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Jill Wechsler is Pharm Exec's Washington Corespondent
Zika vaccine development is hindered by technical challenges and funding shortfalls, writes Jill Wechsler.
The rise in Zika cases in the United States is heightening efforts to develop better diagnostics and an effective vaccine to halt its spread. But as the first-in-human clinical trials begin on vaccine candidates, Washington policy makers continue to argue over where to get the money to support these initiatives. US Department of Health and Human Services (HHS) Secretary Sylvia Burwell now is shifting funds around the department to keep vaccine testing and production on track. This involves transferring $34 million to the National Institute of Allergy and Infectious Diseases (NIAID) from other National Institutes of Health (NIH) operations to avoid delays in conducting anticipated Phase II trials early next year. Burwell also will provide an additional $47 million to HHS’ Biomedical Advanced Research and Development Authority (BARDA) to fund R&D by biopharma collaborators on vaccines and faster Zika diagnostics.
NIAID will use the added money to set up infrastructure for broader trials on a DNA-based vaccine that began first-in-human testing on August 2, 2016. NIAID Director Anthony Fauci explained at a briefing on August 11 in Washington, D.C. that his agency is working on several other potential preventives, including a whole-particle purified inactivated vaccine in partnership with Sanofi Pasteur, BARDA, and the Walter Reed Army Institute of Research; it may be effective, but also difficult to produce and scale up for clinical trials. NIAID also is collaborating on a live-attenuated Zika/dengue chimeric virus vaccine, a vesicular stomatitis virus vectored vaccine, and a vaccine utilizing self-amplifying mRNA technology developed by GlaxoSmithKline.
Up until now, NIAID has been able to fund Zika vaccine research by shifting resources from other projects and tapping some $47 million initially allotted to HHS for research on an Ebola vaccine. The first Phase I trial aims to enroll 80 young, healthy volunteers to test if the needle-free DNA vaccine is safe and produces an immune response. Initial results are expected by January 2017 and hopefully will lead to larger Phase II studies at multiple sites. The additional $34 million now will help avoid delay in launching this next phase, which involves preparing approximately 20 clinical sites, many in South and Central America and in Puerto Rico, that will enroll 2400–5000 men and women of childbearing age (but not pregnant). Without the extra money, “the transition to Phase II trials may be delayed or not go forward,” Fauci warned.
The new money, though, will run out by the end of this year, and HHS needs $196 million more to be able to conduct clinical trials on the additional vaccine candidates beginning next year. At the same time, NIH and other agencies will need to continue its many vital research programs. Shifting funds from critical NIH programs is “extremely damaging to the broader research enterprise,” Fauci emphasized, adding that taking money from cancer and diabetes research really “isn’t ok.” And he worried that the squeeze on research funding may discourage biopharma companies from partnering with NIH and BARDA in developing vital countermeasures to disease and biological threats.
Rick Bright, acting director of BARDA’s influenza division, outlined a broad portfolio of collaborations with industry to assess some 30 platform-based technologies related to vaccines for yellow fever, dengue, and other infectious diseases to determine potential for effectiveness in preventing Zika. BARDA signed an agreement in June 2016 to provide $18 million to Emergent BioSolutions over the next 30 months for its Center for Innovation in Advanced Development and Manufacturing (CIADM) to develop and manufacture three lots of a Zika vaccine for Phase I studies of one of the candidates under development.
BARDA also is funding research to develop better rapid diagnostic tests for Zika, working with at least a dozen companies that are preparing data on assays and technologies. Current tests use PCR technology that can detect if an individual is currently infected, but not whether antibodies are present that indicate previous infection that could be transmissible. An important initiative involves forming an international Zika sample sharing working group to obtain tissue from infected patients that is critical for testing the effectiveness of a diagnostic. BARDA also is developing screening assays for donated blood and methods to ensure the safety of blood supplies.
Meanwhile, funding for Zika countermeasures and other NIH and HHS public health and research programs continues to be a hot political issue, with Republicans and Democrats blaming each other for the current impasse. Congress departed Washington last month without appropriating anywhere near the $1.9 billion emergency Zika funding sought by the Obama administration earlier in the year. State and local governments are struggling to fund preventive and detection programs, efforts that have become more imperative as more pregnant women become infected. The Centers for Disease Control and Prevention (CDC) recently reported more than 7000 cases of Zika in the US, primarily in Puerto Rico, and 15 infants born with Zika-related birth defects.