Breakthroughs Blog: Pandemic preparedness

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, a US Food and Drug Administration (FDA) advisory committee voted to recommend a monoclonal antibody product to protect children one year and under, as well as high-risk children between one and two years old, from respiratory syncytial virus, or RSV. Nirsevimab, which will be marketed as Beyfortus, was developed by AstraZeneca and will be marketed in the United States by Sanofi. The product is intended to be administered to babies via a single injection during RSV season or at birth depending on birth timing. RSV is a major challenge in children, particularly in very young children, causing up to 80,000 hospitalizations and 300 deaths a year in the United States. Pfizer’s RSV vaccine for pregnant people, which is also aimed at protecting babies, is currently being considered by regulators as well.Moderna will launch a phase 1/2 trial of their mpox vaccine this summer with the goal of generating data to inform dose selection and eventually licensure. The company announced the start of preclinical work on an mpox vaccine back in May of last year, with the vaccine being swiftly developed using the company’s mRNA platform. After the immediate mpox outbreak waned in the United States, the vaccine was deprioritized by Moderna, but ahead of this summer, when mpox is expected to re-emerge, Moderna has announced the trial and has been meeting with the US mpox response team.The Coalition for Epidemic Preparedness Innovations (CEPI) last week announced £1.5 million in funding for Germany’s Leipzig University, where researchers have created artificial intelligence technology that will be used to build a vaccine library aimed at streamlining the development of a new generation of vaccines against a future pathogen with pandemic potential, or Disease X. The technology will analyze the genetic structures of pathogens from ten high-risk viral families, starting with those families that include Nipah and Lassa viruses; model protein sites in the viruses that are crucial targets for generating immune responses in human; and then use those viral protein targets to develop vaccine blueprints. Future scientists will hopefully be able use the library to develop vaccine candidates within 100 days of identifying a pathogen with pandemic potential.

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. In June, South Sudan is expecting to begin the rollout of the preventive malaria intervention seasonal malaria chemoprevention (SMC), although there are concerns that high parasite resistance in eastern and southern African countries will limit its long-term efficacy. In June 2022, the World Health Organization (WHO) updated its recommendations that previously restricted SMC’s use to the Sahel region, where malaria transmission is highly seasonal, to encourage its use in other regions after pilot studies showed positive results in countries with high resistance, including South Sudan. Experts have emphasized the need for rigorous monitoring and evaluation to assess SMC’s efficacy in areas of high resistance and to detect any parasite resistance in the Sahel, as well as the development of alternative tools and drugs for malaria chemoprevention.Last week, the European Medicines Agency recommended authorization of GSK’s Arezvy vaccine for respiratory syncytial virus (RSV) in adults 60 years of age and older, which if approved, will be the world’s first available vaccine for RSV. Regulatory agencies in the United Kingdom and United States are expected to make decisions on GSK’s vaccine in the coming months. Pfizer and Moderna are also developing vaccines for the virus, with Pfizer’s candidate already having gained the backing of a panel of US Food and Drug Administration (FDA) advisors earlier this year.Bavarian Nordic, the maker of the Jynneos vaccine, which is approved by the FDA to protect against both smallpox and mpox, is planning to dramatically scale up production capacity for their vaccine. The company’s CEO connected the move to the rapid spread of mpox last year, which highlighted the need to be able to manufacture at a much greater scale than currently available: from tens of millions to hundreds of millions of doses. Bavarian Nordic plans to simplify its production process to facilitate partnerships with other manufacturers in order to have adequate production capacity for stockpiling and in case of a future emergency.