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Are we in the midst of

A Turning Point in the History of Vaccinations?

Dale Dauten, Syndicated Columnist

When DARPA takes an interest in your vaccination work, you know you're onto something important. That's DARPA, as in DoD, as in Defense Advanced Research Projects Agency, as in the highest-level research in the world.

DARPA was the agency created in response to Sputnik and while it only has a couple of hundred employees, they fund projects that helped create the Internet, GPS and my personal favorite, the first "electronic person" created in 1970, Shakey the Robot.

The Project Manager said later, "We worked for a month trying to find a good name for it, ranging from Greek names to whatnot, and then one of us said, 'Hey, it shakes like hell and moves around, let's just call it Shakey.'"

So how was it that DARPA interested itself in vaccinations? Anyone who's watched medical thrillers knows why.

The folks that caught the agency's attention were at Medicago, a Canadian company that, improbably, uses tobacco plants to make vaccines and is now partially funded by Philip Morris.

I learned of Medicago (pronounced MEDI-cog-o, similar to Chicago) when I heard one of their U.S. representatives, Thomas Hess, speak at STC's User Group Meeting earlier this summer. He caught my attention when he explained that Medicago had been put to a test by DARPA in 2009, the year of the H1N1 flu pandemic.

Medicago demonstrated that it could develop a vaccine in 19 days,

then produce 10 million doses of a flu vaccine in 30 days.

That compares to the traditional method, egg-based, that would take 4-6 months.

Medicago proved they could produce those 10 million doses after DARPA helped fund a new manufacturing facility in the Research Triangle in North Carolina.

Thanks to the company's VP of Research & Innovation, Dr. Marc-Andre D-Aoust, I can explain how they do it.


Dr. Marc-Andre D'Aoust

First, a quick review of the traditional vaccine process. When producing a vaccine like the one for flu, the CDC provides manufacturers with viruses grown in eggs. The manufacturers inject the virus into fertilized hen's eggs, which are then allowed to incubate. Fluids containing the viruses are later harvested, the viruses killed, then purified into the virus antigen. (The word "gen" is from the Greek "genos" meaning "birth" or "Genea" meaning "family." So "antigen" is "anti-birth" or "anti-family," a good thing when considering the family member is a virus.)

But instead of using live viruses, Medicago's system depends on producing VLPs, that's Virus-Like Particles to act as the antigen to "educate" the body's immune system. These have a surface that mimics that of the virus, but the particles are "virus-like" because they lack the genetic material of the virus, meaning they can't reproduce and thus are not infectious.

VLPs have been grown in animal cells, and more recently, in insect cells. But back in the early '90s, an institute connected with Cornell University demonstrated that plants could be used. They were seeking to develop a Hep-B vaccine. The results were less than ideal. As Dr. D'Aoust puts it, "limited antigen content in the biomass and the incapacity to formulate the vaccine led to suboptimal immune responses."

However, a small group of scientists in Quebec City continued the work, using alfalfa plants. ("Medicago" is Latin for "alfalfa.") The team eventually turned to tobacco plants. Dr. D'Aoust says,

"Let me clarify that the plant that we are using is not tobacco per se, but a wild relative of tobacco from Australia, and it can't be smoked. The plant name in the wild is Muntju and the scientific name is Nicotiana benthamiana. It proved to be very receptive to the tools that we had developed in our tool box. Other plants can produce VLPs also, but the best productivity is obtained using this species."

If you go to the homepage at Medicago.com you can find a video showing the plants being processed, but, in short, they dunk small tobacco plants in liquid so they can use vacuum infiltration to force the DNA sequence of interest into the plant that will allow it to grow VLPs. The plants are later stripped of their leaves from which the VLPs are extracted and purified, and go into the vaccines.

As complicated and time-consuming as this sounds, remember that they produced 10 million doses in 30 days.

WHAT'S NEXT?

Dr. D'Aoust tells me that they followed up their H1N1 success with positive results in clinical trials for H5N1, including the encouraging news that their vaccine may provide cross-protection against strains not included in the vaccine. They've also shown they can produce Ebola antibodies.

And they now have the capacity to produce 40-50 million doses of their own quadrivalent seasonal flu vaccine.

So back to where we started, to DARPA and scary viruses...

Dr. D'Aoust reminds us that the Spanish flu killled 20,000 people. That was 98 years ago. Imagine what a new virus could do now, given international travel and higher density of populations, not to mention bio-terrorism.

In an increasingly dangerous world, it feels good to know that scientists in Quebec City and now in North Carolina, with the financial backing of DARPA and Philip Morris, have cut the response time to days instead of months.

I think we will eventually look back and say that they year that VLPs could be grown in plants, 2009, was an inflection point in the history of vaccinations.

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