Here's the good news: Vaccines that could help contain and even counter some of the world's deadliest known bio agents have been developed.
But here's the catch: These vaccines must be stockpiled (and, if the need arose, transported) in specific climate-controlled settings or they could be rendered useless, making production a risky financial proposition.
Soligenix appears to have finally found the solution.
The Princeton-based company partnered with the University of Colorado and developed ThermoVax, a method in which the liquid vaccine is dried out to a powder in a vial and can be stored at elevated temperatures, CEO Chris Schaber said.
When the vaccine is needed, it can be reconstituted with sterile water and there is no degradation to the vaccine.
ThermoVax benefits, Schaber said, are twofold: Fewer vials of vaccines will go bad — and more people will be able to get them.
Simply put, he said the potential impact worldwide would be “huge.”
Greg Elder, the deputy director of operations for Doctors Without Borders, agreed.
He said the breakthrough can be a game-changer throughout the world.
“In our experience, the need to keep vaccines in the cold chain all the way to the patient is quite simply one of the biggest barriers to effective vaccination responses by groups like (Doctors Without Borders),” Elder said.
Kate Elder, the vaccines policy adviser for Doctors Without Borders, said developing countries will benefit most.
“This is a barrier that can be addressed and overcome; it’s a question of political will and of acting to meet the needs of kids in developing countries rather than just for the economic bottom line,” she said.
The economic bottom line, however, cannot be ignored, as the cost savings of the solution have enormous potential.
The vaccine market is more than $20 billion annually, the World Health Organization has estimated. And Soligenix estimates 98 percent of all vaccines currently require refrigeration, a process the company says costs at least $200 million.
The industry has known such a solution is needed for years — in 2011, the WHO estimated that 70 percent of all vaccines were wasted.
But it wasn’t until 9/11, and the anthrax and ricin scares of 2003 that much was done about it.
Schaber credits researchers at the University of Colorado for helping to create these heat-stable vaccines. But he readily admits the biggest assist came from the federal government, which saw the need for bio solutions following 9/11.
“There was a need after 9/11 and the government threw lots of money at these bio countermeasures,” Schaber said.
Biz in brief
Name: Soligenix, Inc.
Executives: Chris Schaber, CEO and
Revenue: For the six months ended June 30, 2015, government contract and grant revenue was a combined total of $1.1 million and for the year ended December 31, 2014, the combined revenue was $7.04 million.
One more thing: ThermoVax is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.
A heat-stable ricin vaccine was in the pipeline when Schaber joined the company in 2006. The National Institutes of Health is moving forward with the Soligenix vaccine, which can be used both as a line of defense and has shown neutralizing antibodies when exposed to the toxin.
In August, Soligenix received $2.7 million in funding from the National Institute of Allergy and Infectious Disease, bringing the total awarded by government funding to nearly $40 million. The total is being used toward the development of RiVax and will help it through preclinical, manufacturing and clinical development in order to advance it through the FDA.
But the technology has benefits that reach further than a biodefense arsenal.
Soligenix is also working on a heat-stable Ebola vaccine in partnership with the University of Hawaii, as well as separately looking into an HPV vaccine — two that would be welcomed in underdeveloped countries, mainly in Africa, Schaber said.
The U.S. can benefit as well. Each year, the flu vaccine is available at every corner during flu season, but some areas never use the entire supply. A recent report in California showed numbers ranging from 1 percent to 38 percent of unused flu shots per county.
A heat-stable vaccine would help here, too.
But the global benefits remain the greatest.
Currently, there is a heat-stable vaccine for meningitis, which is mostly needed in Africa, according to Elder.
“We can halve the cost of doing campaigns with thermo-stable vaccines,” Elder said. “We wouldn’t have to freeze up ice packs, which takes up time and capacity. Sometimes we have to borrow freezers from hotels. It would also make packages lighter if we could deliver vaccines without freezing them and (doctors) could trek for a couple of days into rural communities.”
Soligenix is still working on advancing RiVax through the regulatory process, so there has been no price set on the product, nor discussions about where to sell it, Schaber said.
Sales and revenue numbers are still uncertain. But the potential is there.
“Procurement contracts can range from a couple hundred million to a billion in some instances,” Schaber said. “For a company our size, that’s substantial.”
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