AUGUST 29, 2017, FORT DETRICK, Md. – Each August, our country is reminded of the importance of vaccines through the National Immunization Awareness Month campaign. Not only do vaccinations save lives, they also help to halt the spread of disease, both regionally and globally. While most people consider Edward Jenner’s smallpox vaccine in 1796 as the birth of modern immunization practice, evidence shows that a smallpox inoculation may have been used by China perhaps 800 years earlier. Nevertheless, over the past 220 years, the worldwide administration of antitoxins and vaccines has proven extremely successful in eliminating numerous diseases that may have taken, or significantly affected, the lives of millions.
Each day, the team members of the U.S. Army Medical Materiel Development Activity are tasked with developing and delivering quality medical capabilities to protect, treat and sustain the health of Service Members throughout the world — and the men and women of USAMMDA take this assignment very seriously. As a subordinate command of the U.S. Army Medical Research and Materiel Command, the organization develops new drugs, vaccines and medical support equipment that greatly enhance readiness, which helps to maximize the survival of medical casualties both on and off the battlefield.
USAMMDA’s Pharmaceutical Systems Project Management Office is the group charged with managing the advanced development of many critical vaccines intended for our service members. Helping to lead this talented team is Louis Jasper, PSPMO deputy project manager. Over the past decade, Jasper has been involved in numerous efforts that have helped to protect and preserve many lives — and he certainly understands the significance of immunization.
“Vaccinations are important for a number of reasons,” said Jasper. “They protect the individual from getting ill, and they also curtail epidemic spread. Without vaccines, viruses and other pathogens can directly impact the health of our Service Members and our military readiness. This is what we are working to safeguard.”
Jasper said the PSPMO team is responsible for the advanced development of novel vaccines. This category includes:
1. Vaccines that currently do not exist anywhere in the world.
2. Existing vaccines that are not currently licensed in the U.S.
3. Ineffective vaccines that do not meet the needs of the U.S. military.
He explained, “If we have a significant unmet need for a vaccine that does not exist, or if we need a better vaccine, we surveil the market for potential candidates, inclusive of those in development in USAMRMC laboratories such as Walter Reed Army Institute of Research.”
Adding, “Typically, we will work with the technology base to mature a candidate, be it internal or external, until developmental risk has reduced enough to adopt the candidate into advanced development. The USAMRMC team then continues work to see these products through to FDA [U.S. Food and Drug Administration] licensure in the U.S.”
The success of this process is evidenced clearly by the PSPMO’s work in securing a much-needed vaccine requested for U.S. military forces across the country. Since October 2011, the team has been managing the supply of Adenovirus Vaccine Types 4 and 7 for administration to service members during basic training. As a highly effective treatment, the vaccine has helped to greatly reduce febrile respiratory illness in these environments, keeping trainees healthy while saving the federal government millions of dollars. Dr. Clifford Snyder is the Adenovirus Vaccine product manager and has been leading the team since March 2011.
“Our current vaccine has been in use for over five years, and it is a great product,” said Snyder. “It’s given to more than 200,000 enlisted military trainees each year, throughout all service branches, and it is very safe and efficacious.”
Tasked with ensuring future availability of the Adenovirus Vaccine for U.S. troops, Snyder said they are now working on an updated version of the vaccine that has equivalent efficacy but lower lifetime sustainment costs, which would help to conserve federal funds.
“We are always looking for ways to reduce cost and schedule in our processes, even when it involves currently licensed vaccines,” said Jasper.
At this time, the PSPMO team is working with a commercial partner to develop a vaccine for dengue fever, and Jasper said they believe the product will be ready for FDA licensure in 2021. He explained that the development of any vaccine is a “risky venture,” and therefore USAMMDA manages concurrent efforts in the technology base to serve as risk mitigation for the work being conducted in advanced development — in case a product is prevented from moving forward.
“The prime candidate in advanced development is the most mature product, so it’s the one leading the pack,” he explained. “When possible, we like to keep a backup candidate, to ensure that we’re reducing risk for our high-priority efforts, but only if this makes sense as part of the acquisition strategy.”
Other diseases being followed by Army Medicine include malaria, HIV, norovirus, shigella, campylobacter, ETEC, staphylococcus aureus, chikungunya virus and hantavirus; vaccines for any or all of these may be tasked to the PSPMO team at some point in the future.
Of course, this critical work takes a team of dedicated people.
Overseeing the PSPMO is project manager Dr. Lawrence Lightner, who is responsible for the network of team members that manage individual products within the portfolio. Product managers help to drive the numerous ongoing efforts, and they are tasked with managing multiple products and leading the staff members assigned to each.
“Our product managers are the heart of what takes place in a PMO,” said Jasper. “They are responsible for the individual product efforts — they do the analysis and develop the acquisition strategy, which informs go/no-go decisions.”
Jasper explained that if leadership decides to move ahead, the product managers must develop a series of documents demanded by the Department of Defense Directive 5000 series, which are the guidelines for the U.S. Defense Acquisition System. These documents include an Analysis of Alternatives, market research, and lifecycle cost estimates. The PMO also contributes to the development of the Program Objective Memorandum, which is a recommendation to the Office of the Secretary of Defense that explains how it plans to allocate resources for the effort.
“In addition,” he continued, “a significant portion of the product manager’s job is dedicated to working with our contracting office at USAMRAA [U.S. Army Medical Research Acquisition Activity], since for nearly everything we do, we must have a contract in place — manufacturing, clinical, nonclinical.”
Jasper said that many efforts also involve a Cooperative Research and Development Agreement, or CRADA, which is an agreement between a government agency and a private company or university to work together on research and development.
“In most cases, we partner with industry and academia to expedite development and/or handle the items we simply can’t do, such as the large-scale manufacturing and production of our products,” he said.
“We’re involved with vaccine development because infectious diseases have a great impact to our military, and we want to ensure we can achieve our military-unique requirements. We also help to accelerate the effort with additional funds, scientific expertise, and USAMRMC clinical trial centers, so we can get products to our service members as quickly as possible.”
While these vaccines may be developed with our military forces in mind, many approved products are used for civilians throughout the U.S. and, in some cases, worldwide. Examples of this include Army Medicine’s involvement with vaccines for yellow fever and Japanese encephalitis, both of which have been used to immunize military and civilian populations. Clearly, this illustrates how the Army helps to protect citizens well beyond the battlefield.
Jasper is keenly aware that the work of the PSPMO touches many lives throughout the world.
“It’s a matter of readiness and saving lives,” he said. “So many people are involved in developing a vaccine and moving it through to FDA approval — we’re trying to defeat these diseases, and we’re doing our best to keep our military, and the world, healthy!”
By Mr. Jeffrey M Soares (Army Medicine)