FDA Approves New Smallpox Vaccine
In the bioterrorism age, immunization may be needed against once-eradicated disease
WEDNESDAY, Sept. 5 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new smallpox vaccine, ACAM2000, which is intended for use among those at high risk of exposure and as a preventive measure during a bioterrorist attack. The only other FDA-approved smallpox vaccine, Dryvax, is no longer manufactured and supplies are limited.
The vaccinia-based ACAM2000 is manufactured by Acambis Inc., of Cambridge, U.K., and Cambridge, Mass. The vaccine was approved after testing in patients who had never been vaccinated before and in this population it had an immunogenicity similar to Dryvax. In those who had previously been vaccinated, the vaccine proved to be an acceptable booster.
"This vaccine is manufactured using modern cell culture technology allowing rapid and large scale production of a vaccine with consistent product quality," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research, in a statement.
The vaccine contains live vaccinia virus, and as such must comply with a Risk Minimization Action Plan, which requires patients and health care providers to receive education about the risks associated with immunization.