Breakthroughs Blog

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.

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.

Pregnant women in their first trimester are at risk of malaria Eileen Buxton is a Ghanaian nurse who contracted malaria while pregnant with twins. As a health care professional, she recognized the symptoms such as high fever, severe nausea, and vomiting. She sought care and was given artemether-lumefantrine, a medicine that was recently recommended by the World Health Organization (WHO) to treat malaria in the first trimester of pregnancy.Unfortunately, the situation where medicines are available and determined to be safe for use in first-trimester pregnancy is uncommon. According to the Concept Foundation, since the 1990s, only two drugs have been developed specifically for pregnant women. Furthermore, in the clinical research stage of medicine development, pregnant women, especially those in their first trimester, have been historically excluded for fear of causing harm to the mother and the baby. As a result, health care professionals and pregnant women are left with limited information, making it difficult to make informed decisions about the best course of treatment. Well-tolerated and effective antimalarials, as well as medicines for other diseases, must be developed and made available, accessible, and affordable for pregnant women like Eileen. Malaria infection and treatment during the first trimester of pregnancyMalaria, although preventable and treatable, can become fatal if left untreated, and in pregnancy, the disease has severe consequences for both the mother and the baby she is carrying. Malaria in pregnancy (MiP) can result in the severe, rather than uncomplicated, form of the disease for the mother, resulting in gestational hypertension, premature labor, miscarriage, and the fetus being small for its gestational age. Newborns can be born prematurely and with low birth weight, leading to further health complications, such as cognitive delays. During the first trimester, women are especially at risk of malaria infection because they are unprotected, as no preventive therapies are available until later in pregnancy. Data show that around 65 percent of cases of MiP appear late in the first trimester because the placenta becomes more susceptible to infection, demonstrating a clear need for recommended medicines that can both prevent and treat women in early pregnancy. Although the aforementioned effects of malaria in the second and third trimesters are well known, there has been little data collected on the effects of malaria in the first trimester: few women in malaria-endemic countries attend health facilities in early pregnancy due to a mix of cultural and logistical factors, creating an obstacle to generating research.Preventive therapies for the first trimester are urgently needed: currently, there are none. Intermittent preventive treatment of malaria in pregnancy, an intervention used in sub-Saharan Africa, is only recommended by WHO from the second trimester onward to protect pregnant women from the disease.And although WHO recently recommended the artemisinin-based combination therapy (ACT) artemether-lumefantrine for use in the first trimester, the organization’s Strategy to respond to antimalarial drug resistance in Africa also points out that most countries rely on this drug and thus recommends using a wider range of ACTs to mitigate the development of drug resistance. Ethics and regulatory frameworks for including pregnant women in clinical researchThe four main ethical principles of clinical research are beneficence, nonmaleficence, autonomy, and justice. These principles must be adhered to when designing clinical trials that safely and equitably include pregnant women in their first trimester. In fact, excluding this population perpetuates a cycle of underrepresentation in clinical research, while including them adheres to the principle of justice by ensuring that individuals, regardless of status or condition, have equal access to the benefits of medical research. Drug development takes, on average, 10 to 15 years before registration. When pregnant women are excluded from clinical research, there are no data on how well tolerated or effective it is for pregnant women when the drug reaches market. The COVID-19 pandemic demonstrated that it is possible to rapidly develop and distribute drugs, and with the Sustainable Development Goals (SDGs) set to expire in seven years, the malaria community needs to work at an accelerated pace to achieve Target 3.3 of the SDGs: end the epidemics of AIDS, tuberculosis, malaria, and neglected tropical diseases and combat hepatitis, water-borne diseases, and other communicable diseases. Greater priority must be placed on expediting the discovery, development, and delivery of medicines that meet the needs of at-risk groups, like pregnant women in their first trimester.Global health has experienced a paradigm shift: it is now widely acknowledged that pregnant women must be protected through, and not from, research, a principle that is underscored by recent international commitments. In 2022, at the 75th World Health Assembly, WHO member states adopted Resolution 75.8: Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination. While it does not specifically mention pregnancy, this resolution provides a basis for countries in both the Global North and the Global South to develop clinical ecosystems that are “health-needs driven, evidence based, well designed and well implemented and be guided by established ethical guidance.”In 2021, the G7 Health Ministers adopted the G7 Therapeutics and Vaccines Clinical Trials Charter, which commits to “stronger collaboration in large-scale international trials to enable greater diversity of participants, including pregnant people and children” and supporting low- and middle-income countries, where malaria is most prevalent, in sustainably strengthening capacity. Malaria in pregnancy remains a major public health concern that demands urgent attention and action from global health stakeholders. Clinical research plays a critical role in advancing the development of effective interventions with an adequate safety profile. Ensuring that pregnant women are part of this research from the start can help save millions of lives and adhere to fundamental principles of justice and equity.