WEBCAST TRANSCRIPT

Transcript of "Smallpox Vaccine Logistics: Distribution, Storage, and
Security"\
Presented by Dr. Sue Gorman, 5 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/logistics.ppt](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/logistics.ppt)
and
[www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/logistics.pdf](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/logistics.pdf).)

Sue Gorman, PharmD, Associate Director for Science, National
Pharmaceutical Stockpile Program, Office of Terrorism Preparedness and
Response, CDC

(Slides 1 and 2 are title and objectives, respectively)

# GORMAN:

Before I begin the logistics portion of my presentation, I would like to
give everyone a very brief overview of the National Pharmaceutical
Stockpile program.

## Slide 3

Our concept for responding to a large-scale public health emergency or
terrorism event involves providing rapid delivery of a broad spectrum of
support, including pharmaceuticals and other medical supplies in the
early hours of an event to allow local authorities to begin to respond
to an ill-defined threat. Additionally, we can provide shipments of
large and continuous quantities of specific items once a threat is
known. Finally, we can provide technical assistance by sending our
Technical Advisory Response Unit (TARU), which is compromised of five to
seven individuals from the National Pharmaceutical Stockpile, to help
the affected area receive, distribute, dispense and reorder National
Pharmaceutical Stockpile assets. The TARU will remain at the affected
area for as long as there is a need.

## Slide 4

The National Pharmaceutical Stockpile program will use the following
options to respond to an event. Broad spectrum support is provided by
what we refer to as 12-hour push packages. 12 hours, because they will
arrive at the affected area in 12 hours or less after the federal
decision to deploy the assets, and push package, because specific items
do not need to be requested. We will push out over 90 different items in
the hope that some portion of these will be useful in the early hours of
an ill-defined threat. Our push package weighs more than 50 tons and is
packaged in 130 specialized cargo containers. The containers will arrive
by either air or ground and fill the body of a wide-body cargo jet or
eight semi tractor-trailers. Specific item support may include large
quantities of items such as antibiotics that are also in our push
packages or other items such as vaccines or ventilators that we store
and ship separately as they are needed. Many of the items in the
National Pharmaceutical Stockpile are held and maintained by our
commercial partners until we direct their shipment. We refer to these
items as Vendor Managed Inventory or VMI. In the event an item is needed
that is not found on the formulary, we\'re able to exercise our buying
power or surge capacity by working with our acquisition partner, the
Department of Veterans Affairs National Acquisition Center to rapidly
procure the item from the private sector and deliver it to the affected
area. We will also be able to respond with vaccines for pre- event
distribution or post-event distribution as needed. Vaccines are not
stored as part of the 12-hour push packages.

## Slide 5

Now I\'d like to move on to the logistics portion of the presentation
starting with distribution. We will begin shipping vaccine based on
approval of state or project area plans. The vaccines will be packaged
at National Pharmaceutical Stockpile program repositories for direct
shipment to the normal distribution points within the project areas.

## Slide 6

Shipments will be made on Monday, Tuesday and Wednesday of each week and
all shipments will be sent by National Pharmaceutical Stockpile program
commercial partners for overnight delivery. You can expect to receive
your shipment of vaccine by 10:30 in the morning on the following day.

## Slide 7

After the project areas plans have been approved, which should take 48
hours for turn-around and any time needed for changes and final
sign-off, and the National Pharmaceutical Stockpile program is advised
to begin shipping the vaccine, it will take 14 days to complete the
shipping process. The shipments will arrive in EnduroTherm insulated
Styrofoam shipping containers. The vaccine being shipped out at this
time is the licensed Wyeth Dryvax vaccine, and all ancillary supplies,
such as bifurcated needles, diluent, and transfer needles, will be found
in the vaccine kit. Each kit will be able to provide the capability to
inoculate 100 persons.

## Slide 8

The EnduroTherm shipping container is packaged by a validated protocol.
The small container, which measures 16 by 13 by 14 inches, can hold
between one and four vaccine kits. The medium container, measuring 19 by
13 by 17 inches, can hold between 5 and 14 kits. And the large
container, measuring 23 by 23 by 24 inches can hold between 15 and 45
kits.

## Slide 9

This slide shows the insulated EnduroTherm shipping containers. The
EnduroTherm containers contain gel packs that are either refrigerated or
frozen, depending on where the container is being shipped, and what the
ambient temperature is depending on the time of year. The container is
packed according to a validated blueprint. These blueprints have been
tested and validated in controlled environmental chambers. The chambers
simulate all sorts of environmental variables that could occur during
the initial shipment process. All of the National Pharmaceutical
Stockpile protocols on these EnduroTherm shippers must maintain 72 hours
of controlled temperature at 2 to 8 degrees Celsius. The containers are
reusable, however, they should not be reutilized for redistribution
within your state. The containers have a return ship-to address on them
in order for you to return them to the National Pharmaceutical Stockpile
program.

## Slide 10

Now I\'d like to discuss what you can expect to get in your shipments.
The shipments will contain vaccine. Currently we\'ll be shipping the
licensed Wyeth Dryvax vaccine. This vaccine needs to be constituted with
diluent. The diluent is provided in the kit, with one vial of diluent
for one vial of vaccine. The ratio of dilution will be 1 to 1 for this
licensed vaccine. Bifurcated needles are part of the kit with 100
needles in each kit. There is also one transfer needle in each kit so
can you put the diluent into the vial of vaccine.

## Slide 11

The shipments will also contain the package insert for the vaccine and
100 lot number stickers that can be used to affix to the patient\'s
medical record or chart. VIG, Vaccinia Immune Globulin, which is used
for treating certain serious adverse events to the smallpox vaccine will
not be shipped out as part of the initial shipment. VIG will be shipped
on a case-by-case basis as the need is validated.

## Slide 12

There are several products that the National Pharmaceutical Stockpile
program will not be shipping. States or cities or project areas need to
work with local providers and manufacturers to identify the availability
of these products. However, they are usually readily available and are
used in all manner of care. These include non-latex gloves for those
administering the vaccine, gauze pads and cloth or paper tape and
semi-permeable transparent bandages for dressing the vaccination site.

## Slide 13

Additional supplies that will need to be located locally and will not be
shipped by the National Pharmaceutical Stockpile program include
zip-lock type plastic bags to provide vaccinated persons with a supply
of gauze pads, tape and bandages; sharps containers for disposal of
bifurcated needles and transfer needles; and medical waste bags for the
disposal of contaminated bandages or dressings. We will also not be
shipping alcohol or alcohol wipes and we do not recommend that you
procure these locally.

## Slide 14

Now I\'d like to move on to the responsibilities of the project area as
far as distribution and redistribution. In order for us to ship the
vaccine to you, you must provide us with a point of contact and an
alternate point of contact as well as telephone and fax numbers for
those people. We will also need a valid ship-to address for the delivery
of the vaccine. This must be a street address. Post office box addresses
will not be acceptable. We also will need to know the estimated number
of vaccine doses that your project area will require.

## Slide 15

Once the National Pharmaceutical Stockpile program has made the initial
shipments to your designated normal distribution points within your
project area, any redistribution that takes place will be the
responsibility of the project area. Cold chain management must be
maintained throughout any redistribution that take place. This means
that the temperature must be maintained and logged to ensure there are
no variations or interruptions in the temperature. The temperature is
required to be maintained at 2 to 8 degrees Celsius during storage and
movement.

## Slide 16

The National Pharmaceutical Stockpile program will be able to provide
further guidance on proper cold chain management technique and supply
practices if the project areas have any questions on these practices. To
provide some guidance on redistribution practices, I would like to
discuss approved commercial systems that are available to assist in
redistribution. These systems are called Vaxicools and Vaxipacs. The
National Pharmaceutical Stockpile program will not be providing these
containers for the project areas' redistribution needs. These systems
can be ordered commercially by the project areas if they so desire.

## Slide 17

These photos depict the Vaxicool units. The Vaxicool system in basic
terminology is a portable refrigeration unit, however, it incorporates
state-of-the-art electronics to ensure that proper cold chain standards
remain constant. This system has three alert capabilities to warn the
user of any deviation from the desired temperature range. These include
digital readouts, temperature warning lights and audible alarms. These
systems have been field tested and used around the world for
distribution of vaccine by the Department of Defense for a number of
years.

## Slide 18

All of the Vaxicools in the National Pharmaceutical Stockpile program
are dual units. This allows us to store the vaccine at minus 20, and
with the flip of a switch, we can bring the product to 2 to 8 degrees
Celsius. That is the temperature required at the time of inoculation.
These units are able to run on internal battery power for 60 hours,
before requiring recharging or they can run on electrical power. In
addition to battery and electrical power, it is also possible to hook up
a solar panel which will recharge the battery in order to keep the
system running. The Vaxicool unit weighs 110 pounds and can hold 1 to 28
vaccine kits.

## Slide 19

These pictures show a smaller unit called the Vaxipacs. The Vaxipacs are
designed to be complimentary to the Vaxicool or another approved
refrigeration unit. The basic concept is to take a small number of vials
of vaccine from a larger storage area and redistribute them through
hospital or regional area for a short period of time. The Vaxipac
utilizes chemical and vacuum insulated technology as opposed to the
state-of-the-art electronics found in the Vaxicool.

## Slide 20

A Vaxipac is a small portable carrier that when packaged according to
protocol will maintain a temperature range of 2 to 8 degrees Celsius for
24 hours. Inside the Vaxipac is an inner cooler called a Vaxisafe. The
Vaxisafe is a unique phase-change material that must be chilled in the
refrigerator for at least 24 hours before being placed in a Vaxipac. A
Vaxipac can hold up to three prepackaged vaccine kits along with the two
required Vaxisafes. These components are reusable. Both of these items
are an approved method of moving vaccines by the National Pharmaceutical
Stockpile program and the Department of Defense. There may be additional
methods of shipping that have been approved by your project area.

## Slide 21

All vaccine kits must be maintained at 2 to 8 degrees Celsius. Proper
refrigeration must be in place at the point of delivery. A temperature
reading log must be maintained on the refrigeration system that you are
using. This is to ensure that the vaccine has not been compromised. This
will also aid us if the National Pharmaceutical Stockpile ever decides
to recover any unused vaccine. We ask that for any redistribution plan
you have in place, you will provide the details of how you will maintain
cold chain management throughout the process.

## Slide 22

The final topic that I would like to address is that of security. In the
Code of Federal Regulations, there are standards that should be adhered
to relating to the safeguarding of pharmaceuticals and vaccines. We have
provided you with a web page and specific 21 CFR chapters in the
planning guidance that has previously been sent out. We recommend using
fixed storage facilities as part of your plan in order to reduce risk.
These could include hospitals, clinics or other buildings with
appropriate refrigeration in place. A mobile storage facility with
refrigeration such as a bloodmobile will not provide adequate security.
The fixed facility and the storage system must provide controlled
access. The facility should also be monitored by either electronic
surveillance, such as camera systems or infrared detection or the
presence of physical security patrols.

## Slide 23

I would like to wrap up with a few important reminders. The vaccine
should never be frozen. It should be stored at 2 to 8 degrees Celsius.
For the licensed Wyeth Dryvax vaccine that we will be shipping, after
reconstitution with the diluent, the vaccine must be used within 30
days. This is different than the package insert. The package insert says
the vaccine after reconstitution must be used within 15 days. After the
package inserts were printed additional information was provided to the
Food and Drug Administration that supported use up to 30 days after
reconstitution. A letter stating this change will be included with your
shipment.

## Slide 24

For additional information on cold chain management practices, I invite
you to call or e-mail the National Pharmaceutical Stockpile program at
the number (404.639.0459) and Email address (nps_ppt@cdc.gov) on the
screen.

# GORMAN:

I have reviewed several important topics today on various logistical
issues including storage, security, redistribution and distribution of
vaccine. Having adequate processes in place to address these issues will
ensure that our shipments and your redistribution process flow smoothly.
However, the most important take-home message from my presentation today
is to maintain adequate cold chain management practices throughout the
process. This will ensure that the vaccine integrity is never
compromised. Thank you.

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)