Research Roundup: WHO diagnostics resolution, New meningitis vaccine, Using AI to identify new antibiotics

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. Data from late-stage trials showed that Pfizer’s experimental antibiotic drug combination was well-tolerated and effective in treating complicated infections caused by drug-resistant bacteria. The combination, which includes the experimental mix aztreonam-avibactam, existing generic drug metronidazole, and two older antibiotics: meropenem and colistin, is aimed at treating complicated intra-abdominal infections and some types of hospital-acquired pneumonia caused by gram-negative bacteria. The study underscores that innovative, novel antibiotics continue to be an important goal in the face of the rising global threat of antimicrobial resistance.Last week, the US Food and Drug Administration (FDA) approved Pfizer’s Abrysvo vaccine for respiratory syncytial virus (RSV) following strong results from a phase 3 trial, making it the second vaccine to protect older adults from RSV approved in recent months. Both vaccines will not be available until the US Centers for Disease Control and Prevention recommends them, which the agency is expected to do soon. Experts have highlighted the great potential for both vaccines to drastically reduce the number of infections and hospitalizations in adults that result from the virus every year.A new study showed the success of implementing shorter treatment regimens for drug-resistant tuberculosis (TB) in a small cohort in the United States. The six-month, all-oral bedaquiline, pretomanid, and linezolid (BPaL) regimen for rifampin-resistant TB was implemented in 70 patients in 2019, shortly after FDA approval of the regimen. The promising results lend support to the early implementation of new TB treatments and highlight the promise of further innovation to reduce the burden of TB, especially drug-resistant TB, in the United States and around the world.

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.