Breakthroughs Blog: Pandemic preparedness

The World Health Organization's (WHO's) TB Vaccine Accelerator Council recently published a new report calling for action to ensure equitable access to future tuberculosis (TB) vaccines currently in the pipeline. While the only licensed vaccine for TB is 100 years old and has limited effectiveness in adolescents and adults, as of September, there are 16 candidate vaccines in clinical development, six of which are in Phase 3 trials. WHO estimates that a vaccine for adolescents and adults that is at least 50 percent effective could avert up to 76 million TB cases and 8.5 million deaths over 25 years. However, as the report claims, global demand could far exceed supply in the initial years after a vaccine is approved because there is no designated funding for such a rollout in low- and middle-income countries most affected by TB, which are already facing significant funding shortfalls. In anticipation of these potential bottlenecks and barriers to access, the report identifies six solutions to encourage countries with a high burden of TB, manufacturers, and other funders and stakeholders to start preparing now for the rollout to ensure future vaccines can reach people who need them faster. In a Phase 1 randomized controlled trial, an experimental intranasal vaccine against multiple H5N1 avian flu strains generated a broad immune response, demonstrating the potential of such a vaccine to play a major role in preparing for outbreaks of emerging viruses with evolving strains, as H5N1 continues its worrying spread. The University of Maryland research team tested the vaccine against a placebo in 40 adults between 18 and 45, finding that the vaccine was safe, well-tolerated, and stimulated immunity at various doses. One group received a vaccine dose combined with an adjuvant, an ingredient used to trigger a stronger immune response, and their immune systems were better able to neutralize infected cells for longer, suggesting that the use of an adjuvant could be a promising approach that might allow for lower doses, which could stretch limited vaccine supplies in the event of an outbreak. Last week, IAVI published new findings from the first-in-human Phase 1 clinical trial of its Lassa virus vaccine candidate, which show that one dose of the vaccine triggers robust and long-lasting immunity and is safe. There are no vaccines or treatments currently licensed against the dangerous illness, which causes thousands of deaths in endemic West Africa and has been designated as a priority pathogen with pandemic potential. The trial enrolled 114 volunteers in Liberia and the United States. The candidate, now undergoing a Phase 2a trial in West Africa, is currently the most advanced Lassa fever vaccine candidate in the pipeline and uses the same platform as Merck’s single-dose Ebolavirus vaccine, which is approved in more than a dozen countries. 

A systematic review and meta-analysis of studies looking at the effectiveness of typhoid conjugate vaccines found that they are highly effective in preventing typhoid fever in countries where the infection is endemic, adding to the collection of real-world evidence supporting their use. Despite the high burden of typhoid fever—an infection caused by Salmonella enterica serovar Typhi—in Africa and Asia, only ten countries to date have added the vaccines to their national immunization programs. There are three vaccines for preventing typhoid fever that are currently recommended and licensed by the World Health Organization. Last week, California-based True Diagnostics announced that it had received an award of upward of $11 million from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of a blood-based rapid antigen test for Ebola and Marburg viruses. The test, if it proves effective, could help boost testing capacity and national preparedness for outbreaks of pathogens with pandemic potential like Ebola and Marburg viruses, which have caused worrying outbreaks in Africa in recent years. Specifically, the funding will support the further development, validation testing, and regulatory submissions of its VeriClear EbV MARV Rapid Antigen Test to detect and differentiate Ebola and Marburg viruses in fingerstick blood samples.   A research team presented new data at the 2025 European Society for Medical Oncology Congress in Berlin, Germany last week, showing that cancer patients who received COVID-19 mRNA vaccines within 100 days of starting immunotherapy drugs survived more often than non-vaccinated patients. These findings suggest that mRNA vaccines could help improve outcomes for cancer patients being treated with immunotherapies and even patients with treatment-resistant cancers. While these results are preliminary and need to be confirmed in an upcoming Phase 3 randomized clinical trial, scientists say they could revolutionize cancer care, perhaps even paving the way for a universal, off-the-shelf vaccine for cancer. 

Last week, Monod Bio announced that it has received a $750,000 grant from the Gates Foundation’s Grand Challenges initiative to develop a point-of-care test for preeclampsia, a pregnancy complication characterized by high blood pressure, which is a leading cause of maternal deaths. Preeclampsia is a particular challenge in low- and middle-income countries where complex and high-cost testing is not always accessible. The test is designed to detect two protein biomarkers associated with preeclampsia and utilizes an artificial intelligence-derived algorithm to analyze the results. The developers aim for the test to be a rapid, one-step tool that delivers results in under 15 minutes, without requiring complex and expensive laboratory infrastructure and highly skilled health care workers. The Coalition for Epidemic Preparedness Innovations is partnering with the Serum Institute of India, the largest vaccine manufacturer in the world, to develop a new vaccine targeting H5N1 avian flu that elicits a broad immune response across multiple H5 viral strains. The vaccine candidate is intended to serve as a prototype vaccine for Disease X, a yet-to-arise pathogen with pandemic potential. This project is part of CEPI’s 100 Days Mission aimed at having a vaccine within 100 days of identifying a new pandemic threat.A research team from the German University of Würzburg has developed a method for diagnosing viral infections that leverages the unique features of the human tongue, which could be incorporated into gum or a lollipop. The researchers were inspired by prior work on dental implants, developing a method that uses chemical sensors to trigger a taste change in individuals infected with the flu, even before they experience symptoms. The researchers are now working to figure out how to make their method more sensitive and low-cost, tailor it to other diseases, test it on people with different levels of taste perception, and pair it with an app that would enable people to self-report infection, which could help generate real-time data across populations in the case of a large-scale influenza outbreak. 

Last week, the World Health Organization (WHO) published its latest reports on the new antibacterial agents and diagnostics in the pipeline, seeking to encourage research and development (R&D) to invigorate the sparse pipeline of tools to address the growing global threat of antibiotic resistance. The report highlights a lack of innovation in the antibacterial pipeline and major gaps in antibacterials targeting the most critical bacterial threats and addressing needs like pediatric formulations and oral treatments for outpatient use. There are similar persistent gaps for diagnostics, including a lack of new tests that are affordable, robust, and easy to use in low-resource settings. A new study, led by Imperial College London and supported by the Coalition for Epidemic Preparedness Innovations (CEPI) found that vaccines designed to protect against a wide range of coronaviruses, including a novel sarbecovirus, the type of coronavirus that includes the viruses that caused SARS and COVID-19, could be a gamechanger in a future global coronavirus pandemic, dramatically reducing deaths and disruption. A broad vaccine like this could be manufactured and stockpiled before an outbreak arises and quickly rolled out when a new outbreak is identified, providing protection to high-risk populations 60 years and older. This immediate protection could be a powerful stopgap while a new vaccine targeting the specific virus behind the outbreak is developed. An international research team has developed a simple, affordable HPV test that delivers results in less than an hour outside of a specialized laboratory, which could be a breakthrough for improving access to cervical cancer screening for women in low-resource settings. Cervical cancer continues to cause more than 350,000 deaths every year, particularly in low- and middle-income countries with limited regular access to cervical cancer screening. The test uses a swab sample and a battery-operated portable device, projected to cost less than $8 each, and it was found to be highly accurate compared to the reference standard.