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In the 1950s and 1960s, before military scientists identified the causative viruses and developed this effective and safe oral vaccine, 5 approximately 50 percent of recruits fell ill with acute respiratory disease, with certain sites reporting 80 percent attack rates in some years. The vaccine program cut those rates, and the associated hospitalizations, in half. A 1998 cost-effectiveness analysis, using incidence data, a range of vaccination policy options, and medical and training cost data, estimated a savings of approximately $16 million per year were the DoD to reinstate the vaccine program.6

CURRENT DEVELOPMENT EFFORT

Attempts by the DoD to find an alternative solution, including initial negotiations with another vaccine manufacturer, have been unsuccessful to date. To restart an adenovirus-vaccine program, the new manufacturer must go through the full FDA new-product approval process. With a one-time $14 million investment from the Defense Health Program, the Medical Research and Materiel Command is preparing a Request for Proposals (RFP). Challenges include creating a contract strategy, including elements such as commitments to multi-year funding, to which manufacturers might respond. DoD anticipates releasing the RFP for comments in the fall of 2000, working toward the best-and-final offer stage in January 2001. Even without schedule slippage, a vaccine will not be available for use within the next three years.7 The initial funding amount likely will cover only Phase I preparation and some administrative and technical support.8

DISCUSSION

  • The DoD urgently needs adenovirus vaccine to (a) prevent increasingly large epidemics of febrile illness that put military personnel at risk of illness and even death,9 and (b) avoid

5  

Top FH Jr, Grossman RA, Bartelloni PJ, Segal HE, Dudding BA, Russell PK, Buescher EL. Immunization with live types 7 and 4 adenovirus vaccines. I. Safety, infectivity, antigenicity, and potency of adenovirus type 7 vaccine in humans. Journal of Infectious Diseases 124(2):148, August 1971.

Rose HM, Lamson TH, Buescher EL. Adenoviral infection in military recruits: Emergence of type 7 and type 21 infections in recruits immunized with type 4 oral vaccine. Arch Environ Health 21:356, September 1970.

Takafuji ET, Gaydos JC, Allen RG, Top FH Jr. Simultaneous administration of live, enteric-coated adenovirus types 4, 7, and 21 vaccines: Safety and immunogenicity. Journal of Infectious Diseases 140(1):48, July 1979.

6  

Howell MR, Nang RN, Gaydos CA, Gaydos JC. Prevention of adenoviral acute respiratory disease in Army recruits: Cost-effectiveness of a military vaccination policy. American Journal of Preventive Medicine 14(3), 1998.

7  

Howell W. Adenovirus history. Presentation to the Institute of Medicine Committee on a Strategy for Minimizing the Impact of Naturally Occurring Infectious Diseases of Military Importance: Vaccine Issues in the U.S. Military, September 2000.

8  

William Howell, personal communication, October 2000.

9  

Levin S, Dietrich J, Guillory J. Fatal nonbacterial pneumonia associated with Adenovirus type 4: Occurrence in an adult. Journal of the American Medical Association 201:975, 1967.

Dudding B, Wagner S, Zeller J. Fatal pneumonia associated with adenovirus type 7 in three military trainees. New England Journal of Medicine 286:1289, 1972.



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