GHTC delivers statement on global TB research and innovation strategy at HHS WHA listening session

Next week’s World Health Assembly will be setting priorities that could have enormous implications for billions of people around the world. As World Health Organization (WHO) member states considers this year’s agenda items, GHTC urges them to prioritize the following actions to bolster research and development (R&D) to combat long-standing and emerging threats.:Global strategy for tuberculosis research and innovation: Substantially increase investment in tuberculosis R&D in line with fair share targets, improve coordination through global platforms and protocols, and streamline regulatory pathways and guidance processes to accelerate products to patients.Road map for neglected tropical diseases 2021–2030: Expand investment in R&D for urgently needed treatment and prevention tools for neglected tropical diseases, including therapies designed for children and simplified regimens, and advance regulatory and manufacturing pathways for diagnostic products to close the diagnostic gap.Immunization Agenda 2030: Strengthen implementation of recommendations from WHO’s expert body on immunization, accelerate the R&D agenda to advance next-generation COVID-19 vaccines, and support research on the full spectrum of needed immunization innovations, including vaccine administration, storage, and delivery tools.Draft resolution “Strengthening Clinical Trials to Improve Public Health”: Support the draft resolution, including its provisions calling upon countries to link grant funding with requirements to use standard data protocols, improve data sharing and harmonization, and increase investments in strengthening clinical trial capacity globally.Read GHTC’s full position statements on each agenda item below.14.3 Global strategy for tuberculosis research and innovationProgress toward tuberculosis milestones and targets has been hit hard by the COVID-19 pandemic. In 2020 alone, annual deaths from tuberculosis increased from 1.4 million to 1.5 million globally, far fewer people were diagnosed and treated for tuberculosis, and spending on essential tuberculosis services and research failed to increase in line with existing and new needs. This poses a risk to the achievement of the targets set in the political declaration of treating 40 million people diagnosed with tuberculosis and providing tuberculosis preventive treatment to 30 million people by 2022.To reverse the impact of the pandemic, avert preventable deaths, and put the world on track to end tuberculosis, essential tuberculosis 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 tuberculosis 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 tuberculosis research needs to more than double to reach the global target.Therefore, GHTC calls on the World Health Organization (WHO) and member states to:Substantially increase investments in tuberculosis research to drive technological breakthroughs and the rapid uptake of innovations, ensuring they are adapted to the needs of all populations, including children. Member states must mobilize domestic resources, foster public–private partnerships, and incentivize the responsible and well-regulated engagement of pharmaceutical companies, biotechnology firms, and other health product developers to expand the pipeline of new and equitably accessible tuberculosis tools, especially true point-of-care molecular diagnostics, new antibiotic regimens, and vaccines. While the specific call for member states to meet their tuberculosis research funding fair share targets is most welcome, much work remains to make these targets a reality.Address the unmet needs in translational research for tuberculosis. 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. Member states should double down and push for additional coordination and collaboration through these platforms.Address the drug-resistant tuberculosis crisis and close persistent gaps in diagnosis and treatment access and care. WHO and member states should work to ensure that the process for including new technologies to fight drug-resistant tuberculosis on the essential medicines and diagnostic lists and other guidelines is streamlined, and that national regulatory agencies simplify local processes and collaborate regionally to ensure greater harmonization to facilitate the uptake of these technologies.WHO must continue to support the implementation of the global strategy for tuberculosis, including through the Special Programme for Research and Training in Tropical Diseases to provide crucial capacity-building and implementation research support to countries.14.4 Road map for neglected tropical diseases 2021–2030Neglected 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. COVID-19 has also significantly disrupted interventions and activities across the entire spectrum of research and essential health services for NTDs. Leaders must demonstrate greater urgency to ensure that the progress made over the past decade is not reversed due to challenges caused by the pandemic.Therefore, GHTC calls on the World Health Organization (WHO) and member states to:Address the current diagnostic gaps for NTDs. The Diagnostic Technical Advisory Group for Neglected Tropical Diseases recently published a number of target product profiles, and more guidance and support from WHO will be necessary to spur the development of new diagnostic tools. We urge WHO and member states to work together to explore regulatory and manufacturing pathways to facilitate prequalification and regulatory approval of in-vitro diagnostics.Support programs that help catalyze innovation and build capacity to develop new diagnostics, drugs, vaccines, and other health technologies, and urge WHO to facilitate greater coordination across the full scope of diseases. Accelerated programmatic action could advance scientific understanding for developing new tools, improving strategies, and strengthening service delivery. We urge member states to fill key gaps by investing in R&D for new and improved treatments and prevention tools, including therapies designed for children and shorter, simplified regimens with fewer side effects.14.5 Immunization Agenda 2030Many 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 (AMR), and derailed gains made in immunization campaigns around the world. Immunization is a pillar of people-centered primary health care, and we urge the World Health Organization (WHO) and member states to strengthen vaccine-related research and innovation with the most vulnerable populations in mind.GHTC calls on WHO and member states to: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.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, storage, administration, and co-administration with other health interventions as well as novel service delivery, including focused “test & vaccinate” strategies as recently recommended by the Gavi board.Support implementation research and the development of formal feedback loops to monitor follow-up of recommendations made by groups such as the Strategic Advisory Group of Experts on Immunization and regional immunization technical advisory groups.Strengthen manufacturing capacities in low- and middle-income countries. This support must be paired with parallel investment and coordination to ensure sustainable markets exist to procure locally manufactured vaccines. This also includes supporting strengthening regional and national regulatory bodies, ensuring locally manufactured vaccines are safe, effective, consistent, and of high quality.Mandate WHO to immediately lead a comprehensive assessment of the resources and policies needed to meet IA2030’s targets.Draft resolution “Strengthening Clinical Trials to Improve Public Health”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 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 member states to support the resolution and to:Endorse the provision in the resolution calling for grant funding for clinical trials to be linking to requiring using standard data protocols where available and to mandate registration on a clinical trial registry within the World Health Organization’s International Clinical Trials Registry Platform.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.

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.