends that CDC work to ensure that a qualified health professional monitors, conducts a “take” reading, and provides a regular vaccination site inspection for each vaccinee in the program and enters the relevant data into the appropriate smallpox vaccination program data system.

ACIP Working Group on Smallpox Vaccine Safety

In its first letter report (IOM, 2003), the committee recommended that CDC ensure the independent functioning of the group charged with monitoring data and vaccine safety. (The smallpox vaccine data and safety monitoring board now is formally called the Advisory Committee on Immunization Practices [ACIP] Working Group on Smallpox Vaccine Safety, which will hereafter be referred to as the “ACIP working group.”) The committee is pleased that CDC already has taken some steps to address its concerns.

Adverse events reported following smallpox vaccination may be causally associated with the vaccine, or they may be coincidental illnesses that would have occurred anyway. Adverse events also may be interpreted as more serious than they actually are (e.g., generalized vaccinia).



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