Anthrax Vaccine Immunization Program Published March 22, 2007 By Michael W. Wynne Secretary of the Air Force WASHINGTON -- Current Situation · In accordance with the 12 Oct 06 Deputy Secretary of Defense policy memo directing the re-introduction of mandatory anthrax vaccinations and the subsequent Undersecretary of Defense for Personnel and Readiness implementation guidance issued on 6 Dec 06, the AF/A3/5 signed a new Air Force Plan for Implementing the Anthrax Vaccine Immunization Program (AVIP) on 18 Jan 06. · Following formal approval of the Air Force Plan by the Assistant Secretary of Defense for Health Affairs, the AF/A3/5 released an implementation message to the MAJCOMs on 16 Feb 07. This message and the plan provide the Air Force-specific guidance and timelines for implementing the AVIP across the Air Force. · This paper provides background, talking points and senior leader quotes which can be used in explaining the program to Air Force men and women and their families. Background · In 1998, the department began to vaccinate all service members against the disease - a potential biological warfare agent. The vaccination program came under public criticism because of some service members' fears about the vaccine's safety. · Defense officials scaled back the program several times due to vaccine shortages. Bioport, the sole manufacturer of the vaccine, received FDA approval of its renovated vaccine facility in January 2002. · The Department of Defense resumed the Anthrax Vaccine Immunization Program on 28 June 2002, consistent with U.S. Food and Drug Administration approved labeling and the best practice of medicine. · The AVIP was put on-hold on 27 Oct 04 when an injunction was issued by the US District Court for the District of Columbia. The injunction questioned the effectiveness of the vaccine against inhalation anthrax. Overall safety of the vaccine was not an issue. · On 27 Jan 05, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) that allowed the DoD to resume anthrax vaccinations. Under the EUA, personnel in or deploying/PCSing to the CENTCOM AOR or Korea and designated special mission units could voluntarily receive the anthrax vaccination. There was no penalty for refusing to receive the vaccine. The Air Force resumed vaccinations under the EUA in May 05. · On 15 Dec 05, the FDA issued a final order finding that the Anthrax Vaccine Absorbed (AVA) is safe and effective against all routes of exposure to anthrax spores, including inhalation. This finding eliminated the need for the EUA. In Jan 06, consistent with DoD direction, the Air Force issued post-EUA guidance for the AVIP. Vaccinations continued on a voluntary basis for the groups previously covered by the EUA. · On 12 Oct 06, the Deputy Secretary of Defense issued a policy memo directing the re-introduction of mandatory anthrax vaccinations for personnel in or deploying/PCSing to the CENTCOM AOR or Korea and designated special mission units. Personnel who previously received at least one dose of the anthrax vaccine, regardless of current assignment location, may opt to voluntarily complete the vaccination series and receive annual boosters. The Undersecretary of Defense for Personnel and Readiness issued implementation guidance in Dec 06. On 16 Feb 07, the AF/A3/5 distributed the Air Force AVIP implementation guidance. Talking Points: · Your health and safety are our #1 concern. · The anthrax threat remains real and deadly. It may be the most important biological warfare threat facing U.S. forces. · The vaccine is safe, effective and protects against all forms of anthrax infection. · It is DoD policy to use only FDA approved products and we will continue to use the only currently approved vaccine against Anthrax as part of DoD's for health protection measures. · Anthrax is deadly. There is no better round-the-clock protection against anthrax infection than the anthrax vaccine. · This is a force health protection issue. The health and safety of our men and women in the Armed Forces are our top concerns. · Protection of all forces against anthrax exposure remains a critical goal of the DoD's Force Health Protection Program. · Inhalational anthrax is nearly 100 percent lethal in unprotected, unvaccinated people once symptoms begin to appear. · Vaccination offers a layer of protection, in addition to antibiotics and other measures, that is critical for members of the armed forces Websites · Additional information: http://www.anthrax.mil/avip2007 or https://www.a3a5.hq.af.mil/a3s/a3sc/ccbrn_resource/biological/anthrax/index.asp · AVIP Trifold Brochure(PDF): http://www.anthrax.mil/documents/996AvipTrifold.pdf · Military Vaccine Agency (MilVax) Website: http://www.vaccines.army.mil/ · MilVax Anthrax Website Website: http://www.anthrax.mil/ · MilVax AVIP 2007 Website: http://www.anthrax.mil/whatsnew/resumemandatoryselect.asp