FDA issues final order on safety of bacterial vaccines and toxoids.

2004 JAN 21 - (NewsRx.com & NewsRx.net) -- To complete the review of the safety and effectiveness of certain bacterial vaccines and toxoids licensed before July 1972, the U.S. Food and Drug Administration (FDA) has issued a final rule and order that makes final determinations concerning the safety and effectiveness of such products and amends certain biologics regulations.

The final order states FDA's conclusion that the licensed anthrax vaccine, Anthrax Vaccine Adsorbed, is safe and effective for the prevention of anthrax disease - regardless of the route of exposure.

The process of finalizing this rule and order has taken considerable time, as is true with all such documents. Although a District of Columbia Federal Court issued an injunction regarding the anthrax vaccine and its legal status as an approved product recently, FDA made its determinations regarding the anthrax vaccine, as reflected in the final order, long before the court's ruling.

Expert panels were assigned the task of reviewing information on biological products that were licensed under the Public Health Service Act before 1972 when the responsibility for licensing biological products was moved from the National Institutes of Health to the FDA. Based upon their review of the available data, the Expert Panel recommended that the anthrax vaccine, originally licensed in 1970, be classified as a Category I product, meaning that it was safe and effective as it was labeled. The panel recommended that it continue to be licensed on the basis of the evidence of its safety and effectiveness. These findings were originally published in the Federal Register on December 13, 1985.

FDA agreed with the Expert Panel's general recommendation categorizing the vaccine at that time and continues to support that conclusion in this final rule and order.

FDA's final order states that the efficacy analysis in the controlled clinical trial demonstrating the efficacy of the vaccine includes all cases of anthrax disease regardless of the route of exposure or manifestation of disease. Although there were too few inhalation anthrax cases to support an independent statistical analysis, due to the rarity of this method of exposure during the period of time that the study was performed, FDA noted in the final rule that all of the cases of ...