FY 2000 defense appropriations conference report calls for two studies

[Guest guest]

Inside The Pentagon

October 14, 1999

Pg. 1

FDA Concerned About Pentagon's Anthrax Vaccine Program Schedule

Concerned about reports that some military personnel are not receiving

their anthrax vaccine shots on schedule, a high-level Food and Drug

Administration official fired a letter off to the Defense Department making

it clear that FDA approval of the Pentagon's anthrax inoculation program

depends on administering the vaccine according to an approved timetable.

" Because we are unaware of any data demonstrating that any deviation

from the approved intervals of doses found in the approved labeling will

provide protection from anthrax infection, we strongly recommend that the

Anthrax Vaccine Immunization Program [AVIP] follow the approved schedule, "

Zoon, director of FDA's Center for Biologics Evaluation and Research,

writes in a Sept. 29 letter to Assistant Secretary of Defense for Health

Affairs Sue . The letter was obtained by sister publication FDA Week.

Zoon says that FDA learned through congressional sources that some

military personnel " may not be receiving the vaccine in accordance with the

schedule found in the approved labeling. " The labeling indicates that " full

immunization " involves six doses taken within 18 months " to complete the

primary series.

" Labeling calls for doses of the vaccine to be administered, following

the first dose, at two and four weeks, six months, 12 months and 18 months,

with yearly boosters thereafter, " Zoon writes. " This schedule is the only

regimen shown to be effective in protecting humans against anthrax and is the

only schedule approved by the FDA. Data received by FDA from congressional

sources indicate that a number of reserve and active military personnel are

receiving their anthrax vaccine doses significantly later than the

FDA-approved schedule. "

Zoon's letter refers to a Dec. 16, 1997, meeting between FDA and DOD

officials to discuss the anthrax vaccine effort. Then-acting Assistant

Secretary of Defense for Health Affairs Ed told FDA officials the AVIP

program " would not vary from the FDA approval labeling, " according to Zoon,

who reiterated FDA's statement to DOD at that meeting that " FDA's approval of

the anthrax vaccine is based on the six-dose regimen found in the approved

labeling. "

In the past few months, several lawmakers have expressed concerns about

the safety and efficacy of the vaccine, and on the anthrax vaccine program's

impact on recruiting and retention, particularly among reserve forces.

Those concerns have prompted House International Relations Committee

Chairman Gilman (R-NY) and Rep. Walter (R-NC) to introduce

separate pieces of legislation that would suspend the anthrax vaccine program

or make it voluntary (Inside the Pentagon, Aug. 26, p1). Gilman's bill also

calls for a series of health studies on the vaccine.

The Pentagon has maintained that the FDA-licensed vaccine is safe and

effective and has been administered properly. In addition, they point out

that only a tiny percentage of the active and reserve forces have refused the

vaccine.

In the recently released fiscal year 2000 defense appropriations

conference report, lawmakers call on the DOD comptroller general to examine

the immunization program and report on its impact on morale, retention and

recruiting.

The comptroller general's report, which may include a classified annex,

is required to look into " the civilian costs and burdens associated with

adverse reactions for members of the reserve components; adequacy of long-

and short-term health monitoring; assessment of the anthrax threat, including

but not limited to foreign doctrine, weaponization, quality of intelligence;

and other biological threats. "

The conferees also call on DOD to contract with the National Research

Council " to independently study the effectiveness and safety of the anthrax

vaccine. " This report is expected to include:

* " The types and severity of adverse reactions, including gender

differences;

* " Long-term health implications;

* " Inhalation efficacy of the vaccine against all known anthrax strains;

* " Correlation of animal models to safety and effectiveness in humans;

* " Validation of the manufacturing process;

* " Definition of vaccine components in terms of the protective antigen

and other bacterial products and constituents; [and]

* " Identification of gaps in existing research. " " Preliminary reports " on

those issues are to be submitted to House and Senate defense appropriators

and authorizers by April 1.

The Army, which runs the AVIP office, has decided to respond to concerns

by lawmakers and some service members about the anthrax vaccine's safety and

efficacy by forming an interagency team of medical experts to coordinate

long-term studies on the drug.

Officially called the Longitudinal Study Concept Committee, the team,

which met for the first time Aug. 24, includes representatives from DOD, FDA,

the Centers for Disease Control and the Armed Forces Epidemiological Board.

At the group's second meeting, held Sept. 22, members decided to

categorize potential studies into three categories: retrospective studies;

prospective studies; and " analysis of reproductive effects, " according to a

defense source.

The committee agreed that a " portfolio of studies should be conducted to

address questions raised by service members and their families, and the

scientific community, " the source said in response to written questions from

Inside the Pentagon.

Retrospective studies can be performed " quickly and inexpensively, " and

could " include the U.S. Army Medical Research Institute of Infectious

Diseases Special Immunization Program, follow-up of the Tripler Army Medical

Center study and linkage of Defense Enrollment Eligibility Reporting System

immunization data with the Army Center for Health Promotion and Preventative

Medicine's ambulatory and inpatient databases, " the source said. Prospective

studies would " require intricate preparation, long-term implementation and

delayed reporting of results, " the source said. The analysis of reproductive

affects would " combine database studies with a widely advertised pregnancy

registry. The registry would include all vaccinations, not just anthrax.

" Vaccine manufacturers and the CDC have offered to share experience in

operating such registries, " the source added.

The committee also defined long-term studies as about 20 years;

intermediate studies would range from one to five years.

" Members thought that most studies would involve surveys or database

analyses, and that most could be conducted within DOD resources, " the source

said. " The committee recognized the value of independent oversight of any

research agenda it proposes. "

-- J. Costa