Ten million H1NI flu vaccines produced in one month, says DARPA

DARPA's vaccine source

A DARPA-funded vaccine company working on ways to quickly develop immunizations for potential pandemics, has successfully made over 10 million doses of H1N1 flu vaccine in a single month.

The company, Medicago Inc., used a “rapid-fire,” plant-based production method to make them, according to DARPA. The plants used in this case, however, aren’t factories, but the chlorophyll-based kind. Plant-produced vaccine practices hold promise for speedier development of vaccines than traditional egg-grown vaccine techniques. Plants are soaked with a solution that contains a disease’s DNA. The plant responds by producing antibodies almost immediately. Those antibodies can be synthesized into a human vaccine.

DARPA said on July 25, that Medicago Inc. had produced more than 10 million doses of an H1N1 influenza vaccine. The work was part of a test that ran from March 25, 2012, to April 24, 2012, at a facility in Durham, NC, it said, adding that a third-party laboratory tested the production lots to confirm it worked. “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,” said DARPA.

“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,” Dr. Alan Magill, DARPA program manager 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.”

DARPA has been looking to develop speedy methods of producing vaccines for pandemic viruses for the armed forces for some time, through its Blue Angel Program, because production times for traditional vaccines aimed at pandemics can take six to nine months.

The 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, said the agency. 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 Magill. “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.”