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ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) is a live, vaccinia virus smallpox vaccine licensed in the U.S. by the Food and Drug Administration for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. It was developed by Sanofi Pasteur Biologics, LLC (formerly Acambis) under a contract with the U.S. Centers for Disease Control and Prevention (CDC).
ACAM2000 vaccine was developed to be a licensed smallpox vaccine manufactured using modern cell-culture techniques complying with current Good Manufacturing Practice standards. Production of first-generation vaccines ceased in the early 1980s following a successful smallpox vaccination campaign by the World Health Organization that led to the declared eradication of smallpox in 1980.
Today, ACAM2000 vaccine is the primary smallpox vaccine designated for use in a bioterrorism emergency and forms the majority of the U.S. Government's smallpox vaccine stockpile. Sanofi Pasteur Biologics, LLC has supplied more than 200 million doses of ACAM2000 vaccine to the US Government for its Strategic National Stockpile. Sanofi Pasteur Biologics, LLC has also supplied ACAM2000 vaccine under an FDA Investigational New Drug application to several other governments around the world.
Important Safety Information
• Suspected cases of myocarditis and/or pericarditis have been observed in
• Encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia,
These risks are increased in vaccines with the following conditions and may
• Cardiac disease or a history of cardiac disease
• Eye disease treated with topical steroids
• Congenital or acquired immune deficiency disorders, including those
• Eczema and persons with a history of eczema or other acute or chronic
• Infants less than 12 months of age
ACAM2000 is a live vaccinia virus that can be transmitted to persons who have
The risk for experiencing serious vaccination complications must be weighed
ACAM2000 vaccine may not protect all persons exposed to smallpox. ACAM2000 vaccine is contraindicated for individuals with severe immunodeficiency who are not expected to benefit from the vaccine. These individuals may include persons who are undergoing bone marrow transplantation or persons with primary or acquired immunodeficiency states who require isolation.
• The most serious adverse events associated with smallpox vaccination are
myocarditis, pericarditis, encephalitis, encephalomyelitis, encephalopathy,
progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, and
erythema multiforme major (including STEVENS-JOHNSON SYNDROME) and
eczema vaccinatum resulting in permanent sequelae or death, ocular
complications, blindness and fetal death have occurred following either primary
vaccination or revaccination with smallpox vaccines.
• The most common side effects following smallpox vaccination include injection
site erythema, pruritus, pain, swelling, myalgia, itching, swollen lymph nodes,
sore arm, fever, headache, body ache, rash and fatigue.
• Inadvertent inoculation at other sites is the most frequent complication of
vaccination. The most common sites involved are the face, nose, mouth, lips,
genitalia and anus.
Full Prescribing Information
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Medication Guide for vaccine
Information for Health Professionals & the General Public:
Smallpox is a highly contagious disease caused by the variola virus, a member of the Orthopox virus family. It is one of the most devastating diseases known to humanity, with a mortality rate as high as 30%.
In 1967, the World Health Organization embarked upon an intensified vaccination campaign to eradicate smallpox, which culminated in the successful eradication of the disease globally by 1980.1
The events in the U.S. in September and October 2001 highlighted the risk that the variola virus might be used as an agent of bioterrorism.2 Governments around the world are taking precautionary measures to be ready to deal with a potential smallpox outbreak.
Notes & References:
(1) World Health Organization:
(2) Centers for Disease Control & Prevention:
Intended for US Residents Only:
U.S. Department of Defense: