Despite what DOD, CDC and FDA may say, every expert group studying
By Dr. Meryl Nass, mnass@gwi.net
Every Expert, Independent Committee that Has Investigated Anthrax Vaccine Since 1998 Agrees: Long-Term Safety Studies are Needed
1. “The committee recommends a long-term, longitudinal study of participants in the Anthrax Vaccine Immunization Program.
Future research should consider issues related to potential long-term adverse effects of the combinations of these and other vaccines routinely given to armed forces personnel.”
Institute of Medicine Committee on Health Effects Associated with Exposures During the Gulf War.Gulf War and Health: Depleted Uranium, Pyridostigmine Bromide, Sarin, Vaccines.
September 1999
2. “We recommend that the Secretary of Defense direct the Secretary of the Army to design and conduct a study on possible long-term side effects of the anthrax vaccine and develop a communications plan to provide servicemembers information on the status of this effort.”
Government Accountability OfficeMedical Readiness: DOD faces challenges in implementing its anthrax vaccine immunization program. GAO/NSIAD-00- 36
October 1999
3. “Safety of the [anthrax] vaccine is not being monitored adequately. The program is predisposed to ignore or understate potential safety problems due to reliance on a passive adverse event surveillance system and DOD institutional resistance to associating health effects with the vaccine.
DOD should enroll all anthrax vaccine recipients in a comprehensive clinical evaluation and treatment program for long-term study.”
House Committee on Government Reform, United States Congress Unproven Force Protection
April 2000
4. “Other safety issues related to use of anthrax vaccine that should be addressed include development and evaluation of pretreatment strategies to decrease short-term adverse events; assessment of risk factors for adverse events, including sex and preexisting antibody levels; and analysis of differences in rates of occurrences of adverse events by route of anthrax transmission and method of vaccine administration. Because the role of repeated inoculations in local and systemic reactions remains unclear, further research is needed regarding this subject. In addition, the feasibility of studies to evaluate longer term and systemic adverse events should be determined.”
CDC’s Advisory Committee on Immunization PracticesUse of Anthrax Vaccine in the United States.(published in: MMWR 2000; 49: RR-15: 1-20.)
December 15, 2000
5. “DOD should carefully evaluate options for longer-term follow-up of the possible health effects of vaccination against anthrax (and other service-related exposures).”
Institute of Medicine Committee to Assess the Safety and Efficacy of Anthrax Vaccine
The Anthrax Vaccine: Is It Safe? Does It Work? March 2002
6. We recommend that the Secretary of Defense direct the establishment of an active surveillance program (unlike the passive VAERS) to identify and monitor adverse events associated with each anthrax vaccine immunization. This program should ensure that appropriate and complete treatment and follow-up are provided to those who have experienced adverse events and to those who may experience them in the future.
Government Accountability Office
ANTHRAX VACCINE: GAO’s Survey of Guard and Reserve Pilots and Aircrew
GAO-02-445September 2002
7. “The VHC [military Vaccine Healthcare Center] network is expected to serve as a base for research on AVA and other vaccines administered to military personnel.
A VHC-based study to verify reaction rates to AVA and the validity of self-reported data observed in the clinical trial should provide for intensive active surveillance of relatively small cohorts, similar in size to the study groups in the human clinical trial.”
Institute of Medicine Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Program
An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program 2003
8. “Recommendations: That VA work with federal agencies (CDC, NIH, DOD) involved in conducting vaccine trials that include administration of AVA to ensure that these trials include follow-up assessments of study subjects a minimum of five years after inoculation. Such studies should utilize methods and instruments capable of capturing chronic symptoms and cognitive difficulties similar to those experienced by Gulf War veterans.
That VA conduct a retrospective cohort study that compares chronic symptoms and diagnosed conditions experienced by veterans who received AVA as part of the military’s mandatory anthrax vaccination program to those of a comparable group of veterans who did not receive this vaccine.”
VA Research Advisory Committee on Gulf War Veterans’ Illnesses
Scientific Progress in Understanding Gulf War Veterans’ Illnesses: Report and Recommendations
September 2004
Meryl Nass, MD
Every Expert, Independent Committee that Has Investigated Anthrax Vaccine Since 1998 Agrees: Long-Term Safety Studies are Needed
1. “The committee recommends a long-term, longitudinal study of participants in the Anthrax Vaccine Immunization Program.
Future research should consider issues related to potential long-term adverse effects of the combinations of these and other vaccines routinely given to armed forces personnel.”
Institute of Medicine Committee on Health Effects Associated with Exposures During the Gulf War.Gulf War and Health: Depleted Uranium, Pyridostigmine Bromide, Sarin, Vaccines.
September 1999
2. “We recommend that the Secretary of Defense direct the Secretary of the Army to design and conduct a study on possible long-term side effects of the anthrax vaccine and develop a communications plan to provide servicemembers information on the status of this effort.”
Government Accountability OfficeMedical Readiness: DOD faces challenges in implementing its anthrax vaccine immunization program. GAO/NSIAD-00- 36
October 1999
3. “Safety of the [anthrax] vaccine is not being monitored adequately. The program is predisposed to ignore or understate potential safety problems due to reliance on a passive adverse event surveillance system and DOD institutional resistance to associating health effects with the vaccine.
DOD should enroll all anthrax vaccine recipients in a comprehensive clinical evaluation and treatment program for long-term study.”
House Committee on Government Reform, United States Congress Unproven Force Protection
April 2000
4. “Other safety issues related to use of anthrax vaccine that should be addressed include development and evaluation of pretreatment strategies to decrease short-term adverse events; assessment of risk factors for adverse events, including sex and preexisting antibody levels; and analysis of differences in rates of occurrences of adverse events by route of anthrax transmission and method of vaccine administration. Because the role of repeated inoculations in local and systemic reactions remains unclear, further research is needed regarding this subject. In addition, the feasibility of studies to evaluate longer term and systemic adverse events should be determined.”
CDC’s Advisory Committee on Immunization PracticesUse of Anthrax Vaccine in the United States.(published in: MMWR 2000; 49: RR-15: 1-20.)
December 15, 2000
5. “DOD should carefully evaluate options for longer-term follow-up of the possible health effects of vaccination against anthrax (and other service-related exposures).”
Institute of Medicine Committee to Assess the Safety and Efficacy of Anthrax Vaccine
The Anthrax Vaccine: Is It Safe? Does It Work? March 2002
6. We recommend that the Secretary of Defense direct the establishment of an active surveillance program (unlike the passive VAERS) to identify and monitor adverse events associated with each anthrax vaccine immunization. This program should ensure that appropriate and complete treatment and follow-up are provided to those who have experienced adverse events and to those who may experience them in the future.
Government Accountability Office
ANTHRAX VACCINE: GAO’s Survey of Guard and Reserve Pilots and Aircrew
GAO-02-445September 2002
7. “The VHC [military Vaccine Healthcare Center] network is expected to serve as a base for research on AVA and other vaccines administered to military personnel.
A VHC-based study to verify reaction rates to AVA and the validity of self-reported data observed in the clinical trial should provide for intensive active surveillance of relatively small cohorts, similar in size to the study groups in the human clinical trial.”
Institute of Medicine Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Program
An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program 2003
8. “Recommendations: That VA work with federal agencies (CDC, NIH, DOD) involved in conducting vaccine trials that include administration of AVA to ensure that these trials include follow-up assessments of study subjects a minimum of five years after inoculation. Such studies should utilize methods and instruments capable of capturing chronic symptoms and cognitive difficulties similar to those experienced by Gulf War veterans.
That VA conduct a retrospective cohort study that compares chronic symptoms and diagnosed conditions experienced by veterans who received AVA as part of the military’s mandatory anthrax vaccination program to those of a comparable group of veterans who did not receive this vaccine.”
VA Research Advisory Committee on Gulf War Veterans’ Illnesses
Scientific Progress in Understanding Gulf War Veterans’ Illnesses: Report and Recommendations
September 2004
Meryl Nass, MD
