Research Roundup: Cold storage alternative technology, Marburg vaccine trial, NTD R&D

As is tradition, the World Health Organization (WHO) Executive Board (EB) kicked off what promises to be another packed multilateral calendar. While much has remained the same, this year’s forum also ushered in noteworthy shifts in deliberations, dynamics, and dialogue that advocates should be aware of. Here are GHTC’s top takeaways from the week: 1. EB shrinks space for civil society engagement. As civil society delegates entered the halls of WHO for the EB for the first time since 2020, they were confronted with a harsh reality: The ability for non-state actors to meaningfully participate in these meetings is at an all-time low. New protocols had been introduced limiting delegation size and physical and structural changes put in place that left civil society literally on the outside looking in. Gone are the days when civil society could be physically present in the assembly room to follow the proceedings. Instead, advocates were relegated to a small, hot, and stuffy overflow room, more akin to a small press room, located far away from the official proceedings, hampering their ability to connect with officials and country delegates, which is often the most valuable part of the week. As EB participation and the number of agenda items have ballooned, WHO has also imposed new constraints on civil society statements, which have hit non-state actors particularly hard. WHO has tried to force civil society organizations to come together and develop single constituency statements for certain agenda items, a challenge that often further dilutes specific technical feedback from a diverse set of voices as various WHO-accredited institutions try to reconcile diverging views into a single, cohesive communication. Individual interventions are now reduced to just one minute, and they must be uploaded to a WHO database prior to the start of that agenda item. Apart from the challenge of distilling feedback and technical input down to around 100 words, the requirement to upload in advance prohibits advocates from rebutting issues that arise during debate or meaningfully influencing the decision making in real time. Other United Nations (UN) agencies, such as the World Trade Organization and the World Intellectual Property Organization have far more robust and meaningful civil society engagement processes that could serve as better models for WHO to emulate. 2. Debate on WHO’s work in health emergencies goes into the next round. Global politics tend to spill over into the parliamentary debates at EB, and this year was no different with the war in Ukraine creating serious tension between western allies and Russia. Much of the debate surrounding WHO’s role in health emergencies was derailed by several testy back-and-forths between delegations, leading to disruptions and little progress on key agenda items. A new ten-point proposal from WHO Director-General Dr. Tedros Adhanom Ghebreyesus to improve preparedness and response to health emergencies also received mixed reviews from WHO member states, with many warning the WHO secretariat not to move ahead of member states and the already ongoing processes to amend the International Health Regulations and negotiate a pandemic accord.  The latter did make waves at this EB, as the WHO Intergovernmental Negotiating Body (INB) published a “zero-draft,” that included a few surprises. The draft features some strong, equity-focused language, as well as calls for building and strengthening country regulatory, manufacturing, and innovative research and development (R&D) capacities for pandemic-related products. Surprisingly, it also features numerous callouts and provisions focused on intellectual property, including incentivizing relevant transfers of technology and know-how, forcing manufacturers that receive public funding to disclose prices for pandemic-related products, and time-bound waivers on medical countermeasures that can accelerate or scale up manufacturing, signaling the key battlegrounds for upcoming negotiations.  The biggest stunner, though, is a brand-new section focused on creating a new WHO Pathogen Access and Benefit-Sharing System (the “PABS System”) that would collect and equitably distribute a portion of all globally produced vaccines and other medical products during pandemics. According to the draft, 10 percent of total global production of pandemic products would be allocated to WHO, with half donated and half bought at an “accessible” price. Now, deliberations on the specific provisions will begin in earnest ahead of the World Health Assembly (WHA) in May, with the INB hosting two meetings in the next few months to debate individual chapters of the draft.  3. Implementation of the clinical trials resolution enters its next phase as member states argue about scope. Member states also debated the implementation of last year’s clinical trials resolution during the session on global health emergencies. Delegates noted the progress WHO had made over the past year in leading consultations and mapping the current clinical trial networks landscape. A few countries underscored the importance of inclusiveness and equity and called for greater technical support from WHO. On the contrary, in response to a WHO proposal to develop a complementary self-assessment tool to measure the maturity of the clinical trial ecosystem at national and international levels, the United States and United Kingdom instead urged the WHO secretariat to keep its focus limited to the scope of the actual resolution until more progress is achieved. The WHO is now set to move forward with a process to develop draft guidelines for clinical trials, with the help of experts and member states, that is expected to be in place by WHA. 4. Universal health coverage (UHC) reemerges as a priority from COVID-19 slumber. In 2019, UHC was the “it” topic of global health. It featured prominently on the agenda of WHO meetings and the UN held a high-level meeting on the subject to advance a new framework to achieve the Sustainable Development Goals. Then came the pandemic, and focus and attention on the topic slipped. This year, UHC is back on the map, having featured heavily at this year's EB.  During the broader discussion on UHC, WHO member states highlighted the importance of primary health care and health system strengthening, as well as considered and ultimately passed a resolution on strengthening diagnostics capacity. The resolution urges member states to address a range of diagnostic issues, including increasing local production, streamlining regulatory approaches, and addressing access barriers. It also calls for greater investment in diagnostic R&D and more systemic funding of capacity-building infrastructure for diagnostics, as well as urges WHO to enact specific technical changes to facilitate and catalyze diagnostic development.  The next couple of months will continue to deliver multilateral developments at a breakneck pace, and given the interlinkages between the many multilateral processes underway, it will be vital for advocates to understand the full landscape of possible changes to the global health architecture. While the dynamics may be shifting, it is encouraging to see that the research agenda is present throughout these different dialogues, both in Geneva 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.Last week, two new studies reported promising results about the efficacy of the updated bivalent COVID-19 vaccine, which targets both the original virus and Omicron subvariants BA.4 and BA.5. A New England Journal of Medicine study found that the updated vaccine provided additional protection against severe illness, hospitalization, and death when compared to the previously used monovalent vaccine, A second study in the US Centers for Disease Control and Prevention journal Morbidity and Mortality Weekly Report found that the bivalent vaccine is similarly effective against the newer XBB and XBB.1.5 strains as it was against the earlier strains that it was designed to target.A recent outbreak of avian influenza, or H5N1 flu, on a mink farm in Spain is causing alarm after the variant behind the outbreak was found to contain a genetic change that is known to increase the ability of animal-flu viruses to jump to mammals. While there have been H5N1 infections found in various species over the past year, this outbreak is unique because mammal cases in previous outbreaks were spread by contact with virus-contaminated material. In this case, the new strain itself could have the ability to spread to and between mammals. Were the strain to start spreading between humans, authorities should have the ability to quickly produce a vaccine, and the antiviral drug Tamiflu could reduce disease severity.Moderna recently published promising results from respiratory syncytial virus (RSV) vaccine trial in older adults, echoing similarly encouraging results from four other RSV vaccine trials and last year’s approval in the European Union and United Kingdom of a long-lasting antibody treatment that protects babies against RSV. The development of a RSV vaccine has long been a challenge because the main protein on the outside of the virus has the ability to change shape as it infects cells in the body, but researchers have found various ways to address the tricky protein. The recent innovation in vaccines and antibodies for RSV has the potential to dramatically reduce illness and deaths caused by the virus each year.