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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, 0.50.7%

Mannitol USP, 5%

Neomycin, trace amounts

Polymyxin B, trace amounts

Excipients

Brilliant green diluent until the 1980s. 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 12, 2014

2014 Institute for Vaccine Safety