MSF calls on researchers, donors and producers to take pressing actions
Background:
In a commentary published in The Lancet today, MSF requires pressing motion from all stakeholders concerned in analysis on Bundibugyo virus therapy and prevention to make sure that kids are meaningfully included in deliberate, evidence-generating analysis on medical countermeasures, and, particularly, have well timed entry to paediatric formulations for ongoing trials of oral post-exposure prophylaxis (PEP).
The present Ebola illness outbreak attributable to the Bundibugyo virus within the Democratic Republic of the Congo (DRC) has disproportionately affected kids. As of 4 August 2026 and among confirmed cases for whom age is reported, the proportion of kids below 5 years previous who have been recognized and who subsequently died from Bundibugyo virus illness was considerably increased than that of adults.
Delayed inclusion in trials, lack of paediatric dosing steering, and security considerations are acquainted limitations to entry to medical countermeasures for kids and pregnant and breastfeeding ladies and women (PBWG.) At present, the EBO-PEP study, which began on 14 July 2026, is evaluating the oral antiviral obeldesivir for stopping an infection following high-risk publicity to Ebola illness attributable to the Bundibugyo virus. If this proves to be efficient, it may provide a sensible and scalable technique to guard individuals who have had current contact with a case of Ebola. Whereas kids weighing lower than 30 kg (roughly 12 years previous or youthful) are excluded from the trial in its authentic design, we are able to anticipate {that a} deliberate protocol modification to incorporate kids over 20kg will quickly be accepted. Nevertheless, owing to the dearth of an obtainable paediatric formulation of obeldesivir and the absence of revealed information supporting pill crushing or dissolution, kids below 20 kg (6 years previous or below) are nonetheless excluded from this examine. Whereas the trial is conducting a sub-protocol for these excluded consisting of intravenous (IV) remdesivir, a each day IV therapy course over 10 days is operationally very troublesome in outbreak settings, particularly for younger kids. Gilead has just lately expressed willingness to make paediatric formulations of obeldesivir obtainable quickly. It’s but to be seen when the trial with oral formulations will begin.
Dr Neal Russell, Paediatric Advisor, MSF:
We have to generate the proof now in order that kids can entry efficient preventive therapies alongside everybody else, not after the outbreak is over
“Too usually, the inclusion of kids within the growth of medical countermeasures to deal with public well being emergencies is left to the ‘small print’ however at the moment, with kids at a disproportionately excessive threat of dying if contaminated with Ebola within the present outbreak in DRC, their inclusion is paramount.
“Researchers, donors and different stakeholders should urgently help a paediatric obeldesivir sub-study, construct on current dosing steering, and speed up the analysis of different oral antivirals and monoclonal antibodies as post-exposure prophylaxis. We have to generate the proof now in order that kids can entry efficient preventive therapies alongside everybody else, not after the outbreak is over.
“Gilead – the pharmaceutical company manufacturing obeldesivir – has dedicated to breed the antiviral in its paediatric formulation. We hope that Gilead will present a transparent and accelerated timeline for doing so, and that stakeholders can organise paediatric research with this formulation, or with modified grownup tablets as quickly as doable, so that every one kids in danger might be included in research evaluating which post-exposure prophylaxis choices are most sensible, well timed and efficient.”
