Chapter 2 Part A: Description and preparation
of the ACAM2000 smallpox vaccine,
with Dr. Brett Petersen.
In Chapter 2 of this training video, we will describe
and discuss the preparation
of ACAM2000 using the diluent provided and the technique used
to administer the vaccine called the multiple puncture
vaccination technique, often referred to as scarification.
We will also describe how to determine a successful response
to smallpox vaccination, or a "vaccine take."
ACAM2000 is provided as a lyophilized preparation
of purified live vaccinia virus and has trace amounts
of neomycin and polymyxin B. The diluent provided
for reconstitution of ACAM2000 contains glycerin
and phenol in water.
The ACAM2000 vaccine is stored frozen until distribution.
Once distributed, unopened ACAM2000 vials may be stored
refrigerated at 2 to 8 degrees Celsius or 36
to 46 degrees Fahrenheit for up to 18 months.
These are the supplies necessary for vaccine preparation
and administration: A vial of ACAM2000,
diluent for reconstitution, syringes with needles
for reconstitution, and bifurcated vaccinating needles
for vaccine administration.
Additionally, you will need alcohol swabs, gloves,
dry gauzes, medical/first-aid adhesive tape, and leak-proof,
puncture-proof biohazard container
and biohazard sharps container.
Of note, paper tape, although less adhesive,
should be made available to persons
with high sensitivity to cloth tape.
As a vaccine administrator, you should be aware
of the following general information:
During a smallpox emergency,
you should consider being vaccinated yourself
because of your high risk
of inadvertent exposure to vaccinia virus.
In a pre-event situation,
ACAM2000 vaccination should be offered
to you unless you have a contraindication to vaccination.
You should wear surgical or protective gloves when preparing
and administering ACAM2000.
It is important to wash your hands and change gloves
between patients to avoid spread of the virus
to yourself and/or your patient.
Additionally, avoid contact of ACAM2000 to your skin,
eyes and mucous membranes.
If you have been recently vaccinated with ACAM2000,
then you will need to take extra precautions
to cover the active vaccination site
with an additional semipermeable dressing while working
with patients until the scab falls off.
If you are at high risk for serious adverse events
from a replication-competent smallpox vaccine,
then you should not handle or administer the ACAM2000 vaccine.
Before administering ACAM2000, proper reconstitution
of ACAM2000 with the provided diluent is important
to successful vaccination.
It is important that you follow these instructions carefully.
The ACAM2000 vaccine vial should be removed from cold storage
and brought to room temperature, 20 to 25 degrees Celsius or 68
to 77 degrees Fahrenheit, before reconstitution.
The diluent provided for reconstitution is maintained
at room temperature and is ready for immediate use.
Don gloves, then remove the flip cap seals
from the vaccine and diluent vials.
Wipe each rubber stopper with an alcohol swab
and allow the stoppers to dry completely.
Using aseptic technique
and a sterile one milliliter syringe fitted with a 25
by 5/8 inch gauge needle, draw up 0.3 milliliters of diluent
and transfer the entire content
of the syringe to the vaccine vial.
Note that the diluent vial will contain more diluent
than needed.
Only use 0.3 milliliters of diluent
to reconstitute the vaccine.
Gently swirl to mix but try not to get the product
on the rubber stopper.
The reconstituted vaccine should be a clear to slightly hazy,
colorless to straw-colored liquid and free
from extraneous matter.
Visually inspect the reconstituted vaccine
for particulate matter
and discoloration prior to administration.
If particulate matter or discoloration is observed,
do not use the vaccine and safely dispose of the vial
as a biohazardous material.
Record the date the vaccine was reconstituted.
Once reconstituted, the ACAM2000 vaccine vial has approximately
100 doses of 0.0025 milliliters
of live vaccinia virus containing 2.5 to 12.5 times 10
to the fifth plaque forming units per dose.
After reconstitution, the vaccine must be administered
within 8 hours if kept at room temperature throughout the
workday and then discarded appropriately.
If not used immediately after reconstitution,
store reconstituted vaccine refrigerated
until ready for administration.
Reconstituted vaccine may be stored refrigerated at 2
to 8 degrees Celsius or 36
to 46 degrees Fahrenheit for up to 30 days.
The expiration date of reconstituted vaccine begins
on the date that the vaccine was mixed.
Reconstituted vaccine may be returned to refrigerated storage
for future use if it has been exposed
to room temperature conditions for less than 8 hours at a time.
This cycle can be repeated for as many times as is practical,
so long as it is within the 30 days of the reconstituted date.
After 30 days or after the expiration date,
you can discard the vaccine vial in a biohazard sharps container,
if your facility has a biohazard program in place, or autoclave
or incinerate the vials.
Please follow your local
or state regulation for medical waste.
If medical wastes are buried, then it should be soaked in a 1
to 10 dilution of bleach
for at least 10 minutes prior to disposal.