Veteran Services Transparency

Since the war, reported adverse reactions to the anthrax vaccine, and quality control issues related to its production, have given it a particularly high profile as a possible cause of Gulf War illness. There is relatively little scientific research, however, that has provided clear information on the potential for the anthrax vaccine, or other vaccinations received by Gulf War veterans, to produce chronic symptoms similar to those of Gulf War illness.

An important first question, which the Committee was not able to fully answer, concerns the extent to which research on adverse effects of the U.S. anthrax
vaccine, largely conducted prior to 1972 and again after 1998, can be applied to the anthrax vaccine given to Gulf War veterans. There are many unknowns surrounding the anthrax vaccine provided at the time of the Gulf War. This includes a number of indications that AVA has not been an unvarying product with a risk profile that can be assumed to be the same before, during, and after the Gulf War.
…At that time, MDPH changed from glass to stainless steel fermenters and substituted nylon filters for the ceramic filters previously used.680,1678 The changes sped up processing time and increased production volume for a given lot, allowing more vaccine to be produced in a shorter time period.1678 No information is available from testing done by MDPH at the time of these changes, however, to determine possible effects on the vaccine. An investigation by the General Accounting Office (GAO, now the Government Accountability Office) suggested that the filter changes could result in higher levels of proteins in the vaccines, and that MDPH did not test for anthrax proteins edema factor (EF) or lethal factor (LF). The GAO also reported that results of an unpublished Army study, conducted in October 1990, found as much as a 100-fold increase in the level of PA in the vaccine after the filter change.

…..Therefore, it is still important that individuals who received AVA be monitored for an extended period to carefully ascertain rates of both multisymptom illness and diagnosed diseases. …..concerns have been raised in relation to vaccines received for the Gulf War, but relatively little reliable information has implicated individual vaccines as prominent risk factors for Gulf War illness. Several issues related to vaccines received by Gulf War veterans have not been adequately addressed by existing research. These include the need for more thorough evaluation of vaccines as risk factors for chronic health problems in epidemiologic studies, a definitive study to conclusively evaluate the previously-observed association between squalene antibodies and Gulf War illness, and the need for longer-term evaluation of symptoms and diagnosed diseases following receipt of the anthrax vaccine.

Sources: Gulf War Illness and Health of Gulf War Veterans from the Research Advisory Committee on Gulf War Veterans’ Illnesses

 The Committee therefore recommends the following research:

•  In previously-conducted and future epidemiologic studies of Gulf War veterans, analyze associations between Gulf War illness and individual vaccines, combinations of vaccines, and total number of vaccines received using methods that control for potential confounding by other Gulf War-related exposures.
• Commission a case-control study to provide clear answers concerning possible associations between Gulf War illness and squalene antibodies. The study should, at minimum, analyze blinded samples from well-characterized symptomatic and healthy Gulf War veterans for the presence of squalene antibodies using each of the assays developed for this purpose. It should also assess whether there is an identifiable link between levels of squalene antibodies in ill Gulf War veterans and receipt of the anthrax vaccine or vaccines more generally. The project should be organized and overseen by qualified investigators not affiliated with the federal government or civilian scientists whose initial work raised the squalene issue in relation to Gulf War illness.
• Evaluate the association of anthrax vaccine adsorbed (AVA) with chronic symptoms, Gulf War illness, and diagnosed diseases in personnel known to have received the anthrax vaccine during the Gulf War. These health outcomes should also be assessed at least five years after vaccination in deployment and era subgroups of personnel in the Millenium Cohort study as well as other groups vaccinated in association with the military’s anthrax vaccine immunization program and federal anthrax vaccine trials.