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Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Biotech companies Afrigen Biologics and Univercells on Tuesday announced a collaboration to pave the way for the development of the first African-owned COVID-19 vaccine through open-access intellectual property. The companies will focus on the development of a novel mRNA vaccine, using intellectual property from partners, with an emphasis on tackling two major challenges that have hindered COVID-19 vaccine rollout in Africa and other low- and middle-income countries: cold or super-cold chain requirements and a lack of local cost-effective production. The collaboration will be hosted in Cape Town, South Africa, by Afrigen, which also hosts the World Health Organization’s (WHO) global mRNA vaccine technology transfer hub, and the new agreement will build on expertise developed using the hub.At last week’s Kigali Summit on Malaria and Neglected Tropical Diseases (NTDs), Novartis and GlaxoSmithKline (GSK) each pledged to make significant new investments in research and development (R&D) for neglected diseases. Novartis committed $250 million over a period of five years to support work on malaria, Chagas disease, leishmaniasis, dengue fever, and cryptosporidiosis. The funding announcement was made as part of Novartis’ endorsement of the Kigali Declaration, a commitment to ending NTDs. GSK’s pledge—$1 billion over ten years—will be used to accelerate R&D of infectious diseases that disproportionately affect lower-income countries. This research will focus on new and disruptive vaccines and medicines to prevent and treat malaria, tuberculosis, HIV, NTDs, and antimicrobial resistance (AMR).Development of new antibacterial treatments is inadequate to address the escalating threat of antibiotic resistance, according to an annual WHO pipeline report released Thursday. The report, which assesses antibacterial drugs in preclinical and clinical development, describes the pipeline as stagnant and far from meeting global needs. Since 2017, just 12 antibiotics have been approved, 10 of which belong to existing classes with established mechanisms of AMR—demonstrating a major gap in discovery of antibacterial treatments, especially innovative treatments. Urgent, concerted investments in R&D by governments and the private sector are needed to accelerate and expand the antibiotic pipeline, according to WHO, especially for products that can make an impact in low-resource settings, which are most affected by AMR.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. On Friday, the US Food and Drug Administration (FDA) authorized Moderna’s and Pfizer’s COVID-19 vaccines for children as young as 6 months—making kids under 5 years old eligible for the first time. The decision followed a unanimous recommendation from a panel of independent advisers to the agency to authorize Pfizer’s three-dose vaccine for children 6 months to 4 years and Moderna’s two-dose vaccine for children 6 months to 5 years. The FDA also authorized on Friday Moderna’s vaccine, previously cleared in adults over 18, for children and adolescents ages 6 through 17 years old. Centers for Disease Control and Prevention Director Rochelle Walensky signed off on recommendation of the shots this past weekend, and vaccinations are beginning this week.The South African Health Products Regulatory Authority last week approved a sweet-tasting, heat-stable, “4-in-1” fixed-dose combination of four antiretroviral (ARV) treatments—abacavir, lamivudine, lopinavir, and ritonavir—specifically designed for infants and young children with HIV. The new formulation, developed by Cipla Limited and the Drugs for Neglected Diseases initiative (DNDi), does not require refrigeration, has a sweet taste, and is easy to administer to infants and children of different weights and ages, making it a significant improvement over existing pediatric ARV formulations. The accelerated review in South Africa is notable and encouraging for other countries with a high burden of HIV, according to DNDi, which also expressed hope that the necessary steps will be taken to ensure the broadest possible access to the treatment for children who need it.Japanese drugmaker Shionogi and the Global Antibiotic Research and Development Partnership (GARDP) announced Wednesday an agreement to expand access to a novel antibiotic for drug-resistant infections in lower-resource countries. The deal aims to provide access to cefiderocol, which is used to treat serious Gram-negative bacterial infections that may be resistant to other antibiotics, in countries that have experienced delayed or limited access to newer antibiotics. Under the agreement, GARDP will work with partners to manufacture and commercialize the antibiotic, developed by Shionogi, in up to 135 countries. The Clinton Health Access Initiative will also help navigate the technical, regulatory, legal, and economic barriers to getting the antibiotic to patients in these countries.