ZMapp is an experimental treatment, developed by Mapp Biopharmaceutical, for use with individuals infected with Ebola virus. It has not yet been tested in humans for safety or effectiveness.
The product is a combination of three different monoclonal antibodies that bind to the protein of the Ebola virus.
It is too early to know whether ZMapp is effective, since it is still in an experimental stage and has not yet been tested in humans for safety or effectiveness. Some patients infected with Ebola virus do get better spontaneously or with supportive care. However, the best way to know if treatment with the product is efficacious is to conduct a randomized controlled clinical trial in people to compare outcomes of patients who receive the treatment to untreated patients. No such studies have been conducted. It's important to note that the standard treatment for Ebola remains supportive therapy.
This includes the following measures: balancing the patients' fluids and electrolytes; maintaining their oxygen status and blood pressure; and treating them for any complicating infections.
In addition, the most effective way to stop the Ebola outbreak in West Africa is meticulous work in finding Ebola cases, isolating and caring for those patients, and tracing contacts to stop the chains of transmission. It means educating people about safe burial practices and having health care workers strictly follow infection control in hospitals. This is how all previous Ebola outbreaks have been stopped.
At this time, very few courses of the experimental treatment ZMapp have been manufactured. Since the product is still in an experimental stage, it is too early to know whether ZMapp is effective. The manufacturer of this experimental treatment continues to research and evaluate the product's safety and effectiveness. It has not yet been tested in humans for safety or effectiveness and much more study is needed.
Zmapp has been tested on two U.S. patients in Liberia. The experimental treatment was arranged privately by Samaritan's Purse, the private humanitarian organization, which employed one of the Americans who contracted the virus in Liberia. Samaritan's Purse contacted the Centers for Disease Control and Prevention ( CDC ), who referred them to the National Institutes of Health ( NIH ). NIH was able to provide the organization with the appropriate contacts at the private company developing this treatment. The NIH was not involved with procuring, transporting, approving, or administering the experimental treatments.
Zmapp is still in an experimental stage, and the manufacturer reports that there is a very limited supply, so it cannot be purchased and is not available for general use. The manufacturer has been planning for phase 1 clinical trials and does not have the capacity to manufacture large quantities of the treatment. The drug has not gone through clinical trials, meaning its safety and effectiveness has not yet been tested in humans. The manufacturer of the experimental treatment continues to research and evaluate the product's safety and effectiveness.
There are currently no FDA approved vaccines for Ebola. The NIH's National Institute of Allergy and Infectious Diseases is working on developing an Ebola vaccine, and is aiming to launch phase 1 clinical trials of an Ebola vaccine in the fall.
NIH is also supporting the Crucell biopharmaceutical company in its development of an Ebola/Marburg vaccine as well as Profectus Biosciences in its development of an Ebola vaccine.
Additionally, NIH and the Thomas Jefferson University are collaborating to develop a candidate Ebola vaccine based on the established rabies vaccine.
Two other companies, Tekmira and Biocryst Pharmaceuticals have therapeutic candidates for Ebola in early development. The Department of Defense is working with a company called Newlink to develop an Ebola vaccine candidate. BioCryst, with NIH support, is working to develop an antiviral drug to treat Ebola virus that is expected to begin Phase 1 testing later this year. ( Xagena )
Source: Centers for Disease Control and Prevention ( CDC ), 2014