May 18, 2007 — Acambis plc (Acambis), a biotechnology company targeting infectious diseases with novel vaccines, announces that the Vaccines and Related Biological Products Advisory Committee of the FDA voted unanimously that Acambis' smallpox vaccine, ACAM2000, is both safe and efficacious.
The Advisory Committee was asked to review whether the efficacy and safety data were sufficient to support the use of ACAM2000 in situations where it is determined that there is high risk of exposure to smallpox virus. At a meeting held in Gaithersburg, MD, the panel voted 11-0 in favor on both the safety and efficacy of ACAM2000.
The Advisory Committee provides the FDA with independent, non-binding advice from outside experts on issues related to vaccines and biological products. While the Committee provides recommendations to the Agency, the FDA makes all final decisions regarding licensure.
To date, Acambis has supplied 192.5 million doses of ACAM2000 to the U.S. Centers for Disease Control and Prevention (CDC) for the Strategic National Stockpile (SNS) under an FDA Investigational New Drug applicaton. The CDC procured ACAM2000 as part of the Government's policy, adopted after the events of 9/11, to establish a smallpox vaccine stockpile large enough to provide a dose for every man, woman and child in the US.
Acambis developed ACAM2000 under contracts with the CDC and conducted clinical development of the vaccine in parallel with the manufacturing program. ACAM2000 was derived from the smallpox vaccine used during the global eradication programme and is manufactured using modern cell-culture techniques. It is intended to be used for protection of persons determined to be at high risk for smallpox infection, including vaccination of military personnel being deployed to certain regions.
For more information visit www.acambis.com.