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Urgent Attention Needed to Restore Lapsed Adenovirus Vaccine Availability: A Letter Report
Capping 30 years of military medical research, the licensure of adenovirus type 4 and type 7 oral vaccines was a great success story. Epidemics of severe acute respiratory disease (ARD) had been a leading cause of hospitalization among recruits in Army, Navy, and Marine Corps training installations. In 1971, the first year of widespread use, adenovirus vaccines prevented an estimated 27,000 military hospitalizations. The severe ARD epidemics of the 1950s and 1960s were abolished. The impact of the vaccines, including a reduced need to recycle trainees who missed critical training due to hospitalization, as well as savings in the costs of medical care, made the vaccines extremely cost effective. 1
As a result of a series of decisions that were made beginning in 1984 by Food and Drug Administration regulators, the manufacturer, and DoD officials, the sole manufacturer, WyethLederle Vaccines, ceased production of adenovirus vaccines in 1996.2 Discussions between DoD and the manufacturer between 1984 and 1996 failed to lead to a mutually acceptable agreement that would have allowed continued vaccine availability. No alternative source of the vaccine has been found. The military was the only purchaser of adenovirus vaccine and limited its use to recruits in training operations; no civilian market exists at present for this vaccine.
IMPACT ON THE ARMED FORCES
Military surveillance data show minimal adenovirus-related morbidity during the period when the adenovirus vaccine was available and used at the training installations, followed by increased infection rates and hospitalization as vaccine administration became limited and finally ceased. Between October 1996 and May 1998, among symptomatic trainees at four sites, those who did not receive type 4 and 7 vaccine were 13 times more likely to have a positive adenovirus culture and 28 times more likely to be positive for type 4 or 7 adenovirus.3 Ft. Jackson, Ft. Gordon, NTC Great Lakes, Cape May, Ft. Leonard Wood, Lackland AFB, and, most recently, Ft. Benning, have reported adenovirus epidemics, some with serious morbidity. Some epidemics have required adjustments such as the realignment of resources to convert barracks to infirmaries, the opening of new infirmary wards, the cancellation of elective surgeries, and staffing shifts. A few training camps have seen increases—20-fold at one base—in recruit recycling, when recruits miss enough of the training program that they need to begin again. The published surveillance data graphically show the temporal relationship between vaccine administration and respiratory disease rates in training camps.4
Russell PK. Adenovirus infection is not trivial. U.S. Medicine, November 1998.
Barraza EM, Ludwig SL, Gaydos JC, Brundage JF. Reemergence of adenovirus type 4 acute respiratory disease in military trainees: Report of an outbreak during a lapse in vaccination. Journal of Infectious Diseases 179, 1999.
Gray GC, Goswani PR, Malasig MD, Hawksworth AW, Trump DH, Ryan MA, Schnurr DP (for the Adenovirus Surveillance Group). Adult adenovirus infections: Loss of orphaned vaccines precipitates military respiratory disease epidemics. Clinical Infectious Diseases 31:663-670, September 2000.