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. A new study found that LC16m8, an attenuated vaccinia virus strain originally developed in Japan for smallpox and later approved for mpox in 2022, induced strong responses and was safe in mice, monkeys, and healthy adult humans, potentially paving the way for the development of broadly effective mpox vaccines. The researchers vaccinated mice with LC16m8 to see how it protected them from mpox, later vaccinating monkeys and healthy adult volunteers as well to study their blood samples for immune responses and monitor them for safety. The results underscore LC16m8’s potential as a safe, effective, and scalable choice for mpox vaccination and also provide a blueprint for developing next-generation vaccines against other poxviruses and emerging pathogens.Researchers from Abertay University and Bangor University have developed a prototype blood test that can detect up to five infections at the point of care, providing results quickly via a smartphone app. The tool, which was piloted using tuberculosis as a test case, showed high sensitivity and an ability to accurately identify cases. The speed and convenience, as well as the much lower cost compared to lab testing, demonstrate the test’s potential to be a game changer in ensuring access to timely testing and diagnosis, particularly in remote locations and other settings lacking laboratory infrastructure.  The results of a Phase 3 clinical trial published last week found that Moderna’s combination COVID and flu shot outperformed existing individual vaccines for both viruses. The combination shot uses the same mRNA technology as Moderna’s approved vaccine for COVID-19, but there are no currently approved mRNA flu vaccines. In a trial that included more than 8,000 adults, the combination vaccines generated higher antibody levels for COVID and all but one influenza strain in trial participants who got the combination vaccine compared to those who got individual vaccines. A combination vaccine could help boost vaccination levels for both viruses, and an mRNA vaccine, in particular, could also speed up production because they are faster to make than current flu shots.

For the first time, global leaders have come together to lay out a comprehensive plan for pandemic prevention, preparedness, and response. After over three years and 13 formal rounds of negotiations, member states of the World Health Organization (WHO) defied expectations and reached consensus on a Pandemic Agreement. The final draft of this legally binding instrument will lay the groundwork for stronger global cooperation and be a major catalyst for a more robust research ecosystem that ensures that the fruits of innovation are more equitably shared.  A win for multilateralism! This agreement is a major win for multilateralism. At times, there were reasons to think the negotiations might fail, including seemingly intractable disagreements between high-income and low- and middle-income countries on access and intellectual property issues. Then came the announcement in January that the United States intended to withdraw from WHO and would take no further part in the treaty talks. International cooperation has been tested, and it was important for the global health community to clear this hurdle.  While the text agreed upon in Geneva reflects compromise and not all negotiators’ ambitions were met, it represents important progress and lays the groundwork for action toward global readiness and equity in future health emergencies.  What’s in it for R&D? Efforts to accelerate the research and development (R&D) of vaccines, drugs, and other medical countermeasures were at the heart of the negotiations, and member states agreed to the following priorities: Promote technology transfer—which involves the transfer of scientific knowledge and know-how from one party to another to facilitate the broader production and availability of products—under “mutually agreed” terms. While this qualifier was disappointing to some low-income countries who had hoped for stronger commitments to help scale up local manufacturing of lifesaving medical countermeasures, it was ultimately a red line for wealthier countries, which prioritized preserving existing intellectual property frameworks.  In a historic first, the text obligates countries to attach conditions for access to publicly funded R&D contracts, a landmark step toward promoting equity. If implemented effectively, this means countries would be empowered to use contract enforcement measures to ensure public R&D spending ultimately results in products that reach patients. An agreement to promote post-clinical trial access to products for trial populations and for populations at risk in their communities, as well as commitments to support the transparent publication of clinical trials protocols and research results.  A framework for a new Pathogen Access and Benefits Sharing (PABS) system that grants companies access to scientific data, such as pathogen samples and genomic sequences, in return for more equitable sharing of drugs, vaccines, and diagnostics during a pandemic. Countries agreed that 20 percent of the vaccines, drugs, and diagnostics produced by participating manufacturers will be made available to the WHO for distribution. PABS wasn’t finalized during the negotiations and will now have to be fully developed through a new working group and added as a separate annex to the agreement. Establishment of a Global Supply Chain and Logistics Network to coordinate resource allocation, reduce access barriers, and mitigate the practice of hoarding of pandemic products through shared stockpiles. Beyond R&D, other key elements of the proposed agreement include a commitment to a “One Health” approach to pandemic prevention, efforts to strengthen national health systems, and the creation of a coordinating financial mechanism to support implementation of new obligations and capacity-strengthening measures.For a more detailed breakdown of the agreement, check out this briefer!Next steps: World Health Assembly and beyond After three years of intense negotiations and significant progress made toward aligning key provisions, critical procedural steps remain before the agreement can be formally adopted and implemented.   First, the text must be adopted by member states at the World Health Assembly later this month. There will then be an intergovernmental working group that will convene to hash out the details of the PABS system, likely over the course of the next year. Once the PABS annex has been finalized, at least 60 countries must ratify the treaty—in accordance with their own national laws and processes—in order for the Pandemic Agreement to become international law and enter into force. Finally, in order to support implementation and ensure enforcement and accountability, a “conference of parties” will be established to regularly review the agreement’s implementation.  The agreement has now reached an important milestone, but the work is not done. Leaders must carry it across the finish line later this month before committing to the task of ensuring its success through robust implementation. 

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 US Department of Health and Human Services announced a $500 million investment into a vaccine project under a new initiative called Generation Gold Standard, which aims to advance universal influenza vaccines, hoping to get a vaccine into clinical trials next year and approved by 2029. The initiative, funding for which will come from the Biomedical Advanced Research and Development Authority, seems to be replacing Project NextGen, which had previously funded research into potential COVID-19 vaccines and treatments. Some experts and officials have expressed surprise at the direction of the initiative and the size of the investment.Scientists have discovered that a device used to diagnose bacterial meningitis in blood can also measure it in cerebrospinal fluid, helping speed accurate diagnosis and treatment of the illness, which is the most dangerous form of meningitis and a significant global health threat. The device has demonstrated high sensitivity in multiple cohorts of patients and it’s also affordable and delivers results within a half hour after spinal tap. The test was developed at an impressive speed, now available to patients within just a year of its discovery.Newly shared results from a clinical trial from the National Cancer Institute seem to confirm that a single dose of the vaccine used to prevent human papillomavirus (HPV) virus infection is just as effective as two, a finding that could transform efforts to reach the millions of children globally who are not getting vaccinated according to recommendations. Expanding HPV vaccination will also help reduce the global burden of cervical cancer deaths and deaths from other HPV cancers. While two doses are currently recommended, reducing the required dosage could make dissemination much easier and cheaper for many countries.

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 published in The Lancet Infectious Diseases ahead of World Malaria Day last week found that adding a low dose of the widely available antimalarial drug primaquine to artemisinin-based combination therapy is safe and effective at blocking Plasmodium falciparum malaria transmission in young children in areas of low- and moderate-to-high transmission. The new study fills a gap in knowledge of the safety and efficacy of this approach for young children, who face the highest burden of clinical malaria and are particularly at risk of artemisinin-resistant strains but could face adverse complications from adult formulations of primaquine. The findings highlight the need for child-friendly formulations of primaquine and support the expanded use of the drug in regions with a moderate-to-high transmission rate and the threat of artemisinin partial resistance.The Drugs for Neglected Diseases initiative, the National Health Service University Hospitals of Liverpool Group, and the University of Liverpool have initiated a clinical trial in Liverpool, United Kingdom to test an oral drug for visceral leishmaniasis, one of the world’s deadliest parasitic diseases. Current treatments for visceral leishmaniasis, which is almost always fatal if left untreated, include daily injections for up to 17 days, which can cause immediate pain, as well as nausea, vomiting, and more serious complications. The new oral drug, DNDI-6899, is easier to store, transport, and administer than current treatments. If proven successful, the drug could help make treatment more accessible to those who need it most.DioSynVax and ACM BioLabs have signed a new deal to jointly develop a next-generation avian flu vaccine with the potential for mucosal vaccine delivery, as the virus continues its worrying spread. The mRNA vaccine targets all major clades of the H5 avian flu subtype and could be scaled for rapid distribution globally in the case of a pandemic. The vaccine is also designed to be delivered via nasal spray, which could help increase uptake; to induce mucosal immunity, which helps fight the pathogen before it starts circulating the body; and to be temperature stable, enabling rollout in lower-resource settings.