MILVAX
IN COOPERATION WITH THE MILITARY SERVICES, MILITARY VACCINE AGENCY COORDINATES INFORMATION AND EDUCATION OF VACCINE-RELATED ACTIVITIES.
When it comes to protecting the troops against bioweapons like anthrax and smallpox, no amount of germ-resistant clothing or chem-bio shelters can match the effectiveness of another defense mechanism— vaccination. Since 1998 more than 1.5 million DoD personnel have received the anthrax vaccine, and in the past four years more than 1.1 million personnel have had smallpox vaccinations.
In October 2006 the deputy secretary of defense issued a directive to resume mandatory anthrax immunizations for personnel in higher threat areas, as well as voluntary anthrax immunization for others. Two months later, the undersecretary of defense for personnel and readiness issued guidance for the implementation of the program, specifically listing the individuals and units, based upon location and mission, that will be required to receive mandatory vaccinations. The guidance also states the groups that can voluntarily be vaccinated.
Individuals who received at least one dose of anthrax vaccine and who are no longer deployed to a higher threat area or assigned to special mission roles may receive (subject to medical exemptions), on a voluntary basis, all six doses and the annual booster as long as they remain members of the armed forces or maintain a civilian employee or contractor status.
Dr. William Winkenwerder, Jr., assistant secretary of defense for health affairs, said this policy provides commanders the ability to protect their forces against an anthrax biological attack and increases medical readiness. He added, “Americans receive vaccines to protect us against diseases such as tetanus, measles, mumps, polio and influenza. The anthrax vaccine will protect our troops from another threat—a disease that will kill, caused by a bacteria that already has been used as a weapon in America and that terrorists openly discuss.”
VACCINE COORDINATOR
Overseeing the immunization effort is the Military Vaccine (MILVAX) Agency, located at the U.S. Army Medical Command in Falls Church, Va. In cooperation with the military services, MILVAX coordinates information and education of vaccine-related activities. In addition to measuring (and analyzing) the implementation of immunization policies, the agency supports programs that enhance the quality of standardized automated immunization tracking systems, while also working to establish and implement joint clinical quality standards for vaccine administration through education and training in vaccine health care.
The agency started as the Anthrax Vaccine Immunization Program in 1998. It dealt mainly with the anthrax program until 2002 when DoD began its smallpox vaccination program. Three years ago when there was a national shortage of influenza vaccine, the office was again involved in the coordination and implementation of the policies and programs to get through that season. At about the same time it became clear that the office was providing many of the same services to DoD on numerous vaccines, so the decision was made to expand the Army’s role from DoD executive agent for the anthrax program to DoD executive agent for all military immunization programs.
While the MILVAX agency’s core focus remains grounded in the vaccines that protect service members against possible biological weapons such as anthrax and smallpox, the agency is dedicated to providing the same quality of service for any vaccination. “This level of effort is constant for voluntary and mandatory vaccinations, said Colonel Randall G. Anderson, director of the MILVAX Agency. “We want every vaccination to be a safe one. We want every vaccination to be recorded in the DoD electronic immunization tracking systems, and we want every individual that has an adverse event from a vaccination to be treated with the best care, no matter if the vaccination was voluntary or mandatory.”
To monitor rare or unexpected adverse events associated in time to any vaccine, DoD health care providers have participated in the Vaccine Adverse Event Reporting System (VAERS), since its inception in 1990. For anthrax vaccine, each VAERS report involving anthrax vaccine between 1998 and 2001 was reviewed by an independent panel of civilian physicians. This panel detected no patterns of unexpected adverse events related to anthrax vaccination.
An area where the MILVAX Agency and the clinically-focused Vaccine Healthcare Centers Network is watching very closely, said Anderson, is the rate of myo-pericarditis that developed after smallpox vaccination. To date no cases of vaccinia (the live virus in the vaccine) transmission from one person to another in the workplace have been reported. Among almost 28 thousand smallpox-vaccinated health care workers, there have been no cases of transmission of vaccinia from health care worker to patient.
Throughout DoD there have only been about 70 cases of contact transfer of vaccinia virus identified through VAERS, principally to spouses and adult intimate contacts. “I believe this is due to DoD’s effort to educate the vaccinees about care of their vaccination site and the servicemembers’ strong attitude towards compliance,” remarked Anderson. “During education, we repeat the warning ‘Don’t let your guard down at home.’”
IMMUNIZATION UNIVERSITY
Education and outreach is a core focus of the MILVAX Agency. It has developed an “Immunization University” that serves as a focal point to bring together a variety of products and services designed towards excellence in immunizations from the MILVAX Agency partners like the Vaccine Healthcare Centers Network. This site also fosters the best business practices from the Centers for Disease Control and Prevention, schools and military units around the world.
In addition to printed and online information, the university provides online training under Project Immune Readiness on a variety of diseases and immunization topics. These courses provide accredited continuing education credits to those requiring them. There are also two in-person courses, the three-day immunization leaders course and the one day immunization basic course that the agency provides to U.S. forces across the globe, explained Anderson. The basic course was developed to improve quality immunizations right at the immunization clinic’s location.
“We found a majority of young medics are trained in injection techniques, but could benefit from more in-depth training on screening individuals, identifying those that shouldn’t receive the vaccine and knowing the processes to report adverse events, such as submitting the VAERS,” observed Anderson. So the MILVAX Agency is now progressing to providing these courses through live web communication and collaboration applications designed for interactive web conferencing. “This is allowing us to reach out to even more individuals, in a responsive environment where we can answer unique questions, without a large travel budget. By archiving the classes, our service members around the world can access and view these training events whenever is convenient for them.”
The MILVAX Agency’s Websites are an important information dissemination component. In addition to the dedicated Websites for anthrax and smallpox programs, there is also the main Website for all vaccines, at www.vaccines.mil. Each of these sites draws in about 1,600 unique visitors per day, noted Anderson.
He pointed out, “By using some of the best Web analytics applications, we can monitor the information viewed, which helps us ensure that the information we’re providing our customers is useful and tailored towards the data they need and use most often. This allows us to remain responsive to the demands for certain information and can provide early identification of certain types of units—or locations—that might not be getting information through their normal military channels.”
The MILVAX Agency has also developed a secure military vaccine Website available on SIPRNET, which, Anderson adds, has been particularly useful in disseminating information to deployed forces in Iraq and Afghanistan.
Another form of outreach is public service announcement videos that highlight the benefits and risks of vaccines and cover specific diseases of interest, such as pandemic influenza. These videos will be aired by Armed Forces Radio and Television Service and will also be downloadable for podcasts by our individual service members.
Yet another MILVAX initiative was the development of a Military Vaccine Monitoring System (MVMS). During the implementation of the DoD smallpox immunization program in 2002, the agency developed a telephone- and Web-based “symptom diary” to monitor the self-reported adverse events for smallpox vaccine recipients for 14-days post-vaccination. Remarked Anderson, “The application was highly successful in assessing the post-vaccination experience of 1,649 service members vaccinated for smallpox from March through September 2003. The system also allowed the monitoring of reported adverse events and allowed recipients to effectively selfreport their ‘take’ reaction from the vaccine.”
In 2006, MVMS was modified from tracking just injectable and intranasal influenza vaccines, to a system that could monitor any DoD administered vaccine, including the possibility of an H5N1 avian influenza vaccine. The modified system also allowed the recipient to record additional vaccines they received at the same time as the vaccine being monitored. The benefit of this system in an influenza pandemic, said Anderson, is the ability to monitor the adverse events of the new vaccine for a large number of people in a mass vaccination. The application also has a feature that allows the participant to request that a medical professional contact them. He added, “This could greatly reduce the number of potentially contagious people returning to the hospitals for advice.”
IMMUNIZATION TECHNOLOGIES
In 2004, when the United States experienced a shortage of injectable influenza vaccine, DoD introduced the intranasally administered live, attenuated influenza vaccine (FluMist) for the first time to its beneficiaries, said Anderson.
While DoD only uses Food and Drug Administration-approved vaccines and vaccination equipment to immunize the forces, the MILVAX Agency is assessing and helping to develop the new technologies that could be approved and used in the future. Anderson’s agency is working with the Army’s Medical Research and Materiel Command (MRMC) at Fort Detrick, Md., where scientists are developing new vaccines that could help protect U.S. forces, such as a vaccine to protect against malaria. MRMC is also developing vaccine products designed to provide protection against all four Hantaviruses and enhance the sustainability of U.S. forces in regions of the world where Hantaviruses are endemic, such as Asia and Europe.
MRMC scientists are also looking at new methods of vaccinations, such as transdermal and intranasal technology, which would be especially beneficial in protecting forces in a mass vaccination campaign. A collaborative study between United States Army Medical Research Institute for Infectious Diseases and industry has demonstrated that administration of recombinant protective antigens to the skin or nasal mucosa using novel, inexpensive, and disposable medical devices provides a high level of protection against aerosol challenge of animal models with anthrax-causing spores, according to Anderson. Transdermal and intranasal delivery devices are also being studied for use with vaccines against a variety of biological warfare agents.
The Distribution Operations Center (DOC) of the U.S. Army Medical Materiel Agency has been assigned the exclusive mission of the distribution management of anthrax and smallpox vaccines for the entire DoD. DOC, in partnership with the MILVAX Agency, is identifying the new technologies and methods that can improve vaccine shipping and monitoring. It specifically involves cold chain-management of temperature-sensitive medical products that require special handling while maintaining close in-transit visibility.
“The DOC developed many principles and methods for cold chain management distribution while conducting intensive testing on various shipping containers and monitoring devices to evaluate and validate the products currently in use as well as identifying potential new products,” indicated Anderson.
He commented that one of the key principles developed by the DOC to assure product’s quality and potency is the use of temperature monitoring devices in every shipment. The electronic monitors provide history and assurance that the product has been kept within acceptable temperature ranges throughout the many steps in the distribution process. They also have the products transported with state-of-the-art asset visibility (i.e., knowledge of where the shipment is at all times).
“The Department of Defense is dedicated to providing the best medical products available to protect their service members deployed worldwide,” said Anderson. “This mission requires constant reassessment of immunization programs and policies and the vital task of providing up-to-date education to a wide variety of individuals. Working to maximize the quality of care throughout the vaccination process is an endless endeavor, but is accurately captured in the motto of Immunization University— Every Immunization an Excellent One. The MILVAX Agency continues to pursue the best techniques and technologies to accomplish this goal.” ♦