ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) vaccine is a live, vaccinia virus smallpox vaccine licensed in the US by the Food and Drug Administration for active immunisation against smallpox disease for persons determined to be at high risk for smallpox infection. It was developed by Acambis under the contract with the US Centers for Disease Control and Prevention (CDC).

ACAM2000® 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® is the primary smallpox vaccine for use in a bioterrorism emergency and forms the majority of the US Government's smallpox vaccine stockpile. Acambis has supplied more than 196 million doses of ACAM2000® to the US Government for its Strategic National Stockpile. Acambis has also supplied ACAM2000® under an FDA Investigational New Drug application to several other governments around the world.

Important Safety Information

ACAM2000® may not protect all persons exposed to smallpox. ACAM2000® 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, generalised 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 foetal death have occurred following either primary vaccination or revaccination with smallpox vaccines.
  
• The most common side effects following smallpox vaccination include injection site erythema, pruritis, 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 vaccinia vaccination. The most common sites involved are the face, nose, mouth, lips, genitalia and anus.
  
  Full prescribing information may be obtained by calling Acambis at +1 866 440 9440 (toll free) or +1 617 866 4500.

Click here to download the Package Insert, which contains inportant prescribing and safety information.

Click here to download the Medication Guide for ACAM2000®.

Information for Health Professionals - http://www.bt.cdc.gov/agent/smallpox/vaccination/index.asp

Information for the General Public - http://www.bt.cdc.gov/agent/smallpox/vaccination/vaccine.asp

About smallpox

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)

By the mid-1980s, there were only two known repositories of variola virus: the Institute of Virus Preparations in Russia and the US Centers for Disease Control and Prevention (CDC). The events in the US 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 and references
(1) WHO: http://www.who.int/mediacentre/factsheets/smallpox/en/
(2) CDC: http://www.bt.cdc.gov/agent/smallpox/overview/disease-facts.asp

This section is intended for US residents only:

For more on smallpox vaccination please refer to the following sites for the US Department of Defense:

http://www.vaccines.mil/default.aspx?cnt=disease/minidv&dID=22

http://www.smallpox.mil/