Ounce of Prevention

Written by Kelly Fodel

one of the greatest success stories in public health is the reduction and in some cases elimination of infectious diseases, thanks to the use of vaccinations. Immunizations are key to keeping communities safe from deadly illnesses such as measles, polio and smallpox. Because of its deployments around the world and the threat of bioterrorism, the military community faces some additional risks from infectious disease. That is where the Military Vaccine Agency (Milvax) comes into play.

Milvax was first conceived by Congress and the Department of Defense in the late 1990s as a central organization to coordinate policies on vaccination throughout the armed services, as well as coordinate the implementation of those policies. Prior to the creation of Milvax, each branch of the military was responsible for its own policy on immunization.

Milvax works to enhance military medical readiness and protect human health. It fulfills this mission by synchronizing information, delivering education, enhancing scientific understanding, promoting quality and coordinating military immunization programs worldwide. Milvax supports all five armed services from offices it shares with the Army surgeon general’s office.

“It really wasn’t until the anthrax vaccine program was started that DoD realized that they needed one standardized policy throughout DoD, but we didn’t really have an organization to help coordinate and synchronize the implementation. That is really how Milvax got started,” said Lieutenant Colonel Patrick Garman, deputy director for scientific affairs at Milvax. “It wasn’t until we took on the initiative of the smallpox vaccine in 2002–2003 that we changed our name to the Military Vaccine Agency.”

Since that time, Milvax has spread its wings to coordinate a variety of vaccine initiatives, including a DoD influenza program, as well as any other vaccinations that deal with force protection and readiness. The agency is also involved in the immunization of DoD beneficiaries, including the pediatric and retiree communities.

“We are invested in the research of vaccines, the bringing to the market of new vaccines, the education when those vaccines hit the market, the continuing research of the vaccine and … getting the vaccine to the person who uses it,” Garman said.

For the majority of vaccines, Milvax follows the national recommendations and vaccination schedules of the Department of Health and Human Services and, specifically, the Centers for Disease Control (CDC) and Prevention. Some vaccines, however, are used differently for the military population. For example, the anthrax vaccine is used as a force protection method for those being deployed to high-risk areas. Another example is the Japanese encephalitis vaccine, which is administered to specialized units that might end up traveling to an area in the Pacific Rim that carries the risk of that disease.

Milvax is not responsible for setting the military’s policies on vaccination. That responsibility ultimately belongs to the assistant secretary of defense for health affairs, who helps set health care policy DoD-wide. However, Garman describes Milvax as an agency that is fully involved in all levels of the process, keeping a finger on the pulse of everything from policymaking to implementation, working with the preventive medicine divisions of each branch of the military.

“We are active in the entire process,” Garman said. “We can help with the grassroots people who are actually giving the vaccine, and we know about problems they might be having. We can take that information all the way up to Health Affairs, which would help write the policy, and then we could help work with the different services and help with the implementation.”

Though Milvax oversees and implements a variety of vaccinations, two particular inoculations, for anthrax and smallpox, are at the forefront of the agency’s work. To this end, distinct Websites have been developed to provide information on these vaccines: www. anthrax.mil and www.smallpox.mil. Milvax has partnered with the Department of Health and Human Services in these initiatives. The smallpox vaccine, ACAM2000, was licensed by the Food and Drug Association in August 2007. In April 2008, the CDC awarded a $425 million, 10-year contract to manufacturer Acambis, which was acquired by Sanofi Pasteur in September 2008.

Under this contract, Sanofi Pasteur is establishing a U.S.-based manufacturing capability for the production of smallpox vaccine in Canton, Mass., and Rockville, Md., to produce a minimum of 9 million doses of ACAM2000 annually from year three of the contract onward, according to Sanofi Pasteur public relations manager Susan Watkins.

The anthrax vaccine is produced by Rockville, Md.-based Emergent BioSolutions. BioThrax (Anthrax Vaccine Adsorbed) is the only vaccine approved by the FDA for the prevention of anthrax infection. Over 33 million doses of BioThrax have been delivered since 1998, and the vaccine has been given to over 1.2 million people. This past December, the CDC approved reduced dosage of the product as well as intramuscular administration. In October, Emergent BioSolutions signed a new, multiyear, firm fixed-price contract with the Department of Health and Human Services (HHS) to supply an additional 14.5 million doses of BioThrax for inclusion in the strategic national stockpile, noted Tracey Schmitt, Emergent BioSolutions’ director of corporate communications.

Milvax has increasingly moved to collaborate with HHS on vaccine production and research, but when it comes to actually selecting the suppliers of vaccines, Milvax is somewhat removed from those decisions. The Defense Supply Center (DSC), located in Philadelphia, is the troop support center of the Defense Logistics Agency. The DSC contracts with civilian manufacturers for obtaining vaccines deemed necessary by Health Affairs. Milvax works with the DSC to resolve any supply issues, but the DSC is responsible for contracting with wholesalers and manufacturers. When it comes to biodefense immunizations, the Joint Vaccine Acquisition Program (JVAP) comes into play.

The mission of JVAP is to develop, produce and stockpile FDA-licensed vaccine products to protect the warfighter against biological warfare agents. JVAP consolidates DoD’s efforts for the advanced development, testing, FDA licensing, production and storage of biological defense vaccines. Milvax has the authority to help direct the implementation of policy for both the DSC and JVAP, and can get involved if there is a choice between vaccines that must be made, or to determine where immunizations should go in the event of a shortage.

Generally, Milvax has a limited relationship with vaccine manufacturers. However, the agency does turn to manufacturers for educational purposes and uses them for creating the best educational materials to inform commanders and clinicians about the vaccines that are being administered.

“One area that just continues to grow, that our customers want more and more of, is education,” Garman said. “There is an unquenchable thirst for more education. We just reorganized and created a division just for education, [which includes] not only how to vaccinate, but what to look for in adverse reactions, how to administer vaccinations and how to store vaccinations.”

A large portion of the Milvax Website, at www.vaccines.mil, is dedicated to the education of the patient, the clinician and the commander. The Website includes everything from information on dozens of diseases and vaccines to an education toolkit and a resource center.

“There is information for you if you are a commander and deploying, and know you have to have a certain readiness percentage for vaccinations,” said Garman. “We have PowerPoint presentations just for the nonclinical commander to tell them what they need to do. ‘Here is the policy and here is how you accomplish that.’”

The Milvax Website features an “Immunization University” that provides a single point of access to a wide range of training products relating to immunization services. The curriculum targets all health care workers, from the medic to the physician. Immunization University offers training on vaccine products and immunization services through distance learning and on-site classes, and participants can receive certification through these classes. Even physicians can earn continuing medical education credits via Immunization University. 

 “Something that we have been doing for about the past year is Webcasts, where we get experts from both inside and outside DoD to come into our place and give a live presentation that we beam through the Internet and throughout the world. Since it is a live broadcast, people can submit questions [for the expert],” said Garman.

Milvax also has an operations division that monitors readiness of the services. This division monitors the readiness as far as vaccination rates and the percentage of those vaccinated. This is especially important for active duty and guardsmen who are deploying. Milvax uses centralized electronic immunization tracking systems for this task. They also are active on the ground, knowing the names of the surgeons going along with brigades down to the unit level, to ensure no problems exist.

“We know how many Hepatitis A vaccines were given last month, how many smallpox vaccines,” Garman said. “We can drill down to the actual units, all the brigades that are deploying, to see what those rates are.”

Milvax employs a system of regional analysts who work at local commands across America and around the world, in conjunction with the operations division. These analysts look at readiness rates and help with research efforts, among other tasks. Garman says this allows Milvax to use accurate, detailed information to help develop policy.

Garman pointed out that the tracking of vaccinations could use some improvement. He said a big problem in DoD is that there is no effective immunization tracking system for beneficiaries. While there are tracking systems in each service for active duty members, there is currently no good system for tracking the vaccinations of the pediatric or retiree populations.

Garman said it is important for the military’s vaccine policy to be completely transparent, so that people can see both the good and the bad and have all information before getting any immunizations. To that end, Milvax has restructured its communications division into a “training and outreach” division. It handles baseto- base training courses, which include a three-day session called the Immunization Leaders Course, or a one-day training called the Immunization Safety Course. This division also fields questions about vaccinations from the public, Congress and other federal agencies.

“We have a 24-hour vaccine information hotline, 1-877-GETVACC. People can call anytime, and we will get back to them to answer their questions,” said Garman.

A new Milvax division deals with the safety and effectiveness of vaccinations. Vaccines are generally tested on a few thousand people prior to licensure by the FDA. The FDA has made a recent push to take steps to make drug and vaccine manufacturers conduct post-licensure studies on very specific timelines, to ensure the safety of the vaccine. Some vaccines are only used by the military, such as the anthrax or smallpox vaccine, which are not commonly administered to civilians. The Milvax safety and effectiveness division is responsible for coordinating and interacting with manufacturers to do safety studies and research on these vaccines. Milvax is currently coordinating a study with the CDC, the FDA and the manufacturer of the smallpox vaccine ACAM2000 to look at the safety of the shot within the military population.

Garman sees the future bringing some changes to the way vaccines are made and administered. For example, vaccines will be getting more specific, producing fewer antibodies in the body and targeting the most common threats. These vaccines may be administered via patches or pills instead of injection. There is a new vaccine coming out within a year for adenovirus, that will be orally administered to the basic training population. Additionally, Garman expects a new generation of anthrax vaccines and smallpox vaccines to be produced as well.

“There’s another generation of smallpox vaccine that is a killed vaccine; it won’t be alive like the one that is being administered now,” he said.

With time and the evolving methods of vaccination, Milvax will continue to work toward its mission of protecting and enhancing the health of servicemembers and military beneficiaries. Though the dangers of active duty are many, vaccinations will continue to serve as an effective way to protect our troops from invisible threats.

“The fact is, vaccinations work. It is some of the best money that can be spent on force readiness,” Garman said. ♦

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