The Department of Defense today announced findings of two independent panels of medical experts who evaluated the possibility of a relationship between vaccination and the illnesses or deaths of four individuals. Among the four cases, the panels found only one case where vaccination may have contributed to an illness that led to death.
Several million doses of vaccines are administered to the U.S. armed forces annually to protect servicemembers against natural disease and bioterror threats. More than 900,000 members of the armed forces have been vaccinated against anthrax, and more than 500,000 have been vaccinated against smallpox.
Both panels concluded that vaccinations may have triggered an illness that ultimately led to the death in April 2003 of Spc. Rachel Lacy, a 22-year-old Army Reservist, who received several vaccinations at the time she was mobilized for duty. The panels determined that evidence favored a causal relationship, but that the evidence was not conclusive. Each panel said that it was unable scientifically to identify a specific vaccination as the possible cause since several vaccinations were administered at one time.
Dr. William Winkenwerder, assistant secretary of defense for health affairs, stated, “We extend our sympathy to the Lacy family and our appreciation for her service. Specialist Lacy was a valuable member of her unit. She died serving her country.”
Lacy received five vaccinations on March 2, 2003, at Fort McCoy, Wis., where she and her unit were preparing for overseas deployment. She developed a complex set of pulmonary, neurological and other symptoms and died on April 4, 2003. She died due to a severe inflammatory process affecting her lungs, findings consistent with a diagnosis of systemic lupus erythematosus (SLE) or lupus. She did not know she had an underlying immune system disorder, nor did any of her physicians.
The DoD sought the panels’ reviews several months ago as part of the process designed to identify potential adverse effects of vaccinations. The two panels were convened at the request of the assistant secretary of defense for health affairs under auspices of the Department of Health and Human Services as part of DoD’s vaccine safety surveillance program.
The first panel was the Smallpox Vaccine Safety Working Group (SVSWG), a joint subcommittee of the Advisory Committee on Immunization Practices and the Armed Forces Epidemiological Board, a panel of civilian physicians and scientists that advises the DoD. The SVSWG reported that “the weight of available evidence favors acceptance of a causal relationship between the immunization experience and the disease” in the Rachel Lacy case. The panel did not find that the evidence conclusively established an actual causal relationship.
The second panel was the Clinical Expert Immunization Committee (CEIC), a group of expert private, academic physicians convened by the Health Resources and Services Administration, an agency of the Department of Health and Human Services. The CEIC members reviewed Lacy’s case and differed slightly on how to characterize the relationship between the vaccinations and Lacy’s death. Three members considered the relationship “possible,” while two other members considered it “probable.”
In the review of the three other cases, the panels reviewed and found no association with vaccination in any of these cases. The patient diagnoses in these cases were: drug overdose, pulmonary embolism and atrial fibrillation.
Two groups conducted evaluations because each brought complementary expertise to the review process. The SVSWG has monitored adverse-event information about the U.S. smallpox vaccination program since the program’s inception in December 2002. The CEIC is the successor to an experienced panel that reviewed adverse events reported after anthrax vaccination between 1998 and 2001.
"It is important for us to acknowledge the possibility of an association between vaccination and the illness that led to the death of Specialist Lacy. We pledged when we began the military vaccination programs to bring the best science to bear in monitoring adverse events after vaccination, and with these reports we are doing this," said Winkenwerder.
“Vaccinations are important tools to keep our servicemembers protected and healthy,” said Winkenwerder. “Specialist Lacy’s case was rare and clearly tragic. An important conclusion of both expert groups is that nothing was discovered that indicates our screening programs could have prevented the illness and ultimate death of Specialist Lacy, who had an underlying undiagnosed disorder. We plan to continue to carefully administer our vaccination programs, including careful monitoring of adverse events that follow administration. Though it appears no screening procedure could have averted her illness, we have asked our advisory panel to evaluate the practice of simultaneous vaccinations.“
Winkenwerder concluded, “I also want to express my sincere appreciation to the civilian medical experts for their professional and thorough review of all of the cases involved in this investigation. They have furthered our understanding, and that of the entire American medical community, by their work.”
More information on the DoD Vaccination Programs is at http://www.vaccines.mil/.