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As reports of H5N1 bird flu circulating in dairy cow herds across the United States continue, the experts in charge of preparing and responding to pandemics are now considering our ability to quickly develop a vaccine if human transmission were to occur in the future. The world has decades of experience producing, regulating, and updating flu vaccines, as well as the recent memory of the incredibly rapid development of vaccines during the COVID-19 pandemic. However, current global production capacity for flu vaccines would not yield enough doses quickly enough to vaccinate the large portion of the world’s population that would be necessary to quell a bird flu pandemic. Adjuvants—compounds that boosts immune response to the active vaccine antigen —or the introduction of an mRNA vaccine could, respectively, stretch supplies and speed up production, but it is not clear that there is sufficient production capacity for relevant adjuvants, and it is unclear how close producers are to advancing mRNA flu vaccines to market. Additionally, current flu production capacity is highly concentrated in high-income countries with no flu production in Africa, underlining the potential of another highly inequitable pandemic response.
Last week Medicines for Malaria Venture (MMV) and Novartis announced positive data from their Phase 2/3 trial in Africa demonstrating the efficacy and safety of a novel formulation of the Coartem® malaria medicine developed for babies weighing less than 5 kilograms. Previously, this population lacked access to an evidence-based treatment option developed specifically for them, with this trial becoming the first evidence-based trial conducted to evaluate a new antimalarial dose and regimen for all infants under 5 kilograms with acute uncomplicated malaria. This population is currently treated with tablets meant for higher-weight children that are simply adjusted for weight, which can lead to overdose and toxicity in smaller kids. The data have been submitted for regulatory review, and if approved, the partners aim to make the treatment available as soon as possible.
The Drugs for Neglected Diseases initiative (DNDi) and partners have initiated a Phase 2 clinical trial in Ethiopia testing an innovative, safer, simpler, and patient-friendly medicine to treat visceral leishmaniasis, the world’s deadliest parasitic killer after malaria. Visceral leishmaniasis is currently treated with painful injections that must be given at the hospital daily for 17 days and can cause rare but life-threatening side effects. The hope is that the new drug, which is administered via oral pills, will be efficacious, less toxic, and more accessible than the currently available treatment regimen, ensuring earlier access to treatment. A similar Phase 2 trial is also being conducted in South Asia to test if patients in the two endemic regions respond differently to the treatment.