Acambis Gets Positive Recommendations for Smallpox Vaccine

Acambis plc (Cambridge, UK, www.acambis.com) has announced that the Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration has voted unanimously that Acambis’ ACAM2000 is both safe and efficacious. The Advisory Committee was asked to review whether the clinical data demonstrated that ACAM2000 was safe and effective for use in persons at high risk of exposure to smallpox virus. It voted 11­–0 in favor on both the safety and efficacy of ACAM2000. The FDA has identified August 31, 2007, as the target date for its response to Acambis’ ACAM2000 license application under the Prescription Drug User Fee Act.