SUMMARY OF THE FIRST LETTER REPORT
FROM THE INSTITUTE OF MEDICINE
COMMITTEE ON SMALLPOX VACCINATION PROGRAM IMPLEMENTATION
Brian L. Strom, M.D., M.P.H.
Chair of the Committee on Smallpox Vaccination Program Implementation
Institute of Medicine, The National Academies
George S. Pepper Professor of Public Health and Preventive Medicine
Professor of Biostatistics and Epidemiology
Professor of Medicine
Professor of Pharmacology
Chair, Department of Biostatistics and Epidemiology
Director, Center for Clinical Epidemiology and Biostatistics
University of Pennsylvania School of Medicine
Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Committee on Appropriations
JANUARY 29, 2003
Good morning, Mr. Chairman and members of the Subcommittee. Thank you for the opportunity to come speak to you this morning. My name is Brian Strom. I am Professor and Chair of the Department of Biostatistics and Epidemiology and Professor of Medicine at the University of Pennsylvania School of Medicine and Chair of the Institute of Medicine (IOM) Committee on Smallpox Vaccination Program Implementation. The Institute of Medicine of the National Academies is an independent, non-governmental, non-profit organization operating under the 1863 congressional charter to the National Academy of Sciences. The Institute of Medicine has provided advice to the nation on matters of health and medicine for over 30 years.
The Centers for Disease Control and Prevention (CDC) formally engaged the services of the Institute of Medicine in September 2002, and the Committee on Smallpox Vaccination Program Implementation met for the first time in December 2002. The committee’s areas of expertise include internal medicine, infectious diseases (including smallpox disease and smallpox vaccination), dermatology, pediatrics, nursing, epidemiology, public health law and ethics, public health practice, emergency medicine, and pharmacology.
CDC charged the IOM committee with providing advice to CDC and its public health partners on how to best implement the President’s policy on pre-event smallpox vaccination, addressing the following eight areas:
1. the informed consent process;
2. contraindications screening;
3. the system in place to assess the safety profile of the smallpox vaccine;
4. guidance for the treatment of vaccine complications;
5. professional training programs CDC is developing;
6. the communications efforts;
7. guidance CDC offers to states in developing their implementation plans; and
8. overall progress at achieving the goals of the program.
The Institute of Medicine agreed to provide advice on these areas through a series of timely reports.
During its first meeting December 18-20, 2002, the committee heard from CDC, the Department of Defense, Israel’s Ministry of Health, and representatives of health professional organizations. The information provided during these presentations and subsequent research were the basis for the committee’s deliberations. Based on these deliberations, the committee released its first letter report on January 17, 2003, titled "Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation."
The committee would first like to convey its appreciation for the hard work of CDC and its state and local partners in planning the pre-event smallpox vaccination program and helping it to become operational so quickly. CDC has done a tremendous job under very tight timelines.
Before getting into some of the committee’s recommendations and key messages, I would like to point out that the committee realizes that while it had been working on the report, CDC had been moving ahead with plans for the vaccination program. Thus, the committee recognizes that CDC may have already accomplished some of the recommendations laid out in our report.
The committee also recognizes that this is a program that is planned nationally, but implemented locally. CDC is offering guidance, training, and assistance to its state and local public health partners, but the local programs will be making their own decisions about how and when to operationalize the pre-event smallpox vaccination program in their communities.
The report contains 23 recommendations, which are summarized in Appendix A of the report. For the sake of time, I will not discuss all 23 recommendations during my testimony, but would direct you to the full report for a complete description of the recommendations, which I am submitting for the record. I will now focus on the committee’s four key messages and draw attention to a few of the recommendations.
Our first key message was: Highlight the unique nature of the smallpox vaccination program as a public health component of a national bioterrorism preparedness policy, focusing on the delivery of clear, consistent, science-based information.
The committee believes that it is critically important to stress to potential vaccinees and the public that the pre-event smallpox vaccination program is not a typical public health program. Public health vaccination programs are typically undertaken knowing the risks of the disease, and knowing they outweigh the risks associated with the vaccination. With the pre-event smallpox vaccination program, the risk of the disease is based on a risk estimate derived by the President and his advisors, based on national security issues. In this context, the individuals being asked to take this vaccine are being asked to volunteer to join smallpox response teams, for the benefit of the nation’s bioterrorism preparedness. The committee believes that the unique aspects of the pre-event smallpox vaccination program need to be communicated clearly and consistently to the American public. Because the smallpox vaccination program is unusual, it is important for the American public to understand that practices in these circumstances might differ from those in traditional vaccination programs. A clear understanding of the risks and unique aspects of the pre-event smallpox vaccination program will be necessary to ensure that all potential vaccinees can make an informed decision about whether to participate.
Our second key message was: 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.
The current program is designed with the best possible efforts in the limited time frame available, but on the basis of data that are decades old. Our scientific approaches have improved since then, and our society has also changed during this time. This means that, as modern experience is gained, rapid and real-time midcourse corrections might be necessary.
I would like to stress that by recommending that CDC "proceed cautiously," the committee never implied that CDC was proceeding too quickly or without due caution, as has been somewhat misstated in some of the press reports on the committee’s recommendations. The committee did not recommend that the vaccination program be delayed or slowed down. The committee only encouraged CDC to facilitate local implementation at the pace that safety would allow. CDC has acknowledged that these are its intentions, and the committee believes that CDC will proceed accordingly.
I would also like to stress that we have not recommended any specific time interval that is appropriate between the two phases. This is a matter of data analysis, not strictly a matter of time. Recognizing that the CDC has indicated that data analysis will be ongoing throughout phase I, the time needed to analyze phase I data and evaluate the adequacy of different components of the program before embarking on phase II (such as screening guidelines and surveillance for adverse reactions), may range from hours to weeks to months. The committee believes that CDC will be able to determine when enough data analysis has occurred to commence phase II safely.
One way to evaluate the adequacy of different components of the program would be to take advantage of differences in the way that public health departments and hospitals administer their local smallpox vaccination programs. Because local vaccination programs will be making their own decisions about the types of bandages to use, specific site care instructions, adverse reaction investigation, degree of patient contact allowed, and whether to grant administrative leave to vaccinated health care workers, the committee urged CDC to utilize and analyze these data before embarking on phase II.
Our third key message was: Use a wide range of methods for proactive communication, training, and education, and customize it to reach diverse audiences, including potential vaccinees, all health care providers, and the general public.
The committee heard evidence that there is much confusion about smallpox disease, the vaccine, and the details of the vaccination program. The committee strongly believes that clear, consistent communications to many different types of audiences is intrinsic to the success of the pre-event smallpox vaccination program. Given the potential for misinformation and confusion, and the complexity of vaccine information, it is necessary to begin a campaign of informing and educating the general public as soon as possible. Waiting until reports of serious adverse reactions surface is too little too late. Communicating in a time of crisis can only be effective if adequate communication and education have occurred during preparedness planning.
Our last key message was: Designate one credible, trusted scientist as key national spokesperson for the campaign and sharpen and expand communication plans and strategies to ensure rapid, transparent, and sustained contact with the media throughout implementation.
For the public to maintain confidence in the pre-event smallpox vaccination program and CDC, the committee believes that it is important for CDC to speak from its strength—the science of public health. Discussion of national security matters is best left to national security experts. The public’s confidence in the vaccination program will be strengthened by the availability of a key scientific spokesperson who can provide credible and consistent information in a manner that is easily understandable to many different audiences. The spokesperson could be Dr. Gerberding herself, certainly an articulate and credible scientist, or someone else.
Since current discussions of the pre-event smallpox vaccination program are focusing on the issue of compensation for medical expenses or lost income for any health workers who experience adverse reactions from the smallpox vaccine, I will highlight the committee’s recommendations that relate to this issue.
Although not specifically identified as an item for our deliberation, the committee did believe strongly that we needed to address the issue of compensation since it could have implications to the issues of informed consent and progress at achieving the overall goal of the program (that being increasing the nation’s bioterrorism preparedness), both of which are clearly within our mandate.
The committee recommended that informed consent forms include explicit notification of the availability--or lack thereof--of compensation for adverse reactions. The committee was concerned that many potential vaccinees may falsely assume that the provisions of the Homeland Security Act of 2002 or the federal Vaccine Injury Compensation Program would provide compensation for medical expenses or income loss experienced as a result of receiving or being exposed to the smallpox vaccine (when there are no instances of negligence). This information may be an important factor that could weigh on a potential vaccinee’s decision about whether to receive the vaccine.
The committee also recognized that some adverse reactions experienced by vaccinees may be covered by state worker’s compensation programs. However, there is much uncertainty and confusion surrounding the types of vaccine adverse reactions and circumstances leading to those adverse reactions that would be coverable under each state’s worker’s compensation law. Because of this, the committee recommended that CDC and its state and local public health partners work to clarify the scope of worker’s compensation for adverse reactions to the smallpox vaccine.
The committee was also concerned that the lack of compensation for adverse reactions might--I stress, "might"--imperil the ability of the pre-event vaccination program to achieve its goal of preparedness to respond to a smallpox attack. There currently are no data to determine whether or not the lack of compensation for adverse reactions is indeed a deterrent to receiving the vaccine. However, the committee recommends that IF it is determined that lack of compensation is jeopardizing overall progress at achieving the goals of the program (which is an item in our charge), then CDC and the Department of Health and Human Services should support all efforts to bring the issue of compensation for adverse reactions--including those reactions that occur despite non-negligent manufacture and administration of the vaccine--to speedy resolution.
The committee offered many additional recommendations related to the implementation of the pre-event smallpox vaccination program. I would be happy to answer questions about any additional recommendations of interest to you.
Thank you for the opportunity to speak to you today. The IOM Committee on Smallpox Vaccination Program Implementation hopes that its advice is useful to CDC and the broader community concerned about the success of the pre-event smallpox vaccination program. I would be happy to answer any questions you may have.