Annex 2

General Guidelines for Smallpox Vaccination Clinics

######## Annex 2 -- General Guidelines for Smallpox Vaccination Clinics

#### Introduction

This document provides detailed guidelines for conducting smallpox
vaccination clinics. It assumes that smallpox vaccinations will not be
incorporated into immunization services in existing clinical settings,
but rather that smallpox vaccinations will be administered either in the
context of bioterrorism readiness or as a response to a probable or
confirmed case of smallpox.

Guide B in the *CDC Smallpox Response Plan* include information on
vaccination strategies; indications for vaccination; reconstitution,
administration, and storage of vaccine; recognition of vaccine
reactions/take; recognition of adverse events; indications for Vaccinia
Immune Globulin administration; recommendations for handling, cleaning,
and sterilizing bifurcated needles; and contingencies for alternative
diluent use. Annex 5 of this document contains information on ALL
planning activities. This Annex offers general guidance to planning and
conducting smallpox vaccination clinics. The following section, Annex 3,
provides information for conducting large scale clinics to administer
vaccinations against smallpox.

**Preparing for Smallpox Clinics**

**1. Understand the Vaccination Strategy**

In order to organize a vaccination operation to reach a target
population, it is critical that the vaccination strategy be clearly
understood. For example, the i*mmediate* response to a confirmed or
probable case or cases of smallpox would be vaccination of first
responders \[i.e., medical personnel who will attend the infected
person(s) and vaccinate contacts of the case(s)\]. State and local
health department smallpox preparedness plans should include
locality-specific lists of all persons who must receive vaccine
immediately if a case of smallpox occurs. (See Annex 5). In addition,
all face-to-face contacts of the case(s) must be vaccinated. Because the
rapidity with which this can be accomplished will determine the ultimate
extent of the outbreak, organizing a separate vaccination operation
(clinic site, staff, supplies, etc) for each group is recommended.

As soon as possible after the first case is confirmed, state and local
health officials, in collaboration with CDC epidemiologists onsite, will
determine the appropriate scope (who, where, and when) of the
vaccination response, based on size of the initial outbreak, the amount
of vaccine available, and the possibility that additional new and
epidemiologically related cases will be identified in subsequent days.

Ultimately, a decision may be made to vaccinate the entire population
either in response to an outbreak of smallpox or on a purely cautionary
basis as part of bioterrorism readiness. However, any implementation of
targeted or universal vaccination of persons at unknown risk for
smallpox will require the authorization of the State Health Officer in
consultation with CDC and will depend on the adequacy of vaccine
supplies. In either case, the vaccination strategy may include
prioritizing selected groups, such as 1) medical staff
[potentially]{.underline} involved in care of persons infected with
smallpox, public health staff potentially involved with identifying,
tracing and vaccinating contacts, and security staff who would
potentially accompany first responders and support quarantine efforts;
2) persons necessary to maintain essential community infrastructure, and
3) persons providing basic community services.

**2. Determine Resource Needs**

Based on the vaccination strategy, the number of clinics, duration of
clinics, and number of staff required should be calculated. Although the
precise number of personnel needed for any one clinic will vary
depending on the size and layout of clinic facilities, location of
clinic, geographic area being served by the clinic, and estimated number
of vaccine recipients at each clinic, the over-all staffing needs should
be estimated based on the model described under Clinic Operations.

**3. Identify Potential Clinic Sites**

As discussed in [Guide B]{.underline}, the recommended strategy involves
vaccinating primary and secondary contacts of cases identified. An
essential ingredient of this approach requires the establishment of
vaccination clinic sites to which contacts can be referred if
necessary.\* Potential clinic sites should be selected based on the
estimated number of people and the size and layout of the facility. The
clinic sites must be located in close geographical proximity to the
outbreak, and clinic operators must be prepared to relocate the
operation to another site rapidly when the outbreak focal point changes.

The size and type of the facilities needed for smallpox immunization
clinics will vary depending on the number of persons to be served. Very
small clinics, such as those to immunize first responders or primary
contacts, can be conducted in almost any available space, most likely a
local health department or similar facility. Larger clinic sites could
be industrial locations, office buildings, or apartment complexes.

Schools are the preferred location for any clinic larger than can be
held in the local health department. Schools have parking lots, long
corridors, large classrooms, cafeterias, private offices, and other
immediately available resources, such as tables and chairs, and offer an
ideal physical structure that can meet most clinic needs. Elementary
schools are preferable if staffing is adequate, because they are
numerous and serve fairly well defined neighborhoods convenient to the
public. The use of the largest number of locations that staffing permits
will minimize parking and crowding problems. Use of middle or high
schools may also be considered.

If smallpox cases expose many people in locations like schools and
office buildings, these locations may be sites where vaccine clinics can
offer vaccine quickly and efficiently to many

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**\***If authorized by CDC and circumstances dictate, vaccine may also
be administered in *field settings* in the community, while tracking
case contacts, to individuals at highest risk of infection (i.e.,
contacts and contacts of contacts). If authorized, a secondary strategy
may be to vaccinate the population on a house-to-house basis in
expanding geographic rings around cases and contacts. However, to avoid
wasting reconstituted vaccine, clinics should be selected and organized
to administer one vaccine vial --or multiples thereof -- each day. (Each
vial of smallpox vaccine contains 100 (or 500 with the use of the 5:1
dilution strategy) individual doses of vaccine.

In selecting clinic sites, consideration should be given to ensuring a
smooth flow of clients, accessibility of the facility to major streets,
restroom facilities, parking, refrigeration, heating/air conditioning,
and protection from elements if lines will form outside. Before final
selection, a visit should be made to the location to ensure that the
facility meets the needs of the vaccination operation.

**4. Obtain Authorization / Standing Orders**

Before a clinic can be implemented, standing orders must be obtained
from the public health authority, usually the state and/or local health
officer to provide authorization for administration of the smallpox
vaccine. Standing orders are also needed for responding to medical
emergencies that occur during vaccination clinics. In addition to
providing standing orders, the health officer or his/her designee must
approve the content of informational materials and serve as medical
consultants for nursing staff.

**5. Plan Training**

All public and private health care workers who may become involved in
smallpox vaccination efforts should receive training in the proper
administration of smallpox vaccine and screening for contraindications
to smallpox vaccination. Training should also emphasize procedures for
reporting suspected cases and maintaining communications with CDC. Large
numbers of clinic staff can be trained through a train-the-trainer
approach through CDC's satellite-based courses, Web pages, video
cassettes, CD-ROM courses and written training materials. A supplemental
chapter on smallpox will be included in the next edition of the "Pink
Book."

Educational materials targeted to local health workers staff should be
made ready for rapid distribution. These materials should provide
detailed medical information about smallpox and the smallpox vaccine,
and should highlight potential vaccine side effects and their clinical
management.

**6. Publicize the Clinic**

Patient education materials should be developed in multiple languages,
reproduced in appropriate quantities and readied for rapid distribution.
Patient education materials should be developed in consultation and
coordination with immunization partners to ensure that the information
the materials provide is adequate and culturally appropriate for local
audiences. Informed consent materials and including the most recent
smallpox VIS (attached) must also be modified for local use, if
necessary, and readied for rapid distribution.

After a smallpox vaccination clinic site and recipient populations are
determined, public announcements with information about the clinic
should be released as expediently as possible.

The information disseminated must clearly describe the groups for whom
the clinic is intended (and not intended). Specific zip codes or
alphabetic letters may be designated for a specific date and timeframe.
Certain language groups may be asked to come at a specific time and date
when translator resources are available. Also state the clinic location
and directions, dates and times of operation, length of time the
vaccination process may take, type of clothing to wear, and culturally
appropriate information in as many languages as needed. It should be
stated that those who do not meet the defined criteria will not be
accepted for vaccination. If the vaccination clinic will be identifying
and screening for possible contacts or first responders, state this
clearly in the publicity information.

Using professional public relations assistance when available,
announcements should be prepared and released for the television, radio,
and newspaper media. If specific groups require additional information,
(e.g., to counteract misconceptions about vaccination by certain
groups,) clinic organizers may need to distribute flyers to targeted
populations in apartment buildings, neighborhoods, workplaces, schools,
and/or religious centers.

If special transportation can be provided for physically disabled or
elderly persons, the telephone number for requesting special
transportation should be included in all clinic publicity.

To ensure accurate reporting by the media a list of subject experts and
media spokespersons from state and local public health agencies, CDC and
community partners should be developed and made easily accessible to the
media through an approved format. If necessary, individuals who can be
called upon to serve as interpreters should be identified to help inform
non-English speakers. This list should note the foreign languages spoken
by these individuals. To improve understanding of the subject matter,
photographs and graphics should be provided in various media.

In addition to information about the specific clinic being publicized, a
concerted effort should be made to provide information to the public
that emphasizes:

-   The rationale of the vaccination strategy.

-   Disease containment measures are effective.

-   All possible measures are being taken to prevent the further spread
    of the disease.

#### Clinic Operations

**1. The Vaccination Clinic Process**

The following paragraphs describe operation of a medium to large clinic.
However, regardless of clinic size and location, the functions and
routing procedures remain essentially the same. Staffing needs will vary
depending on clinic size, and in a small clinic situation some roles can
be consolidated or eliminated.

###### 

###### Step 1: Orientation and Paperwork

As vaccine recipients arrive, they are routed to the clinic entrance by
security personnel who are handling outside traffic flow and parking.
Upon entering the building vaccine recipients are directed to a location
where the greeter-educator briefs groups (up to 30) about what is going
to take place during the clinic process, provides all required paperwork
(preferably in a packet form) and instructs the vaccine recipients how
to complete the necessary paperwork. Time is allowed for reading and
filling in the required personal information (name, address, etc). The
number of persons in the orientation briefings can vary to accommodate
the rate at which people arrive. Multiple educator-greeters locations
may be necessary, since people arriving after an orientation has begun
will be directed to another location where another orientation will soon
begin. Orientation locations can also serve as holding locations if
bottlenecks occur along the clinic line. This method will insure a
steady flow of vaccine recipients to the next step.

###### Step 2: Registration 

After orientation and completion of the paperwork, the clinic flow
coordinators direct vaccine recipients to registration tables where
staff check each vaccine recipient's form for completeness and accuracy.

###### Step 3: Medical Assessment

After insuring that the paperwork is completed appropriately, vaccine
recipients are directed by clinic flow controllers to the medical
assessment area. Here medical screening personnel discuss with each
vaccine recipient individually the medical conditions that would prevent
receipt of the vaccine and determine if any such conditions are present.
They will also review the common reactions to the vaccine with each
vaccine recipient. Persons with suspected medical contraindications are
directed to a separate station for more in-depth evaluation. Each
vaccine recipient is asked to sign the consent form before proceeding
further.

###### Step 4: Vaccination

After medical assessment, vaccine recipients with no medical
contraindications are directed to the vaccination area. This area is a
screened area that affords privacy to persons who find it necessary to
remove clothing in order to expose to vaccination site. A vaccination
assistant helps vaccine recipients expose their upper arm and cleanses
the vaccination site if necessary. The vaccine recipient then proceeds
to the vaccine administrator who administers the vaccine and completes
the necessary documentation. Immediately thereafter, a vaccination
assistant applies a bandage to the vaccination site and instructs the
vaccine recipient on post-vaccination care of the vaccination site.

###### Step 5: Forms Collection and Exit

Before leaving the clinic, vaccine recipients are routed to a forms
collector stationed near the exit. This individual collects all required
paperwork, answers any remaining questions and informs vaccine
recipients that they are finished with the process.

**2. Staffing and Training**

The official responsible for overall direction of the vaccination
operation must assign a *clinic manager* who is responsible for overall
clinic operation, is the primary decision maker for the site, and
supervises all nonmedical personnel. All staffing assignments should be
documented on a clinic assignment sheet.

Management and Coordination Functions

To assist the manager with large clinic operations, coordinators should
be identified for the various clinic functions as outlined below:

> ***Nurse Coordinator:*** Oversees nursing staff assigned to the
> clinic; assists clinic manager in making clinic assignments for
> nursing staff; assists on-duty nurses as needed.
>
> ***Supply Officer/Vaccine Manager:*** Ensures that all necessary
> clinic supplies are on site and are available in sufficient quantities
> during clinic operations; maintains an inventory of supplies; oversees
> distribution of supplies to appropriate locations in the clinic;
> ensures that sufficient vaccine is available, that the cold chain is
> maintained through proper handling and storage; ensures that vaccine
> is stored in a secure manner at the clinic site and that unused
> vaccine is returned and accounted for; and maintains adequate vaccine
> and other supplies at the vaccination station.
>
> ***Security Coordinator:*** Oversees personnel assigned to security
> activities at the clinic site; assists the clinic manager in making
> duty assignments of security personnel; determines appropriate number
> of security staff necessary according to clinic size and location;
> maintains a list of authorized clinic staff and their phone numbers;
> assigns and coordinates use of cell phones and pagers; establishes
> staff check-in and check-out procedures; ensures that all staff wear
> ID badges; maintains communication with local law enforcement
> officials.
>
> ***Volunteer Coordinator:*** Oversees volunteer activity at the clinic
> site. Assists the clinic manager in making duty assignments of
> volunteer staff; maintains roster of persons available for volunteer
> duty; and maintains a schedule of times that volunteers will be
> available to work.

Staff Functions

Following is a summary of suggested responsibilities of the staffing
roles as outlined in the operational concept above:

### 

### *Greeter-Educators:* *Greet and conduct initial orientation of potential vaccine recipients upon their arrival; provide basic information (verbally or with a video presentation) about the vaccine and the vaccination process; distribute informational material and clinic document; explain how to complete the documents and answers questions.* 

### 

### Greeter-educators must be able to explain the purpose of receiving the vaccine, outline the vaccination clinic process, and distribute and explain the clinic documents to vaccine recipients individually and in groups. 

### 

### *Registration Staff: Review each vaccine recipient's documents for completeness and accuracy; assist clients with completing documents.* 

### 

### The registration staff must be familiar with each form that is distributed. They must be able to follow instructions on how to respond to exceptional situations such as non-English speaking patients or patients who are anxious, hostile, or disoriented. If the form has not been completed correctly or completely, registration staff must be able to address and correct these problems. They should be prepared to read the forms to illiterate or semiliterate persons needing their assistance. 

### *Medical Screeners: Assess clients for contraindications to vaccination; when necessary perform physical examination of patients who state that they have dermatological conditions that may constitute contraindications; and answer medical questions*.

### 

### This role should be filled by a physician, nurse or paraprofessional who has good interviewing skills and is well-versed in the technical information regarding exposure risks, medical contraindications to vaccination, risks of vaccination, and risk-benefit analysis. Medical screeners will review the list of normal or expected reactions to the vaccine with each vaccine recipient. If necessary, medical screening personnel will contact a designated physician consultant to assist in making a final decision about whether or not to vaccinate. If the vaccine is still on Investigational New Drug status, medical screening personnel should ensure that the consent form has been read, understood and signed by each potential vaccine recipient and ask vaccine recipients to sign the consent form. 

> ***Vaccination Assistants*:** *Assist the vaccine administrator with
> all aspects of pre- and post- vaccination activities; prepare vaccine
> with diluent, ensure that vaccination station maintains adequate
> supplies; instruct recipients on location of vaccination; assist
> vaccine recipients in preparing the vaccination site (roll up sleeve,
> remove arm from shirt/blouse, etc.); clean vaccination site with
> acetone, if necessary; apply dressing to the vaccination site;
> instructs clients about care and changing of the dressing.*

Vaccination assistants must have a thorough understanding of the
vaccination process and the necessary supplies, proper technique for
reconstituting the vaccine with diluent, proper care and handling of
vaccine in the clinic, how to disinfect contaminated surfaces and
dispose of soiled materials, and where to access additional. Vaccination
assistants are also responsible for entering the vaccine and diluent lot
numbers on the patient's consent form and clinic record and providing
the vaccine recipient with vaccination card that documents when and
where the vaccine was administered.

> ***Vaccine Administrators**: Oversee the vaccination process;
> administer the vaccine; sign the clinic record; observe vaccine
> recipients for immediate reaction or complications.*

### 

Vaccine administrators can be nurses, physicians, or designated
paraprofessionals who have received technical training in administration
of smallpox vaccine. Vaccinators must have the ability to quickly
develop a high level of skill in vaccinating with a bifurcated needle.
They must have in-depth understanding of proper vaccination techniques,
methods to prevent contamination of the vaccine, exposure risks, the
medical conditions that constitute contraindications for vaccinations,
the risks of vaccination, preparation of the vaccination site, normal
and abnormal post vaccination responses, and proper follow-up care of
the vaccination site. Vaccinators must also be prepared to respond to
medical emergencies that may occur within the vaccination area.

### 

### *Forms Collectors: Verify that forms are correctly completed; collect all necessary forms from recipients before departure.*

### 

### The forms collector is responsible for checking that the vaccination team has signed the clinic record and entered the lot numbers on the appropriate documents. As the last staff to have contact with vaccine recipients, the forms collector must have the ability to ensure a response by the appropriate staff to any remaining concerns that clients may have. 

### *Clinic Flow Controllers:* *Direct vaccine recipients through the clinic process and monitor clinic flow.*

Clinic flow coordinators are responsible for continuously monitoring and
directing client activity throughout the facility. They must be able to
calmly manage and assist people who may be anxious and unable to follow
directions. When congestion (backlog) is noted, flow controllers
determine if staff at other locations are less busy and request assist
in the congested area. They are also responsible for feeding back
information about the number and rate of "upstream" clients to the
vaccination assistants to enable them to maximize use of all vaccine
doses in opened vaccine vials. Flow controllers may be in a position to
provide early alert of situations that that may require additional
security personnel.

> ***Security Staff:** Ensure an orderly flow of traffic and parking at
> the clinic site; assist in maintaining orderly movement of vaccine
> recipients through the clinic process; provide necessary control if
> persons become unruly; assist supply officer in maintaining security
> of vaccines and other clinic supplies*.

### 

Security staff can be off-duty law enforcement officers, professional
security personnel and/or volunteers who are experienced and trained in
crowd control. Potential responsibilities of security staff are describe
in detail below (under Security).

> ***Emergency Medical Personnel:** Respond to medical emergencies*.

### 

Emergency personnel must be able to respond to medical emergencies,
including reactions ranging from the minor to anaphylactic shock and
serious medical emergencies that are incidental and unrelated to
vaccination but can be expected to occur whenever large groups of people
congregate. For large operations, a physician, physician's assistant,
nurse practitioner or emergency medical technician should be on-site at
all times during clinic operations.

###### Staff Training

The staff operating a clinic site should receive a group orientation to
the overall purpose, function, and flow of the vaccination clinic as
well as specific verbal and written directions for their individual
roles.

During the orientation a diagram with annotations should be provided to
show traffic flow (see Figure 1: Clinic Layout), the functions of all
clinic stations, and a list of staff assigned to each role and each
station, if possible. The general responsibilities of each area of the
vaccination clinic are reviewed with the entire staff. All staff need to
know where they will work, where their supplies and resources are
located, and who their consults are as well as how to summon them.

In small clinics there are roles within the clinic that be flexed to
accommodate to the needs of the clinic and decrease congestion and
waiting time ("bottlenecks" and "lags") and to permit breaks for staff.
In larger clinics, this can be accomplished by cross-training.
Therefore, orienting staff in small, interchangeable teams is suggested.

For training vaccine administrators and assistants, a demonstration
video is available from CDC. Ideally, vaccinators should practice on
each other and other staff before administering vaccine to the public.
Copies of package inserts, MMWR, VIS, and any other significant
administration materials should be available during training and actual
vaccine clinic.

If time permits, a mock vaccination clinic or role-playing session
should be conducted to train and evaluate the potential performance of
staff. Vaccinating clinic staff as well as first responders and other
health care providers is suggested as a way to provide critical training
and experience for all staff, especially the vaccine administrators.

Emergency personnel should also attend the group orientation and be
given information about smallpox and managing potential exposure to
smallpox. They should be familiar with the layout of the clinic site and
know where ill patients will be maintained prior to transport.

Daily postclinic debriefings should be held to assess staff performance
and ascertain if additional training or clinic reconfiguration is
needed.

**3. Clinic Layout and Flow**

Clinics should have clearly marked entrance and exit points with
adequate "waiting" space for queues of people seeking vaccination.
Security staff should be posted at both locations to maintain order. The
traffic flow within the clinic should be controlled and should follow a
logical path from entry into the clinic to exit from the clinic. A
linear path of traffic flow from entry to exit on opposite sides of the
facility is optimal. If time permits, easy-to-read signage should be
provided to guide people through the clinic process. See Figure 1 for a
sample clinic flow diagram.

[]{.mark}

If the clinic is being held in response to a smallpox attack, some
persons may arrive at the clinic with a referral form indicating that
they are a contact to a diagnosed case of smallpox. These persons must
be given the highest priority and be escorted directly to a registrar
who will orient them and expedite the paperwork, medical assessment and
vaccination process. Security personnel and greeter-educators must be
alerted to this possibility.

Ideally, greeter-educators and registration staff should be located in a
separate room from the vaccine administration station.

It is likely that the registration and medical screening processes will
be the most time-consuming clinic activities. Sufficient staff should be
assigned to move persons through these areas with some dispatch, to keep
a steady flow of persons to the vaccination areas can be opened. In
preclinic planning, locations should be designated for this contingency.

# Figure 1 - Smallpox Clinic Setup

Traffic in the area where vaccine is being administered should be kept
to minimum. Ideally, the vaccine administration tables should be set up
so that staff have their backs are to the wall and patients are not
congregating or walking behind them. The three steps of the actual
vaccination process (site preparation, vaccination, and dressing
application) will all take place in a relatively small space (one or two
tables) in the same area. Since some vaccine recipients may need to
remove shirts or blouses to be vaccinated, a separate, screened privacy
area should be available out of view of other persons lined up for
vaccination.

The medical emergency area should be located as close to the vaccine
administration area as possible.

[]{.mark}

**4. Documentation and Paperwork**

*Table1* provides a list of recipient-specific documents required in a
smallpox vaccination operation and a summary of the information that
must be collected. One copy of each of the documents listed in Table X
must be available (and in appropriate languages) for each vaccine
recipient. CDC will make these documents available as web-based
applications as part of an electronic smallpox data management system
(SDMS). If computer resources are available, data should be entered on
each vaccine recipient in "real time" during registration and at
appropriate points throughout the vaccination process. In the ideal
scenario, all person-specific documents will be printed on-site for each
vaccine recipient However, paper copies of all documents must be
available in sufficient quantities so that clinic operations can
continue if the computer system fails. Whether during the clinic or
later, electronic entry of critical data will be necessary.

It should be noted that each vial of vaccine will be shipped with three
peel-off labels per dose contained in the vial. At standard dilution, a
roll of 300 stickers will accompany each vial. One sticker will be for
the patient\'s signed consent that becomes part of the IND documentation
returned to be returned to the IND sponsor (CDC). Depending on the
setting in which vaccination occurs (medical clinic, public building
vaccination session, or field vaccination in patient's home, office, or
elsewhere), the second and third stickers may be applied to the Clinic
Vaccination Record of the patient retained by clinic and either the
Vaccine Information Statement retained by the vaccine recipient or a
take-home record documenting the vaccination.

Certain administrative documents and worksheets will be required to
assist in clinic management and keeping track of the vaccine. These
documents are summarized in *Table 2*. Additional information is
provided under **Vaccine Security and Tracking**.

**5. Security**

In the event of a bioterrorism event involving smallpox, the level of
threat perceived by the public -- whether real or imagined -- may be
extreme. In these circumstances, state and local public health officials
should be prepared for a high level of demand for vaccine by the public.

**TABLE 1**

# VACCINATION DOCUMENTS 

**(Documents are under development)**

+-----------------+----------------------+----------------------------+
| **Document**    | **Information        | **How Used**               |
|                 | Collected**          |                            |
+-----------------+----------------------+----------------------------+
| **Medica        | Medical              | Used as preliminary        |
| l/Epidemiologic | Contraindications    | screening tool; persons    |
| Risk Screening  |                      | with potential risk routed |
| Sheet**         | Epidemiological Risk | for in-depth medical       |
|                 | Status               | screening or priority      |
|                 |                      | vaccination                |
+-----------------+----------------------+----------------------------+
| ### IND I       | Name, Address,       | Information entered;       |
| nformed Consent | Age/DOB, M/F, lot    | Vaccine recipient reads    |
|                 | number, date, other? | and signs in presence of   |
|                 |                      | staff                      |
+-----------------+----------------------+----------------------------+
| **Vaccine       | Name, address,       | Vaccine recipients take    |
| Recipient       | age/DOB, M/F, lot    | home and check of any      |
| Diary**         | number, date, list   | symptoms they may have     |
|                 | of                   | each day for 4 weeks.      |
|                 | contra-indications,  |                            |
|                 | list of symptoms     |                            |
+-----------------+----------------------+----------------------------+
| **Vaccine       | Verbal Yes/No:       | Given to Vaccine           |
| Information     |                      | recipients to takes home   |
| Statement**     | Have you read?       |                            |
|                 |                      |                            |
|                 | Do you understand?   |                            |
+-----------------+----------------------+----------------------------+
| **Instructions  | How to care for      | Given to vaccine           |
| on Care of the  | vaccination site;    | recipients to take home    |
| Vaccination     | what vaccination     |                            |
| Site**          | should look like;    |                            |
|                 | who/where to call if |                            |
|                 | reaction             |                            |
+-----------------+----------------------+----------------------------+
| Clinic          | Name, Address,       | Official clinic medical    |
| Vaccination     | Age/DOB, M/F, SS#,   | record                     |
| Record          | lot number, date,    |                            |
|                 | other?               |                            |
+-----------------+----------------------+----------------------------+
| ### V           | Name, Address,       | Information entered on     |
| accination Card | Age/DOB, M/F, lot    | card; Vaccine recipient    |
|                 | number, date,        | receives/keeps card to     |
|                 | signature/stamp,     | verify receipt of vaccine  |
|                 | other?               |                            |
+-----------------+----------------------+----------------------------+
| ### Vaccin      | Name, physical       | Presented by persons       |
| ation Referral  | description, M/F,    | referred for priority      |
|                 | signature of         | vaccination because of     |
|                 | referring case       | their epidemiological risk |
|                 | worker, case ref #., | status (e.g., contact to a |
|                 | date, risk category  | case of smallpox)          |
+-----------------+----------------------+----------------------------+
| ### Expanded    | Name, Address, M/F,  | Documentation of adverse   |
| Vaccine Adverse | date, lot number,    | events for IND and the     |
|  Events Report  |                      | Vaccine Adverse Events     |
|                 |                      | Reporting System (VAERS)   |
+-----------------+----------------------+----------------------------+

######### 

######### TABLE 2

**ADMINISTRATIVE WORKSHEETS**

**(Documents are under development)**

+----------------------+-----------------------+----------------------+
| **Document**         | #######               | **How Used**         |
|                      | # Type of Information |                      |
+----------------------+-----------------------+----------------------+
| **Daily Vaccine      | Beginning Inventory   | Documents where,     |
| Tracking Record**    |                       | when and how vaccine |
|                      | Doses received        | was used             |
|                      |                       |                      |
|                      | Doses Administered    |                      |
|                      |                       |                      |
|                      | Ending Inventory      |                      |
|                      |                       |                      |
|                      | Doses Wasted          |                      |
|                      |                       |                      |
|                      | Disposition of Ending |                      |
|                      | Inventory             |                      |
|                      |                       |                      |
|                      | Signature of clinic   |                      |
|                      | official              |                      |
+----------------------+-----------------------+----------------------+
| **Staffing           | Date of Clinic        | Records staffing     |
| Assignment Sheet**   |                       | assignments          |
|                      | Clinic Roles          |                      |
|                      |                       |                      |
|                      | Individuals Assigned  |                      |
+----------------------+-----------------------+----------------------+

With a significant level of anxiety among the public, the public health
system may quickly lose the capacity to identify and limit vaccine to
individuals who meet the criteria for exposure and consequent
vaccination. Vaccination sites might become quickly known, and areas
around these sites may experience traffic gridlock, thereby limiting
egress to and exit from the clinic site by individuals in critical need
of vaccine and clinic staff (including those delivering supplies and
vaccine).

In the extreme case, state and local health authorities may find it
necessary to call on the state and local law enforcement agencies, or
even the National Guard, for traffic and crowd control near vaccination
clinics, to support logistical and clinic supply needs and/or to impose
geographic quarantines around outbreak areas. The ability of law
enforcement and the military to supply security for a public health
response may be limited by the demands of their duties as defined by
individual state emergency response plans.

[Management Responsibilities]{.underline}

The clinic manager must ensure that the following activities are handled
at each site:

-   Notify state/local police and EMS of the time and location of the
    clinic

-   Assign a security coordinator

-   Ensure presence of police or other security personnel

-   Require that all staff wear identification cards

-   Determine need for trained security guards, crowd control and
    traffic control personnel

-   Designate entrances/exits for staff use

-   Provide list of authorized staff for each clinic site

-   Establish staff check-in/check out procedures

-   Establish methods and locations to safeguard vaccine and other
    clinic supplies

-   Maintain a system to vaccinate clients in their order of arrival

[Staff Responsibilities]{.underline}

Security staff functions include: (1) maintaining orderly clinic
operations; (2) protecting patients; (3) protecting employees; (4)
protecting facility property, including medical supplies and vaccine;
and (5) enforcing quarantine measures (may be unrelated to clinic
operations, but handled by the same personnel). To fulfill these
functions, security staff must have the capacity to:

-   Manage the facilities' security resources.

-   Monitor the physical plant.

-   Recognize potential for mob behavior.

-   Control access to the facility.

-   Control access to specific areas of the facility (e.g., pharmacy).

-   Identify and provide a means for security/facility staff to identify
    authorized employees.

-   Update an authorized personnel list on an ongoing basis.

-   Coordinate with other security agencies.

-   Enforce of mandatory isolation of contagious patients.

-   Direct persons in need of care to alternative facilities.

-   Remove, detain or isolate individuals who pose a risk to the
    facility and its operation.

-   Follow the emergency response plan of the state, local and/or
    facility.

-   Communicate with clinic staff, the command center, and external
    security personnel.

-   Perform a secure lock down of the facility quickly.

-   Demand and receive additional security resources in a predefined
    "emergency" situations.

-   Respond with appropriate force if required.

-   Provide information to persons massed outside the facility.

[Security Strategy]{.underline}

To manage a large numbers of people arriving at clinic sites, the main
strategy of security personnel should be to 1) secure a limited access
perimeter at a designated distance from the physical plant; and 2)
secure the clinic itself (interior perimeter; e.g., the facility's main
and secondary entrances, front drive, and parking area); 3) maintain
order within the facility. To carry out these strategies, security
personnel must be prepared to:

-   Intercept and detain individuals attempting unauthorized entry to
    the facility.

-   Detain persons for examination and quarantine.

-   Continuously provide situation information to state/local disaster
    command and control.

-   Disseminate public information, including leaflet distribution.

-   Control and disperse crowds.

-   Operate available security equipment such as closed circuit
    television, metal detectors, security alarm systems and radio
    communications systems.

[Emergency Protocol]{.underline}

In a medical or public safety emergency, security staff should
immediately undertake the following activities:

-   Set up an outer perimeter.

-   Arrange to meet emergency vehicles at the outer perimeter and guide
    them to the appropriate entrance.

-   Meet mass transit and supply vehicles at the outer perimeter and
    direct them to the appropriate entrance.

-   Meet individuals coming to the facility at the outer perimeter and
    identify them as either authorized staff or eligible for care.

-   Deny ineligible or unauthorized persons admission using standard
    scripts.

-   Direct authorized persons to the admission station at the interior
    perimeter. Offer disabled persons, the elderly, and parents with
    small children an escort, when appropriate.

-   Monitor length of lines at the clinic entrance and relay information
    to the outer perimeter to limit admission, when necessary.

-   Refer over-flow to other clinics, if necessary.

-   Lock down the facility in the event the security objectives were
    compromised.

**6.** **Clinic Supplies** **and Equipment**

A secure area should be identified for maintaining clinic supplies. A
list of clinic supplies should be kept on hand at the clinic site to be
used for staff training, clinic set-up, and restocking. A check-off list
of suggested supplies is provided in *Table 3.*

**7. Transportation**

Depending on circumstances, three types of people may require
transportation assistance:

-   Clinic staff,

-   Persons exposed to known cases and other high-risk individuals, and

-   The general public (i.e., persons with low or unknown risk of
    exposure).

In addition, transportation will be needed to ensure adequate amounts of
vaccine, vaccine diluent and various clinic supplies. Pick-up locations
for staff and supplies should be arranged and clearly communicated to
drivers and staff.

Although transportation of clinic staff can be handled with agency motor
pool or rented vans, special security arrangements may be required.
Until vaccine supplies are no longer critical, vaccine should be
transported in law enforcement or similar secure vehicles. If
transportation of large numbers of vaccinees is required, public and/or
private buses may need to be pressed into service. In these cases, a hot
line or other mechanism must be established to enable individuals to
obtain information about bus departure locations and schedules. Special
consideration should be given if transportation of special populations
becomes necessary \[e.g., children, the elderly, homeless persons,
remote populations, and disabled (including homebound) persons\]. The
ability to communicate with drivers via radio or cell phones is
critical.

**8. Vaccine Storage and Handling**

Guidelines for handling and storage of smallpox vaccine are appended.
The package insert should be consulted for optimal cold storage
criteria. Although smallpox vaccine has proven to be hardy at ambient
temperatures for extended periods of time in emergency situations, the
cold storage recommendations for smallpox vaccine are similar to that of
DTaP (2 to 8 °C). Styrofoam containers and cool packs are adequate for
local transport and day use. If the clinic lasts for more than one day,
arrangements must be made to store the smallpox vaccine in a secure
location. Vaccine usage should be monitored closely, and arrangements
should be made to obtain additional vaccine, if needed. Arrangements
should also be made for returning unused vaccine. Recommendations for
Handling and Storage of Smallpox Vaccine are appended.

**TABLE 3**

######## SMALLPOX CLINIC SUPPLIES AND EQUIPMENT

+----------------+---------------------+-------------------------------+
| General        | Vaccine             | ### Emergency                 |
| Supplies and   | Administration      |                               |
| Equipment      | Supplies            | ### Supplies                  |
|                |                     |                               |
| **\-\-\-\-\    | **\-\-\-\-\-\-      | ### \-\-\-\-\-\-\-            |
| -\-\-\-\-\-\-\ | \-\-\-\-\-\-\-\-\-\ | \-\-\-\-\-\-\-\-\-\-\-\-\-\-\ |
| -\-\-\-\-\-\-\ | -\-\-\-\-\-\-\-\-\- | -\-\-\-\-\-\-\-\-\-\-\-\-\-\- |
| -\-\-\-\-\--** | \-\-\-\-\-\-\-\--** | \-\-\-\-\-\-\-\-\-\-\-\-\-\-- |
|                |                     |                               |
| Tables         | Smallpox vaccine    | Standing orders for           |
|                | cooler/             | emergencies                   |
| Chairs         |                     |                               |
|                | refrigerator for    | Ampules of epinephrine 1:1000 |
| Water and cups | vaccine             | SQ                            |
|                |                     |                               |
| Paper          | Vaccine diluent     | Ampules of diphenhydramine    |
|                |                     | 50mg IM                       |
| Pens, pencils  | Sterilized          |                               |
|                | bifurcated needles  | 3cc syringes with 1\",        |
| Envelopes      |                     | 25-gauge needles              |
|                | "Sharps" containers |                               |
| Rubber bands   |                     | 1.5\" needles                 |
|                | Latex gloves        |                               |
| Tape           |                     | Tuberculin syringes with      |
|                | Latex-free gloves   | 5/8\" needles (for            |
| S              |                     |                               |
| tapler/staples | Antibacterial       | epinephrine)                  |
|                | handwashing         |                               |
| Scissors       |                     | Alcohol wipes                 |
|                | solutions           |                               |
| Post-it Notes  |                     | Tongue depressors             |
|                | Acetone             |                               |
| Clipboards     |                     | Adult and pediatric pocket    |
|                | Rectangle band-aids | masks with                    |
| File boxes     |                     |                               |
|                | Gauze               | one-way valve                 |
| Telephone      |                     |                               |
|                | Adhesive tape       | Adult and ediatric airways    |
| Paper towel    |                     |                               |
|                | Spray bottle of     | Tourniquet                    |
| Kleenex tissue | bleach              |                               |
|                |                     | Gurney                        |
| Table pads and | ###  solution       |                               |
| clean          |                     | Stethoscope                   |
|                |                     |                               |
| paper to cover |                     | Flashlight                    |
| table          |                     |                               |
|                |                     | Cots                          |
| for work site  |                     |                               |
|                |                     | Blankets                      |
| Garbage        |                     |                               |
| containers     |                     | Pillows                       |
|                |                     |                               |
| and trash bags |                     |                               |
|                |                     |                               |
| ID badges for  |                     |                               |
| staff          |                     |                               |
|                |                     |                               |
| List of        |                     |                               |
| emergency      |                     |                               |
|                |                     |                               |
| phone numbers  |                     |                               |
+----------------+---------------------+-------------------------------+
|                |                     | # Co                          |
|                |                     | mputer Equipment and Supplies |
|                |                     |                               |
|                |                     | \-\-\-\-\-\-\-\-              |
|                |                     | \-\-\-\-\-\-\-\-\-\-\-\-\-\-\ |
|                |                     | -\-\-\-\-\-\-\-\-\-\-\-\-\-\- |
|                |                     | \-\-\-\-\-\-\-\-\-\-\-\-\-\-- |
|                |                     |                               |
|                |                     | Computers                     |
|                |                     |                               |
|                |                     | Printers                      |
|                |                     |                               |
|                |                     | Paper                         |
|                |                     |                               |
|                |                     | Internet access               |
+----------------+---------------------+-------------------------------+
|                | # Crowd             |                               |
|                | Management Supplies |                               |
|                |                     |                               |
|                | \-\-\-\-            |                               |
|                | \-\-\-\-\-\-\-\-\-\ |                               |
|                | -\-\-\-\-\-\-\-\-\- |                               |
|                | \-\-\-\-\-\-\-\-\-- |                               |
|                |                     |                               |
|                | Signs for clinic    |                               |
|                | stations and        |                               |
|                |                     |                               |
|                | between stations    |                               |
|                |                     |                               |
|                | Queue partitions    |                               |
|                | (to keep            |                               |
|                |                     |                               |
|                | people in lines)    |                               |
+----------------+---------------------+-------------------------------+

**9.** **Disposal of Needles and Medical Supplies**

All vaccination operations should observe universal precautions for
preventing blood exposures and bloodborne pathogen transmission (i.e.,
hepatitis B and C viruses \[HBV, HCV\], and human immunodeficiency virus
\[HIV\]). Specific guidelines for the proper disposal of instruments and
other potentially contaminated material during a smallpox response
operation (see also Guide B - Vaccination Guidelines) are summarized
below:

1\. The following guidelines should be observed for appropriate disposal
of pre-sterilized bifurcated needles after use (when reuse of the same
needle is not planned):

-   Medical waste sharps containers should be available in the area
    where the sharp is used.

-   Bifurcated needles should be deposited into a sharps container
    immediately after use.

-   Arrangement should be in place for transport and destruction of
    filled sharps containers.

2\. Because bifurcated needles may be in short supply until more are
manufactured, they may

need to be resterilized for reuse. For proper handling of bifurcated
needles that need to be sterilized prior to use (i.e. received from the
manufacturer in bulk) and/or resterilized and reused (i.e., when
supplies are limited), specific guidelines have been provided in Section
H - CDC Recommendations for Handling, Cleaning and Sterilizing
Bifurcated Immunization Needles in healthcare Settings - of Guide B -
Vaccination Guidelines. Some of the key points to remember include:

-   Bifurcated needles can be resterilized and reused up to 50 times.

-   Needles received in bulk from the manufacturer are assumed to be
    clean and ready for packaging and sterilization. If there is any
    concern regarding the cleanliness of these items, they should be
    cleaned before sterilization.

-   Used needles must be cleaned prior to sterilization. The needles may
    be cleaned by placing them in a soaking solution after use and then
    cleaning with an ultrasonic cleaning device (preferable) or
    commercial dish/glassware washer.

-   Bifurcated needles that are cleaned and dried, are ready to be
    packaged and sterilized. Preferred methods of sterilizing are either
    autoclaving or by dry-heat sterilization. However, if an autoclave
    or a forced dry heat is not available, acceptable alternate methods,
    as described in Section H of the Vaccination Guideline, may be used.

3\. Medical waste, including gauze or cotton used during administration
of vaccine, other potentially contaminated material, and empty vaccine
vials should be bagged in appropriately marked biohazard bags and
incinerated or autoclaved on-site if possible. Specific guidelines for
proper handling of contaminated material have been provided in Guide F -
Decontamination Guidelines.

**10. Vaccine Security and Tracking**

Since the supply of smallpox vaccine is limited and the demand for
vaccine may be extremely high, care must be taken to protect the vaccine
supply from theft and fraud. In addition, because each vaccine vial
contains 100 to 500 doses, great care and preplanning must occur to
minimize vaccine wastage that may result from discarding partially used
vials. Because of these factors, each and every dose and vial must be
accounted for before and after each clinic session.

If CDC's electronic smallpox information system is use and data is
entered online in "real time" as vaccine recipients are being processed,
the number of doses administered will automatically be counted and
recorded as doses administered on the Daily *Smallpox Vaccine Tracking
Report*. If CDC smallpox data management system (SDMS) is used or not
operational, the number of doses administered must manually tallied from
the paper copies of the *Clinic Vaccination Records* of persons
receiving vaccine that day. If SDMS is not used or is not operational,
vaccine doses must be manually tallied at the end of each day in each
clinic location and entered on the *Daily Vaccine Tracking Record*.

The *Daily Smallpox Tracking Record* also requires entry of the
following additional information:

-   Beginning inventory balance, i.e., the number of vials and doses
    from the previous day

-   Vials/Doses received (i.e., the number of new vials and doses
    received during the day of the clinic)

-   Total doses administered by age and lot number (brought forward
    electronically or manually from the Smallpox Vaccine Administration
    Forms)

-   Ending Inventory (i.e., vials and doses at the end of the day)

The number of doses wasted will be determined automatically by SDMS
(*Beginning Inventory* plus *Doses received* minus *Ending Inventory*).
If paper forms are used, the number of doses wasted must be calculated
and entered manually.

**11. Communication Systems**

Each clinic must have a working phone, preferably with internet
connectivity so that forms can be accessed and data entered directly
into the CDC Smallpox Data Management System. If available,
walkie-talkies, cell phones, pagers should be distributed to the clinic
staff. Ideally, replacement batteries and/or battery chargers for each
device also should be made available. A list of important phone numbers
should also be distributed to all clinic staff.

**12. Post Clinic Activities**

Post-clinic activities are necessary to ensure that the event is
documented for the public record, to determine the cost of the operation
and to enhance efficiency for future efforts. In this context,
evaluation of smallpox clinics should include review of expenditures and
in-kind costs incurred in the operation, identification of gaps and
problems, recommended changes in emergency response plans, and a
description of implications for the public health infrastructure.

**RECOMMENDATIONS**

**FOR HANDLING AND STORAGE OF SMALLPOX VACCINE**

**[VACCINE]{.underline}**

Vaccinia virus vaccine (Dryvax) is a live-virus vaccine that must be
reconstituted with diluent. It is prepared from calf lymph. Manufacturer
is Wyeth..

**[DILUENT]{.underline}**

Prefilled syringes with transfer needle. Manufactured by Baxter.

# [CONDITION ON ARRIVAL]{.underline}

Vaccine should be between 2 to 8 °C (35 to 46 °F). Refrigerate upon
arrival.

Diluent should be between 2 to 8 °C (35 to 46 °F). Refrigerate upon
arrival.

## STORAGE REQUIREMENTS FOR UNRECONSTITUTED VACCINE AND DILUENT

**Vaccine:**

> Long-term storage - vaccine can be preserved indefinitely at --20 °C.
>
> Short-term storage - store in the refrigerator between 2 to 8 °C (35
> to 46 °F).
>
> Local Transportation and Day Use - Styrofoam containers and cool packs
> are adequate**.**

**Diluent:** Store in refrigerator between 2 to 8 °C (35 to 46 °F).

## DIRECTIONS FOR RECONSTITUTION

> [Reconstitution of Vaccine with Commercially Packaged
> Diluent]{.underline}
>
> Diluent is required for the reconstitution of the smallpox vaccine
> prior to administration. The previously licensed diluent for use with
> smallpox vaccine contained 50% glycerin, 0.25% phenol in Sterile Water
> for Injection USP, and 0.005% brilliant green. Reconstitution of a
> single vial of smallpox vaccine with 0.25 mL of diluent would yield
> approximately 100 doses. However, this pre-packaged diluent is no
> longer available. The diluent that will be utilized in this protocol
> is similar in formulation to the licensed diluent except that it lacks
> the 0.005% brilliant green. This change in formulation does not affect
> **the ability of the vaccine to produce immunity to smallpox**

[Directions for Reconstitution]{.underline}

###### Remove vaccine vial from refrigerated storage, allow vial to come to room temperature. 

###### Lift up tab of aluminum seal on vaccine vial. DO NOT BREAK OFF OR TEAR DOWN TAB.

1.  Wipe off vial stopper with an alcohol pad and allow to dry.

2.  Place vaccine vial upright on a hard, flat surface.

3.  Remove cap from the pre-filled syringe. Take a 1.0 cc syringe (e.g.,
    tuberculin syringe) and withdraw 0.25 mL from the opening in the
    prefilled diluent syringe. Inject the 0.25 mL of the diluent in the
    1.0 cc syringe into the vaccine vial to reconstitute the vaccine.

4.  Withdraw needle and syringe and discard in the appropriate biohazard
    sharps container.

5.  Allow the vaccine vial to stand undisturbed for 3 to 5 minutes.
    Then, if necessary, swirl vial gently to effect complete
    reconstitution.

6.  In the space provided on the vaccine vial label, record the date and
    time that the diluent vial was entered for the purpose of vaccine
    reconstitution. The vaccine is now ready for use.

## 

## STORAGE REQUIREMENTS FOR RECONSTITUTED VACCINE

Store reconstituted Dryvax in the refrigerator between 2 and 8 °C (35 to
46 °F).

## SHELF LIFE AFTER RECONSTITUTION

Reconstituted Dryvax may be used for 3 months if stored below 4 °C (39
°F), or preferably below 0 °C (32 °F) when not in use.

##### VACCINE LABELING AND PACKAGING

**1. Labels**

The existing inventory of smallpox vaccine was manufactured by Wyeth
Laboratories, Inc. The vaccine vials on hand at CDC have commercial
labels: \"Smallpox Vaccine, Dried, Calf Lymph Type, DRYVAX®". However,
they are considered an investigational new drug (IND) product because
they are now being used with a diluent other than the one originally
approved for use with them. These commercially-labeled vials have lot
numbers of seven digits.

The vaccine vials to be deployed in an emergency are stockpiled outside
of CDC. They have all been tested for potency, but have not gone through
the battery of tests for commercial release. Thus, they will have
neither a commercial label with a trade name, nor a National Drug Code
(NDC) number (assigned by FDA and manufacturer to uniquely identify all
pharamaceutical products and packaging). They will be labeled before
shipment with special IND labels (see figure for example). \>\>\>Policy
Issue\<\<\<

![](media/image1.wmf)

**2. Vaccine Packaging and Doses**

Although packaging may change in case of large-scale release for
deployment, the vaccine currently is contained as a freeze-dried pellet
in a glass vial of size comparable to single-dose vaccine vials in
current use, approximately 3.5 cm in height and 1.1 cm in diameter.

The vaccine must be reconstituted before use. The diluent used for
reconstitution contains 50% glycerin and 0.25% phenol in Sterile Water
for Injection, USP, for a final volume of 0.25 mL. It is packaged in
prefilled 0.25-mL syringes.

Fifty vials of vaccine are packaged in each carton (secondary
packaging). Up to 12 cartons will fill special \"VaxiCool\" insulated
shipping containers (about the size of a large Coleman®-style beer
cooler) without further tertiary packaging or overwrap. Diluent need not
be refrigerated and may be shipped outside of the VaxiCool containers.

Using current practice for standard reconstitution with 0.25 mL of
diluent per vial, it is calculated that vaccination with bifurcated
needle will allow approximately 100 vaccinations to be made from each
vial, which converts to 5000 vaccinations from each 50-vial carton of
vaccine, and up to 60,000 doses capable of being carried in one VaxiCool
container.

If clinical studies underway confirm the immunogenicity and safety of
further diluting each vaccine pellet to a total liquid volume of 1.25 mL
(1:5), then each vial of vaccine could theoretically be used to
vaccinate approximately 500 persons, each carton 25,000 persons, and
each VaxiCool 300,000.

##### Identification of Vaccine Lot Received

![](media/image2.jpeg){width="2.65625in"
height="1.2291666666666667in"}The identify of the vaccine and its lot
number received by the vaccine recipient must be transferred accurately
and conveniently onto the IND consent form, the clinic vaccination
record and the take-home proof-of-vaccination card. In conformance with
the guidelines of the Vaccine Identification Standards Initiative (VISI,
[www.cdc.gov/nip/visi](http://www.cdc.gov/nip/visi)), CDC plans to
supply with the vaccine peel-off stickers, approximately 2-inches wide
by 1-inch tall, on rolls or sheets. The following image illustrates such
a sticker:

Information on the peel-off stickers includes:

a\. The full, official, generic name of the vaccine

b\. The boldfaced standardized abbreviation for the vaccine type:
**SMAvac**

c\. The full name of the manufacturer and/or distributor (e.g., Wyeth
Laboratories, Inc.), and/or its VISI-conformant abbreviation (WAL).

d\. Other required text per the investigational nature of the product

e\. The lot number of the vaccine (and, possibly, the lot number of the
diluent on either the same or a separate sticker)

f\. The expiration date printed on the vaccine vial, identified by the
prefix \"Exp.\"

g\. A full-size UCC-EAN-128 one-dimensional barcode, or a Reduced Space
Symbology™ (RSS) two dimensional barcode, containing:

1\) An identifying number for the vaccine (in lieu of a National Drug
Code)

2\) The expiration date

3\) The lot number of the vaccine

4\) Check digits and article identifiers for the above

5\) An official "Proof of Vaccination" card or badge, documenting
vaccination for purposes of restricting entry into any *cordon
sanitaire* that may be established around known cases in isolation or
under quarantine

####### Technical Specifications for Sticker Production

1\. 40-pound liner "flexo" stock

2\. permanent adhesive

3\. water-resistant ink, label, and adhesive

4\. 2\" X 1\" die cut label, with 1/8\" gap, wrapped around cardboard
rolls

5\. 300 labels per roll

6\. Barcoding with X-dimension of minimum 8 mills