If a major global flu pandemic happens, U.S. government and international health care agencies will be hard pressed to manufacture enough vaccine fast enough to keep ahead of the disease. But a research program by the Defense Department’s research and development organization has recently demonstrated the ability to produce ten million of doses of vaccine in just one month.
The goal of the Defense Advanced Research Project Agency’s Blue Angel program is to produce large quantities of high-quality vaccine-grade protein in under three months to respond to a pandemic influenza outbreak.
Blue Angel uses modified tobacco plants to grow virus like particles (VLPs) in the plants. VLPs are protein shells studded with short strands of proteins specific to the disease the vaccine is designed to control.
According to Medicago Inc., one of the biopharmaceutical firms involved in the DARPA program, VLPs are safe because they lack a disease’s core genetic material, making them non-infectious and unable to replicate. Growing VLPs in tobacco also allows large quantities of vaccine to be produced in quantity in a very short time.
Vaccines, especially those used for influenza, are usually made by injecting live virus into fertilized chicken eggs. After an incubation period, the liquid is removed from the eggs and treated with the chemical formalin to render the virus harmless, yet still capable to triggering an immune response in the recipient of the vaccine.
This process has been in use for half a century and has proven to be slow and prone to varying levels of effectiveness, putting disease control agencies at a disadvantage when they need to rapidly produce quantities of vaccine in the event of a global flu pandemic.
Building on DARPA’s Accelerated Manufacture of Pharmaceuticals program, Blue Angel uses the plant-made proteins to rapidly produce large quantities of vaccine-grade material. In a recent milestone test, researchers at Medicago produced more than 10 million doses of a VLP-based H1N1 influenza candidate vaccine in one month.
The doses of vaccine were produced during a “rapid fire” test that ran from March 25, 2012, to April 24, 2012. The viability of the production run was then tested by a third-party laboratory. Tests confirmed that a single dose of the H1N1 VLP flu vaccine produced the right levels of protective antibodies in animal, DARPA officials said. However, they added that it will take human trials to find the right dosage to protect humans.
Based on the results of the test, the program and other efforts to use plant-based vaccine production methods are now in a better position to seek Food and Drug Administration approval for potential vaccines, Alan Magill, DARPA’s Blue Angel program manager said in a statement.
He added that once the FDA has approved a plant-made vaccine, the shorter production times will allow the Defense Department, and the U.S. government by extension, to be better prepared to meet any future epidemics.