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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 US Food and Drug Administration (FDA) advisory panel voted late last week to recommend booster shots of the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines. The committee voted unanimously Thursday in favor of the FDA granting emergency authorization of a half-dose booster of Moderna’s vaccine, at least six months after the second dose, among people 65 and older, those 18 to 64 with risk factors for severe COVID-19, and those whose jobs put them at high risk for serious complications of COVID-19. The following day, the same panel also recommended a second dose of the J&J vaccine given at least two months after the first shot for individuals 18 years and older. Final FDA authorization rulings on boosters are expected in the coming days.The COVID-19 pandemic has reversed years of progress against tuberculosis (TB), according to the World Health Organization’s (WHO) 2021 Global TB Report, released last week. The report, which includes data from more than 200 countries, reveals that global TB deaths increased in 2020, for the first time in more than a decade, and the number of people newly diagnosed with TB and reported to national governments fell from 7.1 million in 2019 to 5.8 million in 2020. WHO estimates an additional 4.1 million people infected with TB were not diagnosed or reported. The increase in deaths and decline in diagnoses is attributable to reduced capacity of countries to provide TB services, including diagnosis and treatment, according to WHO. The report also highlights the inadequate global funding for TB diagnostic, treatment, and prevention services, which fell from $5.8 billion in 2019 to $5.3 billion in 2020.On Wednesday, WHO announced a new team, the Scientific Advisory Group on the Origins of Novel Pathogens (SAGO), to investigate the origins of the COVID-19 pandemic, study origins of future outbreaks and epidemics, and guide studies of emerging pathogens more generally. The proposed list of SAGO team members includes 26 researchers, from 26 countries, six of whom were part of the international team that traveled to China earlier this year to study the pandemic’s origins. SAGO will conduct an independent evaluation of the available evidence on the pandemic’s origins and advise WHO about the next series of COVID-19 origin studies, as well as, beyond the current pandemic, advise WHO on the development of a global framework to define and guide studies into the origins of emerging and re-emerging pathogens of epidemic and pandemic potential.

Last month, G20 health ministers convened for their annual summit to address today’s greatest challenges to global health. As usual, they concluded with a new health declaration, which this year included language in support of multilateral cooperation to end the COVID-19 pandemic and improve access to COVID-19 medical countermeasures. It also recommits to health priorities like combating antimicrobial resistance (AMR), preparing for health emergencies, and achieving universal health coverage (UHC), and provides a framework to prioritize these global health challenges through the lens of equitable access and research and development (R&D) coordination. These seem to be powerful commitments, but where do they fit in context? In this Breakthroughs Blog, we look back on commitments from previous years to reflect on how the declarations have evolved and what they have been missing.Reflecting on five years of ministerial commitments Since the first G20 health ministers’ meeting in 2017, the health declarations have been a powerful platform for confronting long-standing global health challenges and adapting to new ones. While some topics such as AMR, health emergencies, and UHC have been featured repeatedly over the past five years in hopes of achieving equitable quality of and access to care, the declarations have also been used to react in real time to urgent crises such as COVID-19. Here are some key takeaways that help us understand where we’ve been:  Antimicrobial resistance Since 2017, the G20 health ministers have remained consistently committed to combating AMR through international collaboration. R&D has been a critical component of AMR commitments since the establishment of the Global AMR R&D Hub, an independent initiative to identify research gaps and align funders that was launched in 2018 following a call from G20 health ministers the prior year. Health ministers continue to recognize the urgent need for sustained R&D to accelerate the development of safe, effective, and affordable antimicrobials and partnerships to maintain the global supply of existing antimicrobials. Additionally, these health commitments also focus on surveillance and data sharing. Specifically, the World Health Organization (WHO) Global Antimicrobial Resistance Surveillance System (GLASS) Report was a step toward increasing the systematic collection of quality data on antimicrobial sales, consumption, and resistance to understand and mitigate the risks posed by AMR. Though AMR continues to be a focal point and some important initiatives have been launched, it is crucial that health ministers follow through on their agreed-upon proposals.Health emergencies While pledges to combat health emergencies and improve global health security were made prior to COVID-19, this issue has now taken center stage for G20 health ministers. Many of the pledges made in the 2020 health declaration focused on COVID-19 and discussed the adverse effects the pandemic is having on other health areas. Health ministers also recognize the importance of R&D to address infectious diseases with epidemic and pandemic potential. This past month, they put R&D at the core of the G20 agenda with a focus on the Access to COVID-19 Tools Accelerator, new pandemic preparedness initiatives, and reinvestment in existing programs. In 2019, much of the messaging and commitments were similarly focused on containing the Ebola outbreak in the Democratic Republic of the Congo. Along with pledges focused on specific health emergencies, the G20 health ministers have maintained yearly commitments to international cooperation and health systems strengthening under WHO guidance and in accordance with the International Health Regulations (IHR), both critical components of global health security. Despite reaffirming the need for strong health systems and compliance with the IHR as essential for health preparedness, health ministers have fallen short or been unable to secure commitments to the sustainable financing necessary for prevention and response. The lack of sustainable financing has translated into a lack of capacity, particularly in low- and middle-income countries, and left WHO and other multilateral institutions without adequate resources to mitigate pandemic threats. Recognizing these limitations, in January 2021, the G20 established a High-Level Independent Panel (HLIP) that worked at breakneck speed to propose actionable solutions for reliable and sustainable financing of the global commons for pandemic prevention, preparedness, and response by June 2021.Universal health coverage G20 health ministers have consistently recognized that UHC will be best achieved through strengthening health systems and promoting international collaboration, especially through sharing data, exchanging best practices, and sustainable financing. Their commitments reflect the multifaceted elements foundational to achieving UHC including primary care; health care workforce capacity; nutrition; immunization; and water, sanitation, and hygiene, as well as R&D and equitable access to medicines and health services. Health ministers have recognized and articulated the continued need for global investment in those areas, while also emphasizing that countries need to develop their own pathways toward the achievement of UHC by accounting for national contexts and priorities through engagement with civil society and the private sector. Despite consistently reaffirming their commitment to UHC, G20 countries have made few pledges shaping tangible action.The missing wheel for the road aheadFor the past five years, G20 health ministers have agreed on powerful language in their declarations—and yet each year, with a few notable exceptions, progress has rarely been made beyond a stamped paper. Unsurprisingly, the most recent declaration includes strong language on COVID-19, AMR, UHC, and health emergencies, but outside of pandemic financing, it is not connected to a plan to meet those pledges. It is unfortunate that the standard has become all talk and no action. But this month, G20 leaders can set a new course. Following the G20 health ministers’ meeting last month, the G20 heads of state will convene for their annual summit later this month. Together, the heads of state have an opportunity to fulfill the vision set forth by their health ministers; follow through with specific HLIP recommendations on how to fill gaps in pandemic preparedness, prevention, and response; and ultimately set a new standard of combining commitments with tangible action for future G20 health-related meetings.

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. On Wednesday, the World Health Organization recommended broad rollout of the world’s first malaria vaccine, known as RTS,S, among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. The recommendation is based on results from an ongoing pilot program—which has reached more than 800,000 children in Ghana, Kenya, and Malawi since 2019—showing the vaccine’s safety and effectiveness in remote and rural settings. Clinical trials of RTS,S, which was developed by GSK and PATH with funding from the Bill & Melinda Gates Foundation, indicated it reduces the risk of contracting malaria by 40 percent and risk of hospitalization for severe malaria by 30 percent. The vaccine will now face funding decisions from the global health community for broader rollout and country decision-making on whether to adopt the vaccine as part of national malaria control strategies.A new study has identified a compound able to block dengue virus replication in test tube experiments and in mice, researchers reported in Nature last week. There are currently no specific medicines to treat dengue, which infects more than 400 million people annually and can lead to fevers, rashes, and muscle and joint aches. Researchers behind the new study screened tens of thousands of small molecules for anti-dengue activity using an automated high-throughput testing process, then tweaked several molecules to produce more than 2,000 compounds for further testing. One of those drugs, JNJ-A07, proved equally potent against all four dengue serotypes in test tube experiments. In subsequent testing in mice, the compound was highly effective in reducing viral loads and viral-induced disease. The drug will be further tested in clinical trials for safety and efficacy in humans, according to developer Janssen Pharmaceutical Companies of Johnson & Johnson.The African Medicines Agency (AMA) treaty was ratified by its 15th African Union (AU) member country last week, meeting the threshold for the agency to be officially set up. The treaty was adopted by the AU in February 2019, though it required ratification and formal notification from 15 countries to launch implementation. Following Cameroon’s ratification on Tuesday, the AU now has 30 days, or until November 5, to begin setting up the agency, which is intended to support African countries in improving and harmonizing the regulation of medicines across the continent in order to improve access to quality, safe, and efficacious products. The AMA will be Africa’s second continental health agency, joining the Africa Centers for Disease Control and Prevention.

This blog is authored by Abena Poku-Awuku, Silvia Ferazzi, Katya Halil, and Maud Majeres-Lugand of Medicines for Malaria Venture; Valentina Buj de Lauwerier, Clara Pons-Duran, and Joanna Lai of UNICEF; and Clara Menéndez and Raquel González of ISGlobal.From the turn of the millennium until 2015, the global health community has successfully reduced malaria-related deaths by 60 percent and decreased the likelihood of malaria infection among the 3.4 billion people at risk. However, since then, progress has stalled, and in 2019, malaria claimed the lives of approximately 409,000 people, 90 percent of whom lived in sub-Saharan Africa (SSA).As children under 5 years of age and pregnant women are the hardest hit by the disease, most efforts are targeted at protecting these groups. It has been widely reported that malaria still kills a young child every two minutes in SSA. However, less well-known is that, as of 2016, malaria was also the second major cause of death and ill health, after HIV/AIDS, in younger adolescent girls aged 10–14 in the region. Malaria was also the eighth cause of death and the fifth leading cause of ill health among all adolescent girls in SSA. Furthermore, while gains were made in global malaria control between 2012 and 2016, especially among children under the age of 5, little progress was made in reducing malaria-related deaths among adolescents. The protection of populations such as adolescents, and particularly girls, has been largely overlooked due to lack of age- and sex-disaggregated data. For instance, the most recent publicly available data on malaria-related death and ill health among adolescents is from 2016. ISGlobal, Medicines for Malaria Venture, and UNICEF are collaborating to raise awareness of the lack of evidence and information on the vulnerability of adolescent girls to malaria, as well as bring attention to the specific challenges adolescent girls face in accessing malaria protection and treatment interventions.Why are adolescent girls more at risk of malaria?Biologically, younger adolescent girls and pregnant adolescents, especially those in their first pregnancies, have been found to be at higher risk of malaria and anemia than adolescent boys and older pregnant women. An estimated 777,000 girls under the age of 15 and 12 million girls aged 15–19 get pregnant each year in developing regions; malaria and associated anemia can be deadly for both the young mother, her fetus, and her newborn child.Socially, in many malaria-endemic countries, gender-based roles and household hierarchies, as well as the false notion of being less vulnerable to the disease, all raise an adolescent girl’s risk of being infected with malaria. Moreover, adolescent girls often do not have financial resources, may be unaware of their civil rights, and lack information about the disease. Age-of-consent policies equally prevent adolescents, both boys and girls, from seeking health services without the consent of a parent or guardian, or a spouse in the case of girls.The situation is exacerbated when a girl becomes pregnant, because she is less likely to access services due to cultural bias and stigma. For instance, intermittent preventative treatment of malaria in pregnancy is an antenatal care intervention recommended by the World Health Organization (WHO) in SSA to protect all pregnant girls and women against malaria. However, reaching pregnant adolescents with this intervention is difficult, as they are less likely to access antenatal services than women and older adolescents due to societal stigma.Furthermore, when a pregnant girl or woman becomes infected with malaria, very few effective malaria treatment options are available to her. Artemisinin-based combination therapies for P. falciparum malaria, the most common form of malaria in SSA, have only recently been considered by WHO for the treatment of malaria during first-trimester pregnancy, but WHO emphasizes the need for continued monitoring of drug safety, birth outcomes, and death among newborns. In addition, P. vivax malaria, a form of malaria that is predominantly found in Southeast Asia and Latin America, has now been found across Africa and is increasingly growing in parts of East Africa. However, the existing radical cure for relapsing P. vivax malaria is not recommended during pregnancy. Moreover, the development of new antimalarials for pregnant girls and women is constrained, because current drug development processes actively exclude pregnant women and girls during the development of new antimalarial drugs. This hinders the generation of data and creates evidence gaps in the treatment of malaria in pregnant women and girls. Insufficient funding is also a major limiting factor to the research and development (R&D) of new antimalarial drugs for pregnant girls and women. Engaging policymakers and the wider malaria communityBased on existing, but limited, evidence, we urge policymakers and the wider malaria community to join forces in: Developing adolescent-friendly school- and community-based services that facilitate improved outreach to adolescent girls and take into consideration their perspectives and needs. Increasing resources for information, education, and communication on the impact of malaria will also be impactful.Working together with local communities and health workers to build safer environments that encourage girls to access health services, including malaria and reproductive health interventions. Advocating against early marriages and early pregnancies, as key compounding obstacles to a self-determined and healthy, disease-free life.Maintaining the continuum of care for pregnant girls through preconception, prenatal, and postnatal stages to ensure that malaria is eliminated in this group. Supporting the generation of updated and in-depth evidence to back the development and re-evaluation of policies and programs targeting adolescents and focusing on gender equity. Revising national policies that set age limits and create barriers to accessing health services and malaria interventions. Increasing funding for malaria R&D projects to design effective interventions for pregnant girls. Developing new approaches, including leveraging new technologies, to facilitate earlier inclusion of pregnant women in clinical trials.