A quick update on the United States’ strategic Ebola-vaccine reserve: There isn’t one. As the Centers for Disease Control and Prevention told Foreign Policy on Monday, there is no Food and Drug Administration-approved Ebola vaccine for domestic use. And therefore, no reserves. That’s a little terrifying these days. Americans’ geographical and medical insulation from the virus aside, health officials are predicting an African apocalypse now. The epidemic has already claimed 1,000 lives and has sickened more than 1,700, according to the World Health Organization (WHO).
If ever there were a time for untested but potentially lifesaving solutions, now would be appropriate. WHO officials have already given the go-ahead for vaccine clinical trials. The tests will begin within weeks, aiming to have vaccines ready for use next year. On Monday, Aug. 11, the WHO held a meeting in Geneva to talk about the ethics of using experimental treatments, Agence France-Presse reported.
On Tuesday, the WHO released guidelines for how countries should use unauthorized drugs in emergencies like this. The questions are many: How much testing is enough in the face of an unprecedented crisis like this? And who gets them first — health-care workers? The elderly? Children? While a lot of that still needs addressing, the WHO signed off on using experimental drugs to treat Ebola now. The WHO advised health officials to collect and share data about the drugs’ efficacy and to use "transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for [the] person, preservation of dignity, and with the involvement of the community."
The moral questions of making available, or not making available, experimental drugs surfaced when two Ebola-infected American aid workers were airlifted from Liberia — where some 370 people have succumbed to the disease — to Emory University Hospital in Atlanta and were treated with an experimental drug. San Diego-based Mapp Biopharmaceutical manufactures the drug, ZMapp. It strengthens immune systems as they fight the virus and is made from antibodies produced by lab animals exposed to Ebola. That white Americans were the first to receive the drug has not sat well with many.
Washington, meanwhile, is trying to make experimental drugs more available. In March, the Food and Drug Administration (FDA) fast-tracked "TKM-Ebola," an experimental drug produced by the Canadian company Tekmira that targets the virus’s genetic material. But in July, the agency put a hold on TKM’s development, saying more information about its potential side effects is needed. On Thursday, Tekmira told the Associated Press that the FDA abruptly changed course and greenlighted making the drug available. Citing confidentiality policies over experimental drugs, the FDA declined to confirm.
Another drug called AVI-7537, produced by Sarepta Therapeutics, also goes after Ebola’s genetic material, as Forbes‘s David Kroll explained. U.S. Army Medical Research Institute of Infectious Diseases, which develops vaccines and drugs to protect military personnel against biological threats, is a co-assignee on the drug’s two patents, which expire in 2025. Work on the drug, funded in part by the Defense Department, was put on hold during the 2012 fiscal standoff. AVI-7537 was testing well, and Sarepta executives say the drug is ready to go if it can clear the remaining regulatory hurdles. (They’re not giving interviews right now.)
On Thursday, Barack Obama’s administration said it would convene a special working group to figure out how to deploy experimental anti-Ebola drugs in Africa. The team includes scientists from the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). Nicole Lurie, the Department of Health and Human Services’ assistant secretary for preparedness and response, will lead the task force. The NIH is already working on several fronts. Its National Institute of Allergy and Infectious Diseases is speeding up development of an Ebola vaccine. The institute is also partnering with outside institutions, a company called Crucell and Thomas Jefferson University, on a pair of vaccines.
All that would seem to be good news. The bad news is that it’s not profitable for large pharmaceutical companies to invest in the research and development of a product whose demand and use are quite limited and specific. The WHO seems particularly aggrieved by such market forces. It’s "a market failure because this is typically a disease of poor people in poor countries" one official said on Tuesday. So it often falls to smaller companies like Mapp — which announced Tuesday that after providing ZMapp to number of African countries for free, its inventory is empty — to fill the gap.
But public health officials don’t want to get ahead of themselves. "We don’t know if [the drugs] work, and we can’t have them in significant numbers," CDC Director Tom Frieden said at a congressional hearing last week. "I don’t want any false hopes out there." In addition, experimental "treatments shouldn’t be rolled out generally without prior safety testing," global health experts Jeremy Farrar, David Heymann, and Peter Piot wrote in the Wall Street Journal last week.