The Smallpox Vaccination Program Public Health in an Age of Terrorism (2005) / Chapter Skim
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Appendix C: Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation Letter Report #2
Appendix C: Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation Letter Report #2
Pages 162-194
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From page 162... ...
. In particular we note that a number of recommendations have been implemented or their implementation is planned, including, but not limited to: · creating and implementing active surveillance for adverse events; · developing an information sheet for contacts of vaccinees; · adding information about the status of compensation issues in the Vaccine Information Statement; and · enhancing evaluation efforts.
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From page 163... ...
In this report, the committee addresses several important issues: the vaccination program's need for evaluation (including program safety)
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From page 164... ...
The committee extends its congratulations and expresses its admiration to CDC and the thousands of state and local partners in health departments, hospitals, and elsewhere involved in this program. The vaccination program has thus far progressed cautiously and with great deliberation, with states, local jurisdictions, and hospitals taking locally appropriate steps (Henderson, 2003)
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From page 165... ...
. , with expectation of overall benefit to the population receiving the intervention." The committee believes it is important to reiterate the risk-benefit context of the smallpox vaccination program.
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Although original estimates were useful in planning and initiating the program, the practical experience acquired by states and localities in the first several weeks of the program suggests that other benchmarks are equally if not more important. CDC will now be able to consider both the realities of operationalizing the vaccination program and a more careful view of how many vaccinated individuals, and in what roles, it would take to achieve preparedness to respond to a smallpox attack.
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From page 167... ...
CDC's goals for the entire vaccination program (i.e., preparedness/capacity to respond, protection of those who will investigate and treat suspected cases, and gaining experience with vaccination, [Anderson, 2003]
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From page 168... ...
. Expanding the vaccination program may negatively affect other aspects of smallpox preparedness, bioterrorism preparedness in general, and even the delivery of essential public health services.
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From page 169... ...
Determining whether preparedness has been reached might include comparing outcomes to objectives identified in planning, such as number of response teams, and measures for wide-scale vaccination, such as the number and distribution of mass vaccination clinics, and security and transportation issues. Evaluating program safety might include, but not be limited to, careful data collection about adverse events following vaccination, accurate clinical descriptions that are integrated with laboratory data, taking advantage of the national
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From page 170... ...
has vaccinated a much larger cohort than the civilian vaccination program to date, it is hoped that data on adverse events in DoD's vaccination program will be incorporated, to the extent possible, in the overall evaluation of vaccine safety. As the committee has stated previously, evaluation is a matter of data analysis, not specifically of time, and would entail, among other issues, the necessary reasoned analysis of the strengths and weaknesses of the procedures used to ensure patient and contact safety in the first phase.
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From page 171... ...
Efforts to survey the public should be ongoing, to help refine communication materials and diversify channels for communication. The planning, implementation, and evaluation of strategic communication activities for the smallpox vaccination program could begin to form a foundation for broader communication about bioterrorism.
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From page 172... ...
Some media reports about the vaccination program have reflected the concerns of organizations, agencies, and individuals, others have conveyed reassurance about the public health system's readiness to respond to bioterror threats. Some adverse events following smallpox vaccination have been reported in the media before CDC has formally described these adverse events.
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From page 173... ...
· Reassure the public that efforts are in progress to protect them in the event of a smallpox attack. People should be informed that the public health system is increasing its capability to protect them, with response teams ready to vaccinate, and identify and treat cases.
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From page 174... ...
Communicating with the Media Furthermore, while media reports provide the valuable service of informing the public about the vaccination program's progress, they sometimes include inaccurate information (e.g., misrepresenting the severity of adverse reactions)
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From page 175... ...
Given the program's expansion, great care should be given to developing training and education materials to be delivered through a wide range of channels to the potential vaccinees, who may include other health care workers, as well as emergency, law enforcement, and fire personnel. This may require functional modules addressing the occupation issues of all possible areas of practice.
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From page 176... ...
This should be done for all current materials and should routinely be done prior to wide dissemination of all newly developed material, though time constraints might make this more difficult. Special attention is needed to highlight uncertain compensation for adverse reactions, and simplifying legal explanations currently provided on the Informed Consent form.
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Through the Smallpox Vaccine Adverse Events Monitoring and Response System (which includes the Hospital Smallpox Vaccination Monitoring System, the Smallpox Vaccine Adverse Event Active Surveillance
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Because contraindications will be part of the case investigation, and it is possible that revisions will be made to the list of contraindications as the vaccination program moves forward, it will be necessary to know which version of the Pre-Vaccination Information Packet the vaccinee received. The committee recommends that a data field be added to PVS to indicate which version of the Pre-Vaccination Information Packet was provided to the vaccinee, in order to document what information was given to the vaccinee prior to consent.
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From page 179... ...
to accomplish active surveillance for serious adverse events following smallpox vaccination among all vaccinees during phase I of the vaccination program. The Active Surveillance System (and other coordinated data systems)
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From page 180... ...
and cidofovir will allow CDC to systematically collect information on vaccinees' experiences following vaccination and will greatly increase the likelihood that all serious adverse events following smallpox vaccination will be detected. Active Surveillance System The Smallpox Vaccine Adverse Event Active Surveillance System is designed to collect data on all vaccinees at the "close-out" of the vaccination process (this is usually 21 to 28 days after vaccination, when the scab falls off)
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From page 181... ...
To monitor the effectiveness of contraindications screening, the Active Surveillance System will seek to determine if any contraindications were missed during the initial screening of vaccinees. If the Active Surveillance System identifies a vaccinee or a close personal contact of a vaccinee that has a contraindication to vaccination not identified during pre-vaccination screening, an epidemiologist at CDC will follow up with the local Adverse Events Coordinator to determine why the contraindication was not identified during the initial screening process.
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From page 182... ...
. Implications of Program Expansion for Collection of Data on Adverse Events The relatively quick expansion of the vaccination program to include all health care workers, firefighters, law enforcement, and emergency workers creates a number of implications for the capacity to collect data on serious adverse events, common adverse events, and vaccinees' experiences following smallpox vaccination.
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From page 183... ...
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.
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From page 184... ...
Although recognizing that protection of the confidentiality of vaccinees' medical data and private deliberations of the ACIP working group are paramount to ensuring free discussion of data surrounding each reported adverse event, the committee also strongly believes that the working group should be able to freely issue findings or recommendations once they have reached a conclusion. Should the American public come to believe that relevant vaccine and program safety data are not being completely disclosed, the committee fears that lack of public trust in the implementation of the pre-event smallpox vaccination program could become an impediment to continued successful operation of the program.
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From page 185... ...
Reporting Adverse Events Adverse events following smallpox vaccination often have appeared in the media before being formally described by CDC (Melton, 2003; Richardson, 2003)
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The committee encourages CDC and DoD to commit to a regular schedule for reporting adverse events, and to adhere to that schedule. Regular disclosure of adverse events could assure the public that the vaccination program is worthy of their trust.
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From page 187... ...
, the committee noted its concern that the lack of compensation for adverse reactions "could seriously affect achievement of the stated goal of the program -- to increase the nation's bioterrorism preparedness." Recently, there has been a steady increase in evidence that the lack of compensation for adverse reactions to the smallpox vaccine is impeding full implementation of the pre-event smallpox vaccination program as originally envisioned (Connolly, 2003a; Denogean, 2003; Geraghty, 2003; Meckler, 2003)
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From page 188... ...
. The committee is concerned that lack of compensation will be a continuing barrier to full implementation of the pre-event smallpox vaccination program if a smallpox vaccination compensation program is not created.
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From page 189... ...
that "informed consent forms include explicit notification of the availability, or lack thereof, of compensation for adverse reactions." The January 16, 2003 version of CDC's revised Vaccine Information Statement (VIS) includes the statement, "Treatment of severe reactions can be very expensive.
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From page 190... ...
. Funding As reflected in media reports about health departments and hospitals around the country, and as anecdotally or formally documented by some organizations themselves, the smallpox vaccination program has produced significant financial worries among states and local health departments, and also in hospitals whose participation in forming health care response teams has been solicited (Connolly, 2003b; personal communication, R
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From page 191... ...
However, the committee recommends that this inquiry be broad in scope and include not only cost to local and state health departments, but also the financial impact on the provision of other essential public health services, the costs incurred by participating hospitals, and cost estimates of expanding the vaccination program to additional health care and public health workers and emergency first responders. Additional Data That Should Be Gathered The committee applauds CDC for preparing a plan for phase I evaluation and research (CDC, 2003b)
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From page 192... ...
2003a. CDC Telebriefing Transcript: Smallpox Vaccine Adverse Events Monitoring and Response System on February 6, 2003.
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From page 193... ...
2003. Review of the Centers for Disease Control and Prevention's Smallpox Vaccination Program Implementation: Letter Report #1.
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From page 194... ...
2003. Transcript from the IOM's Committee on Smallpox Vaccination Program Implementation Meeting Two on February 13, 2003, Washington, DC:240-294.
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