The company that developed an experimental drug used against the Ebola virus
said it has exhausted its supply after shipping doses to Africa to treat two Liberian doctors.
Liberian President Ellen Johnson Sirleaf announced on her Executive Mansion website
Tuesday that the government had gotten approval from the U.S. Food and Drug Administration and San Diego-based drugmaker Mapp Biopharmaceuticals for use of ZMapp. The Liberian doctors will be the first African recipients of the experimental drug.
“The FDA's approval is to allow the drugmaker to send the experimental drug to the Ministry of Health and Social Welfare only for use on the two doctors,” according to the statement. “The drugs should be in the country within the next 48 hours.”
The U.S. government helped the Liberian government get in touch with Mapp Biopharmaceuticals to procure the drug. "Since the drug was shipped for use outside the U.S., appropriate export procedures had to be followed,” an HHS spokesperson said in an e-mail.
Questions loom about Mapp's capability to produce enough of the drug to help a significant number of the people affected by the Ebola outbreak, which has killed more than 1,000 people as of Monday in Liberia, Guinea, Sierra Leona and Nigeria, according to the World Health Organization.
In a statement posted on its website Tuesday
, Mapp said it has exhausted its available supply of ZMapp and that it had provided it at no cost.
The company declined to answer additional questions regarding any plans to mass produce ZMapp.
The ZMapp doses were procured for Drs. Zukunis Ireland and Abraham Borbor, who are believed to have contracted Ebola while attending to infected patients, according to the Liberian government. Both doctors reportedly gave written consent to have the drug administered to them.
Before the announcement, ZMapp had been used in two American aid workers and a Spanish missionary priest, sparking outrage by some that the treatment had been made available to Western patients while the vast majority of those infected and dying from the disease are African.
The company suggested in a statement that there might be others who have received the drug. “We have complied with every request for ZMapp that had the necessary legal/regulatory authorization,” the Mapp statement read. “It is the requestors' decision whether they wish to make public their request, acquisition, or use of the experimental drug—any decision to use ZMapp must be made by the patients' medical team.”
Others have questioned whether it's ethical to use a drug that had never been tested in humans or approved by the FDA. Such ethical considerations were the subject of a panel discussion held by the WHO on Monday, which concluded that the use of experimental treatment in the face of the ongoing outbreak was ethically sound.
“In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention,” according to a statement released Tuesday
As of Monday, WHO said 1,013 people have died
from Ebola with more than 1,800 suspected or confirmed cases. Between Aug. 7 and Aug. 9, 69 new cases were found and 52 deaths were reported.
There is no vaccine or approved treatment for Ebola virus, though ZMapp is one of a few experimental drugs in development. Last week, the Vancouver-based pharmaceutical firm Tekmira Pharmaceuticals Corp. announced
that the FDA had agreed to ease safety restrictions on their experimental Ebola treatment, TKM-Ebola, which would possibly allow for testing to be conducted in infected human patients but not in healthy volunteers.
The U.S. National Institute of Allergy and Infectious Diseases said it has been developing a potential Ebola vaccine with a Swiss company recently acquired by drug maker GlaxoSmithKline that has shown promising results in primates. The vaccine is expected to enter phase 1 clinical trials as early as this fall, according to the agency
.Follow Steven Ross Johnson on Twitter: @MHsjohnson