Trade name: ACAM2000
Generic names: Smallpox (Vaccinia) Vaccine, Live
Indication and Usage: ACAM2000® is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
Ingredients: ACAM2000, Smallpox (Vaccinia) Vaccine, Live, is a live vaccinia virus derived from plaque purification cloning from Dryvax® (Wyeth Laboratories, Marietta, PA, calf lymph vaccine, New York City Board of Health Strain) and grown in African Green Monkey kidney (Vero) cells and tested to be free of adventitious agents. ACAM2000 is provided as a lyophilized preparation of purified live virus containing the following non-active excipients: 6-8 mM HEPES (pH 6.5-7.5), 2% human serum albumin USP, 0.5 – 0.7% sodium chloride USP, 5% mannitol USP, and trace amounts of neomycin and polymyxin B. Diluent for ACAM2000 contains 50% (v/v) Glycerin USP, 0.25% (v/v) Phenol USP in Water for Injection USP, supplied in 3 mL clear glass vials containing 0.6 mL of diluent.
Manufacturer-listed adverse reactions: ACAM2000 can cause: Erythema (skin redness), Pruritus (itchy skin), Pain/Swelling, Fatigue, Malaise (discomfort), Feeling hot/Rigors, Exercise tolerance decreased, Headache, Limb paresthesias, Dizziness/Vertigo, Meningitis, Encephalitis/myelitis, Bell palsy, Seizures including death, Guillain-Barré syndrome, Accidental infection of the eye (ocular vaccinia), Blindness, Photophobia, Myalgia (muscle pain), Back pain, Arthralgia (joint pain), Pain in extremity, Lymphadenopathy/pain, Nausea/Vomiting, Diarrhea/Constipation, Severe abdominal pain, Toothache, Dermatitis (eczema), Urticaria (hives), Generalized rashes, Inadvertent inoculation at other body sites (face, nose, mouth, lips, genitalia, and anus), Keratis, Corneal scarring, Benign/Malignant lesions, Progressive vaccinia (vaccinia recrosum), Generalized vaccinia, Severe vaccinial skin infections, Stevens-Johnson syndrome, Fetal vaccinia, Fetal death, Myocarditis, Pericarditis, Eczema vaccinated resulting in permanent sequelae or death.
Limitations of Effectiveness: ACAM2000 smallpox vaccine may not protect all persons exposed to smallpox.
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