By Carol M. Ostrom
Remember how the swine-flu scare in late 2009 prompted thousands of
people in the Puget Sound area to wait in line for hours to get a flu
Seattle Times health reporter
What if, instead, they could get their flu vaccine in the mail, packaged with a little device that would allow them painlessly to give themselves a dose that was short on actual vaccine but long on effectiveness?
That's the goal of Seattle's Infectious Disease Research Institute (IDRI), which has just received approval from the U.S. Food and Drug Administration (FDA) to start a Phase I clinical trial for an avian-influenza vaccine that's combined with something called an adjuvant, which strengthens the immune response, and is delivered through a skin-pricking device that uses tiny micro-needles.
Darrick Carter, vice president of IDRI's adjuvant-technology program and co-principal investigator for the project, said the federal government is well aware that the demands for vaccine during the swine-flu scare nearly overwhelmed the public-health system.
"We were already in the orange zone," he said. If a deadly pandemic were to hit, "they think the whole system might collapse."
Being able to quickly produce a vaccine which could be delivered through the mail and self-administered, and which would use adjuvants to enhance immune response, was very attractive to the government, Carter said. It funded the project through a division of the Department of Defense.
Trial starts next month
The trial, which will enroll 100 people in Florida, Texas and Wisconsin, will begin in September to test the vaccine's safety and immune response.
Getting to the clinical-trial stage was a three-company effort. IDRI developed the adjuvant, which allows much less vaccine to be used per dose — important if a pandemic flu caused vaccine to be in short supply.
Medicago, a Canadian biopharma company, developed a plant-based method to manufacture the vaccine, sidestepping the traditional egg-based method, which is difficult to quickly scale up or change as a virus mutates