By Sandra Basu
WASHINGTON – As the U.S. public health community desperately seeks to help contain what experts say is the largest Ebola outbreak in history and the first in West Africa, DoD also is monitoring the situation closely and has created an internal task force to “further review the situation.”
“There’s been no impact to U.S. Africa Command’s operations in Africa as a result of the Ebola virus,” DoD spokesperson Navy Rear Adm. John Kirby said last month at a news briefing. “But clearly, we’re watching this as closely as everybody else is and it’s an interagency effort here in the United States. It’s not just the Pentagon, it’s CDC, USAID, it’s State Department. We’re all talking about this and working on this.”
The outbreak, which began in March 2014 in Guinea and spread to Liberia and Sierra Leone, has been a source of serious concern to world health officials. As of the middle of August, CDC reported 1,848 suspected and confirmed cases in the region.
The gravity of the situation was underscored at a congressional hearing last month where CDC Director Thomas Frieden, MD, MPH, stated that Ebola can be stopped, but that it would be a “long and hard fight.”
“The current outbreak is a crisis. It is unprecedented,” he told lawmakers.
He emphasized that finding and diagnosing individuals with Ebola was the first step to containing the outbreak.
“We, working with partners from the Department of Defense, from the Pasteur Institute of France and other countries as well as the countries where the disease is present are scaling up the ability to diagnose patients,” he told lawmakers.
Within DoD, the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), which researchs and develops products to protect troops from biological threats, has been involved with response efforts to Ebola in West Africa. While DoD medical personnel were not providing direct patient care of Ebola patients, researchers from USAMRIID have helped set up diagnostic labs in Liberia and Sierra Leone.
Researchers from USAMRIID had, in fact, been in the region since 2006, working to develop diagnostic tests for Lassa fever.
“We had people on hand who were already evaluating samples and volunteered to start testing right away when the current Ebola outbreak started.” Randal J. Schoepp, PhD, a diagnostics specialist and chief of the Applied Diagnostics Branch at USAMRIID said in a written USAMRIID statement.
Meanwhile, Frieden said that CDC had activated its Emergency Operations Center to its highest response level in response to the outbreak.
“It doesn’t mean that there is an increased risk for Americans but it does mean we are taking an extensive effort to do everything we can to stop the outbreaks,” he said.
CDC also explained last month that, while currently CDC and the DoD have the only U.S. laboratories capable of conducting diagnostic testing to confirm that a patient has Ebola, additional labs across the United States will soon also have that technology, as part of CDC’s Laboratory Response Network.
“These labs have received detailed guidance on the inactivation and safe handling of samples potentially carrying Ebola virus. Once they demonstrate that they can accurately detect or rule out Ebola in a sample, these labs will be capable of rapidly providing presumptive diagnosis for ill people suspected of having Ebola. These rapid presumptive results will then be definitively confirmed by laboratories at CDC,” according to statement from the agency.
Ebola Product Development
DoD, along with other government entities, has been interested in the development of pharmaceutical products to both detect and treat Ebola.
In August, the Food and Drug Administration issued an Emergency Use Authorization (EUA) for the DoD’s EZ1 Real-time RT-PCR Assay for the presumptive detection of Ebola Zaire virus, detected in the West Africa outbreak in 2014 in TRIzol-inactivated whole blood or TRIzol-inactivated plasma specimens from individuals in affected areas with signs and symptoms of Ebola virus infection. The test also is for use in those who are at risk for exposure or may have been exposed to the Ebola Zaire virus in conjunction with epidemiological risk factors.
USAMRIID scientists, meanwhile, have played a significant role in the development of ZMapp, an experimental therapeutic product for Ebola virus that was given to two U.S. missionaries who contracted the virus while in West Africa and underwent care at Emory University Hospital in Atlanta before being released last month.
The development of the drug was supported by NIH’s National Institute of Allergy and Infectious Diseases, DoD’s Defense Threat Reduction Agency and the HHS’ Biomedical Advanced Research and Development Authority, according to CDC.
Two other companies, Tekmira and BioCryst Pharmaceuticals, receive support from DoD for therapeutic candidates for Ebola in early development, according to CDC.
Tekmira Pharmaceuticals Corp. of Vancouver, British Columbia, which has a $140 million contract with DoD’s Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office, announced last month that the FDA verbally confirmed that the full clinical hold placed on its therapeutic product’s Investigational New Drug Application (IND) had been modified to a partial clinical hold. According to the company, this will enable the potential use of TKM-Ebola in individuals infected with Ebola virus.
“This current outbreak underscores the critical need for effective therapeutic agents to treat the Ebola virus. We recognize the heightened urgency of this situation and are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols,” Tekmira PharmaceuticalsCEO and President Mark Murray, PhD, said in a written statement.
BioCryst Pharmaceuticals of Durham, NC, also announced last month that it had received additional funds from NIAID for the advancement of the development of BCX4430 to treat hemorrhagic fever virus diseases.
NIH explains on its website that the product has “broad spectrum antiviral activity including against Ebola virus.” Earlier this year, USAMRIID scientists published research on the product showing that it protected cynomolgous macaques from Marburg virus infection for as long as 48 hours post-infection when administered by injection.
NewLink Genetics Corp. of Ames, IA, also recently announced a letter contract with the U.S. Defense Threat Reduction Agency DTRA for studies that will bring an Ebola vaccine licensed from the Public Health Agency of Canada closer to human clinical trials.
The letter contract is for $1 million, with additional funding subject to final negotiation, to fund pre-clinical toxicology studies and the manufacture of clinical materials for an investigational new drug.
“There is an urgent need for a medical countermeasure against the deadly Ebola virus,” Charles Link, MD, chairman and CEO of NewLink, commented
in a company press release. “This Ebola vaccine has been 100% effective in preventing lethal infection when given to nonhuman primates before they are infected with the virus. The vaccine also acts rapidly enough to have significant efficacy even when given to animals that have recently received a typically lethal dose of Ebola virus.”