FDA Issues Final Order - AVA Safe and Effective

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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
- ARMY [21 Jan 06]
  CONTINUATION OF THE ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)
- NAVY [19 Jan 06]
  CONTINUATION OF THE ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)
- MARINES [23 Jan 06]
  CONTINUATION OF THE ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)
- AIR FORCE [20 Jan 06]
  EXTENSION OF AUTHORIZATION FOR ANTHRAX VACCINATIONS
- COAST GUARD [22 Dec 05]
  FDA FINAL ORDER ON ANTHRAX VACCINE
PLANNING DOCUMENTS
- DoD AVIP Implementation Instructions 30 Mar 07 [DOC] [PDF]
  Includes compliance assurance documents
QUESTIONS & ANSWERS
- FDA Final Order
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抯 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

EDUCATIONAL PRODUCTS
- Trifold Brochure - FDA Final Order edition [16 Dec 05] [PDF]
- Education Roster - Post-EUA (template) [PDF] [XLS] 12 Jan 06
- Next Dose Scheduled Card PDF 26 May 05
  Anthrax Vaccine

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

POLICIES
- Implementation of Resumption of the Anthrax Vaccine Immunization Program (AVIP) under Emergency Use Authorization (EUA)
  29 Apr 05
  Vaccination under the EUA will be available to those personnel serving in CENTCOM or Korea, for 15 or more consecutive days and designated special mission units.
- Resumption of the Anthrax Vaccine Immunization Program (AVIP) Under Emergency Use Authorization (EUA)
  25 Apr 05
  The Military Services are directed to amend their anthrax vaccination plans to resume the AVIP under conditions set forth by the FDA in the EUA issued January 27, 2005. Notably, the AVIP will be conducted under the EUA with an option to refuse. Unit commanders, leaders, and supervisors at all levels will respect the individual's right to refuse anthrax vaccination.
SERVICE MESSAGES
- ARMY
  ALARACT [28 Jul 05]
  EMERGENCY USE AUTHORIZATION (EUA) FOR ANTHRAX IMMUNIZATIONS EXTENDED
  MMI-05-4002 [6 May 05]
  ARMY RESUMES ANTHRAX VACCINATIONS UNDER EMERGENCY USE AUTHORIZATION (EUA) CONDITIONS
- NAVY
  NAVADMIN [04 Aug 05]
  EXTENSION OF EMERGENCY USE AUTHORIZATION TO RESUME ANTHRAX
  NAVADMIN [20 May 05]
  EMERGENCY USE AUTHORIZATION TO RESUME ANTHRAX VACCINATIONS
- AIR FORCE
  ALMAJCOM [26 Jul 05]
  EXTENSION OF EMERGENCY USE AUTHORIZATION FOR ANTHRAX VACCINATIONS
  ALMAJCOM [20 May 05]
  EMERGENCY USE AUTHORIZATION TO RESUME ANTHRAX VACCINATIONS
- MARINES
  MARADMIN [28 Jul 05]
  EMERGENCY USE AUTHORIZATION (EUA) FOR ANTHRAX IMMUNIZATIONS EXTENDED
  MARADMIN [16 May 05]
  RESUMPTION OF THE ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP) /UNDER THE EMERGENCY USE AUTHORIZATION (EUA)
- COAST GUARD
  ALCOAST [26 Jul 05]
  EMERGENCY USE AUTHORIZATION (EUA) FOR ANTHRAX VACCINATIONS EXTENDED
  ALCOAST [12 May 05]
  EMERGENCY USE AUTHORIZATION (EUA) TO RESUME ANTHRAX VACCINATIONS
FOOD AND DRUG ADMINISTRATION (FDA)
- On 27 January 2005, The Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to vaccinate certain service members with the anthrax vaccine adsorbed (AVA) as protection against inhalation anthrax. The authority for issuing an EUA is a provision of the Federal Food Drug, and Cosmetic Act, as amended by the Project BioShield Act of 2004.
  Details appear at: http://www.fda.gov/cber/vaccine/anthraxeua.htm
EUA REQUEST AND AUTHORIZATION
FEDERAL REGISTER
- [Docket No. 2005N�40] [2 Feb 05]
  Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With Anthrax; Availability
US DISTRICT COURT MEMORANDUM OPINION & ORDER
- John Doe #1, et al, Plaintiffs, v. Donald H. Rumsfeld, et al, Defendants (Order)
  United States District Court for the District of Columbia
  Judge Emmet G. Sullivan
  6 Apr 05
- John Doe #1, et al, Plaintiffs, v. Donald H. Rumsfeld, et al, Defendants (Order & Opinion)
  United States District Court for the District of Columbia
  Judge Emmet G. Sullivan
  27 Oct 04

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