Appendix A: Aventis Pasteur Smallpox Vaccine (APSV)
with Dr. Brett Petersen.
The appendices will provide more information
on Aventis Pasteur Smallpox Vaccine, or APSV, and Imvamune.
However during a smallpox emergency, please refer
to www.cdc.gov/smallpox for the most updated information.
APSV, also referred to as "Wetvax,"
is a liquid formulation of calf lymph origin vaccinia virus
vaccine that has been maintained at -20 degrees Celsius
since it was manufactured in the 1950s.
APSV is a replication-competent smallpox vaccine
and was produced from a vaccinia seed stock derived
from the New York City Board of Health strain used
to create Dryvax and ACAM2000.
Currently, APSV is considered an investigational product
and will be utilized during a smallpox emergency only
after ACAM2000 has been exhausted
and after potency testing verifies
that the vaccine has retained its potency.
Individuals may be vaccinated with APSV either undiluted
or in a 1 to 5 dilution under an Emergency Use Authorization,
or EUA.
APSV is provided in 0.25 milliliter aliquots
in sterile 2.0 milliliter glass vials
which yields approximately 100 doses.
The formulation contains live vaccinia virus in 50% glycerol,
0.4% phenol, and 0.00017% brilliant green.
No antibiotics or other additives are present.
Each vial can be mixed with the diluent provided
to achieve a 1 to 5 dilution.
Once diluted, each vial will yield approximately 500 doses.
The diluent being utilized was manufactured
by Allergy Laboratories Incorporated in 2002
and contains 50% glycerin and 0.21% phenol in sterile water
for injection and is used for APSV dilution only.
The diluent vial contains 1.25 milliliters of diluent
but only 1 milliliter of diluent is needed
to make a 1:5 dilution of APSV.
Administration of APSV will be the same as with ACAM2000
by the percutaneous route via use
of a sterile bifurcated needle dipped into the vaccine.
Because APSV contains the same New York City Board
of Health vaccinia virus strain that was used to produce Dryvax
and ACAM2000, vaccine efficacy is expected to be similar
to that of the other replication-competent smallpox
vaccines.The safety profile of APSV is anticipated
to be similar to that of Dryvax and ACAM2000.
APSV vials will be shipped either at -20 degrees Celsius
or 2 to 8 degrees Celsius from the Strategic National Stockpile
with diluent vials shipped at room temperature.
Once the vaccines are received,
then undiluted APSV vials can be stored as follows:
If the vaccine is received frozen at -20 degrees Celsius,
the vaccine can be maintained either frozen
at -20 degrees Celsius, if freezer capacity is available,
or refrigerated at 2 to 8 degrees Celsius until use.
If APSV is received refrigerated at 2 to 8 degrees Celsius,
the vaccine must be stored refrigerated
at 2 to 8 degrees Celsius.
Do not refreeze.
Store diluent vials at room temperature.
Once thawed, APSV, whether undiluted or diluted to 1 to 5,
must be used within 24 hours if maintained
at room temperature post-thawing.
Store thawed APSV vials at 2 to 8 degrees Celsius
if not used immediately.
APSV, whether undiluted or diluted to 1 to 5,
maintained at 2 to 8 degrees Celsius may be used
up to 21 days post-thawing.
Anticipatory guidance for vaccinees and for individuals
that cannot receive the vaccine will be the same
as those of ACAM2000.