One of the big ideas PATH is pursuing to make vaccines more useful just got a strong vote of confidence. The Seattle-based global health nonprofit is announcing today it has secured a $5.2 million contract from the U.S. government to develop flu vaccines that can remain effective for years when they are stashed away in a stockpile, in case officials ever need it to perform mass vaccinations during a global flu pandemic.
The contract, which can be extended to be worth $9.4 million over time, is coming from the Biomedical Advanced Research and Development (BARDA) group within the U.S. Department of Health and Human Services. PATH is also setting out to ensure the flu vaccine will remain effective even if it’s not refrigerated during the critical days it would take to disseminate vaccines widely in a pandemic situation.
The U.S. government has become increasingly interested in ways to protect the homefront in case of a flu pandemic, especially since last year’s alarm bells went off about the H1N1 virus, which didn’t turn out nearly as bad as first feared. The U.S. and other countries don’t have enough existing manufacturing capacity to make enough flu vaccine every year for everyone around the world. Biotechs like Seattle-based Immune Design have gotten U.S. government support to develop immune-boosting compounds called adjuvants that make vaccines more potent, which would help extend the existing supply. Another Seattle biotech, Theraclone Sciences, has a partnership with a Japanese company to develop an antibody with broad neutralizing capability against flu, which governments could stockpile in case of emergency.
PATH snapped up this contract based on about seven years of R&D. PATH (formerly known as the Program for Appropriate Technology in Health) has been working all those years to find vaccine additives that are cheap and easily available, and which could make it possible to deliver vaccines in remote regions of Africa that don’t have the reliable electricity needed to keep enough vaccines in cold storage. Back in August 2009, PATH published some intriguing findings with collaborators that suggested it may have found a way to keep critical vaccines stable at temperatures of nearly 100 degrees Fahrenheit.
Even though flu isn’t usually perceived as one of the main diseases that PATH usually works to combat in the developing world, it is by definition one of those contagious pathogens that can cross all geographic borders. And helping developing countries manage flu vaccines is something PATH has been pursuing in a variety of ways, beyond just vaccine stabilization.
“The developing world is just really starting to use flu vaccine, and the H1N1 really got people’s attention,” says Dexiang Chen, PATH’s senior technical officer on the vaccine stabilization project. “In many countries they are starting from scratch to address the problem.”
Shelf life is one of the problems with flu vaccines today. Once vaccines are produced, they generally are able to last for one fall-to-spring flu season, then get tossed out, Chen says. For governments to stockpile flu vaccines, the vaccine ideally ought to be stored for five years or more, he says.
If the stockpiled vaccine needs to be used, PATH is hoping that the same ingredients that kept it stable in a refrigerated environment will help it remain stable at room temperature, or high temperatures, for weeks as it is getting distributed, Chen says. That’s the key piece that would make a flu vaccine most valuable in the developing world. It might also be translatable over to other vaccines, Chen says.
Years of work, and lots of dollars, will be needed to prove that the modified vaccines maintain the same safety and efficacy properties as the original refrigerated versions. A project of this magnitude will definitely require academic and industry collaborators if it’s ever going to be implemented in a big way. But the folks at PATH are clearly pumped about the potential. “We all feel passionate about this,” says Ray Cummings, a commercialization officer at PATH.
