Reconstitution of Dryvax® Smallpox Vaccine As taken from the Package Insert, Dec. 2002

Preparation of Vaccine Diluent and instructions for reconstitution will be supplied with vaccine. Diluent and instructions for reconstitution will be supplied with vaccine. Vaccine may be used for 60 days following reconstitution. Vaccine may be used for 60 days following reconstitution. Vaccine must be reconstituted by a pharmacist, pharmacy technician or nurse. Vaccine must be reconstituted by a pharmacist, pharmacy technician or nurse.

Glove Both Hands Prior to Opening Vaccine Vial

Record date of reconstitution on the bottle prior to performing the reconstitution. Record date of reconstitution on the bottle prior to performing the reconstitution.

1. Lift up tab of aluminum seal on vaccine vial. DO NOT BREAK OFF OR TEAR DOWN TAB.

2. Wipe off vial stopper with an alcohol sponge and allow to dry.

3. Place vaccine vial upright on a hard, flat surface. Insert a sterile 21 gauge or smaller needle into the rubber stopper to release the vacuum from the vaccine vial. Discard the needle in biohazard waste container.

4. To reduce viscosity of cold diluent, warm by holding diluent-cartridge in palm of hand for a few minutes.

5. Peel open the needle package (provided with the kit) and aseptically remove the needle

6. Remove rubber cover from end of the diluent syringe.

7. With a twisting motion, aseptically attach the vented needle to the hub of the diluent syringe.

8. Remove protective cover from the vented needle and expel the air from the diluent syringe.

9. Aseptically insert the needle through the rubber stopper into the vaccine vial up to the first hub.

10. Depress the plunger to ensure the entire volume of diluent is delivered into the vial.

11. Withdraw diluent syringe/vented needle and discard in biohazard waste container.

12. Allow vaccine vial to stand undisturbed for 3 to 5 minutes. Then if necessary, swirl vial gently to effect complete reconstitution. The vaccine may have a yellow tint and appear more viscous which is within normal limits for the vaccine.

13. Place small piece of cardboard between the vaccine vial and the cold pack. Do not place vaccine vial directly on the cold pack.

Storage If the vaccine is to be stored for subsequent use, re-stopper the vial and store at 2-8 degrees C (35 – 46 degrees F.) If the vaccine is to be stored for subsequent use, re-stopper the vial and store at 2-8 degrees C (35 – 46 degrees F.) The vaccine may be stored for 60 days after reconstitution. The vaccine may be stored for 60 days after reconstitution. The vial of vaccine can be kept out at room temperature during vaccine clinic. The vial of vaccine can be kept out at room temperature during vaccine clinic.

Security The vaccine will be shipped to the clinics under armed guard. The vaccine will be shipped to the clinics under armed guard. The vaccine will be stored at either the clinic site or at the Health Department when clinic operations are not underway and with security present. The vaccine will be stored at either the clinic site or at the Health Department when clinic operations are not underway and with security present.

Security Security personnel will be responsible for monitoring the temperature of the refrigerators where the vaccine will be stored. Security personnel will be responsible for monitoring the temperature of the refrigerators where the vaccine will be stored. Daily inventory will be performed and compared with previous inventories and reports of doses given at the clinic. Any discrepancies will be addressed upon discovery. Daily inventory will be performed and compared with previous inventories and reports of doses given at the clinic. Any discrepancies will be addressed upon discovery.