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Documents on Terrorism - Anthrax Hearings October 1999
Statement by the Honorable Sue Bailey, Major General Randall L. West and Lieutenant Colonel Gaston M. Randolph


Presentation to the Committee on Government Reform

DEFENSE VACCINES:

Part of Total True Force Protection in an Uncertain World

STATEMENT BY

Honorable Sue Bailey
Assistant Secretary of Defense (Health Affairs)
MajGen Randall L. West
Special Assistant to the Under Secretary of Defense, Personnel
and Readiness, for Anthrax and Biological Warfare
Lieutenant Colonel Gaston M. Randolph, Jr.
Director, Anthrax Vaccine Immunization Program Agency
Submitted To

HOUSE COMMITTEE ON GOVERNMENT REFORM
OCTOBER 12, 1999

INTRODUCTION

Chairman Burton and Distinguished Committee Members, I am honored to appear before your Committee today to address your questions about the Department of Defense (DoD) vaccine immunization program as a component of our biological defense program. I am Dr. Sue Bailey, Assistant Secretary of Defense for Health Affairs. I am accompanied today by Major General Randy West, Special Assistant to the Under Secretary of Defense, for Anthrax and Biological Defense Affairs, and Lieutenant Colonel Gaston M. Randolph, Jr., Director of the Anthrax Vaccine Immunization Program Agency. At your request, our testimony will specifically address the Departmentís policy involving biological warfare and vaccines, refusal process, personnel education, vaccine safety and surveillance, immunization compliance, and Anthrax Vaccine Immunization Program implementation.

THE THREAT

General - Currently, at least ten nation states and two terrorist groups are known to possess, or have in development, a biological warfare capability. The production of biological warfare agents does not require specialized equipment or advanced technology. When comparing equal amounts of biological and chemical warfare agents, the biological agent is far more potent. Small quantities of biological agents can produce very large numbers of casualties. Biological agents can be delivered through a number of means; including aerial bombs, artillery shells, long-range missiles, agricultural sprayers, and spray tanks carried by aircraft, ships, boats or even cars. Many of the materials and equipment that are used to produce biological warfare agents are available from legitimate sources and intended for other uses such as pharmaceuticals or biopesticides, thus making it difficult to limit, detect or stop the spread of biological warfare technologies and capabilities.

Anthrax Itself - Of all biological warfare agents, anthrax spores are the top choice in biological weapons for "germ warfare." Several of the countries that have or are developing offensive biological warfare capabilities are most likely working with anthrax. Iraq has admitted to producing and weaponizing anthrax. The anthrax accident at Sverdovsk in 1979 illustrated Russiaís military research with the organism. Anthrax is many times more lethal than any of the most potent chemical warfare agents, such as VX. It is an infectious disease caused by the bacteria Bacillus anthracis and spread by contact with infected animals, handling infected products, eating infected meat, or breathing weapon-dispersed anthrax spores.

Anthrax Virulence - Compared to many other pathogens with BW potential, starting cultures of anthrax are relatively easy to obtain. Large quantities of the bacteria can be produced in readily obtainable fermentation vessels. The organism naturally converts to a spore form that can be stored as bulk agent or in filled munitions. When disseminated in air, the spores remain viable much longer than other types of infectious agents. The size of the spores (approximately 1-micrometer) is such that when inhaled, they tend to be retained in the lung. The effects usually are lethal unless rapid diagnosis is made and a combination of appropriate medical measures is administered immediately. One deep breath can inhale enough spores to result in fatality. Initial symptoms begin 1 to 6 days after exposure and mimic cold or flu-like symptoms. Once symptoms occur in the unvaccinated, it is too late for vaccination or antibiotic treatment for those contaminated. If untreated, death follows within 1 to 3 days after symptoms first begin. Lethality for unvaccinated persons who are contaminated and do not receive near term antibiotics approaches 100%. Anthrax is considered an effective biological weapon because:

It is lethal if the victim is not treated immediately or prevaccinated. Spores can be produced in large quantities using basic knowledge of biology.

Spores can be stored for years without losing viability.

Spores can be easily spread in the air by missiles, rockets, artillery, aerial bombs sprayers.

There is no effective treatment for unvaccinated inhalational anthrax victims once symptoms are exhibited.

The objective of the Departmentís Nuclear, Biological and Chemical defense program is to enable our forces to survive, fight and win in an NBC-contaminated environment.

To protect our military personnel against this lethal weapon, the Department of Defense has established a force health protection policy which includes the use of vaccines, where possible, in sufficient time to develop immunity before deployment to high-threat areas. It is also the policy of the United States Government, as delineated in the Executive Order of September 30, 1999 to provide our military personnel with safe and effective vaccines that negate or minimize the effects of biological weapons.

Vaccines to Protect U.S. Military Personnel, 1999

In addition to the routine vaccine needs of healthy adults, U.S. military personnel receive various vaccinations, based on the health threats encountered in their basic military training, occupation, travel and operational areas of employment. Military vaccination schedules are frequently presented to the Armed Forces Epidemiological Board (AFEB), an external panel of distinguished civilian medical experts for consultation and concurrence. These vaccines are described by category in Table 1. Vaccines given to all military recruits protect against diphtheria, influenza, measles, meningococcal disease, poliovirus, rubella, and tetanus. Some recruits receive adenovirus, mumps, varicella, and yellow fever vaccines. In addition, all members receive tetanus-diphtheria toxoids every 10 years and are administered annual vaccines to protect against influenza. However, some members are required to take anthrax, hepatitis A, hepatitis B, Japanese encephalitis, meningococcal, plague, rabies, typhoid, and yellow fever vaccines because of deployment to high-risk areas.

Vaccines given based on occupation, personal risk factors, or personal health status include Haemophilus influenzae type b, hepatitis B, Lyme disease, meningococcal disease, pneumococcal disease, rabies, and varicella vaccines. Table 1 displays the timing and routine schedule of vaccines typically administered to military personnel.

Table 1. Vaccines Typically Administered to Military Personnel, 1999 (U.S. Army, U.S. Navy, U.S. Marine Corps, U.S. Air Force, U.S. Coast Guard)

Timing

Vaccine

Routine Schedule for Basic Immunity **

Recruits:

(Adenovirus)
Diphtheria
Influenza
Measles
Meningococcal disease
Mumps *
Poliovirus
Rubella
Tetanus
Varicella *
Yellow fever *

Single dose
Single, every 10 yrs
Annual
Single dose
Single dose
Single dose
Single dose
Single dose
Single, every 10 yrs
Two doses
Single, every 10 yrs

During advanced individual training (AIT) and then throughout career
(both active-duty and
reserve component):

Anthrax
(policy in AVIP phase III)

Six-dose series

Routine during career
(both active-duty and
reserve component):

Diphtheria
Influenza
Tetanus

Single, every 10 yrs
Annual
Single, every 10 yrs

Alert forces; when deploying or traveling to high-risk areas
(both active-duty and
reserve component):

Anthrax (current policy)
Cholera ***
Hepatitis A
Hepatitis B
Japanese encephalitis
Meningococcal disease
(Plague)
Rabies
Typhoid
Yellow fever

Six-dose series
Two doses
Two doses
Three doses
Three doses
Single dose
Three doses
Three doses
Dosage varies
Single, every 10 yrs

Individualized according
to occupational
or personal needs:

Haemophilus influenzae type b
Hepatitis B
Lyme disease
Meningococcal disease
Pneumococcal disease
Rabies
Varicella

Single dose
Three doses
Three doses
Single dose
Single dose
Three doses
Two doses

* Vaccination policy varies among Military Services based on Service needs.

** Booster doses may be required at annual or other intervals to sustain immunity. *** Seldom used: vaccine offers only short-term protection, with painful injections. Vaccines listed in parentheses may not be available due to manufacturing limitations. Adapted from United States Army Regulation 40-562; Navy Bureau of Medicine Surgery Instruction 6230.15; Air Force Joint Instruction 48-110; Coast Guard Commandant Instruction M6230.4E. Immunizations Chemoprophylaxis. Washington, DC, 1 November 1995.

Even with this aggressive program to protect our forces, we know we must remain constantly in search of new avenues to combat the ever-emerging biological warfare and infectious disease threats.

Vaccines are under development for a number of validated biological warfare and infectious disease threats to military forces. Included among these are: nine biological disease vaccines being investigated by the Medical Biological Defense Research Program (Staphylococcal Enterotoxins, Encephalitis viruses, Ricin, Brucellosis, Filoviruses, Othopox viruses, Botulinum Toxin, Plague, and next generation Anthrax vaccine); and five in advanced development at the Joint Vaccine Acquisition Program (Q-Fever, Tularemia, Smallpox, Venezuelan Equine Encephalitis, Botulinum Recombinant Multivalent). In addition, the Military Infectious Disease Research Program currently is investigating vaccines to prevent infections by the following organisms: Malaria (Plasmodium falciparum), Dengue Fever virus, Heptitis E virus, Meningitis (Neisseria Meningitidis Group B), Shigella, Enterotoxigenic Escherichia coli, Campylobacter, and Hantaviruses. This is only a summary of ongoing research and should not be interpreted as future mandatory vaccine policy. Much work is yet to be done on safety, efficacy, threat, protocol, requirements, etc.

Multi-Dose, Multi-Decade Military Vaccine Safety Studies

Given the number of vaccines presently used and the number under investigation, it is prudent for us to evaluate the safety and efficacy of administering multiple vaccines. We have done that for over forty years. Research on the health effects of multiple immunizations first appeared in the 1958 Bulletin of the Johns Hopkins Hospital. Two follow-on studies appeared in the Annals of Internal Medicine in 1965 and 1974 (Peeler, et al., 1958; Peeler, et al., 1965; White, et al., 1974). These successive studies reported on the health of 99 male laboratory workers at Fort Detrick, Maryland, who were hyper-immunized with multiple vaccines between 1944 and 1971. These workers received 52 to 134 milliliters of vaccines (average: 97 ml) against multiple infections. They also received 6 to 93 microbial skin tests (average: 55 tests) to detect hypersensitivity or immunity to dangerous microorganisms. For comparison, note that the six 0.5-ml doses of anthrax vaccine in the primary series total 3 ml. These workers received various combinations of immunizations against anthrax, botulism, brucellosis, diphtheria, Eastern equine encephalitis, influenza, plague, poliomyelitis, psittacosis, Q fever, Rift Valley fever, Rocky Mountain spotted fever, smallpox, tetanus, tularemia, typhus, Venezuelan equine encephalitis, Western equine encephalitis, and yellow fever.

The final report concluded: "It is of prime significance that long-term follow-up examination of these intensively immunized men failed to demonstrate any evidence of illness attributable to the immunizations. There is no indication that intensive immunization interfered with the ability to produce adequate antibody titers after antigenic challenge." The authors also noted "These data and the accompanying evaluation of an intensively immunized population provide evidence that no obvious adverse effects result from repeated immunizationÖ" Thus, this group provides reassurance that schedules for routine immunization with a diversity of vaccines should not produce untoward effects merely because of frequency of inoculation. However, allow me to again clarify that the Department does not plan to administer any additional vaccines without compliance with FDA requirements and when necessitated by existing threats. We are only pursuing prudent, precautionary research and development in response to potential threats.

SAFETY AND EFFICACY OF VACCINES

To ensure that the vaccines administered to our military personnel are safe and effective, the Department of Defense conducts an aggressive, multi-faceted surveillance program. In fact, the safeguards of vaccine administered to DOD personnel meet or exceed every standard for vaccine administration to the civilian population. Our program includes a wide variety of activities that can be grouped into three main scientific method categories: clinical studies of vaccine recipients; database analysis of vaccine recipient automated medical records; and spontaneous reports.

As the Centers for Disease Control Prevention (CDC), the Food and Drug Administration (FDA), and trained epidemiologists discovered over time, these methods need to be used in tandem to fully understand whether or not an adverse event was caused by a vaccine or merely coincided in time with the vaccination. Coincidental events are sometimes referred to as temporal (pertaining to or limited in time) associations. Temporal association alone does not prove causation.

A current example of this tandem surveillance is the anthrax vaccine safety program. The Department is using these same three scientific methods to ensure a vaccine that is both safe and effective against all known strains of anthrax pathogen. Anthrax vaccine adsorbed (AVA) has been approved by the FDA for nearly 30 years, and has been reaffirmed by a civilian advisory panel in 1985 and reaffirmed by senior FDA officials in 1999 during previous hearings.

A new long term study, in addition to several already performed, is also underway to determine whether individual people who received multiple vaccines, including the anthrax vaccine, during their past employment at Ft. Detrick, MD demonstrated any adverse health effects over the long term. A total of 570 study and control volunteers have been enrolled in this case-controlled study that began in 1996. All volunteers signed an approved informed consent document. The study media included a 9-page health history questionnaire, extensive blood tests and urinalysis. The questionnaire queries mental and physical conditions of progeny as well as the health of volunteers. Study end points include symptoms, symptom complexes (including the Gulf War Illness complex of symptoms), diseases, abnormal laboratory and urine tests. Study subjects will be compared to 2-3 race, gender, and age-matched control subjects to determine if any long-term medical effects exist among this unique group of study subjects. Analysis of the data from the extensive health history questionnaire and numerous laboratory tests is currently in progress.

On August 24, 1999, the Anthrax Vaccine Immunization Program Agency convened a team of medical experts to design a set of studies to assess the long-term safety of the anthrax vaccine, in response to concerns expressed from Service Members, their families and the General Accounting Office. In designing these studies, we have drawn from the accumulated experience of some of the nationís best vaccine researchers at CDC and FDA.

Vaccine Adverse Event Reporting System (VAERS)

The Department of Defense has also been a long-time participant in CDC/FDA national programs aimed at collecting information about adverse events temporally associated with vaccines. DoD has reported to VAERS, since its inception.

A DoD policy memorandum ensuring that Reservists have full access to DoD Medical Treatment Facilities for treatment of adverse events from DoD directed immunizations was signed on July 20, 1999, and clearly outlines patient or provider submission of Form VAERS-1.

Health care professionals, as well as patients themselves, report adverse events after immunization to VAERS. VAERS reports, by definition, will include a combination of events caused by the vaccine and coincidences that are only temporally associated with immunization and have no cause-and-effect relationship with the vaccine.

Naturally, we are most interested in serious adverse events, death, anaphylaxis, hospitalization or prolonged disability, but we are also concerned about reactions at the injection site, often called "local reactions." DoD encourages our health care professionals to report all adverse events that they consider important and clinically relevant. As with our civilian clinician counterparts, the criteria for reporting a VAERS event are non-restrictive, as a means to encourage reporting.

Education Communication

The number and variety of vaccines administered to our personnel makes education and communication a high priority. The Department of Defense is committed to fully educating our service members, DoD civilians, DoD civilian contractors and their families on the purpose and value of all its vaccines. One of the most thorough examples of this kind of education is the anthrax vaccination education program. In an unprecedented manner, we use each of the following communications media to accomplish this goal:

u A sophisticated anthrax specific website www.anthrax.osd.mil with multiple layers of information and methods for communicating with our Service Member population, their families, and other DOD beneficiaries and concerned members of the American public.

u Three Service - specific anthrax websites hyper-linked to all known military and civilian websites discussing anthrax, biological weapons, health care, domestic preparedness, terrorism, VAERS reporting, preventive medicine, infectious disease, and more.

u Information sheets (tri-folds) individually tailored for Service Members, Family Members and Civilians. DOD issued Tri-folds to each Service Member receiving the vaccine since administering the first doses in March 1998. The Tri-fold explains the threat of biological weapons, the benefits of anthrax vaccination and the known risks from the vaccine. The Tri-fold is currently under revision to include Reserve Component-specific information on accessing care.

u DOD Leaders Briefing required to be given to all Service Members prior to receiving the anthrax immunization. Distributed by each Service and prominently posted on the www.anthrax.osd.mil website.

u DOD Health Care Providers Briefing given to all DOD health care providers administering the anthrax vaccine ó who then serve as teachers, coaches, mentors for supervisors, commanders, Service Members and their families. Distributed by each Service and prominently posted on the www.anthrax.osd.mil website.

u Open House/Speakers Bureau briefings and open educational forums for all Service Members and their families.

u A 1.877.GETVACC telephone toll-free information line was implemented on 1 Sep 99.

u A variety of anthrax vaccine Ďsilent training aidsí. These highly visible training aids emphasize the key themes of the anthrax threat, safety and efficacy of the vaccine, vaccine dosing schedule, and adverse event reporting.

u Armed Forces Information Service news media, local installation print, radio and television news service initiatives.

A state-of-the-art Anthrax Education CD-ROM which provides Service

Members, families, supervisors, commanders and health care providers with tailored, multimedia information on the anthrax threat, safety and efficacy of the vaccine, signs, symptoms and prevention of anthrax is in production now.

u An Anthrax Vaccine Immunization Program Videotape explaining the threat, safety, efficacy of the vaccine. The video features prominent civilian and Government scientists and vaccine experts explaining and endorsing the vaccine is also in production.

u DOD is currently collaborating with CDC to array this information in the format of Vaccine Information Statements (VIS) that civilian health care providers around the country give Americaís children, adolescents, and adults during routine vaccinations.

u Clinical guidelines for managing adverse events after vaccination were drafted in May 1999, based on a consensus panel of civilian and military physicians experienced both in immunology and the general provision of health care. After a synchronized staffing with the Services, Federal Agencies and other institutions, we will distribute the guidelines worldwide, including posting on the www.anthrax.osd.mil web and all associated, linked health care sites. These guidelines represent DoDís concerted effort to standardize the evaluation and care of people who have adverse events after vaccination against anthrax. It is worth noting that such guidelines have never been developed in the civilian sector.

Administering Vaccines

We realize that no matter how safe a vaccine is or well it is communicated, it is critical to maintain the highest standards in clinical and administrative practices. We do this in variety of ways, including monitoring, documenting, conducting clinical conferences and panels.

Monitoring and Compliance Reporting - Monitoring and compliance using guidelines discussed in the preceding paragraphs are an ongoing quality assurance/quality improvement responsibility of both individual medical treatment facilities and the DOD military health system. Overarching guidance is established in a variety of ways, including standards printed in the joint immunization instruction, "Immunization and Chemoprophylaxis Regulation" (Army Regulation 40-562, Bureau of Medicine Surgery Instruction 6230.15, Air Force Joint Instruction 48-110, Coast Guard Commandant Instruction M6230.4E), dated 1 November 1995.

This regulation represents the current standard for immunizations and chemoprophylactic practices within the military health system. In addition to this joint regulation, each Serviceís formal anthrax immunization implementation plan addresses clinical aspects of vaccine administration. The six shot Anthrax regimen is an excellent example of the requirements of this monitoring and compliance. Using sophisticated information and tracking Service systems, each of the Service immunization tracking systems allows unit leaders to track pertinent individual and unit data from any deployed location. All Service electronic immunization data is ultimately stored in the Defense Eligibility Enrollment Reporting System (DEERS), which serves as the final corporate data repository. In addition to electronically recording anthrax immunizations, each Service employs several redundant paper-based records systems to record immunizations, including the Health Record, the yellow shot record, immunization clinic sign-in logs and other forms.

While the current AVIP Phase 1 focused on immunization of the Active Component, (91% of all service members immunized to date), we are extremely concerned with implementation, tracking, compliance and heath care follow-up of our Reserve Forces. We recognize that the reserve forces will have some special needs as the Department continues its three-phased execution. These challenges include the lack of routine contact with commanders, weekend drill opportunities for immunizations and the concern of Service Member medical follow-up if they have a concern with any expected or unexpected reactions to the vaccine. Through the AVIP Synchronization Team, supported by the AVIP Agency and working with the ASD (Reserve Affairs), we intend to provide additional services and capabilities to the reserves to ensure their confidence and compliance. Reservistsí can receive their vaccinations and follow up medical evaluation as needed at any of our Military Treatment Facilities (MTFs) across the nation. We have begun and have nearly completed implementation of a Federal Strategic Health Alliance for Force Health Protection Initiative that brings together federal agencies and the private sector to increase access to vaccination through internal RC medical assets, DoD Medical Treatment Facilities, the Public Health Service, Veterans Health Administration, and a private contractor, the Arora Group. These resources collectively extend access to care to a provider network of greater than 15,000. A July 1999 Department memorandum reiterates Reserve Component access to DoD Medical Treatment Facilities for treatment of all vaccine adverse events.

The Synchronization Committee will coordinate the phased vaccination of units and locations to better focus our education and communication program and assist commanders, Service Members and their families.

Documentation Ė In addition to immunization tracking, there are several other quality assurance/quality improvement measures commonly adopted in medical treatment facilities to ensure the highest clinical standards are fulfilled. All clinical encounters (e.g. immunizations administered, sick call visits, hospitalizations, etc.) are documented in the patientís health record. Each dose of anthrax vaccine is recorded in service-specific and DoD-wide tracking systems. The service specific tracking system reports when a Service Member is due the next dose or has been waived or deferred.

Clinical Panels -

At the facility level, health care providers use panels called morbidity mortality committees to discuss and investigate negative outcomes such as death (none of which have been reported from anthrax vaccination). Medical treatment facilities have pharmacy therapeutics (PT) committees to review and encourage reporting of all medication or vaccine related adverse events. Medical treatment facilities submit reports of their quality assurance/quality improvement programs to each Service medical headquarters for corporate review and analysis. To monitor and assure compliance, all Services report any adverse events weekly to their higher medical headquarters.

Refusals

Even with careful monitoring, a strong education and communication program, and the highest vaccine safety standards, some members will choose, by reason of conscience or other motivation, to not participate in an immunization program. A recent example is the Anthrax Vaccine Immunization Program (AVIP).

With the current Directive for all members to participate in the AVIP, some local commanders have had to decide which, of several options available, to take when a person in his or her command refuses to be vaccinated. These options include administrative, non-judicial and/or judicial actions. However, prior to beginning any such action, the Service Member is re-educated and counseled on the nature of that refusal, the threat and the safety and efficacy of the vaccine. Service members are encouraged to speak with a Health Care Provider. Commanders review and take action on each refusal case based on its own merit and the service memberís record.

Because the disposition of each case is handled locally, no data is formally collected on personnel, whether active duty, National Guard, reserve or civilian DoD. This permits each commander the opportunity to act independently, without undue outside pressure.

SUMMARY

We believe we have a safe and effective vaccine to respond to a well-documented threat. We are pleased with our recently implemented tracking and documentation system. What we are most proud of, however, is our nationís greatest asset Ė the service men and women who go in harmís way to preserve our freedom and safeguard our national interests.

We cannot depend on advanced warning of a bio-weapon attack. Bio-detectors, though an important component of our biological-chemical defense strategy, are still in an early state of implementation with many concerns to be worked out. Protective clothing, masks and equipment while available quickly degrades individual and unit performance and is impractical to wear for long periods of time. Imminent death or incapacitation from known biological warfare agents is vaccine preventable. Our personnel deserve our best and fullest protection. It would be a dereliction of leadership and our moral and ethical responsibility not to immunize our service men and women with licensed, safe and effective vaccines.



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