Q and A - Mandatory AVIP Resumption
Copied below are excerpts. To read the full Q and A, go to the below link
http://www.anthrax.mil/documents/Anthrax_QA.pdf
3) Will mandatory anthrax vaccinations resume?
This will be determined shortly by the senior civilian leadership, in consultation with the Joint Chiefs of Staff.
7) Will personnel who receive vaccinations now continue their series when they return from the high threat areas?
Most personnel will not continue their vaccination series when returning from the high threat areas.
8) How long will this current policy be in effect?
This current policy will be in effect until the senior civilian leadership completes their full assessment of the FDA's Final Order.
16) What about all those people who received anthrax vaccinations in the past? Will they be allowed to continue the six-dose series?
The Department will only give anthrax vaccinations to designated personnel, with an option to refuse,until DoD's final policy is determined.
17) What happens to those of us who have received several doses and cannot continue the series?
Individuals who already started the series will be in deferral status and not receive further doses at this time.
18) What happens to those individuals who were court-martialed or given non-judicial
punishment for refusing to take anthrax vaccine?
This is a matter for long-established appeals processes and the Board for the Correction of Military (or Naval) Records.
10) Besides the six scientific panels described in detail above, have any other independent scientific individuals or groups rendered opinions about anthrax vaccine?
Gerald R. Burrow, MD, reviewed the health and medical aspects of the Anthrax Vaccine Immunization Program (AVIP) in 1998 before the program began. This is also discussed below. The Society of Medical Consultants to the Armed Forces (SMCAF) endorsed the anthrax vaccination program in September 1999. (moderator's note: Dr. Burrow is a gynecologist who turned down Congress's offer to testify at a hearing regarding the safety and efficacy of the anthrax vaccine, but, did send in a letter which stated that he was not an expert, and that he excepted the challenge to review the AVIP out of patriotism)
8) Do pilots who have received the anthrax vaccine have any troubles with FAA flight
certification?
No, taking the anthrax vaccine has no effect on civilian or military aviation status. An excellent independent source for definitive information regarding aviation-related matters and the anthrax vaccine can be found at http://www.aviationmedicine.com/anthrax.htm. The Federal Aviation Administration reports that people vaccinated against anthrax are not disqualified from performing
civilian airman duties.
2) I heard that the vaccine used in the 1962 Brachman study isn't the same as the vaccine used today. Is that true?
Yes, it is true that the current vaccine has more protective antigen (PA) in it than Brachman's vaccine formula, and also that the current vaccine is more highly purified than the vaccine used in the Brachman study. Between the time of the Brachman study and the licensing of the vaccine produced in Lansing, the conditions under which the anthrax bacteria were cultured were changed. These changes resulted in a purer, more potent vaccine. Government authorities were aware of and approved the changes at that time the license application was considered in 1970. The independent, civilian review panel advising the FDA was aware of the changes, and described them in its 1985 report. Both vaccine formulas are based on protective antigen (PA), the key protein common to all strains of anthrax.
8) Does the anthrax vaccine contain squalene?
In September 2000, DoD became aware of FDA test results finding trace amounts of squalene in three out of three US vaccines tested: anthrax, diphtheria, and tetanus. The level of squalene identified by the FDA test is so minute that it is likely the result of squalene in the oil of a fingerprint not cleaned from lab glassware. The trace level of squalene found by the FDA in anthrax vaccine is less than the
concentration normally present in human blood (250 parts per billion).
1) Is the anthrax vaccination program a result of lessons we learned from the 1990-1991 Persian Gulf War?
Yes. Building upon the lessons of past wars and leveraging superior technologies available today and in the future, the AVIP is one of the cornerstones of Force Health Protection. Additionally, the current world threat environment and the unpredictable nature of terrorism make it prudent to include biological warfare defense in all our force protection planning. We also learned that we need to put more effort into documentation of vaccinations in Service Members' medical records. This is the reason for the new immunization tracking systems operated by each of the military services.
3) Was the anthrax vaccine FDA-licensed at the time it was given to Gulf War veterans?
Yes. The FDA licensed the anthrax vaccine in 1970. All of the anthrax vaccine administered during the Persian Gulf War was produced at the Lansing facility and release according to the lot-release test criteria for potency, purity, safety, and sterility.
3) Then why are you pursuing a next-generation anthrax vaccine?
We want to explore whether a newer anthrax vaccine would be easier to produce and require fewer doses to achieve immunity. The IOM study also recognized the advantages of developing a next generation anthrax vaccine when it said, "the production, testing, and licensure of a new vaccine requiring fewer doses and producing fewer local reactions are needed."
4) What efforts does DoD have underway? Who are DoD's partners?
DoD and the National Institutes of Health (NIH) have been working on a next-generation anthrax vaccine (NGAV). Specifically, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Joint Vaccine Acquisition Program (JVAP) collaborated to develop an NGAV that uses state-of-the-art recombinant technology. The NIAID collaborates with this effort by preparing the
NGAV product and sponsoring human clinical phase-1 trials. The NIAID is independently pursuing multiple "recombinant protective antigen" (rPA) candidate vaccines, to identify and develop the most promising next-generation vaccine as quickly as possible. This is a parallel effort from the DoD/NIAID cooperative effort on the DoD NGAV candidate.
9) When will human clinical trials of next-generation anthrax vaccines (NGAV) begin?
These clinical trials began in fall 2002.
5) Since 1970, how many times has FDA inspected the anthrax vaccine production facility in Lansing?
The FDA or the National Institute of Health (NIH) has inspected MBPI's (now BioPort's) Lansing facilities more than 50 times since 1969. Each inspection focused on one or more of three manufacturing activities: bacterial vaccines and toxoids, viral vaccines, or plasma derivatives. Examined during each of these inspections were elements common to the manufacturing of all products at the Lansing site, including the manufacture of anthrax vaccine. The anthrax vaccine manufacturing
facilities specifically have been inspected 12 times in the years following licensure. Further, the FDA did not force BioPort to close its facility and rebuild. The decision to renovate the anthrax vaccine manufacturing facilities was made in an effort to meet the demand for vaccine from the Department of Defense.
2) Did the Food and Drug Administration revoke BioPort's license to manufacture anthrax vaccine?
No. BioPort's predecessor, the Michigan Biological Products Institute (MBPI), owned by the State of Michigan, approved renovations in 1995 for the Lansing facility. In 1997, the Food and Drug Administration (FDA) issued a notice of intent to revoke licenses issued to MBPI. MBPI responded within 30 days with a strategic plan for compliance to FDA standards. The manufacturer voluntarily closed the anthrax vaccine production line in January 1998 for renovation. BioPort submitted a highly detailed set of quality control documents to FDA in fall 2001. FDA approved BioPort's facilities and processes, as they relate to the manufacture of anthrax vaccine, on January 31, 2002.
5) Is there a connection between deficiencies found in the 20 February 1998 FDA Inspection Report and the fact that MBPI suspended anthrax vaccine production?
There is no connection between the deficiencies found on the 20 February 1998 FDA inspection report and the fact that MBPI ceased production of anthrax vaccine in its original production suite. FDA did not order MBPI to suspend production. DoD in coordination with MBPI determined several years ago that the current production line would require scheduled renovation. The start of the renovation was contingent upon MBPI completing the production requirements needed to meet the terms of the
production contract (DAMD 17-97-D1139). MBPI fulfilled the contract in December 1997, and the planned renovations began shortly thereafter.
6) Given the nature of the problems identified by the FDA in their inspection of the Michigan Biological Products Institute (now BioPort) in 1996, what safeguards did DoD take to assure that the anthrax vaccine is safe and effective?
DoD directed that supplemental testing be done on all lots in the stockpile at MBPI produced under contract DAMD 17-97-D0003. Of these lots, only lots of vaccine that passed supplemental testing were approved for shipment and use by DoD and Coast Guard personnel.
The Facts on Squalene
1) Executive Summary
A few people claim the Department of Defense (DoD) added squalene to anthrax vaccine to stretch the vaccine supply. Four civilian panels have looked into these allegations since 1999 and repeatedly found them groundless. Neither DoD nor anybody else added squalene to anthrax vaccine for our troops. DoD does not conduct illegal experiments. Details and links to independent sources of data appear below.
14) Did DoD mislead or lie to anybody about the squalene tests conducted by SRI?
No. DoD truthfully and fully reported its findings at each step since May 1999, when SRI first developed its squalene test. DoD did not know of FDA's findings until they were publicly released. At the initial limit of detection of its test, 140 parts per billion, SRI found no squalene in anthrax vaccine (Spanggord et al., 2002). It was scientifically proper to say "no squalene was found to the limit of detection of the
assay," which DoD officials sometimes oversimplified to say "there is no squalene present."
http://www.anthrax.mil/documents/Anthrax_QA.pdf
3) Will mandatory anthrax vaccinations resume?
This will be determined shortly by the senior civilian leadership, in consultation with the Joint Chiefs of Staff.
7) Will personnel who receive vaccinations now continue their series when they return from the high threat areas?
Most personnel will not continue their vaccination series when returning from the high threat areas.
8) How long will this current policy be in effect?
This current policy will be in effect until the senior civilian leadership completes their full assessment of the FDA's Final Order.
16) What about all those people who received anthrax vaccinations in the past? Will they be allowed to continue the six-dose series?
The Department will only give anthrax vaccinations to designated personnel, with an option to refuse,until DoD's final policy is determined.
17) What happens to those of us who have received several doses and cannot continue the series?
Individuals who already started the series will be in deferral status and not receive further doses at this time.
18) What happens to those individuals who were court-martialed or given non-judicial
punishment for refusing to take anthrax vaccine?
This is a matter for long-established appeals processes and the Board for the Correction of Military (or Naval) Records.
10) Besides the six scientific panels described in detail above, have any other independent scientific individuals or groups rendered opinions about anthrax vaccine?
Gerald R. Burrow, MD, reviewed the health and medical aspects of the Anthrax Vaccine Immunization Program (AVIP) in 1998 before the program began. This is also discussed below. The Society of Medical Consultants to the Armed Forces (SMCAF) endorsed the anthrax vaccination program in September 1999. (moderator's note: Dr. Burrow is a gynecologist who turned down Congress's offer to testify at a hearing regarding the safety and efficacy of the anthrax vaccine, but, did send in a letter which stated that he was not an expert, and that he excepted the challenge to review the AVIP out of patriotism)
8) Do pilots who have received the anthrax vaccine have any troubles with FAA flight
certification?
No, taking the anthrax vaccine has no effect on civilian or military aviation status. An excellent independent source for definitive information regarding aviation-related matters and the anthrax vaccine can be found at http://www.aviationmedicine.com/anthrax.htm. The Federal Aviation Administration reports that people vaccinated against anthrax are not disqualified from performing
civilian airman duties.
2) I heard that the vaccine used in the 1962 Brachman study isn't the same as the vaccine used today. Is that true?
Yes, it is true that the current vaccine has more protective antigen (PA) in it than Brachman's vaccine formula, and also that the current vaccine is more highly purified than the vaccine used in the Brachman study. Between the time of the Brachman study and the licensing of the vaccine produced in Lansing, the conditions under which the anthrax bacteria were cultured were changed. These changes resulted in a purer, more potent vaccine. Government authorities were aware of and approved the changes at that time the license application was considered in 1970. The independent, civilian review panel advising the FDA was aware of the changes, and described them in its 1985 report. Both vaccine formulas are based on protective antigen (PA), the key protein common to all strains of anthrax.
8) Does the anthrax vaccine contain squalene?
In September 2000, DoD became aware of FDA test results finding trace amounts of squalene in three out of three US vaccines tested: anthrax, diphtheria, and tetanus. The level of squalene identified by the FDA test is so minute that it is likely the result of squalene in the oil of a fingerprint not cleaned from lab glassware. The trace level of squalene found by the FDA in anthrax vaccine is less than the
concentration normally present in human blood (250 parts per billion).
1) Is the anthrax vaccination program a result of lessons we learned from the 1990-1991 Persian Gulf War?
Yes. Building upon the lessons of past wars and leveraging superior technologies available today and in the future, the AVIP is one of the cornerstones of Force Health Protection. Additionally, the current world threat environment and the unpredictable nature of terrorism make it prudent to include biological warfare defense in all our force protection planning. We also learned that we need to put more effort into documentation of vaccinations in Service Members' medical records. This is the reason for the new immunization tracking systems operated by each of the military services.
3) Was the anthrax vaccine FDA-licensed at the time it was given to Gulf War veterans?
Yes. The FDA licensed the anthrax vaccine in 1970. All of the anthrax vaccine administered during the Persian Gulf War was produced at the Lansing facility and release according to the lot-release test criteria for potency, purity, safety, and sterility.
3) Then why are you pursuing a next-generation anthrax vaccine?
We want to explore whether a newer anthrax vaccine would be easier to produce and require fewer doses to achieve immunity. The IOM study also recognized the advantages of developing a next generation anthrax vaccine when it said, "the production, testing, and licensure of a new vaccine requiring fewer doses and producing fewer local reactions are needed."
4) What efforts does DoD have underway? Who are DoD's partners?
DoD and the National Institutes of Health (NIH) have been working on a next-generation anthrax vaccine (NGAV). Specifically, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Joint Vaccine Acquisition Program (JVAP) collaborated to develop an NGAV that uses state-of-the-art recombinant technology. The NIAID collaborates with this effort by preparing the
NGAV product and sponsoring human clinical phase-1 trials. The NIAID is independently pursuing multiple "recombinant protective antigen" (rPA) candidate vaccines, to identify and develop the most promising next-generation vaccine as quickly as possible. This is a parallel effort from the DoD/NIAID cooperative effort on the DoD NGAV candidate.
9) When will human clinical trials of next-generation anthrax vaccines (NGAV) begin?
These clinical trials began in fall 2002.
5) Since 1970, how many times has FDA inspected the anthrax vaccine production facility in Lansing?
The FDA or the National Institute of Health (NIH) has inspected MBPI's (now BioPort's) Lansing facilities more than 50 times since 1969. Each inspection focused on one or more of three manufacturing activities: bacterial vaccines and toxoids, viral vaccines, or plasma derivatives. Examined during each of these inspections were elements common to the manufacturing of all products at the Lansing site, including the manufacture of anthrax vaccine. The anthrax vaccine manufacturing
facilities specifically have been inspected 12 times in the years following licensure. Further, the FDA did not force BioPort to close its facility and rebuild. The decision to renovate the anthrax vaccine manufacturing facilities was made in an effort to meet the demand for vaccine from the Department of Defense.
2) Did the Food and Drug Administration revoke BioPort's license to manufacture anthrax vaccine?
No. BioPort's predecessor, the Michigan Biological Products Institute (MBPI), owned by the State of Michigan, approved renovations in 1995 for the Lansing facility. In 1997, the Food and Drug Administration (FDA) issued a notice of intent to revoke licenses issued to MBPI. MBPI responded within 30 days with a strategic plan for compliance to FDA standards. The manufacturer voluntarily closed the anthrax vaccine production line in January 1998 for renovation. BioPort submitted a highly detailed set of quality control documents to FDA in fall 2001. FDA approved BioPort's facilities and processes, as they relate to the manufacture of anthrax vaccine, on January 31, 2002.
5) Is there a connection between deficiencies found in the 20 February 1998 FDA Inspection Report and the fact that MBPI suspended anthrax vaccine production?
There is no connection between the deficiencies found on the 20 February 1998 FDA inspection report and the fact that MBPI ceased production of anthrax vaccine in its original production suite. FDA did not order MBPI to suspend production. DoD in coordination with MBPI determined several years ago that the current production line would require scheduled renovation. The start of the renovation was contingent upon MBPI completing the production requirements needed to meet the terms of the
production contract (DAMD 17-97-D1139). MBPI fulfilled the contract in December 1997, and the planned renovations began shortly thereafter.
6) Given the nature of the problems identified by the FDA in their inspection of the Michigan Biological Products Institute (now BioPort) in 1996, what safeguards did DoD take to assure that the anthrax vaccine is safe and effective?
DoD directed that supplemental testing be done on all lots in the stockpile at MBPI produced under contract DAMD 17-97-D0003. Of these lots, only lots of vaccine that passed supplemental testing were approved for shipment and use by DoD and Coast Guard personnel.
The Facts on Squalene
1) Executive Summary
A few people claim the Department of Defense (DoD) added squalene to anthrax vaccine to stretch the vaccine supply. Four civilian panels have looked into these allegations since 1999 and repeatedly found them groundless. Neither DoD nor anybody else added squalene to anthrax vaccine for our troops. DoD does not conduct illegal experiments. Details and links to independent sources of data appear below.
14) Did DoD mislead or lie to anybody about the squalene tests conducted by SRI?
No. DoD truthfully and fully reported its findings at each step since May 1999, when SRI first developed its squalene test. DoD did not know of FDA's findings until they were publicly released. At the initial limit of detection of its test, 140 parts per billion, SRI found no squalene in anthrax vaccine (Spanggord et al., 2002). It was scientifically proper to say "no squalene was found to the limit of detection of the
assay," which DoD officials sometimes oversimplified to say "there is no squalene present."
