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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. On Thursday, the US Food and Drug Administration (FDA) granted emergency use authorization to the first COVID-19 test to detect the disease through breath. The InspectIR COVID-19 Breathalyzer is able to identify five volatile organic compounds associated with COVID-19 infection in breath samples and delivers results in less than three minutes. In a study of 2,409 individuals both with and without symptoms, the test had a 99.3 percent specificity rate, which measures the percent of correctly identified negative test samples, and a 91.2 percent sensitivity rate, which measures the percent of correctly identified positive test samples. The breathalyzer device—about the size of a piece of carry-on luggage—will be used in mobile testing sites, hospitals, doctor’s offices, and other locations where samples are both collected and analyzed.An experimental drug halved the death rate among critically ill COVID-19 patients receiving supplemental oxygen and at high risk for serious lung disease and death, the drug’s developer announced last week. Sabizabulin, which works by disrupting the transport of the virus through microtubules in cells, is given in a capsule taken once a day and has no refrigeration requirements. A clinical trial of the drug, the results of which have not yet been published or peer reviewed, was halted early at the recommendation of independent safety monitors after the treatment was shown to drastically reduce deaths among hospitalized COVID-19 patients. Developers plan to meet with the FDA later this month and will be applying for emergency use authorization for sabizabulin.An anti-HIV strategy called vectored immunoprophylaxis—in which an adeno-associated viral (AAV) vector delivers instructions to muscle cells to pump out antibodies that block the virus—showed promising results in a phase 1 clinical trial conducted by the National Institutes of Health. The AAV therapy is able to block HIV’s ability to bind to an immune cell’s receptor that the virus targets before infecting the cell, therefore shutting down the virus’s entry. The phase 1 clinical trial enrolled eight adults with HIV who were on stable antiretroviral therapy for at least three months and found that intramuscular injection of the therapy was safe and well-tolerated. Researchers are continuing to develop this technology, which they say could have wide-ranging clinical implications for preventing or treating HIV and other infections.

A coalition of more than 100 leading global health and research organizations is calling on Congress to provide $250 million in new funding to the US Agency for International Development (USAID) to establish a fund to supercharge global health innovation.In an open letter to congressional appropriators, these organizations urged policymakers to appropriate this dedicated innovation funding to USAID in the fiscal year 2023 State, Foreign Operations, and Related Programs spending bill. This new influx of resources, which advocates are calling the Supporting Innovative Global Health Technologies Fund, or SIGHT Fund, would enable USAID to expand its support of research and development (R&D) of products for a range of global health challenges.The letter highlights how USAID has for decades excelled in facilitating R&D of new vaccines, drugs, and other tools as part of its broader global health mission. But it also notes how stagnant budgets and growing needs have squeezed the agency, resulting in a worrisome trend of USAID investment in R&D declining as a proportion of overall global health spending. The signatories make the case that this new dedicated source of R&D funding would reverse this decline and better enable the agency to make bold, forward-looking innovation investments to stock the global health toolbox of tomorrow.The request for an initial appropriation of $250 million for the SIGHT Fund is an amount representing less than 3 percent of current US spending on global health, yet this modest investment could catalyze the development of game-changing tools that could accelerate progress against both emerging and enduring global health challenges—saving US taxpayer dollars, maximizing the impact of programs, and ultimately improving and saving lives around the world. The full text of the open letter can be viewed here and the full list of signatories is below:1,000 Days3rd Stone DesignAdvancing SynergyAmerican Academy of PediatricsAmerican Society of Tropical Medicine and HygieneAVACBay Area Global Health AllianceBEMPU HealthBetter World CampaignBilimetrix s.r.l.BIO Ventures for Global HealthBoston University Social Innovation on Drug Resistance ProgramBridges to DevelopmentBugworksBurnet InstituteCatalysts for ChangeCenter for Global Health InnovationCenter for Innovation in Global Health, Georgetown UniversityChristian Connections for International HealthCoalition for Epidemic Preparedness InnovationsCoalition for Health Research and DevelopmentCONRADConsortium of Universities for Global HealthCORE GroupDeutsche Stiftung WeltbevoelkerungDr Marri Channa Reddy FoundationDrugs for Neglected Diseases initiativeElizabeth Glaser Pediatric AIDS FoundationEmory UniversityEpiPointeEqualize HealthFINDFREO2 FoundationFriends of the Global Fight Against AIDS, Tuberculosis and MalariaGlobal Antibiotic Research and Development PartnershipGlobal Health CouncilGlobal Health Innovative Technology FundGlobal Health StrategiesGlobal Health Technologies CoalitionGlobal ImpactHarvestPlusHemex HealthIAVIInfectious Diseases Society of AmericaInnovative Vector Control ConsortiumInternational Business & Technical Consultants, Inc.International Partnership for MicrobicidesInternational Union Against Tuberculosis and Lung DiseaseInternational Vaccine InstituteJohns Hopkins Center for Health SecurityKNCV Tuberculosis FoundationLinux Foundation Public HealthLittle Sparrow Technologies, Inc.Lucky Iron FishMakerere University School of Public HealthManagement Sciences for HealthMbarara University of Science and TechnologyMedical IMPACTMedicines for Malaria VentureModula S Inc.MRIGlobalMustERONE CampaignPAIPanAfricarePandemic Action NetworkPanorama GlobalPartners In HealthPATHPathfinder InternationalPolicy Cures ResearchPopulation CouncilPopulation Services International Research!AmericaRESULTSRice University Institute for Global Health TechnologiesSabin Vaccine InstituteSanaria Inc.Seed Global HealthShot@LifeSightsaversSinapi BiomedicalSmile TrainSociety for Children Orphaned By AIDS Inc.South Africa Health Technologies Advocacy CoalitionSpeak Up AfricaTB AllianceTexas Children's HospitalThe BroadReach GroupThe END FundThe Task Force for Global HealthTreatment Action GroupUCSF Institute for Global Health SciencesUnited to Beat MalariaUnlock AidVanderbilt Institute for Global HealthWashington Global Health AllianceWCG CaresWhat To Expect ProjectWhite Ribbon AllianceWomen in Global HealthZenysis

Yesterday, GHTC delivered an intervention during the first round of public hearings on the development of a potential pandemic treaty, which emphasized that the research and development of health technologies, coupled with sustainable financing for research capacity strengthening, should be a central pillar of any framework.In December 2021, the World Health Assembly established an intergovernmental negotiating body to draft and negotiate a World Health Organization (WHO) convention, agreement, or other international instrument on pandemic prevention, preparedness, and response.The guiding question of the first round of public hearings was: What substantive elements do you think should be included in a new international instrument on pandemic preparedness and response?GHTC's intervention as prepared is below and also available via video on the WHO website: The Global Health Technologies Coalition welcomes the opportunity to provide input to the Intergovernmental Negotiating Body (INB) through these public hearings. As deliberations around the creation of this framework continue, we urge member states to consider the following essential elements:Firstly, while these consultations represent a good first step, civil society must continue to be involved in the creation of the instrument itself, including the drafting process. Furthermore, members of the INB should ensure that a broad spectrum of voices can be heard during these discussions, especially those from lower- and middle-income (LMIC) countries and experts.  Second, research and development must be a central pillar of the framework. This includes strengthening norms and standards that support access and benefit sharing of data related to emerging pathogens, supporting mechanisms that strengthen local manufacturing and regulatory capacity, and facilitating research coordination that spurs innovation and the development of novel medical countermeasures that are accessible to all who need them.Lastly, the new instrument should be coupled with sustainable financing mechanisms, including a new global pandemic preparedness fund that increases surveillance, clinical trial, manufacturing capacities, as well as health system infrastructure strengthening in LMIC countries to address both pandemic and existing health priorities.  

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 week, advisers to the US Food and Drug Administration convened to assess the country’s COVID-19 vaccine policy, including guidance on updated vaccines to offer increased protection against variants. Some health officials believe revised vaccines will be needed by the fall, when the virus could resurge in force. Researchers developing modified vaccines would need to settle on a formula as early as June to have a vaccine ready for use this fall, according to the panel, though several trials are just now getting underway—including a National Institutes of Health study analyzing a Moderna vaccine revised to target three different variants, for which results are expected this summer. Once regulators decide on a reconfigured vaccine, manufacturers would need several months to produce doses, according to one expert, and several others underscored the uncertainty and difficulty of the highly compressed timeline.Moderna and IAVI will collaborate to develop vaccines and antibodies for HIV/AIDS, tuberculosis, antimicrobial-resistant enteric infections, and COVID-19 using mRNA technology, the organizations announced Thursday. The partnership aims to accelerate the research and development process, as Moderna’s mRNA platform can help develop material for clinical testing more quickly than traditional recombinant protein synthesis or cell systems can. If candidates are successful, they can also be manufactured quickly and at large scale, according to Moderna. The first candidate the partnership will work on is HIV vaccine antigens delivered by mRNA, for which a phase 1 trial was initiated in January. Preclinical efforts in the collaboration include candidates for tuberculosis, COVID-19, and HIV.The world needs to invest $15 billion this year, and $10 billion annually in future years, to establish and maintain an adequate toolkit to respond to COVID-19 and future pandemic threats, according to a working paper released by the International Monetary Fund last week. The paper, published in partnership with the Coalition for Epidemic Preparedness Innovations, the Global Fund, and Wellcome Trust, outlines the funding estimate while asserting that ending the pandemic everywhere remains an urgent economic, health, and moral priority for the world. Countries need vaccines, tests, treatments, and an improved health infrastructure to tackle COVID-19 and other deadly diseases, as well as investments in global surveillance, research and development, manufacturing, and health systems, global leaders said.