Questions & Answers
Anthrax - People Issues
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Questions

Educational Materials

  1. Will anthrax vaccine recipients receive any educational information about the anthrax vaccine? How will this information be presented?
  2. Anthrax vaccine information is also available through:

Plasma Donation

  1. Why is the Department of Health and Human Services (DHHS) collecting plasma from anthrax-vaccinated people?
  2. How would this AIG be used, once it is manufactured?
  3. Who is in charge of this project?
  4. Why is AIG needed?
  5. Who is eligible to donate plasma for this project?
  6. Do donors have to be in the Service to donate? What if you're a civilian employee or contractor who got vaccinated against anthrax?
  7. How soon after donating whole blood can someone donate plasma? What about vice versa?
  8. What is involved in donating plasma?
  9. Will plasma donors be compensated for their time and travel?
  10. What happens to the plasma after donation?
  11. How often can a plasma donor donate?
  12. Will my immunity against anthrax decrease after giving plasma?
  13. Will plasma donors sign an informed-consent document?
  14. What side effects can happen during or after plasma donation?
  15. Can somebody get AIDS or some other infection from donating plasma?
  16. Will plasma donation increase the odds of adverse reactions to the next anthrax vaccination?
  17. Will plasma donors be able to get their next anthrax vaccinations on time?
  18. Where are donations going to occur?
  19. Can someone go to any plasma center other than the designated centers involved with this project?
  20. Is a product like Anthrax Immune Globulin (AIG) likely to work or be guaranteed to be used?
  21. How can one get more information about this plasma-donation project?
Answers

Educational Materials

  1. Will anthrax vaccine recipients receive any educational information about the anthrax vaccine? How will this information be presented?
    Commanders and health care professionals will provide anthrax vaccine recipients information about the vaccine. Information has been provided to military personnel and DoD civilians through command channels and internal and external public affairs programs to include web sites, commanders’ calls, military newspapers, television, radio and messages.

  2. Anthrax vaccine information is also available through:
    DoD and Service Web Sites
            www.anthrax.mil
            www.vaccines.mil/anthrax

    AVIP Information
            Anthrax Vaccine Trifold Brochure
            Information Paper (Anthrax Infections and Anthrax Vaccine)
            Information Paper (Anthrax Vaccine Route Change and Dose Reduction)
            Individual's Briefing
            Healthcare Provider's briefing
            Toll-free information line (877-GET-VACC)
            Email question-and-answer service (vaccines@amedd.army.mil)

    Other agencies, including:
            Centers for Disease Control & Prevention (http://www.bt.cdc.gov/)
            Food & Drug Administration (http://www.fda.gov/)
            World Health Organization (http://www.who.int/)

Plasma Donation

  1. Why is the Department of Health and Human Services (DHHS) collecting plasma from anthrax-vaccinated people?

    Despite treatment with highly active antibiotics there is still a significant mortality from inhalational anthrax. Because of this, the DHHS Biomedical Advanced Research and Development Authority (BARDA) Office, funded under Project Bioshield, is working to make a new kind of anthrax medication by collecting blood plasma from people who have been vaccinated against anthrax. Antibodies found in this plasma fight anthrax infections and will be used to create a medication which will be known as anthrax immune globulin or AIG.

    Over 1.8 million people have received anthrax vaccine since 1998; most of which were U.S. service members. DHHS asked the U.S. Department of Defense (DoD) to assist with the AIG plasma program to improve the Nation's medical defenses against anthrax attack. The DoD agreed to distribute information about this voluntary DHHS BARDA office program to service members.



  2. How would this AIG be used, once it is manufactured?
    After it is made, the AIG will be stored for emergency use to treat patients with severe anthrax infection. This emergency supply called the Strategic National Stockpile (SNS), has large quantities of medicine and medical supplies to help citizens across the country, including troops and their families. The Strategic National Stockpile (SNS) managed by the CDC is overseen by the Department of Health and Human Services as provided in Project Bioshield legislation.

  3. Who is in charge of this project?
    The Department of Health and Human Services (DHHS) BARDA office is in charge of this project. Through Project Bioshield, the DHHS contracted with Cangene Corporation (www.cangene.com) to collect the plasma from anthrax vaccinated people and make AIG. Cangene Corporation has contracted with plasma-donation centers in cities near selected military bases to collect plasma for this program. Visit www.cangene.com/AIGPDP.locations.a.htm for a complete list of donation centers.

  4. Why is AIG needed?
    AIG is needed because severe cases of anthrax infection are often fatal, despite current therapies. DHHS and DoD became more interested in AIG after the anthrax bioterrorism attacks of fall 2001. Among the 11 cases of inhalational anthrax, 5 (45%) died despite intensive care and antibiotic therapy. The goal of AIG is to reduce the risk of death among people with severe anthrax in case of another anthrax attack. The need for medications such as AIG to use with antibiotics would be even greater for anthrax infections resistant to antibiotics.

  5. Who is eligible to donate plasma for this project?

    Per the brochure, eligible plasma donors who have received at least 4 or more doses of the anthrax vaccine, with the most recent dose within the past 21 days, are eligible for immediate donation without further vaccination.

    In addition at some locations, individuals can also participate if they have ever received:

    • 4 or more doses of anthrax vaccine*, or
    • 1 or more doses of anthrax vaccine*, or
    • Zero doses of anthrax vaccine

    *Last dose of anthrax vaccine not within the last 21 days.

    These additional AIG programs vary by location, so please contact your nearby plasma center for more details. A list of plasma centers can be found at www.cangeneplasma.com.



  6. Do donors have to be in the Service to donate? What if you're a civilian employee or contractor who got vaccinated against anthrax?
    No, donors don't have to be in the Service to donate. Anyone is welcome to donate plasma for this DHHS BARDA office project, as long as they meet the requirements for donation.

  7. How soon after donating whole blood can someone donate plasma? What about vice versa?
    After donating a unit of whole blood, the usual recommendation is to wait 8 weeks before donating plasma. After donating plasma, the usual recommendation is to wait 2 to 3 days before donating whole blood, assuming the blood donor is in good health.

  8. What is involved in donating plasma?
    Donating plasma is similar to donating blood. A sterile needle is put in your vein and attached to sterile IV tubing. Blood goes out into the tubing, then into a spinning centrifuge, to separate plasma from the blood cells. Plasma is the straw-colored portion of the blood and is made up of 90% water. Plasma contains various proteins, including albumin, fibrinogen (to help clotting) and globulins (including antibodies). The blood cells are then returned to you through the same tubing and needle. A sterile saline ("salt water") solution may be given to you by IV after the donation, to help your body replace fluid removed during donation. If the saline solution is not given, the body will replace the fluid naturally within 48 hours. This process of removing whole blood and separating it into its two main parts: blood cells and plasma is called plasmapheresis.

  9. Will plasma donors be compensated for their time and travel?
    Yes! Standard practice at U.S. plasma centers is to compensate plasma donors for their time and effort. Plasma donors are paid for each plasma donation; bonuses may also be paid to those who donate for multiple consecutive weeks.

  10. What happens to the plasma after donation?
    After donation, the plasma is promptly frozen, then shipped to Cangene Corporation for processing. Antibodies, including anthrax antibodies, are separated from other parts of the plasma. Then the antibodies are processed to kill any germs that might be present, and packaged into vials.

  11. How often can a plasma donor donate?

    FDA standards allow plasma donation as often as twice a week.

    However, USAMRIID and DoD laboratory workers are allowed to donate only once per week, if they are involved in duties that involve the risk of potential occupational exposure.



  12. Will my immunity against anthrax decrease after giving plasma?
    Not in any substantial way. Plasma donation does remove anthrax-fighting antibodies from the bloodstream. The reduction is small, compared to total blood volume and the cells that make antibodies are not removed by plasma donation. Therefore the donor does not lose its ability to make more anthrax-fighting antibodies. Here is an analogy. You own an orchard with apple trees. You give away some of the apples, but keep the rest of the apples and the trees for yourself. Then you grow more apples. Similarly, the plasma donor gives away some antibodies, but keeps the rest of the antibodies and the cells that make more antibodies. Then the donor makes more antibodies to replace the donated antibodies.

  13. Will plasma donors sign an informed-consent document?
    Yes. Plasma donors will sign a consent form to record that they voluntarily donate the plasma. This will be done at the plasma center. Plasma donors will not be the subject of any research project.

  14. What side effects can happen during or after plasma donation?
    Side effects are similar to those related to donating blood. Some donors may feel faint or lightheaded during or right after donating plasma. This usually occurs when the donor did not eat or drink enough just before donating. Inserting the needle may cause a bruise. Some donors may have discomfort in the arm during donation from the needle. This can usually be solved by adjusting the needle's position. Some donors may have a metallic taste or tingling in their tongue or feet. This is caused by a blood thinner used to keep the blood from clotting. If this happens, slowing or stopping the plasma donation will stop the feeling. Allergic reactions could occur, but are rare. People with allergic reactions might have a rash, hives, itching, shortness of breath, or wheezing. If you have any of these feelings during or just after donating, tell the plasma center staff right away. Before donating you will be told about the risks of donating plasma, possible side effects, and be given an opportunity to have your questions answered.

  15. Can somebody get AIDS or some other infection from donating plasma?
    No. It is not possible to acquire any disease through donating plasma, because new, disposable, sterilized equipment is used for each donation. Plasma is collected in a highly controlled, sterile environment by professionally trained staff. Any equipment that touches the donor's blood or plasma is used only once, eliminating the possibility of transmitting any infection to the donor by the donation process. All items used - the finger lancet, the needle, cotton balls, swabs and solutions -are thrown away after a single use. Each plasma center is also periodically inspected by FDA representatives.

  16. Will plasma donation increase the odds of adverse reactions to the next anthrax vaccination?
    No. Plasma donation has never been found to cause adverse events after subsequent vaccinations.

  17. Will plasma donors be able to get their next anthrax vaccinations on time?
    Yes. Plasma donation does not affect vaccination schedules.

  18. Where are donations going to occur?
    Donations will occur at specific plasma-donation centers contracted by Cangene Corporation for this project. These centers are licensed by the Food and Drug Administration (FDA) and are known technically as plasmapheresis centers. The specific centers for this project are near military bases which have large numbers of anthrax-vaccinated service members. Visit http://www.cangeneplasma.com for a complete list of donation centers.

  19. Can someone go to any plasma center other than the designated centers involved with this project?
    No, not for this project. Only the designated plasma centers that are part of this DHHS BARDA office program are collecting plasma to produce AIG at this time. Plasma donated at other centers will not go toward this project.

  20. Is a product like Anthrax Immune Globulin (AIG) likely to work or be guaranteed to be used?

    AIG is not yet licensed by the FDA; it is considered an investigational new drug, also called an IND. Products like AIG were commonly used before antibiotics became available in the 1930s and 1940s. Additional research is being done to understand the value of AIG better but animal studies suggest AIG will be useful.

    AIG may also go unused if there is no emergency or if some other event arises that prevents its use.



  21. How can one get more information about this plasma-donation project?
    Contact the designated plasma center participating in the DHHS BARDA office program. For more information about eligibility or how to contact the center, contact the Military Vaccine Agency - Vaccine Healthcare Centers Network by visiting their website www.anthrax.mil/AIG or calling 877-GET-VACC (877-438-8222). Also visit www.cangeneplasma.com for additional information.