Sep 23, 2002 (CIDRAP News) The Centers for Disease Control and Prevention (CDC) today released detailed guidelines to help state and local health departments organize efforts to vaccinate the entire population against smallpox within 10 days in case the disease re-emerges.
The "Smallpox Vaccination Clinic Guide" provides a blueprint for running a clinic that could vaccinate 5,900 people per day, using two 8-hour shifts with a staff of 117 people per shift. Twenty such clinics could vaccinate 1 million people in 9 days, the plan says.
The new plan does not deal with the question of "pre-event" smallpox vaccination, ie, who should be vaccinated as a precaution in the absence of a smallpox outbreak. Federal officials reportedly are working on a plan to vaccinate various groups of healthcare workers in stages, starting with those most likely to be exposed to patients. Officials have said that plan could be announced by the end of this month.
The CDC's general plan for responding to a smallpox outbreak emphasizes "ring vaccination," the rapid identification and vaccination of contacts of patients, and envisions mass vaccination only if officials determined that ring vaccination could not stop the outbreak. But in releasing the vaccination clinic guide today, officials said it does not represent a change of direction.
"It's important to point out that this doesn't represent any change in policy," said David W. Fleming, CDC's deputy director for science and public health, in a telephone press briefing. "Preparation for mass vaccination is something we've all been talking about for a long time. . . . The decision around mass vaccination would be dependent on the particulars of the outbreak we were facing." In some circumstances it would be appropriate to do mass vaccination in addition to ring vaccination, but in others it would not, he said.
The clinic guide is a supplement, or "annex," to the CDC's general smallpox response plan, called CDC Smallpox Response Plan and Guidelines. A revision of the general plan is on its way to state health departments, but the clinic guide is the only major update to the plan, according to the CDC.
The vaccination clinic guide goes into extensive detail about how to run a smallpox vaccination program, with information on personnel, facilities, equipment, public information materials, paperwork, security, and other considerations.
Michael T. Osterholm, PhD, MPH, a bioterrorism expert who serves as Health and Human Services (HHS) Secretary Tommy Thompson's personal representative to the CDC, said, "I think the plan will be extremely valuable as a framework for state and local public health agencies. I think this plan will substantially enhance our ability to respond." Osterholm is director of the University of Minnesota's Center for Infectious Disease Research and Policy, publisher of this Web site.
The guide's introduction says that in the event of a confirmed smallpox outbreak, "rapid voluntary vaccination of a large population may be required" to supplement containment strategies in areas with smallpox cases, reduce the number of people at risk if further smallpox releases occur, and address "public or political concerns regarding access to voluntary vaccination." Mass vaccination would be launched only with the approval of the HHS secretary, the document adds.
In a set of general principles and considerations for a vaccination campaign, the guide says:
- Informed consent will be required of vaccinees because current vaccines are available only under an investigational new drug (IND) protocol, but a shortened consent process should be used.
- Agnecies should consider providing separate clinics for vaccinating and counseling known contacts of smallpox patients.
- People should be screened for contraindications to vaccination, "and vaccination should generally not be recommended for persons with contraindications who are not otherwise identified as contacts."
- As part of community smallpox response plans, clinics will be designated for evaluating symptomatic patients for possible smallpox, and these should be separate from vaccination clinics. The evaluation clinics will be identified publicly.
The guide says the federal government will supply smallpox vaccine and related supplies, including diluent, bifurcated needles, and IND protocols and supporting materials. The government also will provide vaccinia immune globulin (VIG) and/or the antiviral drug cidofovir for treating serious adverse events.
At the press briefing, CDC medical epidemiologist Lisa Rotz said a private company recently contracted with the CDC to produce VIG. She said she couldn't give numbers, but the company has been asked to produce "a substantial number of VIG doses by the end of the year." The present supply of VIG has been put at about 600 doses.
In a section on clinic organization and personnel requirements, the clinic guide calls for showing an orientation video to all potential vaccinees and supplementing that with medical counseling when necessary. The plan details the many types of personnel and duties that the clinic would involve and includes a chart suggesting how the operation should be organized physically.
At the press briefing, CDC officials were questioned about what it would take to trigger mass vaccination and whether it would be up to the states or the federal government to decide to mount such a campaign.
Fleming said, "Given that smallpox has been eradicated from the world, a single case of smallpox . . . would constitute an attack." But Walter Orenstein, director of the CDC's National Immunization Program, said a single case wouldn't necessarily lead to a mass vaccination effort. "We'd have to try and interpret what that single case would mean," he said.
Regarding decisions about mass vaccination, Joseph Henderson, CDC associate director for terrorism preparedness and response, said state and local authorities would generally take the lead in their jurisdictions unless there were a presidential declaration of emergency.
But Fleming said decisions would have to be coordinated. "This [an outbreak] would be a national emergency and a national decision. . . . I can't foresee a scenario where we'll have one state choosing to do one thing and another state choosing to do something else."
Officials also were asked whether enough vaccine is available to immunize the whole population. Henderson initially said the government now has enough vaccine to accomplish that, but he later modified that statement: "On an emergency basis, if we saw smallpox tomorrow, we have enough to vaccinate about 155 million individuals." He added that by the end of this year the stockpile should be large enough to cover everyone.
But Osterholm was more confident. "If we got into a situation like that (an outbreak), there is more than enough [vaccine] to vaccinate the entire population of the US," he told CIDRAP News. He said the Aventis vaccine stockpile, revealed last spring and made available to the government, would, if diluted, be enough. (The Aventis stockpile is estimated at 70 million to 90 million doses; HHS has an existing stockpile of 15 million doses and has 209 million doses of new vaccine on order.)
Fleming estimated that smallpox immunization would cost between $5 and $10 per person, with larger campaigns costing proportionally less.
CDC's "Smallpox Vaccination Clinic Guide"
Link to general smallpox response plan and guidelines