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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. Following the remarkable success of the first COVID-19 vaccines, developed at unprecedented speeds, investment in next-generation shots has so far fallen short, according to some experts. Nasal vaccines, in particular, experts say could prove more effective at preventing COVID-19 infections than intramuscular shots, as they concentrate immune protection in the upper airway and induce mucosal immune responses where the virus typically enters the body. Several nasal vaccine candidates are in development in the United States—though primarily remain in preclinical or early-stage clinical trials—as well as globally, including phase 3 trials in India and China. The National Institute of Allergy and Infectious Diseases, for example, is funding early research on a protein-based nasal spray as well as an mRNA vaccine delivered into the nose using nanoparticles, though any successful nasal vaccine is likely years away from becoming available.As monkeypox cases continue to rise globally, experts and leaders are looking at health technologies with potential to combat the virus—including repurposed smallpox vaccines that have begun to be deployed, predominantly in high-income countries. In addition to vaccines, scientists are evaluating existing drugs that could serve as treatments against monkeypox, for which there are no specific treatments licensed. A recent study in JAMA analyzed several preexisting drugs, including antivirals brincidofovir and tecovirimat, both of which have been tested among monkeypox patients in the past with varying success. The ongoing uncertainty surrounding treatments for the new outbreak highlights the lack of evidence-based therapeutics for monkeypox, according to the journal article, as well as the inequities in the global response as countermeasures have been stockpiled by high-income countries but remain limited in monkeypox-endemic countries.In a new study, researchers describe how a Lassa virus protein drives infection by harnessing a cellular protein in human hosts, as well as identify how future therapies could target this interaction to treat patients. The research suggests that disrupting the link between Lassa polymerase—a protein encoded by the virus—and a specific host protein it interacts with—GSPT1—could stop Lassa virus infection. In pursuit of this, the research team identified an existing drug candidate, CC-90009, that has been shown to destroy GSPT1 proteins and is currently being examined in clinical trials as a cancer therapy. In early experiments, CC-90009 significantly reduced Lassa virus growth without obvious cell toxicity, and researchers plan to continue evaluation in animal models. There is currently no antiviral drug that specifically targets Lassa virus.

GHTC welcomes the recent addition of a specific indicator to measure research and development (R&D) capacity in the third edition of the Joint External Evaluation (JEE) tool—the instrument countries use to evaluate their health preparedness capabilities and compliance with the International Health Regulations (IHR), which govern countries’ obligations in handling public health threats. This is a significant addition, as it marks the first time R&D capacity has been explicitly factored into the JEE as a key measure of a country’s health preparedness.  As we saw with the COVID-19 pandemic, the lack of regionally distributed R&D and manufacturing capacities contributed to gross inequities in the global response, as regions with the strongest ability to develop medical countermeasures prioritized access for their populations while others were left scrambling to try to build their capabilities in real time. GHTC has for many years been calling for measures of R&D readiness to be formally integrated into the IHR and JEE, and we are pleased to see our advocacy efforts have contributed to this important update. We believe that the revised tool, and its inclusion of R&D, will ultimately improve the quality of assessment of countries’ capacities for timely detection, prevention, and effective response to public health emergencies.While the incorporation of an R&D-specific indicator is an important first step toward strengthening R&D capacity globally, GHTC is disappointed that the update has not gone further in comprehensively measuring the multitude of capabilities that are part of R&D readiness. The R&D indicator metrics have an insufficient focus on product development, and don’t measure important elements such as clinical trial, pharmacovigilance, and manufacturing capacity for various types of medical countermeasures, and we would have liked to see those incorporated into the new R&D indicator or elevated somewhere within the updated tool. While there are other separate indicators for surveillance and laboratory systems, they don’t interlink enough to provide countries with a comprehensive understanding of their national R&D capacity.As countries move to utilize this updated tool, GHTC will continue to work with partners and leverage platforms like the Global Health Security Agenda to push for an even more comprehensive R&D capacity assessment and strive to build a more equity-driven framework for prevention and response to future pandemic threats.

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 Wednesday, the US Food and Drug Administration (FDA) authorized Novavax’s COVID-19 vaccine for individuals 18 and over, making it the fourth COVID-19 shot recommended by the agency for use in the United States. The Novavax vaccine is also the first authorized protein-based COVID-19 shot, which works by delivering a protein present on the virus’s service, along with a chemical adjuvant that spurs the immune system to recognize it. The new authorization is for a series of two shots, separated by three weeks; it does not cover use of the Novavax vaccine as a booster shot, which the agency will need to evaluate separately. The vaccine must still be recommended by the Centers for Disease Control and Prevention (CDC) before becoming widely available; the United States has acquired 3.2 million doses of the vaccine to be shipped to states once authorized by the CDC director.The National Institutes of Health has launched a clinical trial of an mRNA vaccine candidate to prevent Nipah virus infection, a zoonotic disease with no currently authorized vaccine or treatment. The phase 1 clinical trial will test an mRNA-based vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate its safety, tolerability, and ability to generate an immune response in 40 healthy adults. NIAID’s Pandemic Preparedness Plan, published earlier this year, established a framework to study viruses of pandemic potential, like Nipah, and prioritize research on prototype pathogens. The newly launched study is the first clinical trial to use the prototype pathogen approach since the plan’s publication.In a new report, the World Health Organization outlines the pipeline of bacterial vaccine candidates and emphasizes the urgent need to step up investment and research into vaccines that can help combat antimicrobial resistance (AMR). The analysis is the first to provide detailed analysis of the pipeline of vaccines with potential to address drug resistance from priority pathogens, identifying 61 vaccine candidates in various stages of clinical development and 94 candidates in preclinical development. While highlighting existing vaccines and the promising candidates in late-stage development, the report also notes a critical need to accelerate trials of vaccines to address AMR and makes a case for bolstered investment that can lead to increased global health equity.