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GHTC delivered the following statement, on the 75th World Health Assembly (WHA) agenda item 14.3 Global strategy for tuberculosis research and innovation, on May 13, 2022 at the US Department of Health and Human Services (HHS) WHA stakeholder listening session:Thank you for the opportunity to provide feedback on the global strategy for tuberculosis research and innovation. To reverse the impact of the pandemic, avert preventable deaths, and put the world on track to end tuberculosis (TB), essential TB services must be restored as a matter of urgency, and more domestic and international resources need to be mobilized. It is also critical that the development and uptake of new technologies is part of that investment. The Treatment Action Group reported TB research and development investment of US$915 million in 2020, far below the 2018 UN high-level meeting target of at least US$2 billion per year. Annual funding for TB research needs to more than double to reach the global target.Therefore, GHTC calls on the United States to:Support research capacity globally to expand the pipeline of new and equitably accessible TB tools, especially true point-of-care molecular diagnostics, new antibiotic regimens, and vaccines.Address the unmet needs in translational research for TB. The pandemic has demonstrated that rapid sharing of data helps accelerate research and discovery. Some countries have already made strides by using common protocols coordinated through the Regional Prospective Observational Research for Tuberculosis (RePORT) network and contributed data and biospecimens to the platform. The United States should continue to push for additional coordination and collaboration through these platforms.Address the drug-resistant TB crisis and close persistent gaps in diagnosis and treatment access and care. The United States should work with the World Health Organization and member states to ensure that the process for including new technologies to fight drug resistant TB on the essential medicines and diagnostics lists and other guidelines is streamlined. 

GHTC delivered the following statement, on the 75th World Health Assembly (WHA) agenda item 14.5 Immunization Agenda 2030, on May 13, 2022 at the US Department of Health and Human Services (HHS) WHA stakeholder listening session:Thank you once again for the opportunity to provide feedback on this important agenda item. Many recent scientific and multilateral agency reports and publications suggest that overall, immunization took a step backward in the past two years. Despite the tireless efforts of countless immunization program staff and health workers to ensure the availability of vaccination services, vaccination coverage globally fell for the first time in a decade. The COVID-19 pandemic has overwhelmed immunization infrastructure and workforce, impacted the global supply chain, increased the incidence of antimicrobial resistance, and derailed gains made in immunization campaigns around the world. Therefore, GHTC calls on the United States to:    Focus on the full spectrum of innovations that support immunization programs. The near term will inevitably be dominated by a continuing focus on COVID-19 vaccine rollouts. Nevertheless, it is vital that these activities are also leveraged to strengthen vaccine manufacturing capacities to address a broader range of health areas. This also includes storage, administration, and coadministration with other health interventions as well as novel service delivery, including focused “test & vaccinate” strategies as recently recommended by the Gavi board.  Support the development of formal feedback loops to monitor follow up and implementation of recommendations made by the WHO Strategic Advisory Group of Experts on Immunization and other regional immunization technical advisory groups.  Accelerate and expand the COVAX facility research and development agenda to advance next-generation COVID-19 vaccines, including “variant-proof” COVID-19 vaccines and shots that could provide wide protection against coronaviruses, vaccines with optimized dosing, and vaccines more suitable for delivery in low-resource settings. World leaders must also do everything in their power to correct the shameful lack of equitable access to these lifesaving tools.  

GHTC delivered the following statement, on the 75th World Health Assembly (WHA) agenda item 14.4 Road map for neglected tropical diseases 2021–2030, on May 13, 2022 at the US Department of Health and Human Services (HHS) WHA stakeholder listening session:Neglected tropical diseases (NTDs) are inextricably linked to poverty and inequality. These diseases exact a heavy toll, causing chronic illness, severe disfigurement, blindness, and death. More than 1.5 billion people are estimated to require interventions against NTDs each year with many existing tools inadequate to effectively screen and treat populations in low-income and low-resource settings. Increased attention in recent years has brought new resources to the fight against NTDs and fueled research breakthroughs. Yet, very significant gaps remain in the arsenal of tools needed to control and eliminate these diseases, underscoring the need for research and development (R&D) of new tools.Therefore, GHTC calls on the United States to:  Address the current diagnostic gaps for NTDs. The Diagnostic Technical Advisory Group for Neglected Tropical Diseases recently published several target product profiles, and more guidance from the World Health Organization (WHO) will be necessary to spur the development of new diagnostic tools. We urge the United States to work with WHO and member states to explore regulatory and manufacturing pathways to facilitate prequalification and regulatory approval of in-vitro diagnostics.We call on the United States to fill key gaps by investing in R&D for new and improved treatments and prevention tools across the scope of NTDs, including therapies designed for children and shorter, simplified regimens with fewer side effects.

GHTC submitted the following statement online as part of the US Department of Health and Human Services (HHS) 75th World Health Assembly (WHA) stakeholder listening session in response to a draft WHA resolution proposed by the United Kingdom:While the pandemic has disrupted and delayed many research activities, it has also highlighted the importance of quality clinical trials in responding to public health threats nationally, regionally, and globally. Leaders recognize the need for additional investment, new capacities, and reform of existing systems to create a stronger enabling environment for research and development (R&D) in low- and middle-income countries. As countries seek to develop a more responsive and resilient global health architecture, it is vital to bolster regionally distributed clinical trial capacity. This resolution on strengthening clinical trials to improve public health is a strong first step, taking concrete action to facilitate investment in high-quality clinical trials, adopt robust clinical trial standards in routine practice to expedite the development of effective health care interventions, and develop the governance infrastructure to support enhanced collaboration and coordination between nations.  We urge the United States to support the resolution and to: Endorse the provision in the resolution calling for grant funding for clinical trials to be linked to required use of standard data protocols where available. Work with the World Health Organization and other member states to support the provision highlighting the need for data sharing between regulatory authorities to speed up and harmonize clinical trial approvals in other countries. Support greater clinical trial capacity globally through investment and technical support, enabling a greater number of clinical trial sites in lower- and middle-income countries and more readily coordinating activity between existing and new clinical trial networks. Elevate the Global Health Security Agenda as a platform where lower- and middle-income countries can articulate investment opportunities, highlight bottlenecks, share best practices, and align around R&D capacity assessment needs.

Ahead of the 2nd Global COVID-19 Summit tomorrow, GHTC Executive Director Jamie Bay Nishi shared the coalition’s commitments to unlocking funding to advance research to expand the pipeline of affordable, easier-to-deploy COVID-19 technologies for low-resource settings and strengthen regionally distributed research and development (R&D) capacity.Her video remarks are below, followed by GHTC’s full commitments across the three summit thematic pillars: Full commitmentsVACCINATE THE WORLD: The Global Health Technologies Coalition will amplify evidence of gaps in the upstream vaccine research and development (R&D) aspects of the COVID-19 response and work to ensure political support and additional resources to support R&D of next-generation vaccines designed to better reach the last mile and address emerging variants and for strengthening regional research and manufacturing capacities. This includes expanding multisector support for research and clinical trials to accelerate vaccine development, strengthening vaccine prequalification and regulatory authorities to facilitate market entry while ensuring quality and safety, and mobilizing sustainable financing for regional vaccine manufacturing hubs that can be deployed for the COVID-19 response but also effectively leveraged and optimized for a broader range of health areas.SAVE LIVES NOW: The Global Health Technologies Coalition (GHTC) will hold public- and private-sector stakeholders accountable to unlocking funding and advancing research to expand the pipeline of affordable, easy-to-deploy diagnostics and therapeutics, particularly for use in low-resource settings. GHTC will galvanize its partners to push for more efficient prequalification and regulatory reviews of novel COVID-19 technologies and work to remove policy barriers to support bolstered testing, surveillance, genomic sequencing, and data sharing to better detect and monitor emerging variants. GHTC will also amplify the calls by its global partners for strengthened regional capacities to manufacture all types of medical countermeasure products.BUILD BETTER HEALTH SECURITY: The Global Health Technologies Coalition (GHTC) supports the creation of a new pandemic preparedness fund and will leverage its platform and network of partners to highlight how the fund should be utilized to bolster country and regional pandemic research and development (R&D) capacities including surveillance, laboratory infrastructure, clinical trial, manufacturing, regulatory capabilities, pharmacovigilance, and supply chain management. The Global Health Security Agenda (GHSA) is a ready-made platform for countries to identify and articulate their capacity gaps and financing needs. GHTC, through the Global Health Security Agenda Consortium, is engaging the GHSA R&D Task Force to develop a tool that enables countries to assess their R&D pandemic preparedness capabilities. The Task Force also serves as a platform to elevate perspectives of national and regional stakeholders, especially those from low- and middle-income countries, to ensure global investments and new sustainable financing for pandemic preparedness are allocated to filling key national and regional R&D capacity gaps.