ITURI REGION — The U.S. Department of Health and Human Services (HHS) confirmed that American citizens facing high-risk Ebola exposures in Central Africa will have access to the investigational MBP-134 antibody treatment. The Biomedical Advanced Research and Development Authority (BARDA) is coordinating a shipment of monoclonal antibodies for potential use in these individuals.
This treatment will be distributed under the Food and Drug Administration's (FDA) investigational use mechanisms for unlicensed treatments. While MBP-134 has demonstrated efficacy in animal testing models, it has not yet completed a human clinical trial to demonstrate efficacy. Mapp Biopharmaceuticals, a San Diego-based company founded in 2003, manufactures MBP-134, and BARDA provided funding for its development. Primate studies indicate MBP-134 is effective against the Bundibugyo, Zaire, and Sudan ebolaviruses. The current Ebola outbreak, occurring in the northeastern Democratic Republic of the Congo and neighboring Uganda, is caused by the Bundibugyo ebolavirus, marking the third recorded outbreak of this specific strain.
Separately, the U.S. government constructed a 50-bed quarantine and high-containment medical facility in Kenya. However, a Kenyan court suspended the facility's planned May 29 opening. Protests against the containment facility plan occurred in Kenya. Despite this, officials stated the administration will proceed with the containment camp.
The administration stated it will transport Americans who develop Ebola to Europe for medical care. Officials argued that transporting patients to Europe for high-level care is faster than repatriation to the U.S. Individuals with Ebola or high-risk exposure will be barred from entering the U.S. until cured or after a 21-day quarantine period. During the 2014-2016 West African Ebola outbreak, patients were repatriated to the U.S. for treatment, and seven of the eight individuals repatriated during that period survived. U.S. funding established a network of high-containment medical facilities for infectious disease treatment.
In relation to clinical trials for the current outbreak, partners planning these trials submitted their protocol to Congolese regulatory authorities, and the ethical review for this protocol has been completed. Personnel from the Institute of Tropical Medicine in Antwerp conducted site evaluations in the Ituri region. "The partners' protocol is in front of the Congolese regulatory authorities." Armand Sprecher, an emergency physician and outbreak response veteran with Doctors Without Borders, said. The U.S. government has not confirmed whether it will supply MBP-134 for a clinical trial.
One American physician, Peter Stafford, contracted Ebola in the outbreak zone and was transported to Germany for medical care. His wife, also a physician, and their four children were transported to Germany for quarantine. Stafford remains under medical care and is recovering. Another physician from the same missionary organization remains healthy in quarantine in the Czech Republic following a high-risk exposure.
No independent assessment was available for this report.