FDA Approves Important Anthrax Vaccine Changes
Route of Administration Changed from Subcutaneous to Intramuscular, and Initial Series Doses Reduced from Six to Five

• FOOD AND DRUG ADMINISTRATION (FDA)
  
  

  FDA Approval Letter
  11 Dec 08
  The FDA has approved the Emergent Biosolutions request to supplement their biologics license application for Anthrax Vaccine Adsorbed (BioThrax®) to include a change in schedule from 0, 2, 4 weeks and 6, 12 and 18 months to 0, 4 weeks, and 6, 12, and 18 months, and a change in route of administration from subcutaneous to intramuscular. Anthrax Vaccine Adsorbed is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons between 18 and 65 years of age at high risk of exposure.

  
  
• SERVICE MESSAGES
  • NAVY
    
    • BUMED
      23 Dec 08
      ANTHRAX VACCINE CHANGE ROUTE OF ADMINISTRATION
      
  • COAST GUARD
    
    • ALCOAST
      05 Jan 09
      ANTHRAX VACCINE - CHANGE IN ROUTE OF ADMINISTRATION AND IN DOSING SCHEDULE
      
  • AIR FORCE
    
    • ALMAJCOM/SG
      14 Jan 09
      CHANGE IN ADMINISTRATION ROUTE AND DOSING SCHEDULE FOR THE ANTHRAX VACCINE ADSORBED (AVA)
      
  
  
  
• MMQC MESSAGES
  • MMQC-08-1629
    29 Dec 08
    IMPLEMENTATION INSTRUCTIONS FOR CHANGE IN ROUTE AND CHANGE IN DOSING SCHEDULE FOR THE ANTHRAX VACCINE ADSORBED (AVA) IN THE DOD ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)
    
  
  
  
• PLANNING DOCUMENTS
  
  
  • Implementation Instructions for Change in Route and Change in Dosing Schedule for the Anthrax Vaccine Adsorbed (AVA) in the Department of Defense Anthrax Vaccine Immunization Program (AVIP)
    16 Dec 08
    
  • Agreement to Participatein Anthrax Vaccine Immunization Program (AVIP)
    27 Feb 09
    
  
  
  
• EDUCATIONAL PRODUCTS
  
  
  • Information Papers
    • Anthrax Vaccine Route Change and Dose Reduction
      23 Dec 08
    • Anthrax Infections and Anthrax Vaccine
      09 Jan 09
  • Package Insert
    11 Dec 08
    
  • Trifold Brochure
    15 Jan 09
    
  • Medical Journal Article
    01 Oct 08
    Effects of a Reduced Dose Schedule and Intramuscular Administration of Anthrax Vaccine Adsorbed on Immunogenicity and Safety at 7 Months: A Randomized Trial
    JAMA. 2008;300(13):1532-1543
  
  
  

   

  ***New information will be added to this page as it becomes available.***