Breakthroughs Blog: Pandemic preparedness

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. Last Thursday, Gavi, the Vaccine Alliance, announced the African Vaccine Manufacturing Accelerator, which will invest up to $1 billion in boosting African manufacturing to address the inequality in vaccine access faced by Africans during the COVID-19 pandemic, as well as to produce vaccines to tackle diseases with a high burden on the continent, including cholera and malaria. The funding for the new scheme comes from leftover money from the COVAX initiative, which aimed to help the world’s poorest countries access COVID-19 vaccines during the pandemic. The accelerator is expected to launch in June of next year and hopes to ensure African manufacturers can offer competitive prices, even for new technologies like viral vector and mRNA vaccines.The startup NanoPin Technologies has developed an ultra-sensitive, blood-based test for difficult-to-detect tuberculosis (TB) cases now on the market, which is also the foundation for a multiplex TB and HIV test the company is developing. Both the NanoDetect-TB blood test, which is supposed to ease and speed up the detection of active TB, and the NanoDetect-TB/HIV multiplex assay, which uses quantitation of viral and bacterial loads to simultaneously detect HIV and TB, offer potential advantages over existing tools. Currently available tests, including the gold standard sputum-based methods for TB detection, can have low sensitivity to samples from patients with HIV and TB coinfection. Further research will be necessary to demonstrate that the multiplex test maintains efficacy in the field and that it can continue to be sensitive while reducing cost, complexity, and instrument requirements as much as possible.Last week at the International Conference on AIDS and STIs in Africa, researchers from the PrEPVacc trial that was testing two different vaccine regimens in Africa announced that the study has been shut down, leaving no HIV efficacy trials underway globally. The trial was halted after an independent data monitoring committee concluded there was little or no chance the study would demonstrate efficacy. The study had previously been dubbed the last chance for an HIV vaccine until the 2030s. PrEPVacc was a pioneering study as one of the first large, African-led HIV vaccine trials and one of the first trials to incorporate PrEP. However, the trial did use older vaccine designs that some scientists doubted would demonstrate adequate efficacy. The hope is that data from the halted trial can eventually inform future trials for new and innovative HIV tools.

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. This month, with support from the local government, German biotechnology company BioNtech is opening an mRNA vaccine factory in Rwanda, which is expected to become the first of what the company says will be a decentralized and robust end-to-end mRNA vaccine manufacturing network in Africa that will manufacture novel vaccines for Africans across the continent. The plant is expected to start by producing 50 million vaccines and will increase production based on demand. BioNTech is currently advancing vaccine candidates to address malaria and tuberculosis based on its mRNA vaccine platform.Last week, Population Council announced that South African company Kiara Health will start producing vaginal rings for HIV prevention in the next few years, which could make the innovative tool cheaper and more readily available to women in Africa. The dapivirine ring, which has been authorized by nearly a dozen countries and the World Health Organization, offers women an alternative HIV prevention method that can be taken without anyone else’s knowledge or consent. Population Council owns the rights to the ring, which is currently produced by a Swedish company. About a half million rings have been made available freely in Africa through donor support. Population Council and Kiara estimate that the company will be able to produce double the currently available supply annually.The Coalition for Epidemic Preparedness Innovations (CEPI), the International Vaccine Institute (IVI), and Medical Research Council Unit The Gambia last week announced the launch of the Research Preparedness Program West Africa, which will support a consortium of regional stakeholders to bolster the growing clinical research sector across the region. Specifically, the partners will work toward building up clinical trial capacity to conduct the first-ever large-scale phase 2b and 3 clinical trials of Lassa fever vaccines in the region. The program also aims to improve general preparedness to ensure the capacity to generate high-quality clinical trial data during future outbreaks of other diseases in the region in as little as 100 days.

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. Last Wednesday, the Global Antibiotic Research and Development Partnership (GARDP) announced the results of a successful phase 3 trial, conducted in collaboration with Innoviva Specialty Therapeutics and supported by the National Institute of Allergy and Infectious Diseases, which found that a single dose of a first-in-class oral antibiotic, zoliflodacin, was as safe and effective as standard therapy for treating uncomplicated urogenital gonorrhea. The growing resistance of the gonorrhea bacteria to many classes of antibiotics has left only one remaining globally recommended treatment available as an option. Zoliflodacin, if approved, could not only help address those rising cases because studies have shown that it is active against multi-drug resistant gonorrhea strains, but the antibiotic will also simplify treatment because it is one pill rather than an injection and a pill like the current standard therapy. Last week, the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford announced the launch of a new project to develop prototype vaccines against an arenavirus called Junin virus, which causes Argentine hemorrhagic fever. The project is aimed at kickstarting the broader development of vaccines for arenaviruses, which include the virus that causes Lassa fever, one of CEPI’s priority pathogens. CEPI will invest $25 million in the development of early prototypes of viral vector and mRNA vaccines against the Junin virus, as well as the improvement of the ChAdOx viral vector technology, part of the broader partnership between CEPI and Oxford to support vaccine development for a variety of viral families with future epidemic or pandemic potential. In a recent study, researchers have identified a new molecule in cells that is necessary for the Ebola and Marburg viruses to infect and spread in the body and that is also involved in SARS-CoV-2 infections. This discovery could eventually lead to new antiviral drugs for Ebola and Marburg, among other viral infections. The molecular, CCZ1, is a protein that regulates the transport of other molecules by cells. Researchers from the Karolinska Institutet and Institute of Molecular Biotechnology used advanced stem cell libraries and lab-grown organs to study how viruses infect the human liver and blood vessels and ultimately demonstrate how CCZ1 operates as a key factor in their spread through the body. 

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 Department of Health and Human Services announced another $500 million in Project NextGen funding, which will support phase 2b clinical trials of three COVID-19 vaccine candidates, as well as other technologies to enhance preparedness against COVID-19 and future disease outbreaks. Specifically, the awards will go to two intranasal vaccine candidates that are administered as sprays and one self-amplifying mRNA vaccine candidate that is administered as an injection; phase 2b clinical trials of those vaccine candidates could start as soon as this winter. Funding will also go to the development of vaccine patches, cold-chain sample management, genomic sequencing, and increased laboratory capacity.The Coalition for Epidemic Preparedness Innovations (CEPI) is leading an initiative with the biopharma data provider IQVIA aimed at enhancing global research capacity to advance the 100 Days Mission, which aims to be able to respond to the next Disease X (a future pathogen with pandemic potential) with medical countermeasures within 100 days of its identification. Under the initiative, IQVIA will provide tools and resources to support research preparedness in underserved regions during ‘peacetime’ (when there is no ongoing pandemic outbreak) and to support clinical trials during future outbreaks of diseases with pandemic potential. CEPI will fill in gaps to ensure high-quality data are generated during an outbreak response to inform further research.Last week, The Lancet and the Coalition for Preventing Pandemics at the Source announced that they have convened the Commission on Prevention of Viral Spillover, which will work to mobilize decision-makers to support research and policies to prevent future viral spillovers and pandemics following the COVID-19 pandemic, which was the fifth viral pandemic caused by a viral spillover in the last century. The commission, which includes 28 experts in a variety of fields from epidemiology to veterinary medicine to food systems management, will conduct original research and publish a comprehensive report within two to three years on recommendations to prevent such spillovers.