Issue Date: November 3, 2014 | Web Date: October 31, 2014
Federal Government Conducts Clinical Trials Of Ebola Vaccine And Approves More Diagnostics
Federal agencies are intensifying efforts to create or approve new tools to help combat the deadly Ebola epidemic, which is raging through three West African countries.
This week, NIH and the Department of Defense announced an early clinical trial of an Ebola vaccine, the second new trial in as many months. FDA also cleared the way for two new diagnostic tests for the disease.
The NIH/DOD Phase I clinical trials will test a vaccine, VSV-ZEBOV, developed by Canada’s Public Health Agency and licensed to NewLink Genetics Corp. of Ames, Iowa. The drug is a version of the vesicular stomatitis virus that has been genetically engineered to express the outer protein of the Zaire Ebola virus strain.
The study at NIH’s Clinical Center in Bethesda, Md., will examine the safety of and immune response to two doses of the vaccine. The DOD trial at Walter Reed Army Institute of Research in Silver Spring, Md., will study the effects of a single dose. Results are expected by the end of 2014.
FDA’s emergency approval of two new diagnostic tests brings the number available in the U.S. to five. The newest approvals for rapid testing are from BioFire Defense of Murray, Utah. One test allows hospitals to conduct a polymerase chain reaction in-house to look for Ebola. The other can examine whole-blood specimens from patients who are presumed to have Ebola.
FDA is actively working with other developers to augment diagnostic capacity, Commissioner Margaret A. Hamburg says.
The agencies’ efforts come amid reports that the epidemic may be slowing in Liberia.
In the U.S., two nurses who came down with the disease after caring for an Ebola patient have recovered, but a doctor infected while treating the stricken in Guinea remains hospitalized in New York City. The handful of cases in the U.S. has triggered partisan debates over the power, reach, and competency of federal health agencies.
Moves by several states to quarantine health care workers who looked after Ebola patients in Africa were met with fears that these actions will discourage others from volunteering to help fight the epidemic overseas.
“We don’t just react based on our fears,” President Barack Obama says, criticizing the state quarantine policies. “We react based on facts and judgment and making smart decisions.”
- Chemical & Engineering News
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