CDC removes troubling designation in research of valley fever vaccine

Reporting on Health CollaborativeOctober 8, 2012 

The federal government is the single biggest source for the primary research that leads to new vaccines.

But, like the pharmaceutical industry, it has not supported a valley fever vaccine. Other diseases that affect far fewer people receive much more federal support.

Tularemia affects about 200 people in the country annually, less than 1 percent of the estimated 150,000 people hit by valley fever. Like valley fever, the disease is primarily concentrated in only a portion of the country, mostly in the south-central and western part.

But this past summer, the National Institutes of Health awarded $10 million to scientists at Albany Medical College to develop a vaccine for tularemia. The grant increased the school's tularemia research funding to $27.8 million since 2002, according to news reports.

Why?

Biological weapon

Although some vaccines are created with profit in mind, others are fueled by fear. Dr. Dennis W. Metzger, a professor and principal investigator of the tularemia research at Albany Medical College, explained that the organism that causes the disease is classified as a potential biological weapon because one way people can become infected is by inhaling airborne bacteria.

"As few as 10 aerosolized bacteria can lead to 50 percent fatality rates in humans," Metzger wrote in an e-mail. "There is no approved vaccine or therapy other than antibiotics."

Because of that attention and funding, development of a vaccine is progressing at a much higher speed than one to prevent valley fever.

In just four years, Metzger's team has determined that a vaccine works, at least partially, in mice.

"We need to refine approaches to achieve full efficacy and also, translational relevance to humans," he said.

He hopes that by the end of the most recent five-year $10 million grant, or maybe sooner, clinical trials on the vaccine could be conducted.

Valley fever, too, is caused by an airborne organism -- spores from a fungus -- and it has been considered a bioterrorism threat, too.

Coccidioides, the fungus that causes valley fever, was added to the federal government's bioterrorism list in 1996 for reasons that include its high morbidity in humans, it is highly infectious when aerosolized, it reproduces easily in culture and there is no vaccine to prevent illness once exposed, according to Jason McDonald, spokesman for the U.S. Centers for Disease Control and Prevention.

Researchers trying to find a vaccine complained that the bioterrorism designation made their work more expensive and cumbersome.

Just this week, the CDC removed the fungus from the list.

Tough to do

The CDC determined that the fungus would be very difficult to develop into a biological weapon, McDonald said. In addition, there is no known instance of the fungus ever being used as a biological weapon, and the disease does not spread easily between humans, he said.

Eliminating the designation will make it easier and cheaper for researchers to study the fungus.

Dr. Garry Cole at the University of Texas at San Antonio is pursuing a promising vaccine for valley fever and said that if he had significant federal funding, he would be able to move to tests in primates and, eventually, humans. But he understands that valley fever has a lot of competition.

"The National Institutes of Health is a major source of federal funding for peer-reviewed research applications and, unfortunately, some worthy projects will not be supported simply because of a tight budget," Cole said. "I am hopeful that other sources of funding can be identified, particularly in the private sector."

Cole and the other scientists who have built their careers on investigating the disease say that the more the public wakes up to the damage done by valley fever, the greater the chance that federal and pharmaceutical industry funding will flow to researchers.

"With time lost for work and medical care, in addition to the misery, you could make the argument that there should be a development program for the vaccine," said Dr. John Galgiani, director of the Valley Fever Center for Excellence at the University of Arizona. "But that's not the same as a business model. If it's to be done, we would need an amazingly cheaper way to do it, or public health funding to do it."


JUST ONE BREATH

The latest part in an occasional series about valley fever.

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ABOUT THE SERIES

Why are people still dying from valley fever and tens of thousands getting sick? Misdiagnosis. A lack of public awareness. And a long history of inaction by government agencies. In this series, we will explore the startling rise of cases, the science of studying the disease, the high costs to patients and taxpayers, the weak federal and private interest in funding treatments and vaccines, and the public health response.

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