Research Roundup: COVID-19 bivalent vaccines, Bird flu outbreak, RSV vaccine

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, CEPI announced a partnership with Dutch biotechnology company, 20Med, to support the development of technology that could eliminate the need for frozen storage of mRNA vaccines. The initial investment of up to US$850,000 will go toward a proof-of-concept of the company’s bio-responsive polymeric nanoparticle platform technology. If effective, the technology could help make major strides in access to mRNA vaccines, which transformed the global response to COVID-19 and have the potential to address a number of other diseases but require cold storage, which creates access challenges to these products, especially in low resource settings.A recent study in The Lancet found that an experimental vaccine against Marburg virus was safe and produced an immune response in a small, first-in-human phase 1 clinical trial. The candidate, cAd3-Marburg, was developed at the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center and uses a vaccine platform called cAd3, which previously demonstrated a good safety profile in investigational vaccines developed for Ebola virus and Sudan virus by the center. Further trials of the vaccine candidate are planned in Ghana, Kenya, Uganda, and the United States, which could propel the candidate as a viable tool in the response to outbreaks of Marburg virus.2022 saw a handful of milestones in the fight against neglected tropical diseases (NTDs) with Togo becoming the first country to eliminate four of the diseases and Malawi eliminating trachoma, among other achievements. However, to address the major challenges that remain, funding for the research and development (R&D) of improved treatments and diagnostics will be crucial. New medicines to treat NTDS are urgently needed as current treatments medicines are often ineffective, intolerable, or entirely absent. While promising innovations for treatments against sleeping sickness and visceral leishmaniasis, among others, are in the pipeline, collaboration and partnerships will be necessary to catalyze further innovation and development.

Next week, the World Health Organization’s (WHO’s) 152nd Executive Board (EB) meetings kick off in Geneva, with delegates and civil society representatives participating in person for the first time in two years. Recent months have seen a shift away from COVID-19 and an increased focus on long-term reforms to the broader global health architecture. While the dialogue around designing global frameworks and new mechanisms to address future health threats is vital, many of the discussions on poverty-related and neglected diseases are seemingly absent from this year’s discourse.  Here are the four issues to watch at this year’s meetings: Continued focus on global health security  2022 was a fruitful year for advancing two processes that will significantly influence the future of pandemic response. First, the intergovernmental negotiating body tasked with shepherding the Pandemic Accord process developed its first conceptual draft for the new framework. This comes following multiple public hearings, member state negotiations, and consultations on specific elements including equity, access and intellectual property, and antimicrobial resistance. Encouragingly, the document includes some strong research and development (R&D) focused language and recognizes R&D as an integral pillar of health preparedness. However, the current draft emphasizes downstream response measures such as manufacturing and registration, with less of a focus on early-stage research, clinical development, and even post-registration access and delivery of health tools. Additional focus on early-stage discovery research, clinical development, regulatory processes, and access and delivery of medical countermeasures is needed to ensure the type of true end-to-end approach critical to global health security. The second major global health security focused process has been centered around targeted amendments to the International Health Regulations. This policy discussion primarily focused on changes to provisions on trade and travel health certificates, as well as data-sharing and reporting requirements. Though perhaps less prominently discussed, disputes over intellectual property, in particular those centered on genetic sequence and pathogen sharing, remain major barriers to consensus. Both of these processes will be debated during EB, and we can expect a concerted effort to clearly delineate these processes and advance dialogues around defining the terminology and scope of both endeavors.  Limited progress on the implementation of the clinical trials resolution Last year, member states passed a resolution on clinical trials with the intent to build on lessons learned from the COVID-19 pandemic. The crisis drove a surge in funding for clinical research on COVID-19 tools, but we also saw many trials that were not large enough or that failed to employ consistent protocols and outcome measurements across geographies, making it difficult to pool and compare data to turn conclusions into medical practice. Among other matters, the resolution urged countries to better coordinate research, standardize protocols, improve reporting on trial registration and results, and work to increase clinical trial capacity globally, particularly in low- and middle-income countries—though none of these actions are binding. It also requested that WHO develop a global action plan to strengthen clinical trial practices to be presented for consideration at this year's assembly.EB will provide a chance to level set the current status of the implementation of the clinical trials resolution and figure out which elements of the framework could be improved. Previous discussions suggest that the current progress in implementing the resolution has been limited. During consultations held last fall, member states highlighted gaps in data on specific population groups and disease targets, as well as gender biases in data, which may result in these groups being precluded from access to needed interventions, as a point of inequity that must be addressed. The public consultation also noted the crucial importance of strengthened national regulatory authorities and national ethics committees, as well as increased international collaboration and coordination for efficient funding of agreed-upon priorities for multinational and multiregional trials, where appropriate.  The EB now has a chance to build on the progress and push WHO to follow through on their global action plan and for member states to support mechanisms like the WHO International Clinical Trial Registry Platform to push this agenda forward.  A new resolution on diagnostics could be passed New on the docket this year is a resolution that focuses on the development of—and access to— diagnostics. A recent Lancet report sounded alarm bells, highlighting that almost half of the global population has little or no access to diagnostics. The COVID-19 pandemic has clearly shown that a country’s diagnostic capacity is directly linked to its ability to respond to pandemics with appropriate public health measures and effective monitoring of emerging variants. Given the depth of the challenge, sustained access to quality, affordable diagnostics will require multi-decade prioritization, commitment, and investment.  This resolution is a good first step in acknowledging the need for more political will in addressing the diagnostics gap. Notably, it urges member states to develop a National Essential Diagnostics List, adapting the WHO Model List of essential in vitro diagnostics and the WHO List of Priority Medical Devices. The resolution further urges countries to invest in R&D, expanding manufacturing capacity for diagnostic medical devices and surveillance and strengthening international collaboration and assistance during epidemics and pandemics.  The resolution also calls on WHO to support member states to strengthen national and regional regulatory systems for diagnostic medical devices, collect data on the affordability and availability of essential diagnostic medical devices, and consider and support mechanisms for procurement that will enable access to high-quality, affordable diagnostic technologies for all member states. Some hurdles to approving this resolution remain, including outstanding disagreements on whether to include provisions pertaining to intellectual property and access, but there appears to be broad support from member states to get this resolution across the finish line in Geneva.  UHC back in the spotlight Universal health coverage (UHC) is also back in focus for this year’s EB, especially with September 2023 marking the halfway point of the timeline to reach the Sustainable Development Goals (SDGs) and leaders preparing for a United Nations High-Level Meeting on them at this year’s General Assembly. While some progress toward the SDGs has been made, the COVID-19 pandemic caused major disruptions in both health services and the development of health system capacities globally.  From a research perspective, a report by WHO ahead of EB highlighted that research and innovation continues to play a crucial role in UHC. Inequitable access to medical products is among the main causes of financial hardship in many lower- and middle-income countries. The report also notes how the recent World AIDS Day 2022 campaign highlighted the dangers of these inequalities, calling on global leaders and citizens to equalize access to essential HIV services, particularly for children and key populations, in order to end AIDS as a public health threat.  EB is a chance to hit reset on the UHC dialogue and for countries to reaffirm their commitment to the SDGs. It is also an opportunity to reassert that health system strengthening supports all health areas, including pandemic preparedness and poverty-related and neglected diseases. It is vital that leaders break down silos and take a more holistic approach to ensure progress toward advancing the global development agenda and 2030 targets. As discussions on global health architecture reforms advance, and new investments in pandemic preparedness are made, it is vital that global decision-makers ensure the benefits of these resources are also leveraged to benefit the fights against tuberculosis, HIV, malaria, and neglected tropical diseases.