Research Roundup: Booster recommendations, TB setbacks, and an advisory group on pandemic origins

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 six-month oral treatment regimen for rifampicin-resistant tuberculosis (TB) is substantially more effective than the current standard of care, according to preliminary trial results presented at the 52nd Union World Conference on Lung Health on Wednesday. The TB-Practecal trial tested a six-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) among 552 patients against the locally accepted standard of care at seven trial sites across Belarus, South Africa, and Uzbekistan. Findings showed around 89 percent of patients in the BPaLM group were cured, compared to 52 percent in the standard of care group. Current standard care for rifampicin-resistant TB can require up to 20 pills daily, along with injections, for up to 20 months.A new fingerstick blood test could be a promising tool for screening TB patients, interim study results indicate. The test, developed by Cepheid, gives results in under one hour using a few drops of blood. The new results, from a study of 195 participants in Gambia, Uganda, South Africa, and Vietnam, show an overall sensitivity of 91 percent and specificity of 86 percent, regardless of HIV status or geographical location, which meets the World Health Organization’s minimum specifications for a TB triage test. Researchers plan to expand trials to further test the technology’s accuracy, including among people who have other risk factors for TB, as well for people who have both TB and COVID-19.On Friday, the US Food and Drug Administration (FDA) released a briefing document indicating the Pfizer-BioNTech COVID-19 vaccine is more than 90 percent effective against symptomatic COVID-19 among children ages 5 to 11. The data is based on a 10-microgram vaccine dose, a third of the dose used for adults and older children, which minimizes side effects but still induces a strong immune response. The antibody response was comparable to the one seen in individuals 16 to 25 years old, and no new safety problems were identified in the companies' studies. The FDA also released an analysis later Friday showing the protection “would clearly outweigh” the risks of the shot. FDA advisers will meet Tuesday to discuss expanding authorization of the vaccine, currently greenlit for people over 12, to those ages 5 to 11.

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.