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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. The latest funding from the Biomedical Advanced Research and Development Authority’s (BARDA’s) Project NextGen will go to Gritstone bio for a large-scale phase 2b study of its mRNA COVID-19 vaccine candidate. $433 million will go toward the trial, expected to start early next year, which will test the company’s vaccine against an already approved one. Gritstone’s candidate aims to provide broader and longer-lasting clinical protection than first-generation COVID-19 vaccines by inducing multiple types of immunity against current and future variants of the virus that causes COVID-19.Two recent studies reviewing the efficacy and safety of higher dose regimens of the antimalarial drug primaquine bolster support for increasing doses in malaria-endemic countries. Primaquine has been used against Plasmodium vivax malaria for more than 60 years, but this new research provides the answer to a problem designated by the World Health Organization as a key research priority: how to reduce malaria relapse. The studies found that doubling the currently used dose of primaquine halved malaria relapses, while delivering a similar safety profile to the lower dose regimen, suggesting widespread implementation of higher dosing could have a significant impact on reducing P. vivax malaria relapses, deaths, and transmission in endemic countries.New research into an innovative injected hydrogel drug method for treating HIV offers hope of a completely novel management method that could drastically reduce the frequency of treatment and eliminate the need for daily pills, greatly improving the quality of life of people living with HIV. The researchers found that one injection of the gel in mice was enough to maintain effective and lasting concentrations of the drug lamivudine for 42 days with nearly no side effects by ensuring the drug was released slowly and consistently in the body. Further tests will look at the hydrogel used in combination with others drugs to prevent HIV as well as simultaneously address HIV and hepatitis B.

With thousands of delegates dashing from one meeting to another in the frenetic New York streets, it was clear that the United Nations General Assembly (UNGA) was back in full swing this year. Given the three High-Level Meetings (HLMs) on global health, including pandemic preparedness, prevention, and response (PPPR); universal health coverage (UHC); and tuberculosis (TB), this was already set to be a major opportunity to reset coming out of the worst of the COVID-19 pandemic. Yet despite high ambitions, this year’s forum fell short of expectations, with many key issues, such as new agreements for sharing medical countermeasures (MCMs), accountability and enforcement mechanisms, or new funding commitments, being either punted to other forums or ignored. Innovation did feature strongly in all three HLMs, and despite the general disappointment, the research community was able to notch a few wins.A milestone in global pandemic preparednessThe UNGA HLM on PPPR marked a historic moment with the adoption of a political declaration. While nonbinding, this declaration carries significant symbolic weight, underscoring the global recognition that pandemic threats transcend mere health emergencies; they are existential threats that must be addressed with a whole-of-society approach. However, it was clear in the lead-up that the ambition had been severely curtailed and much of the text of the political declaration watered down. The meeting saw minimal participation from heads of state and inadequate representation from civil society. Many countries chose to focus on their past accomplishments in PPPR without articulating clear next steps or new commitments.Funding (or lack thereof) was another key theme of the week. The declaration emphasizes the importance of supporting sustainable and alternative financing mechanisms, as well as strengthening the capacity for innovation and production of MCMs. Specifically, it highlights the need to assist low- and middle-income countries (LMICs) by bolstering local production, technology transfer, and voluntary licensing. Support for the Pandemic Fund is noted, acknowledging the need for $10 billion to make the mechanism successful. Despite these encouraging commitments, the adopted declaration does not include specific new financial pledges for the Pandemic Fund nor targets that ensure the realization of the 100 Days Mission Plus, an initiative that would seek to develop and distribute MCMs within 100 days of an outbreak. Some were also hoping to see the declaration lay out some key principles or targets for a potential MCMs platform to succeed the Access to COVID-19 Tools Accelerator, which coordinated and oversaw the rollout of COVID-19 technologies to low-income countries. But while leaders emphasized the importance of achieving equitable access to essential tools in their statements, disappointingly, there was no mention of a platform in the final declaration text, and the idea was hardly mentioned by member states during debate. Instead, it was clear from the statements leaders made at the meeting that they are eyeing the ongoing processes in Geneva on a pandemic accord and reforms to the International Health Regulations (IHR) to resolve many of these issues—further increasing the stakes for the outcomes of these processes, which need to be aligned with each other and with the declaration.Lack of progress on UHC implementationThe UHC meeting began with the adoption of a nonbinding political declaration by member states. During the meeting, issues of equity and access took center stage. Various countries emphasized the importance of ensuring that health care and health products are accessible to all, regardless of income, and advocated for gender-inclusive health interventions.The role of R&D in achieving UHC emerged as another central theme. Many countries highlighted the need for local and regional production of vaccines, diagnostics, medicines, and other health technologies. Several member states stressed the importance of technology transfer to LMICs and the removal of barriers posed by intellectual property rights. Collaboration and innovation were identified as key drivers of improved global health outcomes. In alignment with the sentiments coming out of the previous day’s PPPR HLM, this reflects a growing recognition of the importance of regional and domestic capacity for health care production and innovation.The spotlight on R&D in the broader UHC context is an exciting step in the right direction, but like the PPPR HLM, the UHC discussions lacked targeted commitments. Member states focused on identifying gaps and areas of needed improvement, such as localized manufacturing of health technologies and increased investments, but largely failed to pledge new financing and other concrete commitments to fill these gaps.  TB commitments finally include tangible targetsThe week culminated with the TB HLM adopting a political declaration, setting forth targets and commitments for tackling TB. In the document, governments pledged to mobilize at least $22 billion annually by 2027, with a more substantial commitment of $35 billion annually by 2030 for TB prevention and treatment. Additionally, there was a commitment to mobilize an additional $5 billion a year by 2027 for TB research and innovation. These commitments are ambitious, especially given that governments have delivered less than half of the $13 billion they had committed to raise by 2022 during the 2018 HLM. Similarly, only half of the $2 billion pledged annually for TB R&D has materialized.While many in the TB community celebrated the adoption of the declaration, it is important to note that the document does not go as far as some advocates would have liked, particularly on equity and inclusiveness provisions, and others have expressed disappointment about the lack of engagement from heads of state. That said, the ambitious funding targets set forth in the declaration hold the potential to make a significant impact if they are met with concrete actions, accountability, and global leadership. Now, the challenge lies in holding governments accountable for their commitments by putting in place robust monitoring mechanisms to track progress.So where do we go from here? With all three political declarations adopted at the HLMs, the General Assembly must formally ratify them in the coming week, and there could still be fights ahead, as several member states lodged objections ahead of the summit. The UNGA HLMs shed light on the global community's priorities on PPPR, UHC, and TB but also gave insight on the lack of concrete commitments from member states. Heads of state were disappointingly underrepresented in all three. Statements from ministers were verbose on gaps and needs but short on commitments and implementation.Zooming out to the broader ecosystem, it is reassuring to see alignment between multilateral bodies, such as the G7’s promise to foster innovative technologies for TB and other diseases, acknowledging the need for advancements in this critical area. In fact, one of the major concrete announcements of the week was the government of Japan launching its Impact Investment Initiative for Global Health (Triple I for GH), a new G7 initiative that seeks to align private and nonprofit stakeholders around best practices for impact investment in global health. Finally, the G20 also reaffirmed its commitment to combat TB and other diseases and to support the interim MCMs platform under development by WHO.While the HLMs were significant milestones, the true test lies in the implementation of commitments. With the political declarations being nonbinding, it is now up to other multilateral bodies to pick up the baton and ensure targets are established, commitments are made, and leaders deliver on implementation. Looking ahead, the deliberations around the pandemic accord will next take center stage through the intergovernmental negotiating body on the pandemic accord, with the process set to conclude by next year. Several member states hope this will serve as a vehicle to advance discussions on the development and access to MCMs. Similarly, IHR reforms offer a chance to advance key elements of the PPPR agenda, such as data sharing and other core capacities.  The G7 and G20 will also need to play a bigger role in financing all these ambitions.The HLMs ultimately served as a good reset moment to reemphasize the importance of these global health priorities, but it is now up to other forums and national governments to work collaboratively to translate pledges into action.

The Honorable Xavier Becerra Secretary of the Department of Health and Human Services The U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 RE: Support for an FDA Emerging Pathogens Preparedness Program Dear Secretary Becerra, We thank you for your leadership and contribution towards the United States’ pandemic preparedness strategy. In light of the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), we write to express our strong support for the FDA’s proposal to create an Emerging Pathogens Preparedness Program within the FDA's Center for Biologics Evaluation and Research (CBER). The FDA’s Summary of FY 2024 Legislative Proposals puts forward a plan for an Emerging Pathogens Preparedness Program that would “defend against emerging pathogens so the agency is better positioned to respond to identified threats of concern and focus experienced resources to work quickly on medical countermeasure development.” The increased regulatory capacity CBER provided to review COVID-19 vaccines was crucial to the success of Operation Warp Speed. According to Paul Mango’s Warp Speed memoir, CBER director Peter Marks “restructured his team and its internal processes to work around the clock to accelerate the evaluations.” A permanent office within CBER to handle preparedness and response would enhance this capacity for future pandemics. The reauthorization of PAHPA offers the perfect opportunity to do so, by embedding the regulatory successes of Operation Warp Speed in a more sustainable way. An IMF paper recently estimated that each day of the COVID-19 pandemic in 2020 and 2021 cost the U.S. economy $26 billion. 1 The massive value of preventing or shortening pandemics makes it critical to prepare for “Disease X” – a future catastrophic biological risk that could in theory be far worse than COVID. This has led to proposals by the G7 2 and the Coalition for Epidemic 2United Kingdom Cabinet Office. (2021). 100 Days Mission to Respond to Future Pandemic Threats. 1Baker, J., Chaudhuri, A., & Kremer, M. (2021). Accelerating Vaccinations. Finance & Development, 58(1). Preparedness Innovations 3 for a “100 Day Mission” to roll out vaccines and other countermeasures within a hundred days of the start of the next pandemic. To do this will require conducting early clinical trials on prototype vaccines against pathogen families with pandemic potential before an emergency occurs. These trials will need close supervision by the FDA and proactive guidance of how their data would be used in the event of a pandemic. Providing dedicated regulatory capacity at the FDA for this purpose is crucial to achieving these important goals. Finally, a dedicated CBER office could be used to facilitate future programs in the model of Operation Warp Speed. By ensuring rapid regulatory decision-making for target product categories whose social value greatly exceeds their market value, the proposed office could build a “warm base” of regulatory capacity that could be drawn on in the event of an emergency. We have been excited to see the announcement of President Biden’s “Project NextGen.” Creating an office like the one described can ensure that the next generation of coronavirus vaccines receive the same regulatory capacity and accelerated development that was so crucial to vaccines approved during Operation Warp Speed. The anticipated annual cost of an office to support the FDA’s proposed program is about $10-15 million, but its value in supporting preparation and response for the next pandemic is immense. Merely providing 1% of Project Next Gen’s $5 billion would ensure strong coronavirus vaccine review capacity for the next several years. Therefore the signatories below express our strong support for the program’s creation and funding. Sincerely, 1Day Sooner American Society for Microbiology BIO Coalition to Stop Flu Critical Path Institute Federation of American Scientists Global Health Technologies Coalition Infectious Diseases Society of America Institute for Progress International Vaccine Institute 3 Coalition for Epidemic Preparedness Innovations. (2022). CEPI 100 Days Report: Building a More Prepared World to Stop Pandemics. Medical Countermeasures Coalition National Foundation for Infectious Diseases Research!America Technologies for Pandemic Defense CC: Major General (ret) Paul Friedrichs Inaugural Director of the Office of Pandemic Preparedness and Response Policy (OPPR) and Principal Advisor on Pandemic Preparedness and Response. CC: Ms. Dawn O’Connell Assistant Secretary for Preparedness and Response (ASPR).

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 National Institute of Allergy and Infectious Diseases awarded Kephera Diagnostics two Small Business Innovative Research grants, totaling $5.7 million, for the development and testing of immunoassays for Lyme disease and Chagas disease. The company’s Lyme disease immunoassay could simplify diagnosis by eliminating the need to perform one of the two steps now used in the screening and confirmatory testing process. Kephera’s immunoassay for Chagas disease is designed to monitor treatment response in patients, as current drugs vary in efficacy in adults with chronic infections. It is being developed both for laboratory use and use in the field.A phase 1 trial evaluating a novel preventive HIV vaccine candidate, VIR-1388, has begun enrollment in the United States and South Africa. VIR-1388 is designed to prompt the immune system to produce T cells that can recognize and signal an immune response to prevent the virus from establishing chronic infection. It delivers vaccine material using a cytomegalovirus (CMV) vector, whose discovery and development was funded by the National Institute of Allergy and Infectious Disease (NIAID). Because CMV, while harmless, remains detectable in the body for life, researchers hope this vector will help the body retain the vaccine material for a longer period of time, overcoming the waning immunity seen with other candidate vaccines. The trial is sponsored by Vir Biotechnology with support from NIAID and the Bill & Melinda Gates Foundation.Last week saw the launch of a third phase 1 clinical trial of the ChAdOx1 vaccine candidate for Middle East Respiratory Syndrome (MERS). If eventually approved, the vaccine would be a game-changing tool against the viral illness, for which there are no approved vaccines or treatments, and which is recognized by the World Health Organization as a priority pathogen with epidemic potential, especially in light of new cases reported this year. The University of Oxford’s Pandemic Sciences Institute started developing the vaccine for MERS before the COVID-19 pandemic, and the research for ChAdOx1, which was put on pause during the pandemic, enabled the rapid development of the Oxford/AstraZeneca vaccine for COVID-19.