1) Why collect plasma from anthrax-vaccinated people?
2) Why is AIG needed?
3) What is AIG?
4) How would this AIG be used, once it is manufactured?
5) Who is eligible to donate plasma for this project? 6) Will plasma donors be compensated for their time and travel?
7) How often can a plasma donor donate for AIG?
8) How much time is required of a donor to participate in this program?
9) Where are donations going to occur?
10) Can someone go to any plasma center other than the designated centers involved with this project?
11) What happens to the plasma after donation?
12) Will my immunity against anthrax decrease after giving plasma?
13) Will plasma donation increase the odds of adverse reactions to the next anthrax vaccination?
14) Will plasma donors be able to get their next anthrax vaccinations on time?
15) Will details of the AVA vaccination given at the plasma center be provided to the donor?
16) Is a product like Anthrax Immune Globulin (AIG) likely to work or be guaranteed to be used?
17) Who is in charge of this project?
18) What does the Health Affairs Memorandum issued on December 21st, 2007 state?
19) How do I find out more information on the AIG program?
1) Why collect plasma from anthrax-vaccinated people?
Despite treatment with highly active antibiotics there is still a significant mortality from inhalational anthrax. Because of this, Cangene Corporation and the US DHHS Biomedical Advanced Research and Development Authority (BARDA) Office, funded under Project BioShield, are 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.
2) Why is AIG needed?
AIG is needed because severe cases of anthrax infection are often fatal despite current therapies. The US Government became more interested in AIG after the anthrax bioterrorism attacks of fall 2001. The goal of AIG is to potentially treat 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 not responsive to antibiotic treatment.
3) What is AIG?
Anthrax Immune Globulin (AIG) is a hyperimmune to be used in treating inhalational anthrax.
Hyperimmunes are purified preparations of specific immune globulins (a class of proteins that function as antibodies) that are isolated from blood plasma. AIG may be used to treat seriously ill victims of inhalation anthrax. Cangene AIG can only be made from the blood plasma of vaccinated humans.
4) 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. It would be part of an emergency supply, called the US Strategic National Stockpile (SNS), that has large quantities of medicine and medical supplies to help citizens.
5) Who is eligible to donate plasma for this project?
To be eligible for this program, individuals must meet the following requirements:
- Be in good health and pass a medical history screening
- Not be pregnant
- Not have received tattoos or non-sterile skin piercings within the past 12 months
- Not have a history of vaccine sensitivities
- Received one or more doses of the anthrax vaccine OR
- Be willing to begin receiving the anthrax vaccine
Eligibility to participate in this program is based on your number of previous anthrax vaccinations and the plasma center where you donate. Even if you have never received the anthrax vaccine, you may still be able to participate at select plasma center locations.
If you have received at least 4 doses of the anthrax vaccine, with the most recent dose in the last 21 days:
- You are eligible for immediate plasma donation
If you have received at least 3 doses of the anthrax vaccine: - You are eligible for plasma donation about two weeks after your next dose*
If you have received 1 or 2 doses of the anthrax vaccine, with the most recent dose over 6 months ago:
- You may be eligible for plasma donation about two weeks after your next dose*
If you have never received the anthrax vaccine:
- You are eligible for plasma donation about 6 months after you begin receiving the vaccine*
*To participate you need to be eligible to receive the anthrax vaccine. You can receive the anthrax vaccine by 1) requesting an immunization at your military installation or 2) at select plasma center locations.
Additional eligibility requirements may apply. Contact a participating plasma center for more details.
6) Will plasma donors be compensated for their time and travel?
Yes! Standard practice at US 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.
7) How often can a plasma donor donate for AIG?
FDA standards allow plasma donation as often as twice a week. However, certain government laboratory and research workers will be allowed to donate only once per week if they are involved in duties that involve the risk of potential occupational exposure.
8) How much time is required of a donor to participate in this program?
Once a donor receives an AVA vaccination, they must wait about 2 weeks to begin donations. Donations can occur up to twice a week for at least four weeks. This equals about eight donations in one month.
On rare occasions, donors that maintain higher antibody levels may be asked to participate longer, which would include extending the donation period beyond the typical 4 week period.
9) 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. Click here for a complete listing of Plasma Donation Centers.
10) 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 program will collect plasma to produce AIG. Plasma donated at other centers will not go toward this project.
11) 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.
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 but 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 their ability to make more anthrax-fighting antibodies.
13) 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. 14) Will plasma donors be able to get their next anthrax vaccinations on time?
Yes. Plasma donation does not affect vaccination schedules.
15) Will details of the AVA vaccination given at the plasma center be provided to the donor?
Yes. If requested, the plasma center can provide the individual donor with proof of their AVA immunization to allow updating of individual military medical records.
16) 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. 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.
17) 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 to collect the plasma from anthrax vaccinated people and make AIG. Cangene Corporation has contracted with plasma-donation centers for this program. The Military Vaccine (MILVAX) Agency is coordinating the program with selected military installations.
18) What does the Health Affairs Memorandum issued on December 21st, 2007 state?
The Health Affairs Memorandum issued from the Assistant Secretary of Defense, S. Ward Casscells, MD, asks for installation support in publicizing the AIG program to vaccinated service members. It suggests providing AIG informational brochures at DoD installation immunization clinics and facilitating other appropriate promotional activities.
19) How do I find out more information on the AIG program?
To find out more specific information on individual donor eligibility requirements contact the plasma center nearest you as they will be able to answer any questions related to the AIG plasma donation program. Information is also available at www.anthrax.mil provided by the Military Vaccine (MILVAX) Agency.
Click here to view copies of our various AIG Program brochures.
More FAQ on General Plasma Donation |
