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GHTC responded to Senator Bill Cassidy's (R-LA) request for information (RFI) on modernizing the US Centers for Disease Control and Prevention (CDC).Dear Senator Bill Cassidy, We write to you today representing the Global Health Technologies Coalition (GHTC), a group of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other health tools to bring healthy lives within reach for all people. It is with this perspective that we intend to contribute input on opportunities to continue modernizing the US Centers for Disease Control and Prevention (CDC). After navigating the challenges and learning from the unprecedented impact of the recent pandemic, CDC has initiated a series of strategic policy changes and organizational realignments, as well as established new program areas to fortify its preparedness against future threats. These proactive measures directly address perceived gaps in CDC’s capabilities and warrant acknowledgment through robust intergovernmental support and adequate funding. One of CDC's notable strengths lies in the exemplary work of its global health-related program areas. Notable among these are the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), the Global Health Center (GHC), and the expansive efforts encompassed within the Global Health Security initiatives conducted by the organization. Regarding Fostering Innovation and Collaboration, the CDC should continue and expand its work through GHC. GHC provides expertise on immunizations, disease eradication, and public health capacity-building around the globe through its Global Divisions on HIV & TB, Public Health Protection, and Immunization. Among the far-reaching and high-impact work of GHC, one main priority is to “research, develop, and evaluate new tools and approaches to combat global health threats.” As a global hub for infectious disease research, GHC is uniquely equipped to develop and validate tools for disease surveillance and diagnosis. These tools are critical for both tracking events of public health importance, such as emerging infectious diseases, and monitoring the impact of US global health programs in settings that might otherwise have limited data collection capacity. CDC also provides vital scientific and technical support to interagency initiatives, including the US President’s Emergency Plan for AIDS Relief and the President’s Malaria Initiative. GHC is a great example of, from question 4 under the RFI’s Improving Upon What Works Well, “How can CDC improve linkages between in-country staff and program staff in CDC’s U.S. offices? What would be the benefit of improving these linkages?” Strengthening the global work of CDC would provide US citizens in lower-resourced, remote, and rural settings with health innovations that are fit for use, as well as provide early warning of disease threats that could reach US shores. Similarly, NCEZID and its newest sub-department, previously housed within GHC, the Department of Parasitic Disease and Malaria, uses its globally relevant research and collaborations to inform domestic responses to outbreaks and infections. This work has gained heightened significance in the wake of reports of locally transmitted malaria cases in Florida, Texas, and Maryland. The looming threat of various infectious diseases making their way to the United States underscores the need for continued vigilance. This is a challenge actively monitored by NCEZID, particularly through its Office of Advanced Molecular Detection. Leveraging cutting-edge technologies, such as DNA sequencing and advanced computing, the office delves into the intricate biology of infectious diseases to provide insights pivotal to the development of diagnostics, drugs, and vaccines. For instance, the office has played a vital role in determining the genetics of Ebola and Zika, as well as tracking COVID-19 variants. The agency’s wastewater surveillance programs have also provided pivotal insights into the scale of viral circulation in communities and the spread of COVID-19 variants; yet since this work was funded through emergency appropriations, these programs will run out of funding by fiscal year 2025 unless Congress appropriates sustainable yearly funding. As for Mechanisms to Modernize, the CDC is undergoing rapid and far-reaching improvements and modernization procedures that advocates are excited to see bear fruit. As it stands, the changes are too fresh to reap benefits, but the vision set forth by Dr. Rochelle Walensky and Dr. Mandy Cohen is coming into focus and addresses many of the questions posed in the RFI. One of the changes already mentioned—placing the Department of Parasitic Disease and Malaria under NCEZID – brings the global and domestic portfolios of parasitic diseases together, ensuring that tools and learnings mutually advance protection against parasitic diseases, both globally and in the United States. Other changes highlighted in the RFI like the Data Modernization Initiative and the moves to increase investments in the Epidemiology and Laboratory Capacity Program’s work on electronic laboratory reporting require a longer runway to get off the ground before further policy changes can be seriously considered. While the RFI is well-researched and tackles pertinent issues from multiple angles, the global health community observes the changes being made with optimism, largely predicated on frequent consultation and discussion with CDC officials. It is the advice of GHTC to take these overhauls of past data and lab practices as a clear acknowledgment of the early mistakes made during the COVID-19 response. In addition to the aforementioned changes, CDC is taking on a new approach to how it conducts internal business and presents itself to the public. The idea, dubbed “One CDC,” means to unify what was once a more decentralized organization. By striving to talk with one unified voice, CDC is helping to solve a persistent challenge that the whole of the US government struggled with during COVID-19—unclear and too many streams of communication. Instituting more whole-of-organization approaches to communications around public health emergencies should be considered throughout the government. Ultimately, the pathway for tangible improvements within CDC, as envisioned by GHTC, lies in affording the agency the necessary space and financial resources to attain the ambitious goals set for itself, the United States, and the global community. Recognizing that these investments in CDC's global initiatives directly benefit American global health security is paramount. At a time when global health systems are under immense strain and cumulative gains against persistent threats like HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases risk erosion, safeguarding hard-won advancements demands substantial and sustained funding for all facets of CDC's global health activities. This comprehensive support is not only critical to mitigating potential setbacks but also ensures that Americans are shielded from a spectrum of both enduring and emerging health threats. We appreciate your attention to this matter and would be happy to collaborate further with the Senator’s office as action is taken to modernize CDC. Sincerely,  Alex Long  US Policy & Advocacy Officer  

GHTC responded to Senator Bill Cassidy's (R-LA) request for information (RFI) on modernizing the National Institutes of Health (NIH), highlighting the important globally facing work NIH does.Dear Senator Bill Cassidy, We write to you today representing the Global Health Technologies Coalition (GHTC), a group of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other health tools to bring healthy lives within reach for all people. It is with this perspective that we intend to contribute input on opportunities to continue modernizing the National Institutes of Health (NIH). NIH has long been a cornerstone of basic and early-stage biomedical research, playing a pivotal role in driving scientific discoveries that pave the way for the creation of lifesaving global health technologies by the private sector, nonprofits, and other US agencies. While NIH primarily facilitates basic research on global health challenges through intramural programs and external grants to universities, nonprofits, and other organizations across the United States, its ongoing investments in clinical trials for HIV/AIDS—and increasingly trials for malaria and tuberculosis (TB) products—also makes it one of the biggest global funders of clinical development in each of these disease areas. The foundational research conducted by NIH has been instrumental in facilitating the United States’ COVID-19 response, enabling the nation to lead in the rapid development of new technologies to combat the pandemic. NIH's prior research on coronaviruses, such as SARS-CoV-1 and MERS-CoV, laid the groundwork for understanding these viruses through the development of animal models, scientific techniques, treatments, and vaccines. These past investments enabled NIH scientists to quickly understand and immediately respond to COVID-19 with focused research and accelerated development of diagnostics, therapeutics, and vaccine candidates. Specifically, the National Institute of Allergy and Infectious Diseases (NIAID), in partnership with Moderna, developed one of the initial COVID-19 vaccines, mRNA-1273, and moved the vaccine to human clinical trials just 65 days after the genome of the virus was shared—a record far shorter than any previous vaccine development timeline. This only bolsters the solid track record of NIAID, which also supported, among other breakthroughs, the development of an innovative, automated diagnostic for TB—the Cepheid Xpert® MTB/RIF test; a now-approved Ebola treatment, mAb114, which was found to dramatically improve the survival rate of infected patients in a clinical trial carried out amid the 2018 to 2019 outbreak in the Democratic Republic of the Congo; and the clinical research demonstrating that a combination of two newer drugs, bedaquiline and delamanid, could be safely taken together to treat drug-resistant TB in HIV-positive and HIV-negative individuals. Building upon its leadership in basic research, NIH has also achieved success in driving more directive product development initiatives that should be seen as proof of concepts for the future of US-sponsored targeted research. For example, after COVID-19 emerged, NIH launched and led two public-private partnerships to create new therapeutics and diagnostics for COVID-19: the Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV, and the Rapid Acceleration of Diagnostics initiative, or RADx. What sets these initiatives apart from NIH’s traditional way of funding promising science is the clear focus on a product end goal, the degree of coordination on the research agenda, and the approach of sourcing a portfolio of potential solutions for a problem and flexibly and rapidly infusing funding to speed the development of those that show the most promise as development advances. Expanding these types of more directive, coordinated funding and grant schemes can be particularly valuable for advancing products for diseases that lack a commercial market, including neglected diseases that primarily impact the world’s poorest places and diseases with epidemic potential. Unlike in areas where there is clear profit potential, where companies will build upon NIH-funded basic research discoveries to advance products to market, in these areas, funding basic research alone is not sufficient, and an expanded focus by NIH on targeted product development could help accelerate lifesaving solutions. These initiatives also demonstrate the importance of having a strong overall funding base for NIH, as while ACTIV was eventually powered by significant supplemental funding from COVID-19 relief bills, it was first stood up using the agency’s existing discretionary funding. Another contributing factor to NIH’s success is its ability to create massive impact with constrained resources. The Fogarty International Center (FIC) is a good example of this. With less than one-fifth of one percent of the total NIH budget, Fogarty delivers significant scientific returns for global and American health, forging international partnerships to facilitate truly global research. The center creates a platform for partnerships between scientists in the United States and worldwide. When FIC investments lead to new tools or interventions designed for low-resource settings, these innovations can be deployed back in the United States, where they can drive down costs and improve access to health care in rural settings—an exchange known as reciprocal innovation. By looking at the successes of NIAID, FIC, and the flexible and targeted funding calls, the future of NIH’s work looks bright, as low resource innovation and dynamic funding mechanisms are prioritized throughout the institutes. It should be noted that, while done in good faith, further scrutiny of NIH for the sake of transparency should be measured so as not to interfere with the flow and cadence of ongoing research. One way to mitigate disruption is to work with NIH principal investigators, administrative staff, directors, and all those impacted to roll out new oversight measures with clear deliverables through a transparent process to instill trust in the process and the people. We appreciate your attention to this matter and would be happy to further collaborate with the Senator’s office as action is taken to modernize NIH. Sincerely,  Alex Long  US Policy & Advocacy Officer  

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. On Friday, the US Department of Health and Human Services announced another $500 million in Project NextGen funding, which will support phase 2b clinical trials of three COVID-19 vaccine candidates, as well as other technologies to enhance preparedness against COVID-19 and future disease outbreaks. Specifically, the awards will go to two intranasal vaccine candidates that are administered as sprays and one self-amplifying mRNA vaccine candidate that is administered as an injection; phase 2b clinical trials of those vaccine candidates could start as soon as this winter. Funding will also go to the development of vaccine patches, cold-chain sample management, genomic sequencing, and increased laboratory capacity.The Coalition for Epidemic Preparedness Innovations (CEPI) is leading an initiative with the biopharma data provider IQVIA aimed at enhancing global research capacity to advance the 100 Days Mission, which aims to be able to respond to the next Disease X (a future pathogen with pandemic potential) with medical countermeasures within 100 days of its identification. Under the initiative, IQVIA will provide tools and resources to support research preparedness in underserved regions during ‘peacetime’ (when there is no ongoing pandemic outbreak) and to support clinical trials during future outbreaks of diseases with pandemic potential. CEPI will fill in gaps to ensure high-quality data are generated during an outbreak response to inform further research.Last week, The Lancet and the Coalition for Preventing Pandemics at the Source announced that they have convened the Commission on Prevention of Viral Spillover, which will work to mobilize decision-makers to support research and policies to prevent future viral spillovers and pandemics following the COVID-19 pandemic, which was the fifth viral pandemic caused by a viral spillover in the last century. The commission, which includes 28 experts in a variety of fields from epidemiology to veterinary medicine to food systems management, will conduct original research and publish a comprehensive report within two to three years on recommendations to prevent such spillovers.

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 Wednesday, Moderna announced that its combination COVID-19 and flu shot, mRNA-1083, demonstrated strong immunogenicity in a phase 1/2 trial. The trial found that mRNA-1083 was similarly effective to two already approved flu vaccines developed by GSK and Sanofi and Moderna’s own SpikeVax COVID-19 vaccine. There were also no new safety concerns reported with the combination vaccine compared to each of the vaccines used alone. A phase 3 trial testing the combination shot will begin before the end of the year with potential regulatory approval in 2025 if successful. The company also laid out its broader efforts on combination vaccines, including a combination shot for COVID-19, flu, and respiratory syncytial virus.The Biomedical Advanced Research and Development Authority (BARDA) has awarded Vir Biotechnology $50 million in Project NextGen funds to advance the development of novel monoclonal antibody (mAb) candidates and delivery solutions for COVID-19 and future pandemic threats.  The new funding will support development of alternative mAb delivery technologies that increase antibody expression relative to existing solutions, which could revolutionize mAb delivery by expanding administration options and shortening development and manufacturing timelines. Four-fifth of the funding will specifically go toward advancing Vir’s next-generation COVID-19 mAb, Vir-7229, through a phase 1 trial, expected to be completed in late 2025, while the remainder will support the discovery of new mAbs against a second pathogen of pandemic potential.The World Health Organization (WHO) last week recommended the R21/Matrix-M malaria vaccine, developed by the University of Oxford. This follows two years after WHO recommended RTS,S, the first malaria vaccine. Both vaccines have a similar efficacy profile and delivery method and are targeted to children, but doses of R21 are expected to be cheaper—between $2.00 and $4.00 compared to about $7.25 now charged for RTS,S. The Serum Institute, which will produce R21, has also announced plans to deliver a much higher volume of doses compared to GSK’s current marketing plans for RTS,S. Although it will take more time to collect further safety monitoring data for R21, the recommendation of a second vaccine will hopefully help to ensure adequate supply for malaria-endemic countries that are planning to integrate a vaccine into their national malaria control plans.