Development of Vaccines and Preventive Health
Vaccination and preventive health serve a critically important role in the military. As our own history has taught us, if George Washington did not vaccinate Soldiers against Smallpox, America might have lost the Revolutionary War. Our military can only be effective, if it is healthy, which is why the major role of vaccine research and development is essential. The U.S. Army Medical Materiel Development Activity is leading the development of several vaccines and other preventive medicine to protect our Service Members.
The month of August is Preventive Health Awareness Month which allows time to recognize the advancements being made to protect against illnesses that may affect our Service Members. The idea of ‘preventive health' seems straight forward enough for most people; if you can prevent something bad from happening - do it. In addition to these simple personal measures, however, there exists a whole world of scientists, engineers, clinicians, business managers, regulatory specialists, and many others who are busy working on solutions to complex health problems with the aim of preventing injuries and diseases before they occur and saving lives and money in the process.
As a major component of these preventive medicine efforts, vaccines are either made from the weakened or dead pathogens (biological agents that cause bad diseases), or from small parts of these pathogens (called ‘antigens' by scientists). When administered a vaccine, the human body believes it is being invaded by the real active pathogen and creates what is known as antibodies to ‘destroy' the vaccine. Long after the vaccine product has disappeared from the body, these antibodies then remain in the body, creating immunity. This immunity serves as protection if the individual ever is exposed to the actual disease.
Vaccine development relates specifically to the work USAMMDA is doing. "The Pharmaceutical Systems Project Management Office serves as an investor and manager of the Command's product development resources and a broker and facilitator with the commercial partners in our vaccine development efforts," comments Dr. Larry Lighter, project manager for Pharmaceutical Systems Project Management Office at USAMMDA. "We have been assigned the lead in ensuring that products from our laboratories, academia and industry reach licensure and fielding for DOD Warfighters. This applies to products for which the Army Surgeon General is the regulatory Sponsor to the Food and Drug Administration, and also to products that are sponsored by our partners."
On a routine basis, the PSPMO works closely with the regulatory and clinical divisions of USAMMDA to achieve the Command's goals of providing new vaccines to the DOD.
Along with the numerous external partners, USAMMDA collaborates with other U.S. Army Medical Research and Materiel Command laboratories and subcommands. This includes the Walter Reed Army Institute of Research and the U.S. Army Medical Research Institute of Infectious Diseases who play critical roles in the research and development of preventive medicine, contributing to the ultimate FDA licensing.
The question is often asked why we vaccinate for diseases that are rare. The fact that vaccination makes a disease rare in a given population sometimes causes people to forget that the threat may still be there. In fact, some diseases are rare for the very reason they were largely eradicated or believed to be eradicated through the use of vaccines. Small Pox and Adenovirus are two such examples, where they certainly did not start off rare. Thankfully, Small Pox remains a disease of the past, but the Adenovirus is an example of a disease of the past which returned to infect troops.
The Adenovirus was identified in military recruits in the 1950s. Through years of testing, research and development efforts a vaccine was created and the disease, Febrile Respiratory Illness, was under control by 1973. After 23 years, the manufacturer ceased production and exited the business. Adenovirus vaccine supplies were depleted by 1999 and disease returned to military training sites. Senior DoD leaders identified the loss of adenovirus vaccine as an urgent issue in 2000 and assigned USAMRMC the mission of restoring the vaccine capability. Restoration took about 10 years and $100 million. The vaccine was once again administered to trainees beginning in October 2011.
Dr. Cliff Snyder, product manager in the PSPMO at the USAMMDA was a part of the team that accomplished restoration of the Adenovirus Vaccine capability, and is managing continuing efforts to sustain it.
"The use of Adenovirus Vaccine since October 2011 has prevented about 50,000 cases of febrile respiratory illness and saved about 150,000 training days that would have been lost due to Adenovirus infections," said Snyder. In addition to the health and wellness of our troops, medical readiness, 150,000 training days amounts to over $350 million in tax payer dollars that were saved.
The protection provided by the Adenovirus Vaccine is important during basic training when recruits are living in close quarters and are the most susceptible to spreading illness. By administering this vaccine, we are able to keep these men and women healthy to complete their training in one full cycle, allowing our Service Members the maximum benefits of training.
"Adenovirus Vaccine is a great example of what USAMMDA is all about, working with our government and commercial partners to meet the needs for medical support of our military forces," said Snyder.
Since shipments began in October 2011, our manufacturing partner Barr Laboratories has shipped 1,154,000 doses of Adenovirus Vaccine, and military services have administered approximately one million doses to their enlisted basic trainees.
Along with preventing illnesses is the need to protect against diseases endemic to regions where our Service Members are deployed. Present military efforts are focused on developing and licensing a vaccine for dengue. Dengue is a disease spread via mosquito and is a threat in over 120 countries globally.
Lou Jasper, deputy project manager in the PSPMO at USAMMDA, is a part of the developing the Dengue Vaccine.
"Annually, there are about 100 million dengue infections and about 30,000 deaths, but the disease is still emerging and is frequently impacting the United States," said Jasper. "Illness due to dengue virus has created significant impact to our U.S. forces historically; inclusive of World War II and Vietnam. Recently, dengue virus has impacted our Service Members in Haiti and Somalia."
Dengue illness manifests in the classic dengue fever which causes high fever, severe headaches, and rash and bone pain. The disease's more severe forms are Dengue Shock Syndrome and Dengue Hemorrhagic Fever, which can cause severe abdominal pain, bleeding, fluid leakage, shock and (in rare cases) death.
"The U.S. Army Medical Research and Materiel Command has been working to develop a tetravalent dengue vaccine (made with four different viral strains) for decades; more recently with industry partners such as Takeda Pharmaceuticals (USA), Sanofi Pasteur and Glaxo Smith Kline," said Jasper.
"Our efforts with Sanofi have yielded the world's first Dengue Vaccine; however, the efficacy is moderate and the potential for the vaccine to achieve U.S. FDA licensure is still questionable. We continue to partner with industry so that we can accelerate development of viable candidates and to influence and facilitate U.S. licensure," said Jasper.
Vaccine development is a collaborative process and the Adenovirus Vaccine and Dengue Vaccine are examples of these collaborative efforts.
"I expect that we will continue to evolve in gaining additional expertise in vaccine research and development as we move some of our current products to licensure and fielding," said Lightner.
Our Service Members face many obstacles when being sent to foreign regions. It is critical to the success of every mission that our Service Members are being cared for, especially from the unseen microscopic threats.
This is why it is the USAMMDA mission is to "develop and deliver quality medical solutions to protect, treat, and sustain the health of our Service Members". The advancement of vaccine development and preventive health will remain a priority for the safety of our military, and ultimately, our nation.