Research Roundup: The second Global COVID-19 Summit, a 'variant-proof' vaccine, and a TRIPS waiver proposal

The 75th World Health Assembly (WHA) will kick off Sunday with delegates and limited civil society gathering in person in Geneva, Switzerland, for the first time since the pandemic was declared more than two years ago. While immediate COVID-19 response needs still remain a high priority, the conversation has also shifted to how to reform the global health architecture to better prepare for future health threats and how to reinvigorate the fight against other health challenges. Here are the top five issues GHTC will be tracking:1. Will WHO get a budget boost?Many experts have pointed to the World Health Organization’s (WHO) financial health as a key obstacle hindering the agency’s ability to plan strategically and respond effectively during crises. Over the past two decades, assessed member state contributions—or countries’ mandatory dues to WHO—have stagnated, today accounting for just 16 percent of the WHO budget. This has left the agency increasingly reliant on unpredictable, often earmarked voluntary contributions from wealthy countries and philanthropic donors. In January 2021, the WHO Executive Board (EB) tasked a new WHO Working Group on Sustainable Financing with remedying this problem. In late April, the group announced it had reached a consensus agreement to raise assessed contributions to cover 50 percent of WHO’s base budget by 2030, which would be linked to progress on WHO governance reforms. While this agreement is a positive signal of broad member state support, it still needs to be adopted at WHA, which is not a certainty. If approved, the first increases will take place next year and will hopefully usher in a more solid, sustainable financial future for WHO.2. What changes are ahead for WHO and the global preparedness architecture?Heading into WHA, several processes have begun unfolding that could fundamentally alter how WHO—and the world—prepares for and responds to health emergencies. At the 74th WHA and the November Special Session, member states established a new Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR) and an Intergovernmental Negotiating Body (INB) to advance a potential new pandemic treaty or instrument. While the INB is not expected to meet again until June, after holding a historic public hearing in April, the WGPR has released its draft report of recommendations for WHA consideration. Among other actions, the WGPR proposes independent evaluations to determine the future and evolution of new initiatives like the Access to COVID-19 Tools Accelerator, COVID-19 Technology Access Pool, mRNA vaccine hub, and BioHub pathogen sharing system and calls for member states to grow national and regional manufacturing capacity. Notably, the report also calls for a process to amend the International Health Regulations (IHR), the current legal framework that dictates member state responsibilities to prevent and combat disease outbreaks, urging this year’s assembly to adopt any amendments that are ready. The US government has already submitted its amendments for IHR reform for WHA consideration, but other resolutions from member states could still be forthcoming. It remains to be seen whether the assembly takes forward any amendments this year or pushes the process into 2023.Alongside IHR reform, we’ll also be watching whether WHA takes action to expand the Global Influenza Surveillance and Response System (GISRS), following a report presented at January’s EB that suggested GISRS be broadened to cover other respiratory viruses with epidemic and pandemic potential, building on the success of leveraging the system for the COVID-19 response. In the interim months between, the WHO Secretariat has engaged with stakeholders for feedback on this proposal, but it’s unclear whether WHA will vote on this proposal, and key questions remain as to how this expansion would align with other related initiatives like the WHO BioHub pathogen sharing system and requirements of the Nagoya Protocol, which governs the access and benefit-sharing provisions of biological sample sharing.3. How’s the progress report on TB innovation, NTDs, and immunization?While COVID-19 and health preparedness are consuming much of the political energy going into the 75th WHA, they are certainly not the only global health challenges the world is facing. This year’s assembly will also take up agenda items on the global strategy for tuberculosis (TB) research and innovation, the road map for neglected tropical diseases (NTDs), and Immunization Agenda 2030, which are all WHO-led health-area strategies that run through 2030. While the assembly is just expected to hear progress reports on these matters and interventions from member states and civil society, given the significant impact of COVID-19-related disruptions on many of these issues, it will be important to hear whether targets are on track, gauge the level of political will to reinvigorate efforts against these critical challenges, and see what concrete steps member states highlight as priority areas for WHO. In addition, the assembly is also expected to vote to extend the global strategy and plan of action on public health, innovation and intellectual property, which now runs through 2022, until 2030.4. Will a resolution drive changes in the way clinical trials are approached?While this matter has largely flown under the radar, the assembly is anticipated to consider a resolution introduced by the United Kingdom aimed at improving the quality of clinical trials. The intent of the resolution is to build on lessons learned from the COVID-19 pandemic, which drove a surge in funding for clinical research on COVID-19 tools, but also saw many trials that weren’t large enough or employed inconsistent 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 urges 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 requests WHO develop a global action plan to strengthen clinical trial practices to be presented for consideration at next year’s assembly.5. Will civil society engagement be satisfactory this year?During these past pandemic years, civil society has unfortunately experienced diminished opportunity to meaningfully engage in WHA and other WHO meetings as forums have turned virtual and agendas have become increasingly jam-packed. Last year and this year, WHO experimented with separate pre-WHA consultations for non-state actors (NSAs), which have left many participants dissatisfied as actual member state participation has been low and the mechanism is unclear for how feedback is transmitted to member states. This year, NSAs have been invited back to the Palais in person for the first time since the pandemic began, with passes limited for safety, and they are expected to be able to deliver interventions live before the assembly. Yet continued scheduling constraints often result in limited time for NSA interventions at best, or being excluded from speaking on certain agenda items altogether at worst. In addition, with few technical public consultations and little transparency around the status of negotiations on specific agenda items, NSAs are left with fewer vehicles to influence proceedings than in the past. We’ll be watching closely if this semi-return to normal engenders better opportunity for NSAs to have their voices heard and will continue to push for robust civil society involvement this year and beyond.

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.