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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.A phase 3 trial to evaluate Valneva’s chikungunya vaccine candidate in adolescents has launched in Brazil, the company announced last week. The live-attenuated, single-shot vaccine, VLA1553, is currently the most clinically advanced chikungunya vaccine candidate worldwide, having completed phase 3 trials in adults. Valneva announced positive top-line results of the phase 3 trial in adults 18 and over in August 2021, indicating the vaccine induced protective chikungunya virus neutralizing antibody titers in 98.5 percent of trial participants and was well-tolerated across age groups. The recently launched trial, funded by the Coalition for Epidemic Preparedness Innovations, is designed to evaluate the vaccine in adolescents aged 12 to 17 and to support its extension to use in the younger age group following potential initial regulatory approval in adults from the US Food and Drug Administration (FDA).Healthy, young people who were intentionally exposed to SARS-CoV-2 developed mild symptoms, if any, in a first-of-its-kind COVID-19 human challenge study, according to a UK study of 34 individuals aged 18 to 30. Around half of the participants who received a low dose of virus became infected, some of whom had no symptoms, while others reported mild-to-moderate symptoms, including sore throats, runny noses, and loss of smell and taste. While controversial due to the risk to participants, challenge trials present an opportunity to study viral infections in detail­—and, according to scientists interviewed, the new study results show such trials can be done safely and lay the groundwork for more in-depth studies of vaccines, antivirals, and immune responses to SARS-CoV-2 infection.The HIV treatment Cabenuva has been approved by the FDA for use every two months, reducing treatments to only six times a year. The injectable treatment was first approved last year for use once a month, offering an alternative to antiretroviral regimens that require daily pills. The updated approval is based on data from a phase 3b study that showed dosing of Cabenuva every other month was non-inferior to monthly dosing and that rates of virologic suppression were similar for dosing monthly or every two months. Cabenuva is a combination of cabotegravir and rilpivirine, forming a complete regimen for HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure.

As the world enters the third year of the COVID-19 pandemic, with new variants spreading around the globe and continued inequities in global vaccination and access to critical health tools, this year’s meeting of the World Health Organization (WHO) Executive Board (EB) felt like a make-or-break moment. Global leaders met to determine ways to not only address the current crisis, but also to build and strengthen the very institutions necessary to combat future health threats and reprioritize key programs and diseases that have fallen dangerously off track.  While some incremental progress was made, this year’s forum still left us with more questions than answers, with many key topics of concern remaining unaddressed, and more traditional dialogues related to research and development (R&D) for tuberculosis (TB), malaria, HIV/AIDS, or neglected tropical diseases (NTDs) receiving less airtime than at previous board meetings. Here are my top four takeaways from last week’s proceedings:EB disappoints on R&D topicsOne thing that has repeatedly been made clear at virtually every multilateral meeting in the past two years is that the pandemic has massively disrupted other critical health priorities, and that progress toward the Sustainable Development Goals and other key global targets is under threat. The EB continued the conversation on these challenges, including for TB research and innovation, NTDs, and the Immunization Agenda 2030. Yet despite a clear consensus that more must be done, few member states articulated specific changes that should be made immediately or presented new pledges to change the current trajectory in these key areas. Instead, many, including WHO, highlighted steps taken over the course of the past year, which, while welcome, are clearly nowhere near enough to even bring us back to pre-pandemic levels as we look to progress toward the Sustainable Development Goals. The disconnect seemed particularly striking during the TB session, in which members stressed the need to meet the 2018 United Nations high-level meeting TB R&D investment target of at least US$2 billion per year and address access barriers and other bottlenecks, while also acknowledging that annual funding for TB research needs to more than double to reach the global target, and provided no major recommendations on how to catalyze product development. It is also noteworthy that meeting logistics also played a part in the less robust debate. Due to time constraints, most agenda items were taken up in bundles, which forced all stakeholders to water down their statements and provided little opportunity to delve into the various recommendations presented in the reports and updates by WHO.Incremental progress on WHO’s work in health emergencies One area that continues to receive the bulk of the attention is WHO’s work in health emergencies. While the EB was not expected to finalize decisions on all the various reform recommendations that have been proposed over the course of the last year, significant progress was made in negotiations, opening the avenue for more concrete decisions to be made in the coming months.The EB took its first step in approving a process, introduced by the United States, to consider amendments to the International Health Regulations (IHR). The decision integrates this workstream into the mandate of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies, positioning this forum as a platform for discussion and deliberation on ways to strengthen the existing IHR framework.The board also took steps to advance the formation of a standing committee under the EB on health emergencies. This committee, first proposed by Austria, would be designed to more closely oversee WHO’s emergency response efforts after a public health emergency of international concern is declared. Proponents argue that the goal is to coordinate a response within the EB, and that this new structure will not interfere with the IHR Emergency Committee. While some skepticism remains, member states were ultimately able to compromise to move the process forward.Dialogue on WHO financing stutters—but hope remainsAnother hotly anticipated topic was the item on sustainable financing. Although it was already clear coming into the EB that there is no consensus among member states on an increase in assessed contributions to WHO, it was nevertheless significant to witness many low- and middle-income countries expressing their support for WHO by showing their willingness to contribute more.Despite shouldering a massive burden as the global health multilateral institution, only a fraction of WHO’s financing comes through annual membership dues, leading to a lack of predictability and jeopardizing WHO’s independence and flexibility to carry out its mission. What’s more, an overreliance on heavily earmarked, voluntary, and short-term funding has left more than 25 percent of WHO’s staff on short-term contracts, further compromising its ability to meet its mandate.At the EB, the sustainable financing working group managed to win an extension of its mandate from the EB to continue discussions on these intractable issues until the World Health Assembly in May.The chair of the working group, Björn Kümmel, stated he would continue to push for consensus on the proposal, though he still faces some pushback from the United States, Brazil, and Japan, which cite their voluntary contributions, economic challenges, and WHO’s need for greater budgetary discipline and transparent governance as major considerations that should be considered in this process. The next few months will be a sprint to see whether an agreement can be reached going into the WHA with geopolitical speedbumps to be overcome along the way.Operational efficiency and non-state actor engagement remain challenges for WHOWHO’s finances were not the only existential concern that was thrown into sharp relief last week. As many officials and advocates slogged through the massive agenda, navigating the almost Kafkaesque processes of jumbling agenda items together haphazardly, one couldn’t help but wonder about the necessity of a major reset in how these meetings are run. In order to make it through the whole agenda, items that were tackled in the latter half of the week simply couldn’t be given their proper floor time. Many decisions were ultimately punted, and there was little practical debate. Much of the format remains archaic, with most of the updates and reports being simply text-heavy, and member states and non-state actors continue to have a difficult time picking up on key points or recommendations made by other participants. The engagement of non-state actors was also a topic of conversation, as several stakeholders called on member states to also prioritize interactions with civil society by actively participating in informal sessions and systematically sharing draft documents and resolutions to allow them to engage more robustly in policymaking and technical matters.After another whirlwind EB, member states now have the mammoth task of simultaneously advancing several initiatives, many overlapping, in the lead up to the World Health Assembly to secure the future of WHO and its status in the global health architecture and galvanize the world on the COVID-19 response.

The full and equal participation of women in science is vital to achieving gender equity and advancing progress in global health. Unfortunately, today less than 30 percent of the world’s researchers are women, and female researchers tend to have shorter, less well-paid careers and to see their work underrepresented in top journals.This gender gap has far-reaching implications. Health and gender are inextricably linked. For example, women and girls are at increased risk of a number of poverty-related and neglected diseases (PRNDs), due both to biology and to nonbiological factors like discrimination and gender power dynamics. Women can also feel disproportionate impacts of illness due to wider consequences like stigma, reproductive, financial, and social effects. To meet the health needs of women and girls and better facilitate the integration of sex and gender considerations at all levels of medical research, it’s imperative that women be better represented in leadership and decision-making ranks within research teams.In recognition of International Day of Women and Girls in Science, which aims to inspire and engage more women and girls in science, GHTC is profiling five fierce female innovators who have transformed global health research.1. Dr. Ruth Bishop, discoverer of rotavirusPhoto: Stepping Stone PicturesAs a young bacteriologist working in the 1970s, Dr. Ruth Bishop was on a quest to find the root cause of diarrheal disease—the most common cause of illness and the second leading cause of death among children worldwide. After much research, Ruth concluded that the disease was likely not caused by a bacterial agent, but instead by a virus. To continue her search, Ruth teamed up with colleagues at the University of Melbourne. In 1973, using an electron microscope, the team uncovered a previously unidentified virus in the biopsy sample from an intestinal lining. Ruth and her team went on to confirm presence of the virus in other samples. Their published results elicited a global response and confirmation of the virus’s presence in samples around the globe. The virus identified by Ruth and her team would come to be named rotavirus for its wheel-like shape. Rotavirus is the leading cause of severe diarrhea in children worldwide and the cause of about one-third of all diarrheal-related child deaths. Ruth and her team subsequently developed a diagnostic test for the rotavirus, and their continued research helped pave the way for the development of a rotavirus vaccine, which was first introduced more than three decades after her initial discovery. Gavi, the Vaccine Alliance, estimates that by 2030, 2.4 million lives could be saved through rotavirus immunization. Ruth is now retired, but her legacy lives on in the millions of children’s lives that have been saved by her discovery.2. Dr. Quarraisha Abdool Karim, pioneered use of antiretrovirals to prevent HIV and research on broadly neutralizing antibodiesPhoto: UNAIDSAs a native of South Africa and infectious disease epidemiologist, Dr. Quarraisha Abdool Karim saw the devastating impact HIV/AIDS was having on her home nation, where one out of every five people in the world with HIV lives. While there were many research efforts focused on fighting the growing epidemic, Quarraisha felt too little attention was paid to the disproportionate burden young women bore in the epidemic and solutions to address that. So Quarraisha and her husband, Dr. Salim Abdool Karim, in 2001 brought together a group of top HIV researchers to form the Center for the AIDS Program of Research in South Africa (CAPRISA), which is today regarded as one of the most influential AIDS research programs in the world.In 2010, CAPRISA completed a landmark study proving for the first time that a microbicide gel, using the drug tenofovir—normally used as an antiretroviral to treat HIV/AIDS—could offer some protection from the virus when used before and after sex. While today the field has moved on to other prevention methods like daily pills and long-acting injectables, this research provided the first proof-of-concept that antiretrovirals could be used to prevent, as well as treat, HIV in women and built the foundation for the approach known today as pre-exposure prophylaxis (PrEP), which is widely used globally to prevent HIV infection. CAPRISA research has also led to the development of “broadly neutralizing antibodies,” after it was discovered in 2012 that an HIV-positive woman in one of the center’s studies produced unique antibodies that not only attacked the strain of HIV she had, but also 80 percent of other known HIV strains circulating globally. The isolation and recreation of these antibodies in a lab has led to a growing field of study that could one day lead to longer-acting HIV treatments and pave the way to the ultimate goal of an HIV vaccine. Reflecting on her career, Quarraisha said, “I’ve spent three decades working on preventing HIV infection in young women. Progress has been made, but it’s far from complete. We need interventions that can meet the diverse needs of vulnerable women.”3. Dr. Kizzmekia Corbett, co-developer of Moderna-NIH COVID-19 vaccinePhoto: University of Maryland Baltimore County/Marlayna DemondAs a high school student growing up in North Carolina, Dr. Kizzmekia Corbett knew she wanted to be a scientist, but it was a chemistry internship program for gifted minority students that put her on the path to becoming one of the US government’s lead coronavirus vaccine researchers at a pivotal moment in history. This high school internship program in lab led Kizzmekia to an undergraduate scholarship to study biology and sociology, which in turn led her to a PhD in microbiology and immunology, which ultimately landed Kizzmekia a research fellowship and then job at the US National Institutes of Health’s (NIH) Vaccine Research Center.It was there, on the coronavirus research team, that Kizzmekia found herself in January 2020 when her team first got word of outbreak of an unknown respiratory disease in Wuhan, China, that would later be identified and known as COVID-19. Kizzmekia and her team quickly got to work on trying to develop a preventative vaccine. Applying earlier research she has conducted on making coronavirus spike proteins stabilized in a way that enables the immune system to mount a stronger response and partnering with the biotech company Moderna to use its messenger RNA (mRNA) platform, the research team was able to advance a vaccine candidate into phase 1 clinical trials just 66 days after the virus sequence was released. In a triumph of science, nine months later, on December 18, 2020, the vaccine was authorized for emergency use in adults by the US Food and Drug Administration. While much unfinished work remains to ensure coronavirus vaccines reach everyone worldwide, Kizzmekia has said of her scientific accomplishments, “To be living in this moment where I have the opportunity to work on something that has imminent global importance…it's just a surreal moment for me.” 4. Dr. Tu Youyou, discoverer of artemisinin, a key ingredient in modern malaria medicinesPhoto: Nobel Prize/A MahmoudDr. Tu Youyou was born into a family that valued education, but it was a two-year battle with tuberculosis at the age of sixteen that inspired her to study medicine, so she could find cures for diseases like the one that affected her. After pursuing a degree in pharmacology, with an emphasis on the study of medicinal plants, Tu went on to work at a newly established academy devoted to studying traditional Chinese medicines applying modern research methods. In 1967, Tu was put in charge of an ambitious Chinese government project to find a new cure for malaria, which had become resistant to chloroquine, the standard treatment at the time.In her quest to find a cure, Tu and her team turned their attention to ancient Chinese medical texts, where the team found reference dating back to around 400 A.D. to the use of sweet wormwood to treat fevers associated with malaria. In 1971, Tu and her team isolated one of the compounds from the plant that they believed to have malaria-fighting properties, but after testing it, saw inconsistent results. The team was about to abandon that line of research when Tu had a vital insight: the extraction process used, which involved boiling the plant in water, could be negatively impacting the compound’s medicinal properties. Tu decided to instead use an extraction method with ethyl ether, which boils at a lower temperature. The results were stunning: the compound showed a 100 percent success rate in animal testing and the first 21 patients it was tested on all recovered.The compound Tu and her team isolated—artemisinin—and its derivatives are the basis of combination therapies that are today the gold standard treatment for malaria. In 2015, Tu was awarded a Nobel Prize for her discovery, which she called “a gift from traditional Chinese medicine to the world.”5. Dr. Monique Wasunna, researcher of new treatments for neglected tropical diseasesPhoto: KfWDr. Monique Wasunna, a native of Uganda, grew up in an era when girls were expected to remain in the domestic sphere, but her father’s belief in the power of education and his commitment to advancing equal gender roles in the household helped her realize she could enjoy a different future. While a teen, Monique’s younger sister became severely ill and hospitalized due to measles, and this experience inspired Monique to pursue a career in medicine.For more than 30 years now, Monique has been working to advance treatments for the world’s most neglected patients, most notably as the former long-serving director of the Center for Clinical Research at the Kenya Medical Research Institute and currently as director of the Drugs for Neglected Diseases initiative’s (DNDi) Africa office. Over the course of her career, Monique has been a principal investigator on numerous clinical trials to find better treatment options for neglected diseases and has spearheaded new partnerships to expand clinical trial capacities in the East African region. Her work with DNDi has helped the organization advance several groundbreaking new treatments for neglected tropical diseases, including an improved, affordable therapy for leishmaniasis, which reduced treatment time from 30 days down to 17, and an all-oral cure for sleeping sickness.Monique believes that health is a human right, and that innovation is vital to delivering better health for all. As the world confronts global health challenges, “the most important thing is that we leave no one behind,” Monique said.For a broader look at the gender-related aspects of PRNDs and how policymakers can improve gender equity in global health research, check out this study from DSW.