Hannah Sachs-Wetstone

2023 has seen a flurry of new and old bills relating to global health and pandemic preparedness introduced in the 118th Congress. To help you navigate them and understand how they could ultimately impact global health research and development (R&D) broadly, GHTC has provided a summary below of key pieces of legislation we are closely tracking. 1. PAHPA  The Pandemics and All-Hazards Preparedness and Advancing Innovation Act (PAHPA), the latest version of legislation authorizing the work of the Biomedical Advanced Research and Development Authority (BARDA) and the Administration for Preparedness and Response (ASPR), is set to expire at the end of this fiscal year on September 30, setting up a process for Congress to develop new authorizing legislation. While Congress could choose to ‘cleanly’ reauthorize this work, essentially extending the prior bill and the work of these entities to a new end date, in the wake of the COVID-19 pandemic, some congressional stakeholders want to consider additional reforms to improve the nation’s health preparedness. GHTC has put forward a series of recommendations to influence this forthcoming legislation, including a recommendation to establish and authorize a specific division within BARDA devoted to the development of medical countermeasures (MCMs) for emerging infectious diseases (EIDs), alongside other policy changes to enhance programming for EIDs, antimicrobial resistance, and pandemic influenza and to ensure tools developed by BARDA are fit-for-purpose for use in low-resource settings. As this bill progresses in development, it could become what many in Washington, DC call a “Christmas tree” vehicle, meaning some of the proposed bills below related to pandemic preparedness could ultimately find themselves incorporated into the bill before its passage.  2. End TB Now Act The End Tuberculosis Now Act of 2023 seeks to advance and modernize US engagement in the global fight to end tuberculosis (TB) by improving US and international coordination on research, prevention, diagnosis, and treatment. Specifically, the legislation mandates the US government to update its TB strategies to reflect the latest scientific advances and to align with the World Health Organization’s TB strategy, as well as requires annual reports to Congress on TB assistance activities and technology development and calls for more robust coordination with global bodies and among US agencies, in doing so reinforcing USAID’s mandate to conduct TB R&D. GHTC provided input to and endorsed the legislation, which dates back to the 117th and 116th Congresses and was reintroduced earlier this year in the Senate, by Senators Bob Menendez (D-NJ) and Todd Young (R-IN), and in the House, by Reps. Ami Bera (D-CA) and María Elvira Salazar (R-FL).  3. Disease X ActThe Disease X Act of 2023, introduced earlier this month by Reps. Lori Trahan (D-MA), Michael Burgess (R-TX), Dan Crenshaw (R-TX), and Susie Lee (D-NV), endeavors to improve US preparedness for future pandemics by establishing a program at BARDA to advance MCMs for unknown viral threats, colloquially called “Disease X.” The legislation, which GHTC has endorsed, directs BARDA to accelerate the research, development, and procurement of tools that are designed to address viral families with pandemic potential. While BARDA has in the past played a key role in advancing MCMs for health emergencies, including Ebola, Zika, and COVID-19, financial support for this work has largely come through reactive emergency supplemental funding bills once the crisis has begun, and surprisingly, the agency does not currently have a distinct program or division focused on proactively advancing tools for EIDs, either known and unknown, an oversight this bill could help rectify.4. SUPER BUGS Act The Savings Us from Pandemic Era Resistance by Building a Unified Global Strategy (SUPER BUGS) Act of 2023, which GHTC has also endorsed, would require the US government to develop a strategy to coordinate with multilateral organizations and other countries on the development and commercialization of new antimicrobials and other products to fight antimicrobial-resistant pathogens, or “superbugs.” Introduced in the House in March by Reps. Drew Ferguson (R-GA), James McGovern (D-MA), and Mark Amodei (R-NV), the bill seeks to apply lessons learned from COVID-19 about the need for international cooperation and partnership in R&D.  5. FIGDA  The Fostering Innovation in Global Development Act (FIGDA) of 2023 aspires to support and further innovative and evidence-based approaches in foreign assistance. First introduced in the 117th Congress and reintroduced this past April in the House by Reps. Joaquin Castro (D-TX) and Young Kim (R-CA), FIGDA would see USAID establish or participate in three programs—Development Innovation Ventures, the Global Innovation Fund, and a new Proven Solutions program—that are focused on applying nimble, venture-capital style approaches to finance the scale-up of interventions with good evidentiary backing. Additionally, it would establish several new innovation-focused roles, including a chief innovation officer, senior adviser for innovation, and innovation fellows throughout the agency, as well as expand the use of certain contracting instruments that tie funding to performance. While the legislation covers foreign aid broadly, GHTC has endorsed this legislation, which broadly aligns with our proposal calling for the creation of a Supporting Innovative Global Health Technologies Fund, or SIGHT Fund, at USAID to bolster the agency’s health innovation activities.  6. Reach Act The Reach Every Mother and Child Act of 2023 was introduced on May 10 in the Senate by Sens. Susan Collins (R-ME), Chris Coons (D-DE), Dick Durbin (D-IL), and Roger Wicker (R-MS). The legislation aims to support and increase resources for US maternal, newborn, and child health and nutrition programs. Specifically, Reach would implement a new strategy, establish a coordinator at USAID, and require detailed public reporting, all to ensure coordination and efficiency across US agencies with a focus on high-impact, evidence-based interventions; greater transparency and accountability; and greater country and community ownership. GHTC supports the legislation because it includes innovation, specifically mentioning the development and scale-up of new technologies and approaches as one part of strengthening support for maternal, newborn, and child health and nutrition following backsliding in progress due to the COVID-19 pandemic.  7. PASTEUR Act The Pioneering Antibiotic Subscriptions To End Up surging Resistance (PASTEUR) Act of 2023 would establish a subscription-style model that would offer antibiotic developers an upfront payment from the US government in exchange for ensuring the US health care system has access to their products when they emerge from the pipeline. Endorsed by GHTC, PASTEUR represents an approach to incentivizing private-sector innovation of novel antibiotics in response to the growing threat of antimicrobial resistance. First introduced in the 117th Congress, the bill was reintroduced by Rep. Drew Ferguson (R-GA) in the House and Sen. Michael Bennet (D-CO) in the Senate in April. 8. VALID Act The Verifying Accurate, Leading-edge IVCT Development Act of 2023 aims to reform and modernize regulatory oversight for diagnostic testing. Specifically, the legislation would give the US Food and Drug Administration the power to regulate certain laboratory-developed tests (LDTs), now overseen by the Centers for Medicare and Medicaid Services, by reclassifying them as in vitro clinical tests (IVCTs) and placing them under a single regulatory framework with in vitro diagnostics. While GHTC has not taken a position on the legislation, proponents say the bill will help ensure the safety and effectiveness of LDTs, which have traditionally been developed and performed by single laboratories but are increasingly being broadly marketed, while opponents argue it could impose additional costs and regulations to smaller academic, clinical, and hospital labs that could impede innovation and slow or halt lifesaving research. First introduced in 2018 during the 115th Congress, the bill was introduced in March in the House by Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO).  9. DTPP Act The Diagnostic Testing Preparedness Plan (DTPP) Act seeks to facilitate coordination between the public and private sectors to speed the development of diagnostics during public health emergencies. Newly introduced in the House by Representatives Greg Pence (R-IN), Larry Bucshon (R-IN-6), Andre Carson (D-IN-7), and Kim Schrier (D-WA-8), the bill requires the Department of Health and Human Services via ASPR to develop a cross-government plan to support the rapid research, development, approval, scaling, procurement, and distribution of diagnostics during public health emergencies. ASPR would also be required to update the plan every three years and submit an after-action assessment following any activation during a public health emergency.  10. BIO Early Warning Act Reps. Dan Crenshaw (R-TX) and Scott Peters (D-CA) recently released a discussion draft for a proposed piece of legislation called the Biosecurity Infrastructure for Operation (BIO) Early Warning Act, which aims to reorient public health situational awareness and disease detection as issues of national security and create better early-warning systems. The bill includes measures to improve coordination and streamline disease detection programs across different government agencies; gives ASPR new authorities and responsibilities to oversee and provide early warning of impending disease threats; and requires the US government to stockpile technologies necessary for the safe collection, storage, and transportation of biological hazards during an emergency. Opponents are concerned that as originally proposed, the bill would shift bio-surveillance and other core surveillance and outbreak investigation programs that currently sit in the Centers for Disease Control and Prevention to ASPR.  While some of these bills may pass this Congress and others will be unable to garner enough support, it is certainly exciting to see so much congressional energy around improving global health R&D-relevant activities, particularly in the wake of the COVID-19 pandemic. GHTC will continue to track these bills as well as forthcoming legislation, so stay tuned to our channels for more updates.  

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 Food and Drug Administration’s (FDA’s) scientific advisers recommended that the next round of COVID-19 vaccines include only the newest variants that have become dominant worldwide, the XBB strains of Omicron, echoing recommendations from the World Health Organization’s vaccine advisers and European regulators. After the FDA makes the final decision, vaccine developers say updated shots could be available within months. The recommendation is based on the idea that the XBB variants are different enough from each other to push the immune system to make more diverse, cross-protective antibodies as opposed to keeping the original strain in the shot, which can cause people’s immune systems to respond more strongly to that strain because of previous, repeated exposure rather than the new strains included in the dose.Researchers at the University of California San Francisco and the National Institute of Biological Standards and Control in the United Kingdom have developed two novel oral polio vaccines, the first new vaccines for polio in 50 years. The vaccines are made from weakened poliovirus that has been genetically engineered to reduce the development of mutations to the active form of the virus, which have been a major challenge of oral polio vaccines, leading to outbreaks of vaccine-derived polio even in countries where the disease was previously believed to have been eliminated. To address those outbreaks as well as uneven vaccination rates worldwide that have led to the continued circulation of the virus, the new vaccines can hopefully be part of the World Health Organization’s most recent push to eradicate polio globally.A phase 3 trial recently published in The Lancet found that Valneva’s FLA1553 vaccine candidate for chikungunya disease was generally well-tolerated and produced an immune response in 99 percent of study participants in chikungunya-endemic regions. There are currently no approved vaccines or effective antiviral treatments for the disease caused by chikungunya infection. The vaccine developers hope that this candidate could become the first vaccine available for people living in as well as travelers to chikungunya-endemic regions or regions at risk of an outbreak. The vaccine could become even more important as climate change is expected to drive the global spread of mosquitoes—and therefore mosquito-borne viruses like chikungunya—to new areas.

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, a US Food and Drug Administration (FDA) advisory committee voted to recommend a monoclonal antibody product to protect children one year and under, as well as high-risk children between one and two years old, from respiratory syncytial virus, or RSV. Nirsevimab, which will be marketed as Beyfortus, was developed by AstraZeneca and will be marketed in the United States by Sanofi. The product is intended to be administered to babies via a single injection during RSV season or at birth depending on birth timing. RSV is a major challenge in children, particularly in very young children, causing up to 80,000 hospitalizations and 300 deaths a year in the United States. Pfizer’s RSV vaccine for pregnant people, which is also aimed at protecting babies, is currently being considered by regulators as well.Moderna will launch a phase 1/2 trial of their mpox vaccine this summer with the goal of generating data to inform dose selection and eventually licensure. The company announced the start of preclinical work on an mpox vaccine back in May of last year, with the vaccine being swiftly developed using the company’s mRNA platform. After the immediate mpox outbreak waned in the United States, the vaccine was deprioritized by Moderna, but ahead of this summer, when mpox is expected to re-emerge, Moderna has announced the trial and has been meeting with the US mpox response team.The Coalition for Epidemic Preparedness Innovations (CEPI) last week announced £1.5 million in funding for Germany’s Leipzig University, where researchers have created artificial intelligence technology that will be used to build a vaccine library aimed at streamlining the development of a new generation of vaccines against a future pathogen with pandemic potential, or Disease X. The technology will analyze the genetic structures of pathogens from ten high-risk viral families, starting with those families that include Nipah and Lassa viruses; model protein sites in the viruses that are crucial targets for generating immune responses in human; and then use those viral protein targets to develop vaccine blueprints. Future scientists will hopefully be able use the library to develop vaccine candidates within 100 days of identifying a pathogen with pandemic potential.

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. Data from late-stage trials showed that Pfizer’s experimental antibiotic drug combination was well-tolerated and effective in treating complicated infections caused by drug-resistant bacteria. The combination, which includes the experimental mix aztreonam-avibactam, existing generic drug metronidazole, and two older antibiotics: meropenem and colistin, is aimed at treating complicated intra-abdominal infections and some types of hospital-acquired pneumonia caused by gram-negative bacteria. The study underscores that innovative, novel antibiotics continue to be an important goal in the face of the rising global threat of antimicrobial resistance.Last week, the US Food and Drug Administration (FDA) approved Pfizer’s Abrysvo vaccine for respiratory syncytial virus (RSV) following strong results from a phase 3 trial, making it the second vaccine to protect older adults from RSV approved in recent months. Both vaccines will not be available until the US Centers for Disease Control and Prevention recommends them, which the agency is expected to do soon. Experts have highlighted the great potential for both vaccines to drastically reduce the number of infections and hospitalizations in adults that result from the virus every year.A new study showed the success of implementing shorter treatment regimens for drug-resistant tuberculosis (TB) in a small cohort in the United States. The six-month, all-oral bedaquiline, pretomanid, and linezolid (BPaL) regimen for rifampin-resistant TB was implemented in 70 patients in 2019, shortly after FDA approval of the regimen. The promising results lend support to the early implementation of new TB treatments and highlight the promise of further innovation to reduce the burden of TB, especially drug-resistant TB, in the United States and around the world.

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. At the 76th World Health Assembly last week, World Health Organization (WHO) member states adopted a resolution on strengthening diagnostics capacity, following a recommendation from the Executive Board earlier this year. The resolution is aimed at raising global awareness of the importance of diagnostics and the major gaps in access, to even the most basic diagnostics, that are faced around the world. Implementation of the resolution will be driven by national governments, which are urged in the resolution to integrate national diagnostics strategies that address the regulation, assessment, and management of diagnostics into their national health plans, as well as to develop a national essential diagnostics list, which will hopefully lead to wider availability and access.An affordable meningitis vaccine designed to protect against multiple strains was found to be effective in phase 3 trials in Mali and the Gambia. The NmCV-5 vaccine, developed by PATH and the Serum Institute of India, generated a strong immune response against the five primary meningococcal strains in Africa, including the emerging X strain, for which there is currently no licensed vaccines. The cost of available vaccines for the four other strains of meningitis are currently too high for most African countries to buy the tens of millions of doses they need. NmCV-5 is expected to be available in the coming months and has the potential to dramatically reduce vaccine-preventable cases and deaths, especially those linked to the X strain.Using artificial intelligence, researchers at the Massachusetts Institute of Technology and McMaster University have identified a new antibiotic drug to combat Acinetobacter baumannii, which is responsible for many drug-resistant infections and can lead to pneumonia and meningitis. The drug was identified using a machine-learning model that was trained to evaluate whether drug compounds would inhibit A. baumanii’s growth, which then reviewed a library of nearly 7,000 potential compounds. The finding has the potential to reduce drug-resistant infections and also highlights the potential role of artificial intelligence in accelerating the search for novel antibiotics in the face of growing antimicrobial resistance.

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, Indian drug company Cipla confirmed that a generic version of the HIV prophylaxis long-acting cabotegravir (CAB-LA) will be manufactured at its plants in South Africa for the first time, which could potentially offer millions of people at risk of HIV infection in Africa access to the groundbreaking drug. CAB-LA is a two-monthly jab that is easier to take regularly and has also been found to work better than the daily HIV prevention pill, which is currently available for free in South Africa and several other countries on the continent. The introduction of generic manufacturers into the market for HIV drugs has the potential to dramatically reduce medicine prices, which are often out of reach for low- and middle-income countries, even at prices discounted by the manufacturers that hold the original patents.IAVI and Zendal Group’s subsidiary Biofabri have signed an expanded deal to develop MTBVAC, the only live, attenuated mycobacterium tuberculosis (TB) vaccine in the pipeline. The developers are targeting the vaccine for use in adults and adolescents and are aiming for the candidate to be more effective and potentially longer lasting than the bacillus Calmette-Guérin, or BCG, vaccine that is currently in use to prevent TB in newborns. IAVI is planning to commence a trial for the MTBVAC in 2024 after sufficient funding is secured. The deal also includes support for advancing MTBVAC for infants following Biofabri commencing a phase 3 trial of MTBVAC in neonates last year.Last week, the US National Institutes of Health announced that they are beginning to enroll patients in an early-stage clinical trial testing an mRNA universal flu vaccine that is aimed at protecting against a wide variety of strains of the flu and providing long-term immunity. The shot, designed by researchers at the National Institute of Allergy and Infectious Diseases, will test whether the shot is safe and produces an immune response in 50 healthy adult volunteers. If proved to be safe and effective, a universal flu vaccine could eliminate the need for scientists and vaccine manufacturers to predict the dominant flu strain and produce shots in advance of prime flu season, as well as reduce the risk of illness and hospitalization, particularly when the shots available are not well matched to the dominant circulating strains.