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FDA Approves ACAM2000(TM) Vaccine for Protection Against Smallpox
Date:9/3/2007

e with a safety and efficacy profile comparable to the previous US vaccine but manufactured using advanced production capabilities. Until the development of ACAM2000, smallpox vaccines were last manufactured in the US in 1982 and were produced from calf lymph.

ACAM2000, which is a single-dose vaccine, is the primary smallpox vaccine for use in an emergency and forms the majority of the US Government's smallpox vaccine stockpile.

The clinical trials data generated on ACAM2000 were reviewed by the FDA Vaccines and Related Biological Products Advisory Committee in May 2007, which voted unanimously (11-0) in favor of the vaccine's safety and efficacy. In addition to being stockpiled for emergency use, ACAM2000 will be used by the US Department of Defense for protection of military personnel.

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, 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 itching, swollen lymph nodes, sore arm, fever, headache, body ache, mild rash, and fatigue.

Full prescribing information may be obtained by calling Acambis at +1-866-440-9440 (toll free) or +1-617-866-4500.


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