1. Review of The CDC’s Smallpox Vaccination Program Implementation Kristine Gebbie, R.N., Dr.P.H. NVAC June 2003

2. Charge to the Committee CDC charged the IOM committee with providing guidance on how to best implement the President’s policy regarding pre-event smallpox vaccination, addressing the following eight areas:

3. Charge to the Committee (continued) the informed consent process contraindications screening the system in place to assess the safety profile of the smallpox vaccine guidance for the treatment of vaccine complications

4. Charge to the Committee (continued) professional training programs CDC is developing the communications efforts guidance CDC offers to states in developing their implementation plans overall progress at achieving the goals of the program

5. Committee Membership State and Local Public Health Epidemiology and Biostatistics Ethics, Law, Communication, and Behavioral Sciences Pediatrics, Internal Medicine, Infectious Disease, Dermatology, Emergency Medicine, Occupational Medicine, Nursing Experience with Smallpox Vaccination

6. Letter Report #1 Meeting December 18-19, 2002 Report Released January 16, 2003 Presented to NVAC by K. Stratton February 4, 2003

7. Key Messages: Report #1 Highlight the unique nature of the smallpox vaccination program as a public health component of bioterrorism preparedness policy, focusing on the delivery of clear, consistent science-based information

8. Key Messages: Report #1 Proceed cautiously, allowing continuous opportunity for adequate and thoughtful deliberation, analysis, and evaluation. Embark on phase II only after adequate evaluation of phase I has occurred.

9. Key Messages: Report #1 Use a wide range of methods for proactive communication, training, and education and customize to reach diverse audiences Designate one credible, trusted scientist as key national spokesperson for the campaign

10. CDC Response to Report #1 Includes but is not limited to: Creating and implementing active surveillance for adverse events Developing an information sheet for contacts of vaccinees Adding information about compensation issues to the Vaccine Information Statement (VIS) Enhancing evaluation efforts

11. Letter Report #2 Meeting February 13-14, 2003 Report Release March 27, 2003

12. Focus of Report #2 the need for evaluation (including program safety) and clearly defined objectives; defining preparedness against smallpox attack; communications plans; training and education efforts; the systems for monitoring the safety of the vaccine; the need for a compensation program; and matters of resource allocation

13. Key Messages: Report #2 1.Carry out all aspects of ongoing discussion, planning, and analysis of the smallpox vaccination program with the intent to advance the goal of smallpox preparedness. 2.Conduct comprehensive evaluation of the program and its outcomes in order to improve its implementation and to protect the vaccinees and the public.

14. Preparedness Increasing the number of vaccinated persons might contribute to meeting that goal, but it does not mean preparedness to respond to a smallpox attack has been achieved. Having more vaccinated individuals is only as effective as the plans for deploying these individuals in a potential smallpox bioterrorist event ….

15. Preparedness Thus, the committee recommends that CDC work with states to decide what more is needed to achieve smallpox preparedness, if anything. Further, given the routine turnover in personnel, each state should evaluate what it needs to maintain this preparedness.

16. Concerns About Rapid Program Expansion May inhibit efforts to evaluate the program May negatively affect other aspects of smallpox preparedness, BT preparedness, and essential public health services Inability to develop new objectives and detailed plans Lack of linkages with agencies involved in expansion

17. Communicating With The Public About Preparedness The committee recommends CDC revisit and communicate to the public the program’s objectives in view of state-level realities, and provide a preliminary perspective on the national and state success in reaching those objectives.

18. Communicating With The Public The CDC should continue to support, as well as build on the experience of state and local health departments who are developing their communication strategies about state and local program implementation.

19. Communicating With The Public The committee recommends that CDC and its state and local partners develop communication strategies that: Provide adequate quality and quantity of information; Are timely; and Reassure the public that efforts are in progress to protect them in the event of a smallpox attack

20. Training and Education The committee recommends that all print materials addressed to a diverse audience (e.g., the public) should be easily read and understood by all members of that audience. Also, all communication materials in other languages should be culturally appropriate.

21. Training and Education The committee recommends that educational and training materials be tested for ease of comprehension with samples representing a cross-section of sex, race, ethnicity, and level of education.

22. ACIP Working Group on Smallpox Vaccine Safety The committee recommends that whenever the ACIP working group issues findings/recommendations to the ACIP and through it to the Director of CDC, it carefully consider concurrent release to the public, and do so if it would be in the interest of transparency and maintaining the public’s trust in the program.

23. Reporting Adverse Events Considering the confusion that can arise from the timing of reports on adverse events and the multiple sources of adverse event data that are available, the committee recommends that CDC be very clear about what types of adverse events will be reported to the public and when.

24. Reporting Adverse Events The committee recommends that CDC report on a regular basis how effective screening practices have been at identifying contraindications (e.g., pregnancy, HIV status, eczema or atopic dermatitis) prior to vaccination.

25. Reporting Adverse Events If protocols governing such a situation have not yet been developed or finalized, then the committee recommends that CDC work with DoD to decide how adverse events that involve both the civilian and military populations will be reported.

26. Lack of Compensation Letter reports 1 and 2 had a number of comments on compensation: the importance of communicating about compensation as a key component of informed consent, and contributing factor for people declining to participate in pre-event vaccination

27. Compensation for Adverse Events Compensation bill passed April 30, 2003 Possibly (hopefully) no longer a barrier to participation in the program Some key details remain to be worked out.

28. Opportunity Costs 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.

29. Letter Report #3 Meeting May 1-2, 2003 Report Released May 27, 2003 A fourth report is under preparation.

30. Key Message: Report #3 Facilitate the efforts of those states that wish to pause to evaluate their vaccination efforts to date and to plan for next steps before deciding whether and when to begin vaccination of new personnel.

31. Importance of a Pause A natural pause is underway in many places. It is important to use this for planning and evaluation of next steps related to: Safety Changing circumstances (types of vaccinees) Thoughtful integration of vaccination into overall smallpox preparedness

32. Comments on Guidance to States Must every hospital have a team to be a “participant” or to be prepared? Prioritization of personnel categories More guidance on timeframe for vaccination of entire population “Working links” or relationships might need to be a “critical” capacity instead of an “enhanced” capacity

33. Summary: Key Messages To Date The smallpox vaccination program is not a typical public health campaign, but a bioterrorism preparedness campaign. A pause is important to ensure safety, accommodate changing circumstances, and to incorporate vaccination appropriately into overall smallpox preparedness. Preparedness is much more than just numbers of vaccinated personnel.

34. Contact Information IOM Committee on Smallpox Vaccination Program Implementation Phone: (202) 334-1707 Email: smallpox@nas.edu Website: www.iom.edu/smallpox