News Release

For Immediate Release -- March 16, 2011

FDA Approves the New Adenovirus Vaccine

(Fort Detrick, Md.) - The U.S. Army Medical Research and Materiel Command announced March 16 that the U.S. Food and Drug Administration approved the Adenovirus Vaccine (Types 4 and 7).

"The adenovirus vaccine is designed to protect military basic trainees of all Services, including the Coast Guard, against febrile respiratory infections," said Dr. Lawrence Lightner, USAMRMC project manager for Pharmaceutical Systems. "These infections cause approximately 15,000 illnesses per year in basic trainees."

Each infection in basic trainees may result in several days of illness characterized by fever, sore throat, cough and upper respiratory symptoms, occasionally resulting in pneumonia and, in rare cases, death. Adenovirus-infected individuals often must re-cycle through basic training due to missed training days as a result of the disease.

The adenovirus vaccine was developed to replace a previously FDA-approved adenovirus vaccine administered to basic trainees for roughly 25 years, ending in 1999 when the previous manufacturer ceased production. The new adenovirus vaccine was developed by Barr Pharmaceuticals, recently acquired by Teva Pharmaceutical Industries Ltd., under a contract with the Department of Defense managed by the USAMRMC's U.S. Army Medical Materiel Development Activity. The effort received continual support and funding from the Office of the Assistant Secretary of Defense for Health Affairs and endorsement from both the Institute of Medicine of the National Academies and the Armed Forces Epidemiological Board.

"The vaccine is unique in that it is administered in two enterically coated tablets," said Lightner. "One contains type 4 vaccine and the other type 7. The tablets dissolve in the small intestine and stimulate an immune response."

Clinical trials supporting licensure were conducted jointly by Army, Walter Reed Army Institute of Research, and Navy, Naval Health Research Center, investigators at Fort Jackson, S.C., and Great Lakes Naval Training Center, Great Lakes, Ill. In a large study of approximately 4,000 volunteers, the adenovirus vaccine provided 99.3% protection against febrile respiratory illnesses due to the adenovirus type 4 and stimulated protective levels of antibodies against the adenovirus type 7.

Administration of the adenovirus vaccine to all basic trainees is intended to begin in mid to late 2011.

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