CDC's Draft Policy Options¹⁵

In June 2001, ACIP published a statement on vaccinia vaccines in the Morbidity and Mortality Weekly Report. In February 2002, CDC asked ACIP to re-visit the issue in light of the terrorist attacks in fall 2001. In response, ACIP and the National Vaccine Advisory Committee (NVAC) formed a joint working group on smallpox to review a series of questions regarding possible immunization plans. In addition, four community forums were convened in New York, San Francisco, St. Louis, and San Antonio.

Information provided to ACIP indicated that the risk for smallpox occurring as a result of a deliberate release by terrorists is considered low, and the population at risk for such an exposure cannot be determined. Therefore, pre-exposure vaccination is not recommended for any group other than laboratory or medical personnel working with non-highly attenuated orthopoxviruses.

Recommendations regarding pre-exposure vaccination should be made on the basis of a calculable risk assessment that considers the risk for disease and the benefits and risks regarding vaccination. Because the current risk for exposure is considered low, benefits of vaccination do not outweigh the risk regarding vaccine complications. If the potential for an intentional release of smallpox virus increases later, pre-exposure vaccination might become indicated for selected groups (e.g., medical and public health personnel or laboratorians) who would have an identified higher risk for exposure because of work-related contact with smallpox patients or infectious materials.

CDC asked ACIP to consider three questions and develop options under each. The results of its deliberations, presented as options, follow each question:

Question 1: With no known cases of smallpox worldwide, should there be any change in the current recommendation for not vaccinating members of the general public?

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).

Option 2: In the absence of a confirmed smallpox case, or a confirmed smallpox bioterrorism attack, ACIP does not recommend that members of the general public be vaccinated; however, members of the general public may choose to be vaccinated. (This is a negative recommendation by ACIP, but there is choice by members of the public.)

Option 3: In the absence of a confirmed smallpox case, or a confirmed smallpox bioterrorism attack, ACIP recommendations for smallpox vaccine do not now include members of the general public; however, members of the general public may choose to be vaccinated. (ACIP is neutral, and there is choice by the public.)

Option 4: In the absence of a confirmed smallpox case, or a confirmed smallpox bioterrorism attack, ACIP recommends vaccination for those members of the general public who decide to receive the vaccination.

Question 2: In addition to laboratory workers who work with viruses related to smallpox, are there other individuals in specific occupational groups who should be vaccinated to enhance smallpox preparedness? If so, what guidelines should be used to determine which individuals should be vaccinated?

Option 1: In the absence of a confirmed smallpox case, or a confirmed smallpox bioterrorism attack, ACIP does not recommend pre-exposure vaccination for any individuals other than laboratory or medical personnel who work with non-highly attenuated orthopox viruses.

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 confirmed smallpox case, or a confirmed 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.

Question 3: Should there be any change in the current recommendation that surveillance and containment be the primary strategy for control of smallpox in the event of a case or an attack?

Option 1: In the event of a confirmed smallpox case or a confirmed smallpox bioterrorism attack, ACIP recommends surveillance and containment (ring vaccination) be the primary strategy for the control and containment of smallpox.

Option 2: In the event of a confirmed smallpox case, or a confirmed smallpox bioterrorism attack, ACIP recommends surveillance and containment (ring vaccination) be the primary strategy for the control and containment of smallpox, and that it be supplemented by vaccination of medical, health, law enforcement, and other personnel who would assist in responding to, managing, and investigating the outbreak or attack.

Option 3: In the event of a confirmed smallpox case, or a confirmed smallpox bioterrorism attack, ACIP recommends that surveillance and containment be the primary strategy for control and containment of smallpox, and encourages offering vaccination to those people in the affected community(ies) who would like to be vaccinated.

Option 4: In the event of a confirmed smallpox case, or a confirmed 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.

The options considered by ACIP assume: that the threat level is low; that there will be sufficient VIG available should widespread vaccination occur; that appropriate pre-vaccination screening for contraindications can and will be implemented; that the current vaccine is an investigational new drug; and that vaccination programs will be conducted by federal, state, and local health agencies. In addition to vaccination, appropriate infection control and use of personal protective measures will be utilized by health care workers and others in the event of a case or an attack.

Summary of Regional Meetings¹⁶

As part of the process developed by ACIP and the NVAC Smallpox Vaccine Group, CDC convened a series of meetings over a two-week period in New York City, San Francisco, St. Louis, and San Antonio to engage the public in the deliberations.

NVAC noted in February 2002, that the development of policies and programs on bioterrorism preparedness would benefit from public dialogue involving medical and related groups, as well as the lay public. Nearly 500 people attended the 4-day-long meetings: representatives from 43 agencies and organizations and 23 members of the public, primarily from the health care professions, spoke. Written comments have been received from 25 individuals. In addition, in May 2002, 130 organizations were represented at a meeting to discuss the ACIP recommendations. Additionally, the Association of State and Territorial Health Officers has been actively engaged in discussing the policy options, which is critical given the need for state and local health officials to be involved in the decision-making process.

The public forums sought input on the ACIP options described above. A summary of the public response follows:

Most participants favored Option 1, Question 1, regarding vaccination of the public, that is, “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).” The reasons for favoring this option included shortage of VIG, risks to vaccine recipients and their contacts, and distrust of government. Some persons expressed a preference for a permissive recommendation reflecting their desire to make a personal choice in consultation with their physician.

As for Question 2, providing vaccinations to selected occupational groups, most who commented supported expanding vaccination beyond the current limited group, which is only those working with orthopoxes, to either Option 2 or Option 3. Those supporting Option 2 stressed the need for state smallpox response teams to rapidly respond should a suspected or a proven case occur. Those favoring Option 3 represented health care agencies and organizations, and noted that many occupations face risks, including primary care providers, laboratory workers, home health care providers, and others. Other participants wanted vaccination of other essential groups in bioterrorism if an emergency should occur, such as firefighters, transportation workers, and law enforcement workers—those necessary for the continued functioning of society. Limited support was expressed for Option 1. A common theme was, irrespective of those to whom the vaccine would be recommended, immunization of first responders should be voluntary, with fully informed consent.

Regarding Question 3—the use of surveillance and containment as a control strategy—little support surfaced for mass vaccination once an attack occurred throughout the United States. Those who commented readily appreciated the success of the smallpox eradication campaign, but expressed considerable doubts about whether that program would be sufficient in a bioterrorism attack given today's highly mobile society. They noted the difference between natural smallpox, that is, endemic disease and smallpox resulting from an attack, which might be in multiple places. The need for flexibility in the policy was noted.

Surveys of public opinion, such as by the Harvard School of Public Health, indicate that a substantial number of Americans, if offered the vaccine, might accept it. However, focus groups convened by CDC indicate that there are considerable gaps in knowledge and substantial misunderstandings, both on the part of the public and the medical community.

Footnotes

15

This section summarizes the presentation by Joel Kuritsky, Centers for Disease Control and Prevention.

16

This section summarizes the presentation by Georges Peter, Brown University School of Medicine.