ZMapp is granted fast track approval in America. LeafBio says the grant is an “important milestone” which brings them closer to eventually gaining approval. The drug has been administered under emergency use authorization to nine infected patients in Africa in addition to two infected missionaries in Europe during its first clinical trial. LeafBio CEO Whaley:
We are gratified to receive this designation for ZMapp. We are hopeful that this step will accelerate its access once safety and efficacy are demonstrated to satisfaction by FDA in ongoing clinical trials.
Early stage clinical trials find experimental vaccine VSV-ZEBOV is safe and promotes antibody response in all 40 adult recipients according to the National Institutes of Health (NIH) and Walter Reed Army Institute of Research (WRAIR). Some recipients experience fever, but except in one case, the fever abates within 24 hours of vaccination. Volunteers are being enrolled in Liberia for the second phase of the trial. Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), states
Until a safe and effective vaccine is available, the world will continue to be under-prepared for the next Ebola outbreak.
WHO calls for “drastic action” to fight the deadliest Ebola breakout on record and is convening an 11-nation meeting to address the crisis. 635 cases of haemorrhagic fever (most confirmed to be Ebola), including 399 deaths, have been reported across Guinea, Liberia and Sierra Leone, making this the larges breakout ever reported. Doctors Without Borders (MSF) said that the deadly outbreak of the virus is “out of control”.