FDA will hold a public workshop on May 8 to develop a vaccine for the fungal infection after requests from Congressman Kevin McCarthy
By Reggie Ellis
BAKERSFIELD – As public health officials around the nation scramble to find treatments for the coronavirus pandemic, the FDA is beginning work to find a cure for a deadly disease endemic to the San Joaquin Valley.
On March 5, the U.S. Food and Drug Administration (FDA) announced it will hold a public workshop to find a cure for valley fever, an infection from a fungus that lives in soil that presents flu-like symptoms and can mimic pneumonia. The workshop, titled “Coccidioidomycosis (Valley Fever): Landscape and Considerations for Development of Antifungal Drugs,” will discuss Valley Fever’s epidemiology, prevention, clinical disease manifestations and clinical trial design considerations for developing antifungal drugs. Coccidioidomycosis, or cocci (pronounced coxi), is the scientific name for the infection.
The workshop will be held on May 8 at the FDA’s main campus in Silver Springs, Md.
Those interested in attending the public workshop online must register on EventBrite.com under the title “coccidioidomycosis valley fever landscape and considerations workshop.” For more information, contact the OND Public Meeting Support Team at [email protected].
People contract the infection from inhaling fungal spores, which usually enter the air when soil or dust is kicked up, like from agriculture or construction work. The spores prefer to live in undisturbed and dry natural soil. Once they’ve entered the air, valley fever spores can travel up to 75 miles. People who work outside, like farm workers, tend to be at a greater risk of contracting the infection.
Less than 10% of people who contract valley fever are diagnosed and about two-thirds never present any symptoms. About 3% of people infected with valley fever deal with some aversion to the infection that requires life-long treatment. For less than 1% of patients, the infection travels to other parts of their body, like their bones, spine, skin and brain and can be fatal.
Congressman Kevin McCarthy, who represents most of Kern County and the southeastern Tulare County, commended the FDA on its decision to develop new treatments for the disease.
“The FDA’s announcement is welcome news – this workshop will serve as an important opportunity to gather experts in order to increase collaboration on this neglected disease,” McCarthy said. “This forum will be an excellent springboard for continued discussions on Valley Fever diagnostic and vaccine development, as well as clinical trial designs for antifungal treatments. I highly encourage those who are interested in attending the workshop to sign-up on the FDA’s website.”
On Feb. 14, Congressman McCarthy, who is also the House Minority Leader, and Congressman David Schweikert (AZ-06) sent a letter to the FDA and the U.S. Department of Health and Human Services requesting the FDA hold public workshops to help with the development of Valley Fever drugs and vaccines.
“We were pleased to see in FDA’s October 9, 2019 correspondence regarding the Tropical Disease Priority Review Voucher Program that the FDA is planning on holding a public workshop on the development of therapies to treat Valley Fever, including a discussion on trial designs, endpoints, and patient populations.
The FDA routinely holds public workshops that bring together researchers, drug developers and government officials to discuss best practices for getting drugs or vaccines approved for specific diseases. These public workshops can help inform FDA’s Guidance for Industry documents, which contain non-binding recommendations to help drug developers secure FDA approval for their treatments.
Cases of valley fever in California have steadily increased for nearly 20 years. The rise in cases peaked in 2017 and 2018 with 7,658 and 7,515 respectively. In Tulare County, the numbers follow a similar pattern, with 281 in 2017 and 248 cases in 2018. The rise in cases is a complex correlation between the severe drought from 2012-2015, a shortage of doctors and an import of doctors who are not familiar with the area and the disease, that symptoms mimic the flu and pneumonia, and that most residents don’t ask to be tested for the rare infection.
Rep. Kevin McCarthy, who is also the co-chair of the Congressional Valley Fever Task Force, co-sponsored a bipartisan bill in May to address the challenges of detecting, treating, and eventually eradicating valley fever. House Resolution (HR) 2858, also known as FORWARD Act, would direct the FDA to hold public workshops on Valley Fever drug and vaccine development and issue a Guidance for Industry document to help with the development of such treatments.
““Valley Fever is a serious health problem that has affected our community for years. Since coming to Congress, I have worked with my colleagues to bring more national awareness to this infectious disease by hosting seminars and roundtables with local community leaders, doctors, and members of the Centers for Disease Control and Prevention and the National Institutes of Health,” McCarthy said last year.
The bill was supporting by Dr. Royce Johnson, Medical Director of the Kern Medical Valley Fever Institute and Chief of Infectious Diseases at Kern Medical, Dr. John Galgiani, Director, University of Arizona Valley Fever Center for Excellence, and Rob Purdie, Patient and Program Development Coordinator at the Valley Fever Institute.
In December, the federal appropriations bill included an additional $2 million for the Centers for Disease Control and Prevention (CDC) to expand Valley Fever surveillance, research, and awareness efforts.
In 2018, Gov. Jerry Brown approved $8 million in state funding for valley fever. Of that $6 million was dedicated toward research and split between the UC system and the Valley Fever Institute. Two million dollars was allocated for awareness and outreach through the California Department of Public Health.
“It is our belief that increased collaboration through public workshops, as well as the FDA issuing a guidance for industry document, will be an important step to facilitate the development of novel therapies and a vaccine for Valley Fever,” McCarthy said. “Accordingly, we fully support these public workshops and look forward to them being scheduled as soon as possible. Furthermore, we hope that FDA uses these workshops to inform and ultimately initiate a guidance for industry process with respect to Valley Fever diagnostics, drugs, and biologics.”
-Kaitlin Washburn, agriculture reporter for The Sun-Gazette, contributed to this report.