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Questions and Answers About Smallpox Vaccine Storage and Distribution

What is smallpox vaccine?
The smallpox vaccine helps the body develop immunity to smallpox. The vaccine is made from a virus called vaccinia which is a "pox"-type virus related to smallpox. The smallpox vaccine contains the "live" vaccinia virus—other vaccines containing live virus include measles, mumps, and German measles. For that reason, the vaccination site must be cared for carefully to prevent the virus from spreading. Also, the vaccine can have side effects. The vaccine does not contain the smallpox virus and cannot give you smallpox.

If an outbreak occurs, will the Strategic National Stockpile be able to quickly ship smallpox vaccine?
The Strategic National Stockpile plans to distribute smallpox vaccine on the first day of a bioterrorism event to anyone who has been exposed. After that initial shipment, CDC will ship smallpox vaccine over the next 5-6 days to the rest of the country as needed.

How is smallpox vaccine shipped?
The smallpox vaccine will be shipped in Vaxi-Cool™ containers in order to maintain the proper temperature of between 2° and 8° degrees Celsius. Programs should make arrangements to immediately move the vaccine into refrigeration units maintained at those same temperatures upon arrival and return the Vaxi-Cool™ containers to CDC as quickly as possible so that more shipments can go out.

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 30 days after being reconstituted and may be taken in and out of refrigeration as many times as needed during the 30-day time frame.

Can reconstituted vaccine be transported to another vaccination clinic within the state?
Yes, reconstituted vaccine can be transported as long as cold chain is maintained throughout the process.

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.

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 to use?
The manufacturer (Acambis) recommends storing the vaccine between 2 and 8 degrees Celsius only. After reconstitution, ACAM2000 vaccine may be administered during a 6 to 8 hour workday at room temperature (20-25°C, 68-77°F). The Department of Defense Deployment Guidance ( states “For the Vaccine and the Diluent, Stability, Potency, and Chemical Integrity of the component mixtures appear to be unaffected by short duration storage and/or temperature fluctuations or excursions in the range from -20°C to +8°C.” If the vaccine is determined to have been frozen, or if there has been any compromise of the vaccine shipment, call the Strategic National Stockpile (SNS) immediately for guidance.

Are immunization programs required to provide uniformed security guards for their smallpox vaccine?
The Strategic National Stockpile (SNS) has indicated that there are no security requirements per se and that the level of security is really to be determined by the state or local government where the vaccine is being used. Further, the SNS stated that the formulation of smallpox vaccine security measures should be based upon risk assessments available to state and local governments. CDC expects the states to keep the vaccine safe and secure, as any other vaccine, following the Code of Federal Regulations. Smallpox vaccine must be stored in fixed storage facilities with controlled access to both the facility and storage system with surveillance and/or security staff provided. Armed guards on constant duty at the storage facility are not expected. Once vaccine is distributed to the dispensing clinics, the same precautions for protecting any vaccine should be used.

Do individuals who are involved in the packaging, shipping, general handling, or distribution of the smallpox vaccine need to be vaccinated themselves?
CDC only provides smallpox vaccine that has been properly packaged by companies with adequate manufacturing and production quality control or quality assurance standards in place. Because these quality control or assurance procedures ensure a properly packaged vaccine product, it is not necessary to vaccinate individuals who routinely package, ship, handle, or distribute small quantities of smallpox vaccine. If there is concern because an individual managing the vaccine distribution has contraindications, the shipper can either use gloves when handling smallpox vaccine shipments or another person without contraindications to the vaccine should handle the vials, especially if there has been any damage to the vials in transit.

Before it is reconstituted, does smallpox vaccine pose a hazard?
Accidental vaccination, as a result of contacting dry vaccine after a spill, has not been documented, although it is theoretically possible. The parenteral route of accidental vaccination is plausible if an abrasion exists or a portal of entry is created by the glass of a broken vial. Risk of accidental vaccination as a result of inhalation should be considered remote; there have been no documented cases of serious adverse events associated with this exposure. All of the known potential adverse reactions associated with smallpox vaccine may result in the event of accidental vaccination.

What should be done when reconstituted or unreconstituted smallpox vaccine is spilled?
Smallpox vaccine contains a poxvirus called “vaccinia.” Unreconstituted or reconstituted, vaccinia is potentially infectious and should be treated using Biosafety Level 2 (BSL2) precautions. The techniques used for Universal Precautions suffice as protection for clean-up. Spilled smallpox vaccine should be cleaned with a solution containing 10% household bleach and 90% water. The solution should be prepared immediately prior to use, as it is less effective if it is more than one day old. For optimal disinfection, use household bleach which has been opened for less than 3 months. Absorb the spill with paper towels and then slowly pour the bleach from the edge of the spill towards the center. Allow absorbed spill to sit for 20 minutes; then clean it up. Wipe the area with towels soaked in the bleach solution, followed by clean water. The area is now disinfected. In clinical settings, the waste should be disposed of as biohazardous or regulated medical waste.

If a clinic has concerns about the viability of vaccine, to whom can they speak?
They should contact the manufacturer.

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