Research Roundup: New PEPFAR leadership, shorter TB regimens, and novel COVID-19 vaccine platforms

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. World leaders convened virtually Thursday for a second Global COVID-19 Summit to accelerate collective efforts in the global pandemic response, pledging about $3.1 billion in new 2022 funding along with commitments to bolster availability of COVID-19 tools. The funding commitments, though falling short of the goal of $10 billion for vaccinations and $3 billion for therapeutics and oxygen, included more than $2 billion in funding for the immediate COVID-19 response and $962 million for a new pandemic preparedness and global health security fund to be established at the World Bank. The United States, which cohosted the summit alongside Belize, Germany, Indonesia, and Senegal, also announced a new National Institutes of Health licensing agreement to share technologies with the World Health Organization’s COVID-19 Technology Access Pool and the Medicines Patent Pool to support the development of therapeutics, early-stage vaccines, and diagnostic tools.The Coalition for Epidemic Preparedness Innovations (CEPI) will provide up to $19.3 million to support development of a “variant-proof” COVID-19 vaccine by an international consortium consisting of Bharat Biotech, the University of Sydney, and ExcellGene SA. The funding will support preclinical and clinical proof of concept for an adjuvanted subunit vaccine candidate—including immunogen design, preclinical studies, manufacturing process development, and a phase 1 clinical trial—with the goal of providing broad protection against all known SARS-CoV-2 variants of concern as well as future variants of the virus. The project could contribute to long-term control of COVID-19, according to CEPI, and the partnership has committed to achieving equitable access to any outputs of the project.A World Trade Organization (WTO) proposal to temporarily waive patent protections on COVID-19 vaccines is receiving tepid reactions from members ahead of a long-delayed ministerial conference set for June. The current compromise proposal would ease some existing barriers to issuing compulsory licenses for patents on COVID-19 vaccines, but also introduces new impediments, including a condition requiring countries to list each patent they intend to waive. The deal is a result of discussions between the European Union, United States, South Africa, and India, following the original proposal by South Africa and India presented in 2020, which sought to not only waive intellectual property protections on patents, but also trade secrets, copyrights, and industrial designs, for treatments, tests, and vaccines. WTO member states expressed mixed views at a recent meeting of the Council on Trade-Related Aspects of Intellectual Property, or TRIPS, ultimately leaving the fate of the proposal uncertain.

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. More newborn babies with sepsis are dying because their infections are not responding to the usual antibiotics, according to the largest global study on the subject to date. The study, sponsored by the Global Antibiotic Research and Development Partnership (GARDP), which enrolled 3,200 newborns diagnosed with sepsis in 11 countries, found that 11 percent of newborns died over the course of the study and that 15 percent were prescribed last-line antibiotics due to the high degree of resistance to standard recommended antibiotics in treatment units. Antibiotic resistance is now one of the major threats to newborn health globally, according to researchers, with virtually no studies underway to develop novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections. GARDP is now designing an interventional trial to identify better treatment regimens to combat rising resistance.World Health Organization (WHO) member states reached a preliminary agreement this week to gradually increase mandatory fees, or “assessed contributions,” to cover 50 percent of the organization’s core budget needs. WHO currently relies heavily on voluntary contributions and private donors, which can leave its financing inflexible and unpredictable. The new funding reforms would be contingent upon certain conditions, such as increased transparency, with the funding linked to a member state review of WHO progress on promised internal reforms. The agreement will still need to be formally approved by governments at the World Health Assembly in May to take effect.COVID-19 diagnostic testing has fallen by 70–90 percent around the world, making it increasingly difficult to monitor the pandemic’s evolution, treat patients, and track variants, according to FIND, a co-convener of the Access to COVID-19 Tools Accelerator diagnostics pillar. While reported cases and deaths are declining globally, changes in testing strategies and reductions in the number of tests being used globally means there is little confidence in actual case trends. The testing decline also undermines the ability to treat patients with new therapeutics—like Pfizer’s antiviral Paxlovid, which requires early diagnosis to get the most benefit—and has led to a decrease in the number of genomic sequences submitted to global databases, which helps track emerging variants.