PVS. However, the committee has heard that some state and local vaccination programs view the difficulty in entering data into PVS as outweighing the perceived benefits they receive from their participation (Committee on Smallpox Vaccination Program Implementation Study Staff, 2003). The committee encourages CDC to facilitate and support regular, timely data reports from PVS and other sources to its state and local partners so they can gain value from their participation in the range of data systems used for the pre-event smallpox vaccination program.

Utility of the Active Surveillance System

As described above, the data systems that CDC has utilized during the pre-event smallpox vaccination program seem to have been effective at identifying serious adverse events following smallpox vaccination. However, the committee cannot be completely certain of how effective the Active Surveillance System has been at identifying these serious adverse events until all vaccinees are entered into the system. An “active” surveillance system is effective when there is a confirmed outcome on virtually every vaccinee. As of June 11, 2003, only 10,835 (44 percent) of 24,781 PVS records of vaccinees that had at least 28 days elapse since the time of vaccination were included in the Active Surveillance System (Mootrey, 2003b). The recent reports of two cases of cardiomyopathy identified three months after smallpox vaccination (CDC, 2003n) also point to the need to continue active surveillance of all vaccinees, including follow-up of those vaccinees who report only mild symptoms in the weeks after vaccination. CDC conducted a survey of their grantees to gain a better understanding of their participation (or lack thereof) in the Active Surveillance System. The 48 grantees that responded to the survey identified four main reasons for data entry delay in the Active Surveillance System: (1) follow-up time is longer than anticipated; (2) data entry is slow because of general lack of personnel or infrastructure resources; (3) technical difficulties related to digital certificates; and (4) problems with PVS (Mootrey, 2003a).

The committee understands that CDC has diligently encouraged every state and local vaccination program to create an Active Surveillance System entry for every vaccinee. Because the civilian smallpox vaccination program is a true partnership among 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. In these communications, CDC should stress that the number of people vaccinated in the expanded vaccination program could be many times larger than the number of response team members vacci-

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement