July 25, 2012
Rapid fire test of novel, plant-based production method delivers more than 10 million doses of H1N1 VLP influenza vaccine candidate in one month
U.S. military forces are the front line of U.S. national security, but as a globally deployed force they are also on the front line of any new pathogen-based health threat that may emerge. As overall human activity pushes ever further into previously undeveloped territory, the likelihood of exposure to new pandemic diseases increases.
The 2009 Army Posture Statement, cites a World Health Organization estimate of between 20 and 50 percent of the world’s population being affected if a pandemic were to emerge. WHO forecasts “it may be six to nine months before a vaccine for a pandemic virus strain becomes available.” In a separate report on pandemic influenza, the WHO describes several challenges to producing sufficient volumes of vaccine using current, egg-based protein-production technology, including the likelihood that two doses per person could be required due to the absence of pre-existing immunity.
In short, the potential for a pandemic exists and current technological limitations on defensive measures put the health and readiness of U.S. military forces at risk. A technological solution to increase the speed and adaptability of vaccine production is urgently needed to match the broad biological threat.
DARPA’s Blue Angel program seeks to demonstrate a flexible and agile capability for the Department of Defense to rapidly react to and neutralize any natural or intentional pandemic disease. Building on a previous DARPA program, Accelerated Manufacture of Pharmaceuticals, Blue Angel targets new ways of producing large amounts of high-quality, vaccine-grade protein in less than three months in response to emerging and novel biological threats. One of the research avenues explores plant-made proteins for candidate vaccine production.
“Vaccinating susceptible populations during the initial stage of a pandemic is critical to containment,” said Dr. Alan Magill, DARPA program manager. “We’re looking at plant-based solutions to vaccine production as a more rapid and efficient alternative to the standard egg-based technologies, and the research is very promising.”
In a recent milestone development under Blue Angel, researchers at Medicago Inc. produced more than 10 million doses (as defined in an animal model) of an H1N1 influenza vaccine candidate based on virus-like particles (VLP) in one month. Production adhered to Phase 1 appropriate current good manufacturing practices. The work was part of a “rapid fire” test that ran from March 25, 2012, to April 24, 2012, at a facility in Durham, NC. A third-party laboratory tested the production lots to confirm the immunogenicity of the vaccine candidate. Testing confirmed that a single dose of the H1N1 VLP influenza vaccine candidate induced protective levels of hemagglutinin antibodies in an animal model when combined with a standard aluminum adjuvant. The equivalent dose required to protect humans from natural disease can only be determined by future, prospective clinical trials.
“The results we’ve achieved here with plant-based production of vaccines represent both significant increase in scale and decrease in time-to-production over previous production capabilities in the same time period. The plant-made community is now better positioned to continue development and target FDA approval of candidate vaccines,” Magill said. “Once the FDA has approved a plant-made vaccine candidate, the shorter production times of plant-made pharmaceuticals should allow DoD to be much better prepared to face whatever pandemic next emerges.”
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