During the ongoing Ebola outbreak in the Democratic Republic of Congo, which has claimed over 3,000 lives since mid-May, children under five face a mortality rate exceeding 60%—far higher than that of adults, according to a commentary in The Lancet by Doctors Without Borders.
The disparity, medical experts argue, stems largely from a systemic gap: children are frequently left out of early-stage clinical trials for new antiviral drugs, leaving doctors without clear guidance on how to treat young patients during emergencies.
At the center of the current debate is the EBO-PEP study, launched in mid-July, which investigates obeldesivir—an experimental antiviral designed to protect people exposed to the Bundibugyo strain of Ebola. While protocols may soon expand to include children weighing more than 20 kilograms, those under that threshold remain excluded.
For the youngest patients, an alternative treatment exists: intravenous remdesivir. However, administering a 10-day infusion course during an outbreak is logistically difficult, particularly for young children, said Doctors Without Borders.
Neal Russell, a London-based pediatrician who consults for the aid organization and led the Lancet commentary, noted that children are especially vulnerable during epidemics. Their weaker immune systems, coexisting health conditions, and difficulty communicating symptoms make diagnosis and treatment more challenging.
“Children cannot simply be viewed as small adults,” explained Han Ngoc Le, a physician at Berlin’s Charité hospital. “Their metabolisms work differently, their pharmacokinetics are different, and their reactions to medications vary.”
Last May, an American doctor contracted Ebola while treating patients in Congo and was hospitalized in Berlin. His wife and four children were also at high risk. Doctors there opted to administer MBP134, an experimental antibody drug, prophylactically to the family.
Data on the drug’s effects in children was scarce, but after treatment, all family members remained healthy with no apparent side effects. Le said the successful use of the antibody—even in children as young as one—provides a foundation for future pediatric research.
Marc Biot, an access coordinator for Europe at Doctors Without Borders, stressed that pharmaceutical companies often deprioritize pediatric studies because they are more expensive and time-consuming. “It is faster and cheaper to focus only on adults,” he said. “Our plea is that research should advance at the same pace for children and pregnant women as for adults.”
The issue extends beyond Ebola. During the 2024 mpox outbreak in the DRC, vaccines were available but not specifically designed for children, forcing health authorities to rely on off-label use—a pattern repeated with HIV, tuberculosis, and COVID-19.
In 2020, the World Health Organization helped launch the Global Accelerator for Pediatric Formulations to speed up the development of child-friendly medicines. Yet experts warn that progress remains slow.
Russell argued that while excluding children from research makes sense in non-emergency settings to avoid potential harm, the balance shifts during outbreaks. “The most vulnerable should not be the last to benefit from medical progress,” he said.
Le echoed the call for inclusion from the start of any clinical trial. “Sub-studies or parallel studies involving children and pregnant women should be set up from the outset,” she said.
As the DRC continues to battle the deadliest Ebola outbreak in its history, advocates say the crisis underscores the need to rethink how medical research prioritizes the most vulnerable populations.
Pharma companies cite cost, but isn’t excluding half the population bad science? We need child-friendly formulations as standard practice now.
I didn’t realize the mortality gap for under-fives was over 60%. The logistical issues with remdesivir make this even more urgent.
This is incredibly disturbing. Children being left out of trials during outbreaks is a moral failure we need to fix immediately.