Smallpox Vaccine Storage and Handling
How do you suggest protecting the smallpox vaccine from light between
It is not necessary to protect the vaccine from light. The vaccine package insert does
not indicate that the vaccine is light sensitive. (Dec 16, 2002)
What do we do with the smallpox vaccine if we determine it has been
frozen? If it hasn’t been reconstituted, wouldn’t it be okay?
You should contact the manufacturer for a determination. (Dec 16, 2002)
Do we really need to use cardboard to separate the vaccine from the cold
packs? We’ve always used paper.
Any inert substance may be used to separate the vaccine from the cold source. This
may be corrugated cardboard, crumpled paper, styrofoam peanuts, etc. (Dec 16, 2002)
Do we need to worry about maintaining the vaccine at a certain temperature
while it’s out during the vaccination clinic?
Normal ambient room temperature is acceptable. (Dec 16, 2002)
What are the guidelines for care and handling of the vaccine vial?
Both unreconstituted and reconstituted vaccine should be stored at between 2 and 8
degrees C when not in use. It may be kept at normal room temperature during the
course of a clinic session and then placed back into refrigeration. The vaccine is good
for 90 days after being reconstituted and may be taken in and out of refrigeration as
many times as needed during the 90-day time frame. (Feb 21, 2003)
How long can reconstituted smallpox vaccine be stored?
Properly reconstituted and maintained Dryvax vaccine can be stored and used for 90
days after being reconstituted. During that time it may be kept at normal room
temperature during the course of a clinic session and then placed back into
refrigeration at 2 to 8°C when not in use. The reconstituted vaccine can remain in
storage between 2 to 8°C when not in use during those 90 days. (Feb 21, 2003)
The package insert says the reconstituted vaccine should be stored for 15
days. Why is there a discrepancy?
Wyeth Pharmaceuticals, the manufacturer of Dryvax, sent a letter to the attention of
CDC stating that the FDA approved additional data that Wyeth submitted to support
the storage of the reconstituted vaccine for 90 days at 2 to 8°C. This letter will
accompany each kit of vaccine. Please note that the date of reconstitution should be
recorded directly on the vaccine vial in the space provided. (Mar 13, 2003)
How do we get the stability holders mentioned during the broadcast?
Stability holders will be shipped as part of the supplies provided by the National
Pharmaceutical Stockpile. (Mar 13, 2003)
Can vaccine that has been reconstituted and used for 4 hours be
refrigerated overnight and then reused the next day?
Yes. Please follow the package insert directions (Store reconstituted vaccine at 2-8
degrees C [36-46 degrees F] when not in actual use. The vaccine may be stored for
no more than 90 days after reconstitution). (Mar 13, 2003)
What should be done with a spilled open vial?
The spill should be cleaned with a "tuberculocidal" agent, and the contaminated
cleaning material disposed as infectious waste. (Mar 13, 2003)
*Material used with permission of CDC.