drugset
Drugs / ACAM2000
last change Jun 2026 re-read 9 days ago

ACAM2000

Vaccine

Developed for
smallpox · vaccinia
Investigated by
Emergent BioSolutions · Bavarian Nordic · Centers for Disease Control and Prevention · US Army Medical Research Institute of Infectious Diseases

Trials 5

today NCT02443623 · Ph 4 NCT01913353 · Ph 3 NCT01158157 · Ph 3 NCT00053482 · Ph 2 NCT00053495 · Ph 2
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT00053482 Jan → Apr 2003 smallpox Emergent BioSolutions Completed No outcome recorded
Phase 2 NCT00053495 Jan → Jun 2003 smallpox Emergent BioSolutions Completed No outcome recorded
Phase 32 trials · 1 met primary
Phase 3 NCT01913353 Mar 2015 → Mar 2017 — Bavarian Nordic Completed Met primary
Phase 3 NCT01158157 Sep 2010 → Feb 2012 vaccinia Emergent BioSolutions Completed No outcome recorded
Phase 41 trial
Phase 4 NCT02443623 Sep 2015 → Jul 2021 vaccinia Emergent BioSolutions Completed No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2026-05-18 Emergent BioSolutions Regulatory Emergent BioSolutions Receives Saudi Food and Drug Authority Approval for ACAM2000® [Smallpox and Mpox (Vaccinia) Vaccine, Live] emergentbiosolutions.com ↗
Emergent BioSolutions (NYSE:EBS), a global biodefense company, today announced that the Saudi Food and Drug Authority (SFDA) has approved the registration of ACAM2000® [Smallpox and Mpox (Vaccinia) Vaccine, Live], for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox or mpox infection.
2026-04-30 Emergent BioSolutions Regulatory Emergent BioSolutions Receives Approval from Singapore Health Sciences Authority for Expanded Indication of ACAM2000® (Smallpox and Mpox (Vaccinia) Vaccine, Live) to Include Mpox emergentbiosolutions.com ↗
This regulatory milestone expands the authorized use of ACAM2000® in Singapore to support public health preparedness and response efforts.
2024-08-29 Emergent BioSolutions Regulatory Emergent BioSolutions’ ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication; Public Health Mpox Outbreak Continues Across Africa & Other Regions emergentbiosolutions.com ↗
2017-11-20 Emergent BioSolutions Regulatory Emergent BioSolutions Receives FDA Approval to Manufacture ACAM2000 at Canton, Massachusetts Facility emergentbiosolutions.com ↗

All press releases naming this drug 9 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as ACAM2000 “one dose of the established replicating-vaccinia vaccine ACAM2000” PMID 31722150 ↗ Nov 2019
5

NCT01158157 ↗

NCT02443623 ↗

NCT01913353 ↗

NCT00053482 ↗

NCT00053495 ↗
Modality Vaccine “ACAM2000 smallpox vaccine” NCT00053482 ↗
Route Other “Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.” NCT01158157 ↗