ACAM2000

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

 

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
       (5.1)].

   •   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 (5)]. 

       These risks are increased in vaccines 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 vaccine and the risks in contacts are the same as those
   for the vaccine.

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

 

 

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

Click to Download: 

PDFPackage Insert, which contains important prescribing and safety information

 

Click to Download:
PDFMedication Guide for vaccine

 

Information for Health Professionals & the General Public:
External Linkhttp://www.bt.cdc.gov/agent/smallpox/vaccination/index.asp


About Smallpox

About SmallpoxSmallpox 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: 

External Linkhttp://www.who.int/topics/smallpox/en/

 

(2) Centers for Disease Control & Prevention:

External Linkhttp://www.bt.cdc.gov/agent/smallpox/overview/disease-facts.asp

 

Intended for US Residents Only:


U.S. Department of Defense:

External Linkhttps://www.vaccines.mil/Smallpox