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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. As reports of H5N1 bird flu circulating in dairy cow herds across the United States continue, the experts in charge of preparing and responding to pandemics are now considering our ability to quickly develop a vaccine if human transmission were to occur in the future. The world has decades of experience producing, regulating, and updating flu vaccines, as well as the recent memory of the incredibly rapid development of vaccines during the COVID-19 pandemic. However, current global production capacity for flu vaccines would not yield enough doses quickly enough to vaccinate the large portion of the world’s population that would be necessary to quell a bird flu pandemic. Adjuvants—compounds that boosts immune response to the active vaccine antigen —or the introduction of an mRNA vaccine could, respectively, stretch supplies and speed up production, but it is not clear that there is sufficient production capacity for relevant adjuvants, and it is unclear how close producers are to advancing mRNA flu vaccines to market. Additionally, current flu production capacity is highly concentrated in high-income countries with no flu production in Africa, underlining the potential of another highly inequitable pandemic response.Last week Medicines for Malaria Venture (MMV) and Novartis announced positive data from their Phase 2/3 trial in Africa demonstrating the efficacy and safety of a novel formulation of the Coartem® malaria medicine developed for babies weighing less than 5 kilograms. Previously, this population lacked access to an evidence-based treatment option developed specifically for them, with this trial becoming the first evidence-based trial conducted to evaluate a new antimalarial dose and regimen for all infants under 5 kilograms with acute uncomplicated malaria. This population is currently treated with tablets meant for higher-weight children that are simply adjusted for weight, which can lead to overdose and toxicity in smaller kids. The data have been submitted for regulatory review, and if approved, the partners aim to make the treatment available as soon as possible.The Drugs for Neglected Diseases initiative (DNDi) and partners have initiated a Phase 2 clinical trial in Ethiopia testing an innovative, safer, simpler, and patient-friendly medicine to treat visceral leishmaniasis, the world’s deadliest parasitic killer after malaria. Visceral leishmaniasis is currently treated with painful injections that must be given at the hospital daily for 17 days and can cause rare but life-threatening side effects. The hope is that the new drug, which is administered via oral pills, will be efficacious, less toxic, and more accessible than the currently available treatment regimen, ensuring earlier access to treatment. A similar Phase 2 trial is also being conducted in South Asia to test if patients in the two endemic regions respond differently to the treatment.

The last few years have highlighted more than ever the incredible power of vaccines—from the millions of lives saved by the unprecedented rapid development of COVID-19 vaccines to the approvals and early-stage rollout of the first-ever vaccines for malaria and chikungunya.  We are now fortunate to have vaccines to prevent more than 20 life-threatening diseases, and immunization currently prevents 3.5 to 5 million deaths every year. While it is vital that countries continue to strengthen routine immunization programs to reach the 20 million children who missed out on one or more of their vaccines in 2022, it is also important that countries sustain strong investments in research and development to deliver the next generation of breakthrough vaccines.In recognition of World Immunization Week 2024, GHTC is highlighting five vaccines in development that could be game changers for some of world’s most threatening diseases, reminding us not only of the tremendous impact vaccines have already had but also of the great promise of innovative vaccines to save even more lives in the future.1. TBIn 2022, 1.3 million people worldwide died from tuberculosis (TB), which is the second leading infectious disease killer after COVID-19. Currently, the only approved vaccine for TB is the bacille Calmette-Guérin, or BCG, vaccine, which was developed more than 100 years ago. Though effective at preventing some types of TB in infants, it offers inconsistent protection in adults and adolescents against pulmonary TB, which is why new vaccine options are urgently needed.Last month, the Bill & Melinda Gates Medical Research Institute announced the launch of a pivotal Phase 3 trial evaluating a novel vaccine for TB, which researchers hope could become the second licensed vaccine for TB. The adjuvanted subunit vaccine M72/AS01E vaccine was originally developed by GSK, along with Aeras and IAVI. The trial, which is supported by the Bill & Melinda Gates Foundation and the Wellcome Trust, is testing the vaccine’s ability to prevent latent TB from progressing to active pulmonary TB in adults and adolescents. While it is expected that the trial could take at least five years, if successful, it could lead to an urgently needed new tool with the potential to transform TB control globally.2. ZikaZika is a mosquito-borne virus that can cause congenital malformations in infants born to individuals infected during pregnancy, as well as preterm birth and miscarriage. There are currently no vaccines available to prevent or treat Zika, nor are there specific treatments.There have been numerous outbreaks of Zika around the world, with a widespread outbreak in the Americas just under a decade ago sparking the World Health Organization (WHO) to declare a Public Health Emergency of International Concern in 2016.Last month, Valneva announced the launch of a Phase 1 clinical trial to investigate the safety and immunogenicity of a vaccine against the Zika virus. The second-generation adjuvanted inactivated vaccine candidate, VLA1601, will be tested in 150 adult participants in the United States, with the first topline data from the trial expected as soon as early next year. Additionally, Moderna is advancing an mRNA-based Zika vaccine, mRNA-1893, which is currently in a Phase 2 trial in the United States and Puerto Rico; the trial is expected to end in July 2024.3. Lassa feverLassa fever is an acute viral hemorrhagic illness that is endemic primarily in parts of the West African region. Annually, there are around 5,000 deaths from Lassa fever and an estimated 100,000 to 300,000 cases. There are currently no approved vaccines that protect against Lassa fever.This month, the first participants were vaccinated in a Phase 2 clinical trial of a vaccine candidate for Lassa fever virus, which is being led by an international collaboration between IAVI, the Coalition for Epidemic Preparedness Innovations (CEPI), and in-country partners in Nigeria. The hope is that this trial, which is the most advanced Lassa vaccine trial to date, will lead to the availability of a vaccine candidate for evaluation and use in future Lassa outbreaks and, eventually, an approved vaccine for routine immunization.  4. Nipah virusNipah virus is a zoonotic virus that can cause a wide range of illnesses, from asymptomatic infection to severe respiratory illness and, sometimes, fatal brain inflammation. Nipah has an estimated case fatality rate of 40 to 75 percent, with South Asia facing the greatest burden of outbreaks. There are currently no specific drugs or vaccines for Nipah virus infection.The first human trial of a new vaccine against the deadly Nipah virus began in January of this year after the work, which started in 2017, was paused during the COVID-19 pandemic. The new vaccine, ChAdOx1 NipahB, which was developed using the same viral vector vaccine technology as the University of Oxford and AstraZeneca’s COVID-19 vaccine, will be evaluated over the next 18 months in a Phase 1 trial led by the Oxford Vaccine Group and funded by CEPI.5. ETECEnterotoxigenic Escherichia coli (ETEC) is one of the leading causes of moderate and severe diarrhea in children worldwide. It is estimated that ETEC causes about 220 million diarrhea episodes globally each year, resulting in an estimated 42,000 child deaths. There are currently no approved vaccines for ETEC, and bacterial resistance to the antibiotics often used to treat it is growing globally, underscoring the need for a preventative vaccine.ETVAC is an oral vaccine candidate for ETEC developed by Scandinavian BioPharma, which is being advanced in two different formulations, one for travel use, adults, and older children and a second “self-contained” solution requiring no mixing, which is designed for ease of administration in children under five in low- and middle-income countries. The vaccine has shown promising results in both populations in Phase 1 and 2 trials, which received partial funding from PATH through the Bill & Melinda Gates Foundation, and a Phase 2b trial was implemented among nearly 5,000 children in The Gambia, with efficacy results expected later this year, alongside the potential launch of a planned Phase 3 study in Zambia. If successfully advanced and approved, an ETEC vaccine could be a powerful new tool in our arsenal to reduce suffering and death from diarrheal disease and slow the emergence of antimicrobial resistance.  Breakthrough technologies like these vaccine candidates are possible because of long-term, consistent investment throughout the R&D process, from early-stage product development to implementation and rollout. With these promising technologies and more on the horizon, it is critical that we sustain investment in R&D to push these exciting new tools over the finish line and ensure everyone everywhere can access them. Learn more about global efforts for World Immunization Week to recognize the lifesaving power of vaccines here. 

Malaria is one of the world’s oldest and deadliest diseases. Thanks to international efforts to develop and scale up prevention tools and treatments, significant gains have been made over the past few decades in fighting this dangerous disease. But challenges, such as growing drug and insecticide resistance, climate change, and disruptions from COVID-19, have hampered control efforts. While both malaria cases and deaths steadily declined from 2000 to 2019, since then, cases have been on the rise and reported deaths have not returned to pre-pandemic levels—indicating progress against the disease has stalled and underscoring the need for continued research and development of new tools.In recognition of World Malaria Day, test your knowledge of this deadly disease and the innovations being advanced to end malaria:

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. The Combating Antibiotic Bacteria Biopharmaceutical Accelerator (CARB-X) last week announced that it will award up to $1 million to the company Scout to develop a rapid, inexpensive, and easy-to-use point-of-care diagnostic test for gonorrhea, which could expand access to testing and proper treatment in the face of a rise in gonorrhea cases and drug-resistant gonorrhea cases globally, especially in low- and middle-income countries. The test, STI-Scout, is designed to detect and differentiate between Neisseria gonorrhoeae and Chlamydia trachomitis and can provide results in only 30 minutes using urine samples or vaginal swabs at less than half the cost of other available tests. The test uses a proven isothermal technology that was validated for SARS-CoV-2 detection. Last week, EuBiologics and the International Vaccine Institute (IVI) announced that the World Health Organization (WHO) had prequalified Euvichol-S, an improved oral cholera vaccine produced with a simplified method that will hopefully help to address the rise of cholera outbreaks globally and a dire vaccine supply shortage. The vaccine, whose development was supported by the Bill & Melinda Gates Foundation, is produced in a way that can improve formulation and manufacturing productivity by 40 percent compared to the company’s prior oral cholera vaccine and demonstrated efficacy in a Phase 3 trial in Nepal last year. The prequalification paves the way for United Nations agencies and Gavi, the Vaccine Alliance, to buy the vaccine for countries experiencing outbreaks.The New Nets Project, funded by Unitaid and The Global Fund to Fight AIDS, Tuberculosis and Malaria, recently reported results from several pilot studies showing that a pair of second-generation bed nets tested in malaria-endemic areas helped to prevent up to 13 million additional cases of malaria, saving close to 25,000 lives—exciting news that comes as malaria cases, as well as resistance to the standard insecticide used to treat nets, rise globally. The studies found that the new nets, the Interceptor G2 and Royal Guard—which both use dual insecticides to address resistance—were between 20 and 50 percent more effective than traditional nets, which only use pyrethroid insecticide, in reducing mosquito exposure and reduced the risk of infection by up to 55 percent. Although the new nets are more expensive, the additional cost seems to be offset by the public health savings of malaria prevention. Researchers expect malaria parasites to eventually become resistant to the new nets, highlighting the need for continued research into other methods of vector control, as well as ensuring population-scale protection through vaccination.