Going Out of Production

Adenoviruses are transmitted by direct contact, fecal-oral transmission, and occasionally waterborne transmission, according to the CDC. With large numbers of young people brought together from all over the country to live in close quarters in a stressful setting, military basic-training sites create an ideal environment for the spread of these illnesses, which in rare cases can even cause death.

The Institute of Medicine (IoM) estimates that use of the adenovirus type 4 and type 7 oral vaccines prevented about 27,000 military hospitalizations in 1971, the first year the vaccine was in widespread use.

Use of the original vaccine continued until the manufacturer, Wyeth, discontinued production of the vaccine in 1996 after Wyeth and DoD failed to come to an agreement that would have allowed production to continue.

Epidemiologists correctly predicted that the incidence of adenovirus-associated disease would increase in trainees after the vaccine supplies were exhausted in 1999, Snyder said. In 2000, two Navy recruits died and were thought to be the first two deaths probably associated with adenovirus infection in the U.S. military since 1972, according to the July 6, 2001, CDC Morbidity and Mortality Weekly Report.

 DoD leadership was urged by health officials, both internally and externally, to take action to get the adenovirus vaccine restored.

An IoM report in 2000 was critical of DoD’s efforts to restore the vaccine and recommended, “a much greater sense of urgency be placed on re-acquiring an effective adenovirus vaccine.”

Even before the vaccine ran out, the Armed Forces Epidemiological Board, which is now the Defense Health Board, also warned of the risks of the virus to troops.

After funding was secured for the new vaccine, the Army awarded Barr Laboratories a contract for development in 2001. Snyder explained that Wyeth provided Barr Laboratories with the manufacturing information, but Barr still had to “establish production of the type 4 and type 7 viruses; build and equip a Good Manufacturing Practices — compliant tableting facility; and conduct both phase 1 and phase 3 clinical studies.” All of those steps took time.

 “When it comes to getting FDA approval for a new submission — although it is not a brand-new invention, it is a new submission — 10 years isn’t really all that long, particularly when you consider that the FDA did require clinical studies, a relatively small phase 1 study involving around 60 people and a considerably larger phase 3 study involving 4,000 people,” Snyder said.

Adenovirus

Urgent Attention Needed to Restore Lapsed Adenovirus Vaccine Availability

Summary Basis for Regulatory Action

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