Thanks to the recently approved $1.1 billion in federal funding
to support Zika virus-related efforts, various government agencies are ramping up efforts to develop novel vaccines designed to prevent infection.
On a conference call with reporters on October 3, officials from the Centers for Disease Control and Prevention (CDC), the US Department of Health and Human Services (HHS), and the National Institutes of Health (NIH) said that newly released funds for Zika virus have already been allocated to fund 9 separate projects seeking to develop a vaccine for the mosquito-borne virus, which has infected some 25,000 people in the United States and its territories, including 3,600 in the 50 states. In fact, the NIH has begun human clinical trials on a DNA-based vaccine product, a “milestone reached nearly a decade faster” than is typical in vaccine development, according to HHS secretary Sylvia M. Burwell.
Anthony Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases, told the press that the $152 million budgeted to NIH for vaccine development has helped support the ongoing Phase I clinical trial of the DNA-based vaccine, which began in August and has already enrolled the planned 80 patients at 3 sites (NIH, the University of Maryland, and Emory University). Assuming the vaccine proves safe and efficacious, Dr. Fauci expects follow-up Phase II trials, at 15 sites in “high-risk areas” (namely South America and Puerto Rico), to begin within the year, enrolling up to 5,000 patients. Meanwhile, HHS is using $245 million of the federal funding to push forward initiatives led by NIH, the Department of Defense (DoD), and its own Biomedical Advanced Research and Development Authority (BARDA). BARDA has already awarded millions of dollars to several private companies to assist in preliminary efforts to “rapidly scale up” manufacturing capacity to enable the development and distribution of a viable vaccine once it’s ready, said Nicole Lurie, MD, Assistant Secretary for Preparedness and Response at HHS.
“We have worked very carefully with NIH and the DoD to make sure our efforts are complementary,” she added. “We just don’t know yet which vaccine or type of vaccine will work [against Zika virus]. So, we have portfolio of candidates that includes DNA-based, particle-inactivated, mRNA-based, live attenuated and other platforms.”
Even with all of the progress in these efforts, officials lament the delay in Congress approving the new funding, and the shortfall in the funds ultimately provided—the CDC, DHHS, and NIH, via President Obama, originally asked for $1.9 billion in February—has likely delayed the development of a new vaccine. In fact, Dr. Lurie said that several pharmaceutical manufacturers “walk[ed] away from negotiations” on potential partnerships because of the uncertainty over whether the government would ultimately release the money. All three agencies had to defund other programs—primarily in Ebola and cancer research—in order to support “emergency” Zika virus programs.
“We are behind where we should be on vaccine development because manufacturers couldn’t count on the fact that money would be there,” Dr. Lurie said. “We likely missed out on some other promising vaccine candidates.”
Brian P. Dunleavy is a medical writer and editor based in New York. His work has appeared in numerous healthcare-related publications. He is the former editor of Infectious Disease Special Edition.
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