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FDA Issues Final Order - AVA Safe and Effective, Protects Individuals at High Risk for Anthrax Disease

 

 

  • POLICIES
    • Continuation of the Anthrax Vaccine Immunization Program (AVIP)
      22 Dec 05
      On 15 Dec 05, the FDA issued a Final Rule & Order on the license status of anthrax vaccine adsorbed (AVA). After reviewing extensive scientific evidence and carefully considering comments from the public, the FDA again determined that AVA is licensed for the prevention of anthrax, regardless of the route of exposure.

      In response to the FDA's action, policy options for AVIP are now under review. Unless otherwise directed by the Secretary or Deputy Secretary of Defense, the services are directed to continue implementation of the AVIP as authorized in April 2005. This interim approach will protect the same personnel, and include an option to refuse and periodic reporting requirements.

 

  • SERVICE MESSAGES


  • PLANNING DOCUMENTS
    • DoD AVIP Implementation Instructions 30 Mar 07 [DOC] [PDF]
      Includes compliance assurance documents


  • QUESTIONS & ANSWERS

  • NEWS
    • DoD Statement
      The Food and Drug Administration (FDA) issued a Final Order reaffirming previous conclusions that the anthrax vaccine prevents anthrax resulting from any route of exposure, including inhalation anthrax.


  • FOOD AND DRUG ADMINISTRATION (FDA)
    • On 15 December 2005, The Food and Drug Administration (FDA) released a Final Order with respect to anthrax vaccine adsorbed (AVA), to be published in the Federal Register on 19 December 2005.
    • After review of the comments and finding no additional scientific evidence to alter the proposed categorization, FDA accepts the previous Panel’s recommendation and adopts Category I as the final category for AVA and determines AVA to be safe and effective and not misbranded.
    • View the FDA Final Order

 

 

 

 

AVIP EUA expired 14 Jan 06
The following content is provided for archival purposes

 




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