Components of Smallpox Vaccine	Excipients Table Allergens Table Components Table
Indication For active immunization against smallpox disease for persons determined to be at high risk for smallpox infection Proprietary Name ACAM2000 Manufacturer sanofi pasteur Viability Live attenuated Approved Ages 1 year and older Dose A droplet (0.0025 mL) of reconstituted vaccine is picked up with a bifurcated needle by dipping needle into ACAM2000 vial. A droplet of ACAM2000 is administered by the percutaneous route (scarification) using 15 jabs of a bifurcated needle. ACAM2000 should not be injected by the intradermal, subcutaneous, intramuscular, or intravenous route. Route Percutaneous using bifurcated needle Dose form Powder for suspension Appearance Clear to slightly hazy, colorless to straw-colored Concentration 1.0-5.0 x 108 plaque-forming units (PFU)/mL or 2.5-12.5 x 105 PFU/dose determined by plaque assay in Vero cells Preservatives Phenol 0.25% Adjuvant HEPES (pH 6.5-7.5), 6-8 mM Human serum albumin USP, 2% Sodium chloride USP, 0.5–0.7% Mannitol USP, 5% Neomycin, trace amounts Polymyxin B, trace amounts Excipients Brilliant green diluent until the 1980’s. Since 2002 diluent no longer brilliant green Adjuvant   Allergens   Preservatives Skin of vaccinated bovine calves Media Skin of vaccinated bovine calves Packaging Vial and Diluent for 100 vaccinations Routine Storage 2 to 8° C Package Insert data Sep 2009 updated Feb 2013
This page was last updated on February 15, 2013 © 2013 Institute for Vaccine Safety