Breakthroughs Blog: WHO

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. At the 76th World Health Assembly last week, World Health Organization (WHO) member states adopted a resolution on strengthening diagnostics capacity, following a recommendation from the Executive Board earlier this year. The resolution is aimed at raising global awareness of the importance of diagnostics and the major gaps in access, to even the most basic diagnostics, that are faced around the world. Implementation of the resolution will be driven by national governments, which are urged in the resolution to integrate national diagnostics strategies that address the regulation, assessment, and management of diagnostics into their national health plans, as well as to develop a national essential diagnostics list, which will hopefully lead to wider availability and access.An affordable meningitis vaccine designed to protect against multiple strains was found to be effective in phase 3 trials in Mali and the Gambia. The NmCV-5 vaccine, developed by PATH and the Serum Institute of India, generated a strong immune response against the five primary meningococcal strains in Africa, including the emerging X strain, for which there is currently no licensed vaccines. The cost of available vaccines for the four other strains of meningitis are currently too high for most African countries to buy the tens of millions of doses they need. NmCV-5 is expected to be available in the coming months and has the potential to dramatically reduce vaccine-preventable cases and deaths, especially those linked to the X strain.Using artificial intelligence, researchers at the Massachusetts Institute of Technology and McMaster University have identified a new antibiotic drug to combat Acinetobacter baumannii, which is responsible for many drug-resistant infections and can lead to pneumonia and meningitis. The drug was identified using a machine-learning model that was trained to evaluate whether drug compounds would inhibit A. baumanii’s growth, which then reviewed a library of nearly 7,000 potential compounds. The finding has the potential to reduce drug-resistant infections and also highlights the potential role of artificial intelligence in accelerating the search for novel antibiotics in the face of growing antimicrobial resistance.

Geneva is back! For the first time since the beginning of the COVID-19 pandemic, delegates from both World Health Organization (WHO) member states and civil society felt as if this World Health Assembly (WHA) marked a return to normal. In fact, given an almost unprecedented number of side events and meetings and the sheer volume of delegates swarming around the usual spheres of influence, including the United Nations Palais and the Intercontinental Hotel (and beyond), this year saw a massive surge in engagement and energy for this important milestone on the multilateral calendar. Here are some of the top takeaways from the week:1. WHA maintains constraints on civil society engagement.As civil society delegates descended on Geneva, the question that hung in the air was would non-state actors be able to meaningfully engage in this year’s assembly? Would we see improvement after we saw access further curtailed at the Executive Board (EB)? The answer was largely no. Over the past year, new protocols and structural changes have been put in place at WHO meetings, which have limited delegation size and left civil society sometimes literally on the outside looking in. As was the case at EB earlier in the year, in order to counter the ballooning number of agenda items, WHO maintained constraints on statements—an action that has hit non-state actors particularly hard. WHO forced civil society organizations to come together and develop single constituency statements for certain agenda items, further diluting specific technical feedback from a diverse set of voices as various WHO-accredited institutions tried to reconcile diverging views into a single, cohesive communication. In fact, in some cases, WHO pushed even further this time, as separate constituencies were forced to further consolidate, creating the almost impossible task of reconciling stakeholders with vastly diverging views. ⁦@WHO⁩ has sliced the already small NSA section for Committee A on #UHC in half at #WHA76. Press access is important but so is inclusive CSO participation. Don’t shut us out! pic.twitter.com/MnLOf4H2Dm— Elisha Dunn-Georgiou (@elisha_dg) May 22, 2023 It is disappointing to see no positive improvement for non-state actors after a horrendous EB experience. This underscores the likelihood that some of these restrictions may become the new normal and that without a concerted effort that involves member states advocating for the meaningful participation of civil society, these challenges will persist. 2. Geopolitics derails debate on WHO’s work in health emergencies.While we got a preview of this at the EB, the geopolitical fights reached a new crescendo at this year’s assembly. Much of the debate surrounding WHO’s role in health emergencies was derailed by several testy exchanges between western and Russia delegations on the current war in Ukraine. Many speakers retooled their interventions to primarily focus on the war, giving little airtime to other substantive issues covered under that agenda item. While not on the official agenda of this assembly—meaning no decisions would be made this year—the pandemic accord also remained a central topic of discourse during the week among both member states and advocates in Geneva.A draft from the Intergovernmental Negotiating Body (INB) leaked during WHA, and the new 42-page document provides member states with several text options to consider. It is generally a compilation of feedback and suggestions made on the zero draft released in February.The latest version, which comes on the heels of a number of largely member state-only deliberations and technical consultations on specific chapters with a wider group of stakeholders, has changed significantly. The previously strong language that set robust conditions on public research and development (R&D) funds for price transparency and technology transfer, among other measures, has been dropped or diluted. The new text still contains references linking access to pathogen samples or genomic data with the sharing of “benefits” from health products produced as a result, something that the pharmaceutical industry has strictly opposed.  Member states now face a big test as there is growing skepticism that differences can be reconciled by the next WHA, which is when the accord was set to be voted on. Some have voiced concerns over the process itself. The representative from Jamaica said the rush to complete the accord puts small island states at a disadvantage, preventing them from fully participating and contributing to the final document.3. Implementation of the clinical trials resolution remains discussion point despite not being on official agenda.During the session on global health emergencies, member states were set to follow up on the EB debate regarding implementation of last year’s clinical trials resolution, but the topic received little airtime from country delegates. A few leaders did underscore the need for greater clinical trial capacity in low- and middle-income countries, but few specifics were covered during the parliamentary debate. Outside of the official proceedings, there was certainly a focus on the topic as several organizations discussed implementation during side events throughout the week. In a big win for the advocacy community, WHO’s new Chief Scientist, Dr. Jeremy Farrar, publicly committed to including in clinical trial guidance being developed by WHO later this year an entire section that focuses on vulnerable populations, including pregnant individuals and children.4. Diagnostics resolution passes as UHC debate is overtaken by noncommunicable diseases.As was the case at the EB, universal health coverage (UHC) is back on the map, having featured heavily at this year's assembly. While the topic overall received substantive airtime, there was little focus on the role of research and innovation in achieving UHC, and much of the discussion centered around addressing noncommunicable diseases. However, in a win for the R&D community, WHO member states passed a resolution on strengthening diagnostics capacity. The resolution urges member states to address a range of diagnostic challenges, including increasing local production capacity, streamlining regulatory approaches, and addressing access barriers. It also calls on them to increase investment in diagnostic R&D and provide more systemic funding of capacity-strengthening infrastructure for diagnostics, as well as urges WHO to enact specific technical changes to facilitate and catalyze diagnostic development.  All eyes are now on the G2O and the United Nations High-Level Meetings this fall, where advocates hope to shift the focus towards creating greater political will and ensuring follow-through. While this WHA official agenda did not prominently feature research, it was encouraging to see R&D continue to play a prominent role in both informal and technical discussions throughout the week. With growing momentum, our community must now capitalize on all the work from the past year and seize upcoming opportunities to reshape the global architecture to accelerate health breakthroughs.

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 Thursday, the World Health Organization (WHO) declared the end of the global health emergency for mpox following a recommendation from WHO’s emergency committee on mpox, which also recommended continued management to prevent the virus from evolving. Bavarian Nordic’s vaccine for smallpox was deployed in the United States and Europe under emergency authorizations and recommended by WHO primarily for post-exposure during the mpox emergency, although the limited available stock that was already earmarked for wealthy countries created access challenges in low- and middle-income countries. Randomized control trials planned in endemic countries will provide more essential data about the efficacy of the vaccine against mpox. Additional data is also needed to fully understand how the strain of the virus evolved to sustain prolonged transmission between humans.Last week, the US$30 million Human Pangenome project, launched in 2019 and funded by the US National Human Genome Research Institute, published the first phase of the first human pangenome, which aims to be a genome that is more representative of the diversity of DNA in humans around the world. The genome could be an important guide for researchers building genetic tests and looking for new drug targets. This initiative addresses diversity gaps in the first reference genome, released in 2001, which have undermined the ability to develop tests that work across diverse populations.A new global research consortium organized by the Centres for Antimicrobial Optimisation Network aims to fight antimicrobial resistance by improving clinical use of antimicrobials and improving practices and guidelines for prescribers, users, and policymakers. Research hubs in Kampala, Cape Town, São Paulo, Liverpool, and London—where there is a high burden of drug-resistant infections and where there are communities highly affected by the burden of infectious disease—will generate essential data on the optimal use of antibiotics. Researchers hope this will in turn lead to more effective treatment and prevention of bacterial infections in the face of rising antimicrobial resistance worldwide.

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.The US Food and Drug administration (FDA) last week approved the first-ever vaccine for respiratory syncytial virus (RSV). GSK’s Arexvy vaccine is a single shot intended for use in adults aged 60 and older and could be available as soon as fall of this year, as long as the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices provides further approval. RSV, which has an annual global death toll of 160,000 people, has challenged vaccine researchers for six decades. Building on those years of efforts, GSK’s Arexvy showed strong results in an ongoing trial of nearly 25,000 adults. Further FDA approvals for RSVP vaccines developed by Pfizer, Moderna, and Bavarian Nordic could follow soon, with the decision on Pfizer’s candidate expected as soon as this month.Last week at the 2nd Global Forum on Childhood Pneumonia in Madrid, Spain, the Bill & Melinda Gates Foundation announced a nearly US$200 million commitment, to be awarded over the next year and a half, to support the development and delivery of affordable vaccines for some of the leading causes of childhood mortality, including pneumonia, meningitis, neonatal sepsis, and RSV. This includes supporting a more affordable next-generation pneumococcal conjugate vaccine, Pneumosil, developed by the Serum Institute of India and PATH and advancing a Group B streptococcus vaccine entering phase III trials later this year. The foundation is partnering with the companies developing these vaccines to ensure they are available and affordable to Gavi and low- and middle-income countries, therefore narrowing the gap between the rollout of vaccines in high-income and Gavi-supported countries.A new gold-standard clinical trial in Kenya showed that a single dose of the human papillomavirus (HPV) vaccine may be as effective as two or three doses over at least three years. Deploying a single-dose strategy could dramatically lower the rates of cervical cancer and other associated diseases, as well as extend vaccine supplies, lower costs, and simplify distribution, especially in low- and middle-income countries. At least 24 countries have already shifted to a one-dose approach, and this trial could make it a more widely adopted strategy, which the World Health Organization estimates could prevent 60 million cervical cancer cases and 45 million deaths worldwide over the next 100 years.