Scientific and Policy Considerations in Developing Smallpox Vaccination Options A Workshop Report (2002) / Chapter Skim
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Contents of Report
Contents of Report
Pages 1-50
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Smallpox vaccination of civilians is now indicated only for laboratory workers directly involved with smallpox (variola virus) or closely related orthopox viruses (e.g., monkeypod, vaccinia, and others)
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Previously, the vaccine had been prepared from calf lymph with a seed vans derived from the New York City Board of Health strain of vaccinia virus. Vaccine was administered by us~After the anthrax attacks of 2001, CDC formed smallpox response teams of 200 people, who were vaccinated with vaccinia.
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Previous experience with immunization has shown that serious complications can arise in as much as 20 percent of those who come in contact with vaccinees but are not yet vaccinated and are susceptible to complications for a variety of reasons. SCIENTIFIC BACKGROUND ON SMALLPOX AND SMALLPOX VACCINATION Smallpox Diseases The last case of naturally occurring smallpox occulted almost 25 years ago, and 24 years ago the last episode occurred in Birmingham, England, with the laboratory escape of variola virus.
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The hemorrhagic form accounts for less than 3 percent of cases but has a 100 percent fatality rate. The other classifications of smallpox are the modified form (occurring in less than 2 percent of cases and having less than a one percent fatality rate)
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Airborne precautions, including discharge of air to the outside or through a HEPA filter, closed doors, and using a N-95 or better respirator would be expected to prevent this disease. 4This section summarizes the presentation by Harold S
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There are 162 million doses of calf-lymph-derived vaccine and there will be 362 million doses of cell-cultured-derived vaccine by January 2003. The vaccines are currently part of the national pharmaceutical stockpile, located in four regions throughout the United States.
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5This section summarizes the presentation by Anthony Fauci, National Institute of Allergy and Infectious Disease, National Institutes of Health. 6Frey SE, Couch RB, Tacket CO, Treanor JJ, Wolff M, Newman FK, Atmar RL, Edelman R
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In summary, primary smallpox vaccination probably provides filll immunity for at least three to five years. However, beyond that, the immunity duration is still somewhat uncertain.
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|3~iS section summarizes the presentation by Vincent A Fulginiti, University of Arizona, University of Colorado.
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Other populations that are vulnerable if inoculated include those with graft-versus-host disease following solid organ transplantation, cancer survivors, and HIV-infected individuals. Thus, appropriate screening for contraindications to vaccination should be implemented and should include vaccinated persons as well as their contacts.
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Option 1: In the absence of a confirmed smallpox case, or a confirmed smallpox bioterrorism attack, ACIP does not recommend vaccination of members of the general public (i.e., no change from the current recommendation)
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Option 2: In the absence of a confirmed smallpox case, or a confirmed smallpox bioterrorism attack, ACIP recommends smallpox vaccination of persons pre-designated by the appropriate bioterrorism and public health authorities who have responsibility for direct contact or investigation of the initial cases of smallpox. Option 3: In the absence of a confused smallpox case, or a confused smallpox bioterrorism attack, ACIP recommends extending Option 2 above to include smallpox vaccination of"essential" medical and non-medical service personnel pre-designated by the appropriate bioterrorism and public health authorities.
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who would like to be vaccinated. Option 4: In the event of a confused smallpox case, or a confused smallpox bioterrorism attack, ACIP recommends surveillance and containment and mass vaccination of members of the general public be used as concurrent strategies for the control and containment of smallpox.
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THE MODELING BASIS FOR VACCINATION POLICY OPTIONS Three models on which vaccination policies might be based were presented, as was a report of a 1971 smallpox outbreak in a region of the former Soviet Union, which is now the city of Aralsk, Kazakhstan.
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Sensitivity This section summarizes the presentation by Martin Meltzer, Centers for Disease Control and Prevention.
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76 Rlsk Neutral Figure 1 Hospital personnel Risk N_ 1~ 1~ 1 Rlsk of release ~9^ _ a . ~ 1~0 1~ Figure 2.
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However, this model suggests that families of vaccinated health care workers are actually at less risk in the case of an outbreak than the general population because the individual who would bring the infection into the home is most likely using protective measures in the workplace. If policy makers think that the chance of an attack on a single large building, for example, a federal building, is 19 percent or greater over the next five years, then vaccinating first responders and other health care workers makes This section summarizes the presentation by Sam Bozzette, University of California, San Diego; RAND Corporation; Veterans Affairs Hospital, San Diego.
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. This This section summarizes the presentation by Edward Kaplan, Yale University School of Medicine.
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Even in this scenario, the qualitative result holds—a small initial attack size and small reproductive number favor trace vaccination. Larger numbers of both favor mass vaccination.
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In addition, despite very aggressive searching, according to the official report, no other cases of smallpox were identified in the area and no delegations from Afghanistan, the nearest 20This section summarizes the presentation by Alan Zelicoff, Sandia National Laboratories.
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Michael Richardson of He Department of Heals in Washington, D.C., Susan Allan of the Arlington County, Virginia, Department of Human Services, and Georges Benjamin of the Maryland Depa~l~ent of Health and Mental Hygiene provided their perspectives on the anthrax response and its implications for a smallpox response strategy. District of Colombian The anthrax exposures via a letter to Capitol Hill Trough the Brentwood Postal Facility in Washington, D.C., necessitated the rapid deployment of a mass 2iThis section summarizes the presentation.by Michael Richardson, Washington, D.C.
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The types of information and messages that are necessary to reach diverse audiences was a challenge for the District of Columbia health officials, who faced vast ethnic, racial, and socioeconomic diversity. It was also difficult to get real-time information out to health care workers in the field, so vital staff had to be equipped with two-way pagers and establish inter-site communications.
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Public 22This section summarizes the presentation by Susan Allan, Arlington County, Virginia, Department of Human Services.
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Whatever the eventual policy becomes regarding smallpox vaccine, it cannot be considered in a vacuum. A larger system of disease preparedness and protection must be developed.
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Likewise, the first death from the vaccine will change the risk perceptions and expectations of the public. Moreover, public health officials must anticipate how a smallpox vaccine death might negatively alter public attitudes about other vaccination programs.
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The anthrax response failed in that regardpublic health officials did not communicate to the public that things were going to change. Although public health departments were continuing to chase the epidemic and were being responsible public health officials, there was no media strategy already developed to tell the American public that the official response might change, so be prepared.
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The second measure calls for amending the EMT and paramedic national standardized curriculum to insure that all EMTs and paramedics are adequately educated about all terrorism responses, their implications, and their impacts on the health, safety, and well being of the EMT community. The third measure calls for the voluntary smallpox vaccination of EMTs and paramedics in the absence of a confirmed smallpox case or a confirmed smallpox bioterrorism attack.
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California also stands ready to assist other states with the resources and expertise of the emergency management communities within California. While OES does not represent any one class or discipline of responder, it does have extensive experience working with and coordinating the efforts of 25This section summarizes the presentation by Matthew Spengler, International Association of Fire Chiefs.
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In reaching its recommendations regarding smallpox vaccination, OES made two additional assumptions surrounding the use of the live vaccinia vaccine. The first is that respect for individual autonomy requires that any use of smallpox vaccine in any situation be voluntary.
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OES recogruzes that knowledgeable persons may differ in the designation of the relative higher versus lower intermediate risk groups, and strongly urges that to the maximum extent possible, objective and consistent guidelines be used by the states in identification of these occupational groups. It is vital that these pre-exposure smallpox vaccination volunteers be thoroughly educated in the risks and benefits, that appropriate safeguards be in place to reduce inadvertent subjective coercion of the responders' decision to receive a pre-exposure vaccination, and that these persons, because of their vaccinated status, be fully utilized in a smallpox response program in the event of reintroduction of smallpox virus into the population.
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Education of health care providers regarding recognition, isolation procedures, protection, and vaccination are likely to assist in early identification and reduce exposure. Currently, nurses are not educated in smallpox vaccination 27This section summarizes the presentation by Patricia Lenaghan, Nebraska Methodist Hospital.
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At minimum, each community should have protected and competent public health officials who can begin vaccination procedures and care for infected patients. In the event of a smallpox outbreak, emergency department staff should be considered first responders.
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Emergency Room Physicians28 Emergency physicians are obligated to treat all patients, regardless of their illness, so they must be prepared for anything. The experience with anthrax taught the public health community that it was not prepared, and conflicting, delayed, and sometimes inaccurate reports from public health officials exacerbated the inefficiency of the response and its logistics.
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Recent vaccine shortages have created new pressures on universal immunization strategies that might be far more important to address 30This section summarizes the presentation by Julia McMillan, Johns Hopkins University.
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In addition, members of the Service Employees International Union are already asking why CDC is vaccinating its own employees and not offering the same protection to hospital personnel. Until public confidence can be bolstered and public education implemented, a mass smallpox vaccination program should be delayed.
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The real concerns for health systems are issues such as liability and indemnification, availability of clear and explicit protocols and guidelines for the administration of vaccines and dealing with the complications, and programs for education of health professionals, not only in terms of the illnesses and the complications but also in the techniques and methods of immunization. 32This section summarizes the presentation by George Isham, Health Partners, Inc.
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If there is a policy to vaccinate sity. 33This section summarizes the presentation by John Bartlett, Johns Hopkins Univer
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Public health officials need to think about how to address situations in which individuals choose to do the opposite of what ACIP recommends. For example, what if ACIP reco~ends against vaccination and an individual patient insists on being vaccinated, perhaps because of an unconfirmed bioterrorism attack?
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35This section summarizes the presentation by John Calfee, American Enterprise In
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Indeed, public health programs have, with carefully developed communication strategies, usually succeeded in garnering public trust, cooperation, and participation. Mostly, Americans cooperate with 36This section summarizes the presentation by Anthony Robbins, Tufts University.
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As a corollary, secrecy is counterproductive and destroys trust. The public should know what the public health officials know.
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37This section summarizes the presentation by Tim Tinker, Widmeyer Communica
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Further, the public health community needs to consider the issues involved in communicating public health risks and engendering trust and not panic. Public health officials need to stop talking about percentages and start talking about individuals.
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Consequently, mass vaccination is going to take place whether or not ring vaccination is the official policy. 39This section summarizes the presentation by Kenneth Berns, Mt.
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Experience with swine flu vaccine taught the public health community that efforts like developing consent forms and mobilizing enough people to vaccinate enough people are incredibly difficult to mount and can be halted for political cation. 4iThis section summarizes the presentation by June Osborn, Josiah Macy, Jr.
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However, developing a plan for smallpox response also readies the public health system for other infectious diseases, whether naturally occurring or deliberately spread. Vaccine Development and Approval New vaccines will be subject to an END, which will require the usual protections for those volunteering to be research subjects, including IRB review, informed consent, and data and safety monitoring.
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In setting domestic vaccine policies, public health officials must also consider what, how, and when the United States makes recommendations to other countries. Uncertainties One area of uncertainty in the many public discussions about the vaccination policy options is the risk-benef~t ratio.
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Pre-Release Vaccination of the General Population Under current circumstances, with no confirmed smallpox, and the risk of an attack assessed as low, vaccination of the general population is not recommended, as the potential benefits of vaccination do not outweigh the risks of vaccine complications. Recommendations regarding pre-outbreak smallpox vaccination are being made on the basis of an assessment that considers the risks of disease and the benefits and risks of vaccination.
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Pre-Release Vaccination of Selected Groups to Enhance Smallpox Response Readiness Smallpox Response Teams Smallpox vaccination is recommended for persons predesignated by the appropriate bioterrorism and public health authorities to conduct investigation and follow-up of initial smallpox cases that would necessitate direct patient contact. To enhance public health preparedness and response for smallpox control, specific teams at the federal, state and local level should be established to investigate and facilitate the diagnostic work-up of the initial suspect casuist of smallpox and initiate control measures.
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The issues include provider and public education, health care provider training, availability of vaccine and VIG, developing the appropriate investigational new drug protocols, screening, strategies to mirumize vaccine wastage, vaccine adverse event surveillance, and other logistical and administrative issues.
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