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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.

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 Thursday, the US Senate confirmed Dr. John Nkengasong as US global AIDS coordinator to head the President's Emergency Plan for AIDS Relief, or PEPFAR. Dr. Nkengasong, a Cameroonian virologist who currently serves as director of the Africa Centres for Disease Control and Prevention (CDC), is the first person born on the African continent to take on the global AIDS coordinator role. President Joe Biden nominated him for the position last September, following a gap in permanent leadership since Dr. Deborah Birx departed in 2020. Prior to his position at Africa CDC, Dr. Nkengasong worked at PEPFAR on strengthening laboratory capacity across Africa. Africa CDC Deputy Director Dr. Ahmed Ogwell Ouma will head the agency in the interim while the African Union Commission selects a new director.The World Health Organization (WHO) last week released a rapid communication stating that patients 15 and older with multidrug-resistant tuberculosis (TB) or rifampicin-resistant TB can take a six-month, all-oral treatment regimen—comprising the drugs bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM)—instead of a regimen lasting nine months or longer. The guidance also indicates that patients with multidrug-resistant TB or rifampicin-resistant TB who have developed resistance to fluoroquinolones can subscribe to the same six-month treatment regimen, but without moxifloxacin—known as BPaL. WHO has previously recommended the BPaL and BPaLM treatment regimens, but only under operational research conditions; the new recommendation will allow programmatic implementation of treating almost all forms of drug-resistant TB with either of the shorter regimens.Two novel COVID-19 vaccine platforms—a plant-based coronavirus-like particle vaccine and a receptor-binding domain (RBD)–dimer-based vaccine—showed promising results, according to studies published last week based on phase 3 clinical trials. The two-dose, plant-based particle vaccine, developed by Medicago and GlaxoSmithKline, showed 69.5 percent efficacy against symptomatic COVID-19 caused by five variants identified in sequencing, and no severe cases or deaths were recorded. The RBD-dimer-based vaccine, developed by Anhui Zhifei Longcom, is a three-dose shot that showed 75.7 percent efficacy against infection and 87.6 percent efficacy against severe to critical disease. Neither vaccine requires extreme cold chain storage, which makes them appealing candidates for global COVID-19 vaccination efforts.

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. More newborn babies with sepsis are dying because their infections are not responding to the usual antibiotics, according to the largest global study on the subject to date. The study, sponsored by the Global Antibiotic Research and Development Partnership (GARDP), which enrolled 3,200 newborns diagnosed with sepsis in 11 countries, found that 11 percent of newborns died over the course of the study and that 15 percent were prescribed last-line antibiotics due to the high degree of resistance to standard recommended antibiotics in treatment units. Antibiotic resistance is now one of the major threats to newborn health globally, according to researchers, with virtually no studies underway to develop novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections. GARDP is now designing an interventional trial to identify better treatment regimens to combat rising resistance.World Health Organization (WHO) member states reached a preliminary agreement this week to gradually increase mandatory fees, or “assessed contributions,” to cover 50 percent of the organization’s core budget needs. WHO currently relies heavily on voluntary contributions and private donors, which can leave its financing inflexible and unpredictable. The new funding reforms would be contingent upon certain conditions, such as increased transparency, with the funding linked to a member state review of WHO progress on promised internal reforms. The agreement will still need to be formally approved by governments at the World Health Assembly in May to take effect.COVID-19 diagnostic testing has fallen by 70–90 percent around the world, making it increasingly difficult to monitor the pandemic’s evolution, treat patients, and track variants, according to FIND, a co-convener of the Access to COVID-19 Tools Accelerator diagnostics pillar. While reported cases and deaths are declining globally, changes in testing strategies and reductions in the number of tests being used globally means there is little confidence in actual case trends. The testing decline also undermines the ability to treat patients with new therapeutics—like Pfizer’s antiviral Paxlovid, which requires early diagnosis to get the most benefit—and has led to a decrease in the number of genomic sequences submitted to global databases, which helps track emerging variants.