Three employees of the U.S. Army Medical Research Institute of Infectious Diseases received the highest honor given to Defense Department civilians at a Pentagon ceremony March 14.
Dr. Louise Pitt, Dr. Bruce Ivins and Stephen Little were awarded the Decoration for Exceptional Civilian Service, which is equivalent to the Distinguished Service Medal for military service. Patricia Fellows, formerly of USAMRIID and now with the Southern Research Institute in Frederick, also received the award. From April 2000 to February 2002, they served as members of the Anthrax Potency Integrated Product Team, which was responsible for solving technical problems associated with the manufacture of the anthrax vaccine used by the Department of Defense.
Anthrax Vaccine Adsorbed, or AVA, is manufactured by Bioport Inc. of Lansing, Mich. In 1997, U.S. military personnel began receiving the vaccine to protect against a possible biological attack. Several months later, Bioport encountered difficulties with the potency test required for the vaccine to maintain licensure with the Food and Drug Administration. A number of vaccine lots failed the potency test, causing a shortage of vaccine and eventually halting the Anthrax Vaccine Immunization Program.
Getting the anthrax vaccine back into production was the mission of the IPT. Over a nearly two-year period, the team performed numerous site visits to Bioport, working directly with the manufacturer. This close coordination was important, Ivins said, to determine where the problems were and resolve them so the vaccine would pass the potency test.
"Their expertise is in production, while ours is solving scientific problems," Ivins explained. "Both perspectives were necessary."
Each of the USAMRIID scientists contributed something unique. Pitt's expertise in aerobiology was tapped to design, conduct and interpret key aerosol studies of the vaccine's efficacy using animal models. She solved procedural problems related to the potency assay and helped plan the studies that compared different lots of anthrax vaccine in rabbits and among guinea pigs from different vendors, thus identifying a major source of variability in the potency assay. These studies paved the way to regaining AVA licensure, acting as an anchor that allowed test results obtained with numerous vaccine lots, conducted at different laboratories, to be compared in a meaningful way.
Ivins, experienced in the characterization and handling of anthrax spores and in animal models of anthrax vaccine immunization, helped perform studies comparing vaccine efficacy from different vaccine lots in the rabbit aerosol model of anthrax. He also solved problems associated with the production, purification, storage and use of the anthrax spores needed for challenge in the potency assay.
Little's specialty, serological testing of host immune responses to anthrax infection and anthrax vaccine immunization, was also critical to the team's success. He established the immune assay systems used in studies comparing serological responses to the human anthrax vaccine by the manufacturer. He also supplied Bioport with the diagnostic reagents needed for these serological studies.
Fellows provided expert advice to Bioport for spore storage procedures and protocols, and she provided technical assistance to a Bioport contractor with respect to methodology for producing, harvesting and purifying anthrax spores. She also assisted with a number of the animal studies that were performed.
Thanks to the efforts of the IPT, the anthrax vaccine was reapproved for human use early in 2002.
"I'm proud of our scientists," said USAMRIID Commander Col. Erik Henchal. "They were able to translate over three decades of our knowledge and experience with anthrax into action to improve production of the vaccine. Their success underscores the enormous value of USAMRIID to the war fighter and to the nation's defense against biological threats."
All three USAMRIID team members said they were surprised to receive an award for, as they called it, "just doing our job."
Ivins summed it all up by saying, "Awards are nice. But the real satisfaction is knowing the vaccine is back on-line."