Excerpt from Smallpox Vaccination Clinic Guide, September 16, 2002
The Centers for Disease Control and Prevention
This document describes the logistical considerations for voluntary, large-scale, postevent smallpox vaccination clinics. This example model may be used to supplement other state and local vaccination planning considerations for responding to a smallpox outbreak within their community.
Following a confirmed smallpox outbreak within the United States, rapid voluntary vaccination of a large population may be required to: 1) supplement priority surveillance and containment control strategies in areas with smallpox cases, 2) reduce the “at-risk” population for additional intentional releases of smallpox virus if the probability of such occurrences is considered significant, or 3) address heightened public or political concerns regarding access to voluntary vaccination. Large-scale voluntary smallpox vaccination would be considered part of an overall national vaccination strategy and would be initiated following the approval of the Secretary of Health and Human Services.
The following considerations apply:
- Current smallpox vaccines are available under an Investigational New Drug (IND) protocol only, and informed consent must be obtained. (See attached draft combination medical screening/consent form.
- The shortened IND process for obtaining informed consent should be followed. (See attached description of shortened IND informed consent process and draft supporting documents.
- Separate clinic(s) should be considered for vaccination and counseling of identified contacts of smallpox cases, but resources must also be available at voluntary clinics because some contacts may show up for vaccination at those facilities.
- Medical screening for contraindications must be done, and vaccination should generally not be recommended for persons with contraindications who are not otherwise identified as contacts. Medical screening planning should include strategies to facilitate referral to local public health or medical laboratories or clinics for voluntary and confidential HIV or pregnancy testing if requested by the participant. Consideration should be given to the potential use of rapid HIV tests at laboratories and clinics performing voluntary HIV testing if such a test is available and FDA approved.
- Appropriate amounts of vaccinia immune globulin (VIG) should be available within the National Pharmaceutical Stockpile (NPS) to treat anticipated adverse events prior to initiating large-scale, voluntary vaccination as a component of the national response to a smallpox outbreak.
- Treatment of adverse events will occur in facilities separate from vaccination clinics.
- Existing immunization program resources should be utilized in the implementation of voluntary vaccination programs, and coordination should occur between state and local immunization program and bioterrorism planning personnel.
- Predesignated sites or clinics will be established, as part of the community smallpox response plan, for the evaluation of symptomatic individuals to rule out smallpox. These evaluation sites should be separate from designated vaccination clinics, but should also have the capability to administer vaccination, using the IND information and informed consent process. (Written scripts of the video may be used if video viewing facilities are not available.)
- The predesignated sites for evaluating symptomatic individuals for smallpox will be identified in public service announcements and these individuals will be discouraged from presenting to voluntary vaccination clinics.
- Vaccine clinic and transportation personnel should be vaccinated prior to beginning vaccination clinic activities in order to provide protection against exposure from symptomatic contacts who may inadvertently present to the vaccination clinic. Establishment of voluntary clinics may need to be done in a stepwise fashion over 2 to 3 days to accommodate administration of staff vaccinations prior to opening a clinic. (NOTE: Vaccination clinic personnel do not require a “waiting period” before beginning vaccination activities as long as a triage system to prevent admission of ill/potentially infectious individuals into the clinic is in place at each clinic site. Personnel involved specifically in the triage and/or evaluation of ill individuals who may present to vaccination clinics should use other personal protective measures until a vaccine take is confirmed. Vaccination take rates are expected to be 95%.)
- The recommended guidelines for the logistics, design, and implementation of a voluntary vaccination clinic are interim and are meant to support existing emergency vaccination clinic plans that state or local public health authorities have developed.
Federal Resources Provided for Vaccination Clinics
The Federal Government will provide the following resources to state and local public health authorities for use in voluntary vaccination programs established following confirmation of a smallpox outbreak:
Smallpox vaccine and the following vaccine administration supplies: diluent for reconstitution of vaccine and bifurcated needles.
Vaccine administration directions (written and video demonstration)
IND protocols and supporting materials in major languages (at a minimum English and Spanish), including:
a. Medical screening and consent form
b. Information sheets on:
i. Smallpox vaccine
ii. Vaccine adverse events
iii. Specialized information for persons
iv. Smallpox disease
c. Contact information
d. Vaccine take recognition card
e. Vaccine site care instructions
f. Vaccination card for duplication and use within clinics
4. VIG and/or Cidofovir for use as IND products for the treatment of serious adverse events that may be expected
to respond to these treatments.
5. Technical assistance with clinic design, development of clinic databases, and vaccination tracking systems.
6. Assistance as otherwise outlined in the Federal Response Plan, if activated. [See Annex 2.]
The amount of personnel resources provided by the Federal Government will be dependent upon the scale of the voluntary vaccination program. Additional government personnel resources available to the state and local authorities will be limited for any programs implemented on a large-scale in multiple sites (e.g., implementation of a nationwide voluntary vaccination program).