You are here
FDA Advisory Panel Unanimously Votes on Safety and Efficacy of Smallpox Vaccine
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, Maryland, 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 US 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.
Ian Garland, Acambis' Chief Executive Officer, said:
"We welcome the Advisory Committee's recommendation and look forward to the FDA's decision on ACAM2000's license application. Our ACAM2000 smallpox vaccine is already an important component of the US Government's emergency preparedness strategy and SNS stockpile, and we hope to provide the US with long-term protection against this bioterrorist threat."
Acambis is in discussions with the CDC for a contract to provide the US Government with long-term manufacturing capability of ACAM2000 located entirely in the US and license maintenance activities. Licensure of ACAM2000 is a prerequisite for awarding this contract.
The FDA has identified August 31, 2007 as the target date for the FDA's license application response for ACAM2000 under the Prescription Drug User Fee Act.
Smallpox is a contagious and sometimes fatal disease marked by fever and a progressive skin rash. The majority of patients with smallpox recover, but death may occur in up to 30% of cases. Many smallpox survivors have permanent scars over large areas of their body (1).
In 1980, smallpox was declared eradicated following worldwide vaccination programmes and commercial manufacture of licensed smallpox vaccines ceased. However, following the events of September and October 2001, the CDC has identified smallpox as a high-priority agent posing the highest risk to the public and national security (2).
Acambis' investigational smallpox vaccine, ACAM2000, is derived from Dryvax(R), a first-generation vaccine used during the global smallpox eradication programme. Unlike previously licensed smallpox vaccines, ACAM2000 is manufactured using modern cell-culture techniques designed to comply with current Good Manufacturing Practice standards.
ACAM2000 has been tested in just under 3,000 subjects and its clinical safety has been shown to be the same or better than that of Dryvax. Acambis submitted a Biologics License Application for licensure of ACAM2000 in 2006.