Review of the Centers for Disease Control and Prevention's Smallpox Vaccination Program Implementation: Letter Report #4 (2003)

SUMMARY OF RECOMMENDATIONS

REVIEW OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION’S SMALLPOX VACCINATION PROGRAM IMPLEMENTATION

Letter Report #4

The committee recommends that CDC provide guidance to assist state public health agencies (and their partners⁶, as appropriate) in establishing a baseline level or a minimum standard of preparedness for a smallpox attack, after which, each state could individually assess its priorities and further expand its preparedness against smallpox and other threats to the public’s health as needed.

The committee recommends that CDC support the establishment of state and/or local, and if appropriate, national, voluntary registries of individuals who have undergone vaccination to be mobilized, trained, and assigned as needed in the event of a smallpox attack. Such registries would include all willing vaccinated personnel not associated with a response team ranging from retired or relocated health care or public health workers to military reservists and former military personnel.

The committee recommends that CDC facilitate the development of a range of scenarios for potential smallpox attack(s), including one or more multi-threat scenarios, and urge states to use these to expand and continuously improve their plans to respond to a wide range of possibilities.

The committee recommends that CDC proceed with a deliberate and stepwise approach toward meeting the President’s policy of offering vaccine to members of the general public who insist on receiving it by:

1. Conducting brief quantitative surveys to determine public interest and desire for smallpox vaccine. These surveys should include public and private health agencies as well as the general public, in order to understand the potential scope of public interest.

2. Determining the budgetary and other requirements that would meet the demand noted.

3. Identifying, monitoring, and referring people to existing or planned smallpox vaccine clinical research trials or other well-structured clinical arrangements that meet the basic requirements of medical and public health ethics, including assurances for safety of vaccinees and their contacts, acceptable balance between risk and benefit, and acceptable distribution of scarce public health resources to meet all preparedness as well as other public health goals. The committee encourages CDC to consider utilizing a pilot program or some other means of evaluating the initial experiences with this effort.

To help ensure that the adverse event reporting and follow-up procedures work as seamlessly as possible, the committee recommends that CDC coordinate better with their state partners and provide feedback to local partners who reported the adverse event.

The committee recommends that CDC pursue ways to streamline the data systems that are used in the smallpox vaccination program, improving user-friendliness and integrating the multiple systems to avoid duplicate data entry, especially considering that any future expansion of the vaccination program would require a larger number and greater diversity of data system users, some of whom may be using these systems for the first time.

Because the civilian smallpox vaccination program is a true partnership between CDC, states, and local jurisdictions, the committee recommends that CDC continue and expand their communication with states and local jurisdictions about the imperativeness of their participation in the Active Surveillance System, stressing that the safety of the vaccination program cannot be guaranteed without their full participation and cooperation.

Considering that the rate of inadvertent exposure to smallpox vaccine during pregnancy is lower than expected and it is impossible to detect all pregnancies at the time of vaccination, the committee does not recommend extra pregnancy screening efforts at this time.

The committee recommends that CDC begin developing a structured, prioritized research agenda that can aid decision-making as the smallpox preparedness program moves forward.

The committee recommends that in the short-term, studies of the serious adverse events should receive the highest priority. For safety-related questions, in the longer-term, studies examining long-term outcomes for those who experienced both serious and mild adverse events and studies of how mild adverse events contributed to lost work or social function should be a high priority. For system-related questions, in the longer-term, studies of cost and opportunity costs should be a high priority.