Profectus BioSciences yesterday was awarded a one-year, about $5.8 million contract by the U.S. Biomedical Advanced Research and Development Authority (BARDA) toward developing an Ebola vaccine.
Profectus plans to manufacture vaccine for use in animal safety studies and future clinical trials. The contract includes funding as well as subject matter expertise and technical assistance. The contract can be extended to a total of 13 months and $8.6 million, according to BARDA’s parent agency, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).
Once the work covered by the contract is completed, Profectus is expected to submit an NDA to the FDA to allow Phase I clinical trials for safety in humans.
“We are pushing hard to advance the development of multiple products as quickly as possible for clinical evaluation and future use in preventing or treating this deadly disease,” BARDA Director Robin Robinson, Ph.D., said in a statement. “Our goal is to close the global gap in vaccines and therapeutics needed to protect the public health from Ebola as highlighted by the epidemic in West Africa.”
The BARDA contract comes at a time the federal government is under political fire for its response to the Ebola outbreak that began this summer in West Africa. As of October 12, the outbreak has claimed the lives of 4,493 people, according to the World Health Organisation.
President Obama yesterday said he would consider naming a single official or “Ebola czar” to coordinate Washington’s response to the outbreak, now divided among several agencies: “It may be appropriate for me to appoint an additional person, not because they haven’t been doing an outstanding job, really working hard on this issue, but they are also responsible for a whole bunch of other stuff,” the president told reporters.
However, several Republicans lawmakers and presidential candidates have publicly criticized the administration, saying it has not acted quickly or effectively enough to halt the spread of the vaccine in the U.S., and demanded the resignation of CDC Director Tom Freiden, M.D., M.P.H.
Profectus vaccines are based on the company’s Prime/Boost System of Vaccines (PBS Vax™), designed to enable quantitative and qualitative tailoring of effective immune responses to specific disease targets.
In March, Profectus joined The University of Texas Medical Branch at Galveston, Tekmira Pharmaceuticals and the Vanderbilt University Medical Center in winning a five-year, up to $26 million from NIH to develop and test vaccines for the Ebola and Marburg viruses. The funding was a collaborative Center of Excellence for Translational Research grant supported by NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
Under the award, the Vanderbilt Vaccine Center will carry out three interdependent research projects, supported by the Galveston National Laboratory at UTMB, the only operational BSL-4 laboratory on a university campus in the U.S.
NIAID is also a partner with two among several teams scrambling to develop Ebola vaccines. Investigators at NIAID’s Vaccine Research Center (VRC) have developed the vaccine cAd3, for which a Phase I clinical trial was launched last week in Mali by the Center for Vaccine Development (CVD) at the University of Maryland School of Medicine (UM SOM), the Center for Vaccine Development of Mali (CVD-Mali) and Mali’s Ministry of Health.
The Mali trial followed two months of work by an international consortium dedicated to advancing the vaccine into human clinical studies. Consortium members include the vaccine’s manufacturer, GlaxoSmithKline (GSK) Biologicals.
NIAID is also a partner with Johnson & Johnson, along with Bavarian Nordic, in development of an Ebola vaccine quickly for which human clinical trials are planned to be launched early next year.