Questions & Answers
Anthrax - Current Anthrax Policy
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Current Policy

Questions
Answers
  1. What is the current DoD policy for anthrax vaccinations?
    • Vaccinations are mandatory for DoD Service members, emergency essential designated civilians, and contractor personnel performing mission-essential services assigned to:
      • Central Command area of responsibility for 15 or more consecutive days.
      • Korean Peninsula for 15 or more consecutive days
      • Special units with bio-warfare or bio-terrorism related missions
      • Specialty units with approved exception to policy
    • Vaccinations shall begin, to the extent feasible, up to 120 days prior to deployment or arrival in higher threat areas.
    • Vaccinations are voluntary for DoD Service members and U.S. Government civilian employees of DoD who are not in the mandatory groups and have received at least one dose of anthrax vaccine adsorbed during or after 1998.
    • Vaccinations are voluntary for DoD civilians and adult family members; contractors and their accompanying U.S. citizen family members: Residing in Central Command area of responsibility for 15 or more consecutive days or Residing on Korean Peninsula for 15 or more consecutive days.
    • Vaccine manufacturing and research personnel and others, as designated by the ASD (HA)


  2. Is anthrax vaccination now mandatory for all Service members?
    No. Anthrax vaccination is mandatory for DoD Service members, emergency essential designated civilians, and contractor personnel performing mission-essential services assigned to:

    • Central Command area of responsibility for 15 or more consecutive days.

    • Korean Peninsula for 15 or more consecutive days.

    • Special units with bio-warfare or bio-terrorism related missions.

    • Specialty units with approved exception to policy.

  3. Is it mandatory to complete the series once I am no longer in a higher threat area?
    No. Vaccinations are voluntary for DoD Service members who are not in the mandatory groups and have received at least one dose of anthrax vaccine adsorbed during or after 1998.

  4. How long will this current policy be in effect?
    This current policy will be in effect until the senior civilian leadership directs the Services otherwise.

  5. Will those people who received anthrax vaccinations in the past be allowed to continue the six-dose series?
    Yes. Vaccinations are voluntary for DoD Service members who are not in the mandatory groups and have received at least one dose of anthrax vaccine adsorbed during or after 1998.

  6. What happens to those of us who have received several doses of anthrax vaccine previously but choose not to continue under voluntary status?
    There is no reason for concern that stopping the anthrax series will cause any harm. However, when anthrax vaccine is reintroduced to your body (you get your next dose); published evidence shows that your body has a good immune memory and will have a good antibody response. Each dose of anthrax vaccine is like walking up a set a stairs. You may remain on one step longer than originally planned, but the next dose of vaccine will resume development of protective immunity (climbing further up the stair case).

  7. What are the recent events regarding the anthrax vaccine, the injunction, the EUA, the FDA Final Order, and the resumption of the program?

    • Following a suit filed by several unnamed Service members, the U.S. District Court of Washington, D.C. placed an injunction against the DoD's mandatory anthrax vaccination program on 27 October 2004.

    • DoD immediately issued orders to comply with the court decision, stopping anthrax vaccinations for all personnel on 27 October 2004, pending resolution of all legal issues.

    • Following the procedure established by law, the Deputy Secretary of Defense (under authority assigned by the Secretary) determined that a significant potential for a military emergency exists that involves a heightened risk of U.S. military forces of attack with anthrax spores. To avoid the harm to the Armed Forces associated with stopping the vaccination program for high-risk personnel, DoD sought an Emergency Use Authorization.

    • The Assistant Secretary of Defense for Health Affairs (ASD (HA)) submitted to the FDA a detailed summary of the evidence for safety and effectiveness that form the scientific foundation for the current FDA license for anthrax vaccine. • The ASD (HA) asked the Commissioner of FDA to approve the EUA.

    • The Commissioner of FDA considered the evidence regarding the safety and effectiveness of anthrax vaccine for protection against anthrax disease via inhalation exposure, consulted with the Centers of Disease Control and Prevention and National Institutes of Health, and then issued the Emergency Use Authorization on 27 January 2005.

    • On April 6, 2005, the District Court modified it's injunction to allow program resumption under EUA.

    • On December 15, 2005, the FDA issued a Final Rule and Final 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 infection regardless of route of exposure.

    • On 12 October 2006 Deputy Secretary of Defense approved resumption of a mandatory AVIP program for military and civilian personnel in higher risk areas or with special mission roles. The policy allows voluntary vaccinations for other groups.

    • The Under Secretary of Defense for Personnel and Readiness released DoD implementation guidance for the AVIP on 6 December 2006

    • Service implementation plans were approved by the Assistant Secretary of Defense for Health Affairs on 08 February 2007

    • On December 11, 2008, the Food and Drug Administration (FDA) approved a change in route of administration and the dosing schedule for the anthrax vaccine.



  8. What are the recent changes for the route of administration and dosing schedule for the administration of anthrax vaccine?
    On December 11, 2008, the Food and Drug Administration (FDA) approved a change in route of administration for the anthrax vaccine adsorbed (AVA) from a subcutaneous (SC) injection to intramuscular (IM). The FDA also approved a change in the vaccination series by removing the 2 week dose and asserting the safety and effectiveness of the new 5 dose regimen. This is a change from the originally licensed 6 dose regimen.

  9. Does the change in route of administration and dosing schedule effect the policy?
    The policy remains unchanged. Anthrax vaccination is mandatory for uniformed personnel and all emergency essential and equivalent civilian personnel assigned to the CENTCOM area of responsibility (AOR) or to the Korean Peninsula for 15 or more consecutive days. The vaccine will be offered on a voluntary basis to family members 18-65 years of age accompanying Department of Defense (DoD) military and civilian personnel for 15 or more consecutive days to the CENTCOM area of responsibility (AOR) or Korean Peninsula.

  10. Given the new anthrax dosing schedule, will the recommendation for receiving at least three doses before deploying change to two?
    Yes. Eliminating the 2-week dose does not change the immune status. Receiving a minimum of two doses of vaccine, at day 0 and 4 weeks, prior to arrival in theater is the new recommendation.

  11. While in a voluntary status, will military members be informed about their right to refuse vaccination?
    Yes, Service members will be informed about DoD policy that allows for individual consent to vaccination while in voluntary status. They will also be told that the military and civilian leadership of DoD strongly recommends that they be vaccinated. Anthrax is a deadly infection and anthrax vaccine is an important force protection measure. In the fall of 2001, 22 cases of anthrax resulted from attacks with anthrax spores. Five people died in these attacks. Anthrax vaccine is not experimental, not investigational, and does not require special authorization or informed consent. Anthrax vaccine was licensed for general use on November 4, 1970. It is a routine, common vaccination for people whose occupation places them at-risk for exposure to anthrax. No one will be required to sign consent forms. Members will be informed in writing about the vaccine and told that they have the option to refuse with no punishment of any kind and no adverse personnel action while in voluntary status.

  12. Why did the Food and Drug Administration (FDA) change the anthrax schedule and route of injection?
    In December 2008, the FDA changed the dose schedule and injection route for anthrax vaccine. This change was based on anthrax clinical research, which showed that dropping the second dose did not affect your protection again anthrax disease. The research also showed that injecting the vaccine into the muscle reduced local reactions at the injection site. Click here for the 2008 revised package insert for anthrax vaccine.