May 25, 2017
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ACAM2000

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ACAM2000

ACAM2000
(Smallpox (Vaccinia) Vaccine, Live,)

WARNING

  • Suspected cases of myocarditis and/or pericarditis have been observed in healthy adult primary vaccinees (at an approximate rate of 5.7 per 1000, 95% CI: 1.9-13.3) receiving ACAM2000 [see WARNINGS AND PRECAUTIONS].
  • Encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including STEVENS-JOHNSON SYNDROME), eczema vaccinatum resulting in permanent sequelae or death, ocular complications, blindness, and fetal death have occurred following either primary vaccination or revaccination with live vaccinia virus smallpox vaccines [see WARNINGS AND PRECAUTIONS].
    These risks are increased in vaccinees with the following conditions and may result in severe disability, permanent neurological sequelae and/or death:
    • Cardiac disease or a history of cardiac disease
    • Eye disease treated with topical steroids
    • Congenital or acquired immune deficiency disorders, including those taking immunosuppressive medications
    • Eczema and persons with a history of eczema or other acute or chronic exfoliative skin conditions
    • Infants less than 12 months of age
    • Pregnancy

ACAM2000 is a live vaccinia virus that can be transmitted to persons who have close contact with the vaccinee and the risks in contacts are the same as those for the vaccinee.

The risk for experiencing serious vaccination complications must be weighed against the risks for experiencing a potentially fatal smallpox infection.

DRUG DESCRIPTION

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.

After reconstitution, each vial of ACAM2000 vaccine contains approximately 100 doses (0.0025 mL/dose). The concentration of vaccinia virus is 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. ACAM2000 is administered by the percutaneous route (scarification) using 15 jabs of a stainless steel bifurcated needle that has been dipped into the vaccine.

Last reviewed on RxList: 9/29/2014
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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