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. 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.

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. A new study that tested Gilead’s antiviral drug, obeldesivir, in primates given a lethal dose of the Ebola Sudan virus found that the drug may be effective in curing infections from the Sudan strain, for which there are currently no approved vaccines or treatments. The study tested a regimen of once-daily pills for ten days. If proven effective in humans and approved, it would be the first oral treatment for any subspecies of Ebola. Moreover, the drug can be stored at room temperature and is relatively inexpensive to manufacture, especially compared to the monoclonal antibodies approved for Ebola Zaire. Previous work in cell culture also showed that obeldesivir seems to work against all known species of Ebola and the related Marburg virus. Further research could confirm the drug's use as a pan-ebolavirus therapy; however, running clinical trials will prove challenging as there are long stretches between outbreaks of Ebola Sudan, in particular.A new initiative led by Imperial College London and co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI) aims to develop next-generation coronavirus vaccines that not only reduce disease severity but also stop viral transmission, reducing the spread of disease. The project will deliberately infect healthy human volunteers with betacoronaviruses, including the virus that causes COVID-19, to test the efficacy of vaccines that are administered via nasal spray. Experts believe this method could be more effective in triggering the highly specialized mucosal immunity that can stop transmission by directly acting at the cells lining the nose, throat, and lungs—where the viruses enter the body. The human challenge trial design of the project is also unique. Imperial College London last year announced that the world’s first COVID-19 human challenge trial was safe, paving the way for broader use of this approach.A research team has discovered an enzyme in the species of sandfly that is primarily responsible for the spread of leishmaniasis in South America that they hope will lead to the development and commercialization of targeted traps to control the insect population and reduce the spread of the disease. Leishmaniasis can be disfiguring, and the severe form, visceral leishmnasis, which mostly occurs in Brazil, can be lethal if left untreated. The researchers analyzed the genome of the Lutzomyia longipalpis, a species of sandfly native to Brazil and South America, and identified the enzyme, Terpene Synthase, which is responsible for making the pheromone used to attract mates, a discovery that could be leveraged for future control technologies.

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 at the Conference on Retroviruses and Opportunistic Infections, researchers presented exciting results from two different HIV vaccine studies that they hope will lead to an effective vaccine that can provide long-term immunity against the virus and greatly reduce the almost million new HIV infections yearly. One study found that a modification to the simian version of HIV drove monkeys to produce broadly neutralizing antibodies against HIV, and the other showed promising results in encouraging the immune system’s B cells to produce broadly neutralizing antibodies. Over the past four decades of HIV vaccine research, there have many failed and halted trials, thus, all current research into HIV vaccines in now in preclinical development, animal studies, or very early human trials. Nonetheless, HIV vaccine science has consistently driven innovation and science that benefits other infectious disease efforts and global health in general, such as mRNA vaccine technology. With maintained funding and global collaboration, researchers hope to see human trials for an HIV vaccine candidate resume as soon as the 2030s.The Coalition for Epidemic Preparedness Innovations (CEPI) is providing up to $1 million in funding to Amplitude Therapeutics to test a new vaccine approach that could address some of the challenges associated with current mRNA vaccine designs and cut down vaccine development times in future pandemics to as little 100 days. The trans-amplifying mRNA vaccine approach could serve as an advantageous alternative to the currently used self-amplifying method and works by separating the RNA fragment that contains the genetic instructions for the body’s cells to make the antigen that induces the body's immune response and the fragment that teaches the body how to replicate more mRNA. The trans-amplifying approach simplifies production and saves time and resources by extending antigen supply and allowing for key components of the vaccine to be developed ahead of time, underlining its ability to speed vaccine development in future pandemics.The results from a large clinical study presented last week at the Conference on Retroviruses and Opportunistic Infections demonstrated that the monthly dapivirine vaginal ring and daily oral pre-exposure prophylaxis with tenofovir disoproxil fumarate and emtricitabine were safe HIV prevention methods among pregnant people, who are an estimated three times more likely to acquire HIV through sexual intercourse than similarly aged non-pregnant people. The study, which was carried out in Malawi, South Africa, Uganda, and Zimbabwe by the Microbicide Trials Network, found that both methods were safe among cisgender women who started using one of them in their second trimester of pregnancy. These results fill data gaps for these two technologies, offering additional prevention options for this population.

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, the Coalition for Epidemic Preparedness Innovations (CEPI) announced that it will give up to $14.9 million in funding for a new four-year project led by FIND to identify the most reliable tests to detect Lassa and Nipah virus infections, two zoonotic diseases that have, respectively, led to outbreaks in West Africa and South and Southeast Asia. The hope is the initiative will lead to the licensing and widespread availability of tests to help identify and contain future outbreaks early on, reducing cases and deaths of these serious diseases. This project will contribute to CEPI’s broader 100 Days Mission of rapidly developing tools against pandemic threats, as both diseases are among CEPI's priority pathogens.Researchers have developed a new synthetic antimicrobial compound, cresomycin, which can target many strains of antibiotic-resistant bacteria, including multidrug-resistant strains of Staphylococcus aureus and Escherichia coli. Many antibiotics work by binding to components of the bacteria that make proteins and disrupting them, but some bacteria have adapted resistance mechanisms to prevent this effect; cresomycin has improved binding ability. The researchers hope future studies will show that cresomycin and other compounds like it are safe for use in humans and effective against a variety of deadly resistant bacteria, paving the way for new solutions to stem the rising threat of antimicrobial resistance.A new study shows that Merck’s Ervebo Ebola vaccine was able to substantially lower the risk of people dying if they still developed the disease compared to those who were unvaccinated, even if they received the vaccine after they had already been infected. It is the first study to show that in addition to preventing infections, the vaccine can also save the lives of people who are already sick. The study, which looked at data from the 2018-2020 Ebola Zaire outbreak in the Democratic Republic of the Congo, found the fatality rate was halved among those vaccinated two or fewer days prior to illness compared to those who were unvaccinated. In addition to confirming the effectiveness of post-exposure use of Ervebo, the study also combated concerns that there might be interference between Ebola antibody treatments and the vaccine by showing that people who developed Ebola after being vaccinated were treated as effectively with antibody products as those who had not been vaccinated.