WEBCAST TRANSCRIPT

Transcript of "Introduction to Developing a Vaccination Strategy for
Smallpox Preparedness"\
Presented by Dr. Walter Orenstein, 6 December 2002, on the satellite
broadcast of "CDC Bioterrorism Update: Smallpox Preparedness"

(Associated graphics can be found at
[www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/develop-vac-strat.ppt](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/develop-vac-strat.ppt)
and
[www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/develop-vac-strat.pdf](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/develop-vac-strat.pdf).)

Walt Orenstein, MD, Director, National Immunization Program, CDC

# ORENSTEIN:

Hello, I'm Walt Orenstein, Director of the National Immunization Program
at CDC. Today, I will briefly discuss additional supplemental guidance
for recipients of federal funding through the Public Health Preparedness
and Response for Bioterrorism Cooperative Agreement for the purpose of
supporting smallpox preparedness and response. This supplemental
guidance amends the Guidance for Post-event Smallpox Planning issued by
CDC on October 28, 2002, and provides additional specificity to support
the vaccination of healthcare and public health smallpox response teams.
CDC will provide technical assistance to cooperative agreement
recipients or grantees throughout the program, for both planning and
implementation, as well as smallpox vaccine, once grantee plans are
approved.

## Slide 2

In Europe, between 1950 and 1971, more than 50% of transmission by
imported smallpox cases occurred in hospitals. Health care workers
accounted for about 20 percent of all cases after these importations.

## Slide 3

Mathematical modeling suggests the contagiousness of smallpox is reduced
by half if transmission in health care settings is stopped. The reasons
for this last finding are clear: smallpox spreads from very sick
patients, who are the most likely to go to hospitals for care.

## Slide 4

The goal of this program is to increase the nation's smallpox
preparedness capacity by offering vaccination safely to two groups:
First, volunteer public health teams to conduct investigations and
outbreak control for the initial cases of a smallpox event. And second,
to key volunteer healthcare workers who would treat and manage the
initial smallpox cases and suspects.

## Slide 5

The supplemental program guidance was issued November 22, 2002, and the
plans are due to CDC on Monday, December 9. The guidance supplements
earlier guidance issued for plans for smallpox outbreak control, which
were to have been submitted to CDC by December 2. Throughout this
broadcast, the required eleven elements have been and will be covered in
much more detail than I will cover now. Immunization operations should
be completed within 30 days of the program's announced start date.

## Slide 6

The first element is Organization and Management. Public Health
Preparedness and Response for Bioterrorism state and local grantees will
be responsible for implementing and managing the smallpox immunization
program. Each grantee must appoint a coordinator for the smallpox
immunization program. Advice on program implementation should be sought
from the health department's Bioterrorism Advisory Committee and
appropriate healthcare partners.

## Slide 7

State and local grantees will identify: management personnel by title,
program function, contact information; the timeline for program
implementation; an organizational chart showing the structure and
management of the smallpox immunization program.

## Slide 8

State and local health departments will determine: the estimated number
of hospitals and healthcare response teams expected to participate; a
policy defining hospital responsibilities, including pre-program
education, screening, adverse event evaluation, and treatment, daily
vaccination site management, and evaluation of vaccination takes; the
estimated number and occupational types of healthcare personnel expected
to be vaccinated, and a timeline for selection of hospitals and
individual health care workers and the vaccination of healthcare
response teams.

## Slide 9

Each grantee should have at least one public health smallpox response
team. Each team should include a medical expert as team leader, public
health advisors, medical epidemiologists, nurses, disease investigators,
diagnostic laboratory scientists, including those assigned to perform
vaccinia and orthopox diagnostics within the Laboratory Response Network
or LRN, vaccinators, and other necessary personnel as determined by
state and local officials. The Advisory Committee on Immunization
Practices suggests that where possible previously vaccinated public
health personnel be made part of the response teams.

## Slide 10

Health care response teams should be selected so that each participating
hospital has enough vaccinated staff to care for a smallpox patient or
patients for 7-10 days. Team members should be appropriate for the
institution, such as staff from emergency departments and intensive care
units.

## Slide 11

In considering selection of clinic sites and vaccination teams, CDC
envisions limiting the number of vaccination clinic sites in each
grantee area to a few, fixed, geographically distributed sites. In
addition, grantees may choose to use clinic teams or sub-teams that
operate from a clinic base to perform vaccinations as required by
population and hospital distributions. The rationale for this includes:
the packaging of smallpox vaccine in 100 dose vials, the currently
limited supply of smallpox vaccine, the need for careful vaccine
handling that minimizes wastage and ensures security, and the level of
supervision and expertise required to maintain the highest quality of
patient screening and vaccination practices, thereby maximizing the safe
use of the vaccine.

## Slide 12

Each grantee will be responsible for determining: the number and
tentative location of clinic sites; a timeline for selection of clinic
sites and clinic vaccination teams; a plan for training members of the
clinic teams and for providing supervision management and evaluation of
the clinic and clinic team members; the intended days and hours of
clinic operation; and the estimated total number of clinic personnel
needed.

# ORENSTEIN:

In considering vaccine logistics and security, you should know that CDC
is prepared to ship vaccine to all 62 grantees and will be responsible
for security from the repository designated by each grantee. CDC will
provide smallpox vaccine, vaccine handling instructions, cold chain
management guidance, and all appropriate documentation. CDC will deliver
Dryvax smallpox vaccine, packaged and shipped in increments as small as
one vial, or 100 doses.

## Slide 13

Licensed vaccine is packaged as a 'kit' made up of 1 vial smallpox
vaccine, 1 vial of diluent for 100 doses, 100 bifurcated needles, one
transfer syringe and needle, package insert and lot number stickers.
This vaccine, reconstituted with the diluent, can be used over several
clinic sessions, if handled correctly.

## Slide 14

Every grantee will be responsible for: description of the process for
ensuring adequate screening of potential vaccinees; plans to ensure
clinics have adequate supplies and equipment and educational and
screening materials and a timeline for implementing clinic operations.

## Slide 15

An important part of clinic operations is CDC's recommended two-step
vaccination process. In step one, potential vaccines will receive
information about the program, including vaccine contraindications and
options for screening tests, usually at their hospital or place of work.
Potential vaccinees will then have time to decide about any need to
consult their family members, physicians, or receive screening tests,
such as those for HIV infection or pregnancy, both of which conditions
are contraindications for vaccination. In step two, some days later,
those agreeing to be vaccinated will go to a designated vaccination
clinic, and be vaccinated.

# ORENSTEIN:

Vaccine safety monitoring, reporting, treatment and patient referral is
essential to the success of this vaccination program. Grantees' plans
must describe how they will interface with a Smallpox Immunization
Safety System that will be described elsewhere in this broadcast.

## Slide 16

State and local health departments will provide general education and
training on the components of the smallpox vaccination plan for their
own staff, as well as those from hospitals, professional organizations,
and others. A variety of methods, venues, and materials can be used. CDC
will provide and deliver training and educational materials in a variety
of methods including live satellite broadcasts, webcasts, audiocasts,
videotapes, CD ROMS, web-based and printed materials.

# ORENSTEIN:

Detailed information and data will be needed on an ongoing, real-time
basis to inform policy makers, health officials, clinic managers, and
the public about the status of a smallpox vaccination program. Data
derived from the clinics must be analyzed frequently to enable managers
at all levels to identify and resolve problems, evaluate progress toward
meeting objectives and redirect the activities, as necessary.

## Slide 17

Grantees will choose from one of the three following options for
providing smallpox vaccination information to the CDC: one, use the
Pre-Event Vaccination System, or PVS, with named data; two, use the PVS
application without named data; or three, perform data exchange with the
CDC from a certified, alternative state system. Grantees are strongly
encouraged to pursue option 1 or option 2 until certification of data
exchange from an alternative system is established. The use of named
data is solely for the support of state functionality of the PVS
application. The CDC will not use named data. Grantees will also
describe how the State and clinics will support and integrate with the
Vaccine Adverse Events Reporting System or VAERS, and PVS.

## Slide 18

Effective communication is essential. Medical and public health
professionals and the public must realize the purpose of this activity.
Federal, state, and local health officials, hospitals and provider
professional organizations are collaboratively responding to strengthen
the nation's ability to effectively manage a smallpox emergency if one
were to occur. Given the short timetable for program implementation,
grantees are encouraged to use existing CDC communications materials but
should develop grantee-specific communication when time allows. In
addition, they should identify a point of contact responsible for
communications associated with this activity, and address critical
communication issues, such as the purpose of the smallpox vaccination
program and vaccine safety monitoring.

## Slide 19

The final point I will cover is that of reporting requirements. Grantees
will be required to submit semi-weekly status reports on each Monday and
Thursday throughout the vaccination program. These reports should be
submitted to National Immunization Program's Data Management Division.
\[PAUSE\]

# ORENSTEIN:

The implementation of a vaccination program for smallpox preparedness
and response will be a challenge for all of us. We look forward to
working with you to accomplish this important public health effort.

END

For more information, visit
[www.cdc.gov/smallpox](http://www.cdc.gov/smallpox), or call the CDC
public response hotline\
at (888) 246-2675 (English), (888) 246-2857 (Español), or (866) 874-2646
(TTY)