VARIVAX and ZOSTAVAX - Shipping Insert and Transport Information

"Merck, the manufacturer of VARIVAX and ZOSTAVAX has recently changed the shipment packaging for these frozen vaccines and issued new FDA approved guidance regarding caution in the use of dry ice for storage of frozen vaccines.  New shipment packaging became effective June 6, 2011.

Merck no longer ships these vaccines to customers on dry ice as they did in the past.  The quantity of gel packs placed in the container is based on carefully determined guidelines that are designed to maintain proper temperatures for three days from the shipment date located on the packing list.  It also takes into account the maximum temperature to which the container will be exposed, the time in transit, and the need to keep the vaccine at the appropriate temperature during shipping. If the container is received after the three-day shipping time period, the provider should contact the Merck Order Management Center immediately for replacement instructions at 1-800-637-2579.  Such requests for replacements must be received by Merck within 15 days of the original shipment date.

Shipments now contain shipper inserts in brightly distinguishable colors (attached) that inform the recipient of the new pack-out, storage of vaccine and diluent as well as reporting and replacement instructions if there is a question regarding the shipment.  This shipper insert will also be available at www.merckvaccines.com in the near future.

The vaccine is located in the lower compartment of the shipping box.
Providers should immediately open the container and store the vaccine in the freezer.  To maintain potency the vaccine must be stored frozen between -58°F and +5°F (-50°C to -15°C).  The diluent is located in the top compartment of the shipping box underneath the cardboard cap.  The diluent should be stored on arrival in a refrigerator (2°C to 8°C/36°F to 46°F) or at room temperature (20°C to 25°C/68°F to 77°F).

The CDC and the vaccine manufacturer do not recommend transport of frozen vaccine.  However, we understand that under certain circumstances (emergencies, power outages, etc) frozen vaccine may need to be transported.

The manufacturer does not recommend reuse of shipping materials, including gel packs and shipping containers, to further transport vaccine products.  Improper re-packaging using these materials and improper transportation could negatively impact the vaccine.

If frozen vaccines must be transported, the CDC recommends transport with a portable freezer that maintains a temperature between -58°F and
+5°F (-50°C and -15°C).

In addition, according to the manufacturer's Prescribing Information, Varivax and Zostavax may be stored at refrigerator temperature (36°F to 46°F, 2°C to 8°C) for up to 72 continuous hours prior to reconstitution.  If transporting frozen vaccine under refrigerated conditions, document
EXPLICITLY: 1) time refrigerator storage began; 2) time refrigerator storage ended; and 3) storage temperatures under which the vaccine was kept for this period of time.

The manufacturer should be called before discarding frozen vaccine that has been kept under refrigerated storage conditions.

Questions regarding vaccine shipments should be directed to the manufacturer at the number listed above. The CDC is currently working with Merck, the vaccine manufacturer of Varivax and Zostavax, to respond to questions generated by the new shipment packing for frozen vaccines and the manufacturer's advisement that dry ice should not be used for storage of these frozen vaccines."