Military Resumes Adenovirus Vaccinations After More than a Decade Lapse

by U.S. Medicine

December 7, 2011

WASHINGTON — After more than a decade with military recruits vulnerable to adenovirus (ADV), DoD has begun inoculating personnel with a new vaccine to prevent the sometimes severe respiratory infection.


Adenovirus Vaccine.jpg: Army recruit receives the adenovirus vaccine
during basic training at Fort Benning, GA, Oct. 26, 2011. Photo courtesy of Traci
Vactor, Health Systems Specialist, Military Vaccine Agency.

This fall, DoD began shipping out the new vaccine, which is protective against adenovirus type 4 and type 7, to all military and Coast Guard basic trainee sites, with the expectation that it will prevent about 15,000 cases of the febrile acute respiratory disease each year. The vaccine replaces an adenovirus vaccine that went out of production in 1996; DoD’s supplies were exhausted in 1999.

“In a sense, this is a new vaccine. In another sense, it is just a restoration of an old vaccine,” explained Clifford Snyder Jr., PhD, JD, the adenovirus product manager at the U.S. Army Medical Materiel Development Activity.

Febrile acute respiratory disease has wreaked havoc on trainees over the years. In the absence of immunization from 1999 to 2011, about 4% to 5% of all military trainees have had febrile acute respiratory disease caused by adenovirus type 4 or type 7, Snyder noted.

According to the FDA approval document for the new vaccine, the incubation period for ADV is usually four to five days, at which time the infected person presents with a fever of around 100.5° F (38.06° C), cough, coryza, nasal congestion, headache and chest pain, which typically last three to 10 days. Pneumonia develops in about 7% to 10% of cases.

In addition to the symptoms and inconvenience experienced by trainees, these illnesses are costly to the military. Adenovirus causes respiratory problems that may last as long as 10 days. Snyder said estimates suggest that about $30 million dollars is lost in training time and treating illnesses.

“Some of the illnesses did end up in hospitalizations, which is quite expensive,” he added.

Immunizations

Immunizations began Oct. 24, and the goal is to vaccinate every recruit. The vaccine is approved by the FDA for military personnel 17 through 50 years of age and is recommended by DoD for military recruits entering basic training. Snyder said data revealing reductions in disease for trainees is expected in January.

Clinical trials indicated that the new vaccine provided 99.3% protection against febrile respiratory illnesses due to the adenovirus type 4, while the adenovirus type 7 showed a seroconversion rate of 93.8%, according to the FDA document.

The vaccine is administered via two tablets that must be swallowed whole. The tablets contain live adenovirus that is shed in the stool for as long as 28 days following immunizations. Providers have been urged to emphasize that those vaccinated must use proper procedures for hand-washing to prevent spread of the virus.

A Military Vaccine Agency memorandum on the Implementation Guidance for Administration of Adenovirus Type 4 and Type 7 Vaccine Live, Oral also states that “during the 28-day shedding interval, vaccine recipients should exercise caution when in close contact with children less than 7 years of age, immunocompromised individuals and pregnant women.”

 The Military Vaccine Agency is offering an online course for providers that it said on its website would provide “military-healthcare personnel with important and comprehensive information concerning the adenovirus vaccine.”

Military Resumes Adenovirus Vaccinations After More than a Decade Lapse Cont.

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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