Adenovirus Vaccine: Making It Happen
The adenovirus vaccine (officially known as the Adenovirus Type 4 and Type 7 Vaccine, Live, Oral) has been used since Oct. 24, 2011. It protects military trainees against febrile respiratory illness (FRI)—with fever plus symptoms such as coughing and sneezing—caused by adenovirus Types 4 and 7. The adenovirus vaccine goes into the mouth of every basic trainee of the Army, Navy, Air Force, Marine Corps, and Coast Guard.
It does not get there by accident.
The U.S. Army Medical Research and Materiel Command manages the development of adenovirus vaccine. The Pharmaceutical Systems Division of the U.S. Army Medical Materiel Development Activity (USAMMDA) houses the product manager and support staff. The Integrated Product Team (IPT), chaired by the product manager, developed the concept for deployment and distribution of adenovirus vaccine well before the U.S. Food and Drug Administration licensed the vaccine in March 2011. The Milestone Decision Authority approved the basic distribution concept—just-in-time deliveries directly from the manufacturer to the points of use—at Milestone B and C decision reviews.
When basic trainees become ill, the U.S. government expends resources by diagnosing and treating illness, paying trainees who are too ill to train, and making adjustments to the training schedule. The use of adenovirus vaccine is cost-effective when the cost of vaccine is less than the sum of the costs avoided. Under the low-rate initial production contract, the Army procures adenovirus vaccine at a cost lower than the threshold cost, defined as the highest cost at which procurement of vaccine is favorable, as assessed in a cost-benefit analysis.
Analysis of data collected by the Naval Health Research Center shows that the use of adenovirus vaccine has had a very favorable impact on the FRI rate. Disease caused by adenovirus Types 4 and 7 is no longer an issue during basic training.
The manufacturer supplies adenovirus vaccine in a package of two bottles. The IPT’s logistics working group, which includes the manufacturer, conducted a series of test shipments to ascertain the effectiveness of procedures to maintain the cold chain for the vaccine, which must be kept at a certain temperature during transportation and storage. Adenovirus vaccine reached all of the points of use, the nine basic training installations for the U.S. military services, within 48 hours after packing—the period within which the packed vaccine could reliably be kept within temperature limits.
The number of shipping containers sent by commercial carrier varies from month to month and by destination. The product manager develops a shipping plan from estimates of the number of recruits who will arrive at each site. The services need approximately 240,000 doses per year, a figure that includes a safety margin. Upon receiving the shipping plan, the manufacturer ships the number of doses of vaccine needed to immunize recruits in the following month. Since shipments began in October 2011, the manufacturer has shipped 100,800 doses to the training sites without incident.
The Adenovirus Vaccine Product Management Office has two links to the field, both represented on the IPT. The Distribution Operations Center of the U.S. Army Medical Materiel Agency (USAMMA) communicates with relevant logistics personnel at each of the receiving sites to call their attention to imminent deliveries, inquire about the condition of vaccine received, and respond to any questions or concerns relating to shipments.
After the receiving personnel evaluate basic information from the temperature monitors, they ship the monitors to USAMMA, where its personnel download a complete data set and then contact the manufacturer for information and advice on any questions regarding vaccine quality.
The Military Vaccine Agency, a component of the Office of the U.S. Army Surgeon General, is the IPT’s link to preventive medicine staff at each installation, and to senior public health officers of each of the services. With these links, the product manager and IPT are well-positioned to acquire, process, and disseminate information on a timely basis, which remains critical to the distribution of this important vaccine.
- CLIFFORD E. SNYDER JR. is the Product Manager for Adenovirus Vaccine in the Pharmaceutical Systems Division of USAMMDA. He holds a B.A. in natural sciences from Johns Hopkins University, a Ph.D. in biology from the University of Virginia, and a J.D. from George Washington University. He is a graduate of the U.S. Army Medical Service Corps Officers Basic Course. Snyder is Level III certified in program management, and is a member of the U.S. Army Acquisition Corps.