ACAM2000 FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 2, 2024.

FDA Approved: Yes (First approved August 31, 2007)
Brand name: ACAM2000
Generic name: Smallpox and Mpox (Vaccinia) Vaccine, Live
Company: Emergent BioSolutions Inc.
Treatment for: Smallpox Prophylaxis, Mpox

ACAM2000 [Smallpox and Mpox (Vaccinia) Vaccine, Live] is a live vaccinia virus vaccine indicated for active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox or mpox infection.

• ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) was first approved in 2007 for immunization against smallpox disease for persons determined to be at high risk for smallpox infection. ACAM2000 was the first biodefense vaccine to be approved as part of the US response to the 2001 bioterrorism attacks.
• Mpox, previously called monkeypox, is an infectious disease endemic to central and west Africa caused by the double-stranded DNA mpox virus. In 2022, there was an outbreak of clade II mpox resulting in more than 95,000 cases across 115 non-endemic countries. In August 2024, the World Health Organization (WHO) declared mpox a public health emergency of international concern under the International Health Regulations. Clade II mpox causes less severe infections and a lower mortality rate compared to clade I mpox. The clade Ib variant of mpox first identified in 2023 exhibits enhanced transmissibility through close contact and has led to an increase in cases, particularly in Central Africa.
• ACAM2000 is a single-dose vaccine administered percutaneously via a bifurcated needle that is dipped into the vaccine solution and the skin is pricked several times in the upper arm with a droplet of the vaccine.
• ACAM2000 comes with a Boxed Warning for serious complications including myocarditis, pericarditis (suspect cases observed at a rate of 5.7 per 1000 primary vaccinees (95% CI: 1.9-13.3)), 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, accidental eye infection (ocular vaccinia), which can cause ocular complications that may lead to blindness, and fetal death. These may occur following either primary vaccination or revaccination with live vaccinia virus vaccines, including ACAM2000. These risks are increased in certain individuals and may result in severe disability, permanent neurological sequalae and/or death.
• Common adverse reactions include inoculation site signs and symptoms, lymphadenitis, and constitutional symptoms, such as malaise, fatigue, fever, myalgia, and headache. 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.

Development timeline for ACAM2000

Further information

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