Breakthroughs Blog: Pandemic preparedness

Last week, Shionogi announced that its US subsidiary has received a $119 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to boost production and advance development of a key antibiotic, helping improve US preparedness for future outbreaks of drug-resistant bacterial pathogens. Specifically, the funding will go toward the establishment of a US manufacturing site and procurement of cefiderocol, an antibiotic that has the ability to target difficult-to-treat, multidrug-resistant infections, which is already approved for several indications. The award will also fund the development of cefiderocol to respond to high-priority bacterial threats. In a newly published study, a Cornell University research team shared the results of a long-term study that could be a first step toward developing the first safe, reversible, long-acting, and 100 percent effective nonhormonal male contraceptive. In a proof-of-principle study in mice, the researchers targeted a natural checkpoint in meiosis, the reproduction process for sex cells, and were able to safely stop sperm production and, importantly, then recover normal meiosis and complete sperm function, with no impacts on other functions or on offspring. If this approach continues to demonstrate success in further studies, it could eventually be utilized in an every-three-month injection or patch contraceptive product. IAVI recently announced that the first participants have been vaccinated in a Phase 1 clinical trial evaluating the safety and immunogenicity of its investigational vaccine for Marburg virus disease, a highly fatal, high-priority disease, which has been behind a growing number of outbreaks in sub-Saharan Africa in recent years and for which there are no specific approved vaccines. In nonclinical studies, the candidate demonstrated consistently strong efficacy results: a single intramuscular vaccination protected 100 percent against lethal challenge with the virus. IAVI is simultaneously continuing to work with partners in sub-Saharan Africa to ensure the availability of candidate doses for evaluation during future Marburg outbreaks. 

A new real-world study found that a recently approved vaccine designed to reduce deadly meningitis in Africa is safe when used at scale. Neisseria meningitidis, or meningococcus, is a bacterium that is the leading cause of bacterial meningitis, a dangerous infection, in Africa. The African meningitis belt, which encompasses 26 countries in sub-Saharan Africa, has the highest rates of meningococcal disease, facing frequent epidemics. Since 2010, the introduction of a vaccine targeting one of the 12 bacterial strains has dramatically reduced meningitis in the region. The newer vaccine targets the five subtypes that are responsible for almost all epidemic meningitis in the region, and it was shown to be safe in a study analyzing data from more than 4.8 million people vaccinated during outbreak response campaigns in Nigeria and Niger in 2024. A research team has developed a breath-based test for diagnosing bacterial infections that showed promise in early studies in mice, which could eventually offer a non-invasive, portable, and quick alternative to the current toolbox of blood tests, imaging, cultures, and molecular diagnostics that can be slow, non-specific, and expensive. The researchers were inspired by a breath test for Helicobacter pylori, which works by a patient drinking a liquid containing traceable substances metabolized by H. pylori and then exhaling into a device that measures the components of their breath, indicating if an infection is present. Aiming to develop a breath-based test for a broader range of infections, the team developed a prototype using sugar and sugar alcohols tagged with a traceable form of carbon that bacteria metabolize but is not harmful to human cells, analyzing the breath using a simple technique. A team of researchers has designed a vaccine that turns mosquitoes into delivery vehicles to immunize bats against rabies and Nipah virus. Bats host a wide range of dangerous pathogens, which are increasingly spilling over into human and livestock populations. Researchers have previously tried testing experimental vaccines on captive bats, but the vaccines haven’t worked as effectively in the wild. Culling bat populations is another way to reduce disease transmission, but this can cause disruption to the ecosystem and can inadvertently heighten virus transmission by increasing human exposure. The new method involves an experimental vaccine that is delivered via the saliva of mosquitoes, which is transferred when bats eat the mosquitoes or the mosquitoes feed on the bats, directly targeting the natural reservoirs of these viruses to prevent spillover transmission. 

2026 marks 20 years since Congress passed the Pandemic and All-Hazards Preparedness Act (PAHPA)—now titled the Protecting Americans from All Hazards Preparedness Act—landmark legislation to strengthen the nation’s public health emergency preparedness and response capabilities. PAHPA was reauthorized in 2013 and 2019, but its authorization lapsed at the end of 2023, leaving many authorities dependent on temporary extensions advanced through appropriations bills and continuing resolutions (CRs). As a result, key policies and structures guiding the US government’s pandemic playbook predate a generation-defining pandemic, underscoring the urgency of reauthorizing this legislation to integrate lessons learned and ensure the United States is better equipped against current and future threats.Efforts to reauthorize PAHPA have proved challenging in a post-COVID-19 political environment. The Senate advanced in mid-2023 a largely clean PAHPA bill with some additional provisions addressing drug pricing, drug shortages, and related issues. However, differences between House proposals stalled further progress, ultimately leading House Republicans and Democrats to introduce separate proposals. A potential breakthrough emerged in late 2024, when a bipartisan health care package containing PAHPA gained traction as part of an end-of-year continuing resolution. The broader health package ultimately fell apart, leaving PAHPA reauthorization unresolved.PAHPA originally amended the Public Health Service Act to establish two cornerstone institutions: the Administration for Strategic Preparedness and Response (ASPR) to lead the nation’s public health emergency response, and under it—and most notably for global health R&D—the Biomedical Advanced Research and Development Authority (BARDA) to accelerate the development of medical countermeasures (MCMs) against emerging infectious diseases (EIDs), antimicrobial resistance (AMR), and pandemic influenza. Together, these entities transformed how the United States invests in, coordinates, and implements medical preparedness and response capabilities. Reauthorization now offers a critical opportunity to renew and strengthen these authorities for future threats.Reauthorization is not simply procedural—it is essential to restoring and enhancing the authorities that enable BARDA and partners to advance lifesaving MCMs. Done thoughtfully, PAHPA renewal could reinforce accountability, transparency, and coordination while safeguarding the United States’ position as a global biomedical innovation leader. Stable, modernized authorities ensure scientists and innovators have the support needed to develop and scale up next-generation technologies that protect Americans and strengthen health security worldwide.GHTC’s vision for PAHPAPrompted by a request for information shared by Representatives Neal Dunn (R-FL) and Lori Trahan (D-MA), GHTC has identified clear opportunities through reauthorization to maintain the strong momentum PAHPA has driven and build an even more proactive, innovative preparedness architecture that keeps us one step ahead of emerging pathogens. From reactive to readyBARDA and external partners estimate that $775 million is needed to successfully advance an EID MCM portfolio at the agency. While a dedicated Influenza and Emerging Infectious Disease (IEID) Division exists, predictable, dedicated funding for this work does not. Historically, investments for EID MCM development have come primarily through emergency supplemental funding bills passed in the wake of public health crises like Ebola, Zika, and COVID-19, reinforcing a reactive rather than proactive posture. To address this gap in preparedness, PAHPA should establish dedicated funding for BARDA's IEID Division to ensure sustainability and readiness.To reinforce BARDA’s critical efforts against AMR, Congress should advance complementary legislation—including the newly reintroduced Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act and the Saving Us from Pandemic Era Resistance by Building a Unified Global Strategy Act (introduced in the 118th Congress)—to strengthen the pipeline of new tools for antimicrobial-resistant pathogens and support pull incentives that accelerate AMR R&D.MRNA is a critical platform technology for advancing next-generation vaccines and therapeutics. Sustained investment in mRNA research will be critical to maintaining US scientific leadership. Congress should explicitly authorize BARDA to invest in mRNA technology and prioritize its investment via report language directives to ensure the United States sustains the necessary capabilities for a rapid response. Protect the gainsWith the current BARDA Strategic Plan set to end in 2026, a new plan is needed to articulate its goals for the next five years, incorporating lessons learned from the last five. To strengthen the effectiveness and credibility of this plan and ensure it is informed by the best available science and aligned with real-world preparedness needs, BARDA should look to scientific experts, product developers, and other external stakeholders to inform the 2027-2031 strategy via an open, consultative process. Congress should direct BARDA to complete this plan.PAHPA should also mandate BARDA to regularly and publicly report on its MCM research and product-level investments to ensure consistent reporting, regardless of future leadership changes at the department. BARDA's improved efforts on reporting have already been instrumental in a host of ways, so codifying this practice is essential to strengthening transparency and accountability.In an effort to further support national preparedness, BARDA should be directed to run a feasibility study on the creation of a loan authority program to better enable the agency to finance large-scale, capital-intensive projects such as innovative biomanufacturing facilities like those for microneedle patch vaccines. Too often, constrained health workforce and laboratory capacity can hinder the deployment of MCMs in low-resource settings, both in the United States and globally. To ensure this issue does not persist, PAHPA should direct ASPR to study barriers to MCM deployment in low-resource communities and authorize national and global engagement activities during MCM development to ensure products are usable and effective in these settings. Keep what worksAn authority established by the 21st Century Cures Act, the Medical Countermeasure Innovation Partnership, which uses venture-capital-style investment from BARDA to advance MCMs, will expire at the end of fiscal year 2028 under current PAHPA legislation. Given the program’s successful track record—advancing at least eight promising innovations—Congress should eliminate the sunset clause to preserve this productive mechanism. BARDA’s commitment to combatting AMR remains more pertinent than ever. Bacterial AMR was directly responsible for an estimated 1.14 million deaths in 2021 and associated with a total of 4.71 million deaths. Without action, annual deaths attributable to AMR could increase by almost 70 percent, totaling 10 million by 2050, with significant deaths among children and newborns. The pipeline of new antimicrobials and other tools remains insufficient. The critical support BARDA has provided for the development of AMR products must be maintained to meet this escalating threat.See the formal letter that GHTC submitted to Reps. Dunn and Trahan detailing each of these recommendations in full here.The future of R&D preparedness Reauthorizing and modernizing PAHPA is not just about restoring an expired statute; it is about defining the kind of biosecurity leader the United States intends to be in the decades ahead. PAHPA occupies a unique position in the health security landscape. It provides not only the authority to respond effectively during public health emergencies, but also the framework to make proactive, forward-looking investments that keep us one step ahead of emerging biological threats. There is growing bipartisan recognition of the urgency behind many of PAHPA’s core provisions, particularly as the global health and biomedical innovation landscape has shifted dramatically in recent years. Through thoughtful policy refinements, Congress can help shape a future that catalyzes more inclusive innovation, builds stronger public-private partnerships, and ensures the benefits of MCM development are fully realized, saving more lives in the United States and around the world.  At a moment when the cost of being unprepared is painfully clear, the choices made around PAHPA reauthorization will reverberate far beyond US borders and for years to come, helping determine how the world anticipates, confronts, and ultimately mitigates the next generation of health emergencies.

A new study has found that five human cases of a mysterious, bat-borne virus in Bangladesh, initially thought to be Nipah virus, were actually caused by another emerging bat-borne virus called Pteropine orthoreovirus (PRV). Between late 2022 and early 2023, five patients were admitted to hospitals with severe symptoms, all of whom had consumed raw date palm sap, which is also consumed by bats. Health care workers thought they had the Nipah virus, for which bats are a known vector, but they all tested negative. Several of the patients continued to experience severe symptoms after being discharged, and one ultimately died the following year. Human PRV cases have been reported other countries, but typically resulted in much milder respiratory illness, suggesting that the virus may have undergone genetic changes, making it more transmissible and virulent. These findings underscore the need for robust, vigilant surveillance of emerging diseases, particularly bat-borne pathogens. Last week, the Population Council announced that it has executed a global, exclusive license agreement for the Nestorone®/Testosterone (NES/T) male contraceptive gel, transferring the program to Contraline Inc., which will lead late-stage development toward potential global regulatory approvals as the first reversible contraceptive drug for men. The product, if approved, could transform contraception, enabling men to take on a responsibility that has historically fallen on women. NES/T is the most advanced investigational male contraceptive in the pipeline, and the Phase 3 clinical trial being planned is expected to be the first-ever Phase 3 trial of a hormonal male contraceptive. It is a daily topical gel that suppresses sperm production while maintaining normal testosterone levels, which was co-developed by the Population Council and the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health.  An early-stage trial evaluating a nasal spray vaccine for H5N1 bird flu found that the vaccine generated a strong immune response in rodents, a significant first step toward a vaccine capable of slowing the spread of bird flu, which in recent years has continued its worrying global spread among animal populations, with occasional human cases. While traditional injected flu vaccines are highly effective at preventing serious illness, they are less effective at reducing infection in the first place. Nasal vaccines, which work at the place of infection, can more effectively stop infections and prevent onward transmission to others. They are also believed be more effective against rapidly mutating viruses because they train the immune system differently than traditional vaccines, stimulating mucosal immunity in the nose and upper airway, and can respond to features of the virus that are shared across different strains, meaning they can remain effective for longer without needing updating. There are H5N1 vaccines stockpiled in several countries, but most of these were developed to target previously circulating strains of the virus and are poorly matched to the newer, rapidly mutating strains we have seen in recent years.