Breakthroughs Blog: BARDA

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. 

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.

Last week, French biopharmaceutical company Osivax announced that it received a $19.5 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to further develop its broad-spectrum influenza A candidate vaccine for pandemic and seasonal flu preparedness. The vaccine is designed to target a part of the virus that is highly conserved and less likely to mutate, hopefully offering a broader, more universal immune response, and it has demonstrated promising results in early clinical trials. BARDA’s funding will support ongoing clinical development and large-scale trial and manufacturing preparation, with potential options for future funding to support Phase 2b and scale-up activities. A team of researchers at the University of Nottingham successfully produced antibodies that kill the parasite that causes Chagas disease, an important step toward the development of a much-needed vaccine. Chagas is a serious neglected tropical disease, which causes 56,000 cases and 12,000 deaths every year. The researchers developed antibodies targeting two key proteins in the parasite that were found to be extremely effective at neutralizing the parasite in a crucial developmental phase when it’s capable of infection, which is key for vaccine development.   A University of Maryland research team developed an artificial intelligence (AI) tool that can quickly scan electronic medical records to identify high-risk patients who may be infected with H5N1 avian flu, as this year’s outbreak highlights the need for more robust screening interventions to ensure infections are not going undetected. The researchers used their generative AI large-language model to analyze the records of more than 13,000 adults who had visited the emergency department in Maryland in 2024 for acute respiratory illness and common H5N1 symptoms. With less than half an hour of human input, the model found 76 records that mentioned a lifestyle risk factor for H5N1, 14 of which were confirmed to have a recent exposure to animals that transmit H5N1. The tool highlights the shortcomings of the response to the latest outbreak and offers a potential new tool to help improve surveillance and testing in future outbreaks of H5N1 and other infectious diseases.

On Thursday, Senate appropriators advanced out of committee a fiscal year (FY) 2026 spending bill for the Department of Health and Human Services (HHS) that rejects billions in health spending cuts proposed by the Trump Administration and protects programs vital to global health innovation.The bill increases or flat-funds global health research-relevant agencies, including the National Institutes of Health (NIH) and Biomedical Advanced Research and Development Authority (BARDA), and slightly reduces funding for the US Centers for Disease Control and Prevention (CDC) compared to FY25 enacted—an outcome that is in stark contrast to the President’s Budget Request (PBR), which proposed deep cuts across all three. Funding at this level will enable these agencies to continue to advance medical breakthroughs and operate programs that deliver better health outcomes for people around the world and fortify our defenses against disease threats.Funding highlightsThe legislation allocates $48.7 billion in funding for NIH, which is a $400 million (.8 percent) increase compared to FY25 enacted and nearly $22.2 billion (77 percent) above the PBR, and $1.015 billion for BARDA, which represents level funding from FY25 but $361 million (55 percent) more than the White House request. While the legislation unfortunately cuts funding for CDC by $72 million, or 1 percent, this allocation is $4.8 billion or 112 percent greater than the President’s request.While advocates expected the Senate to reject the steep cuts proposed by the Trump Administration, many still anticipated significant reductions. It is therefore both welcome and surprising that Senate appropriators advanced a spending package that maintains strong funding for many programs the President aimed to slash or eliminate.Beyond topline funding for agencies, the bill and accompanying report also diverge from the PBR in other crucial ways. While the President proposed eliminating the CDC Global Health Center (GHC), this spending bill keeps the center intact, maintaining level funding from FY25. The bill also maintains flat funding for the NIH Fogarty International Center—which supports global health research partnerships and training—and provides a 0.5 percent increase to the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). This stands in sharp contrast to the White House’s proposal to eliminate Fogarty entirely and cut NIAID’s budget by 58 percent. Additionally, it provides level funding to the Advanced Research Projects Agency for Health (ARPA-H), a new agency established under the Biden Administration to support high-risk, high-potential health research, rejecting the President’s proposal to reduce its funding by $555 million.Beyond  funding numbers, the bill’s accompanying report includes welcome directives affirming the Senate’s support for research activities critical to global health, including across health areas like neglected tropical diseases, malaria, tuberculosis, emerging infectious diseases, antimicrobial resistance (AMR), and more, and underscores the importance of international health research partnerships and training programs supported by the Fogarty International Center and global health activities undertaken by CDC GHC and NCEZID.  Taken together, the funding and directives can be viewed as a strong rebuke of the president’s efforts to downsize and dismantle US global health efforts and a strong affirmation of the Senate’s support for programs that save and improve lives around the world and protect Americans from disease threats. The report also dictates stricter reporting requirements to Congress for HHS, indicating bipartisan concern by lawmakers as to whether the agency is dispersing funding as directed and making scientifically-drive decisions.The report also conveys Senate appropriators’ desire to see BARDA devote robust funding to developing countermeasures against emerging infectious diseases, AMR, and pandemic influenza, and directs BARDA to spend no less than $10 million on advancing countermeasures against “Disease X,” which is a term to denote priority viral pathogens that could cause the next pandemic. Despite an overall positive picture, the bill does include some decreases to subaccounts relevant to global health, including an 80 percent cut to  the CDC-wide Infectious Disease Rapid Response Fund, which was a fund originally created to provide flexible funds for the agency to rapidly respond to pandemic and epidemic threats. See the chart below for a more detailed comparison of funding in the Senate bill and percent changes compared to FY25 enacted and the PBR.What comes nextThe bill’s passage out of committee is just an initial step in a lengthy political process. It will next go to the full Senate for a vote, the House of Representatives will need to advance its parallel bill, and then the two bills will need to be conferenced to work out their differences before going back to both chambers for a vote and then to the President for signature.It is anticipated that the House will propose lower spending levels for health programs than the Senate, so these numbers are a likely high watermark where negotiations begin between the two chambers. Nonetheless, if one reads the House’s spending bill on global health as a tea leaf of what’s to come, it’s unlikely the House will cut as deep as the President wishes , so if the two chambers can reach a compromise and pass a budget, we could see funding levels land somewhere below the Senate but still substantially above the PBR. In the House bill, we are likely to see stronger relative numbers for NIH over CDC, given heightened criticism for the latter agency among Republican lawmakers.For many advocates, this bill is welcome news that Congress is reasserting its power of the purse in opposition to the president, yet significant concerns remain. Will the two chambers actually reach a promising compromise? And even if Congress appropriates strong funding for FY26, given all the recent moves by the Administration to rescind, halt, or slow the disbursement of federal spending, will this money actually reach researchers and health implementers to deliver impact? While we can’t predict for certain, GHTC and other advocates will continue to keep a close watch on what’s to come and activate where we can in order to protect vital funding for global health and medical research.