Smallpox Vaccine
»Smallpox Vaccine conforms to the regulations of the FDAconcerning biologics (630.70to 630.76)(see Biologics á1041ñ).It is a suspension or solid containing the living virus of vaccinia of a strain of approved origin and manipulation,that has been grown in the skin of a vaccinated bovine calf.It meets the requirements of the specific potency test using embryonated chicken eggs in comparison with the U.S.Reference Smallpox Vaccine in the case of Vaccine intended for multiple-puncture administration or with such Reference Vaccine diluted (1:30)in the case of Vaccine intended for jet injection,and the requirements for the tests for absence of specific microorganisms.It may contain a suitable preservative.
Packaging and storage— Preserve and dispense in the containers in which it was placed by the manufacturer.Keep liquid Vaccine during storage and in shipment at a temperature below 0.Keep dried Vaccine at a temperature between 2and 8.
Expiration date— The expiration date for liquid Vaccine is not later than 3months after date of issue from manufacturer's cold storage (-10,9months as glycerinated or equivalent preparation).The expiration date for dried Vaccine is not later than 18months after date of issue from manufacturer's cold storage (5,6months).
Labeling— Label it to state that it contains not more than 200microorganisms per mLin the case of Vaccine intended for multiple-puncture administration,or that it contains not more than 1microorganism per 100doses in the case of Vaccine intended for jet injection,unless it meets the requirements for sterility.In the case of Vaccine intended for jet injection,so state on the label.In the case of dried Vaccine,label it to state that after constitution it is to be well shaken before use.Label it also to state that it was prepared in the bovine calf.
Auxiliary Information— Staff Liaison:Tina S.Morris,Ph.D.,Senior Scientist
Expert Committee:(VVI)Vaccines,Virology,and Immunology
USP28–NF23Page 1773
Phone Number:1-301-816-8397