Research Roundup: A global COVID-19 summit, a new EU health agency, and an effective typhoid vaccine

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 Thursday, US Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky signed off on a recommendation from a CDC advisory panel endorsing Pfizer-BioNTech COVID-19 booster shots for millions of older or otherwise at-risk Americans, following an emergency use authorization from the US Food and Drug Administration the previous day. Dr. Walensky expanded on the advisory panel’s recommendations—which supported the use of boosters in people 65 and older, nursing home residents, and those ages 50 to 64 who have risky underlying conditions—to also include those ages 18 to 64 who are health care workers or live in institutional settings that put them at increased risk for COVID-19 exposure. Boosters will begin rollout among individuals at least six months past their last dose of the Pfizer-BioNTech vaccine.The World Health Organization (WHO) updated its COVID-19 therapeutics guidelines Friday to include a recommendation for use of Regeneron’s antibody cocktail among non-severe patients at higher risk for hospitalization. The antibody treatment, a combination of casirivimab and imdevimab, is currently recommended in the United States for use in patients with mild-to-moderate COVID-19 cases to prevent a need for hospitalization, but WHO will now work to expand its use to low- and middle-income countries where access has been more difficult due to its high cost and limited availability. WHO and Unitaid are working with manufacturers to ensure equitable distribution around the world, as well as potential donation and distribution of the drug through UNICEF.A COVID-19 vaccine candidate developed by Clover Biopharmaceuticals showed 67 percent efficacy against illness in a global phase 2/3 clinical trial, the company announced last week. The vaccine demonstrated 84 percent efficacy against moderate-to-severe COVID-19 and 100 percent efficacy against severe COVID-19 and hospitalization. The results also varied among variants of the virus, with efficacy at 79 percent against the delta variant and 59 percent against the mu variant. Clover plans to use the data to seek conditional approval later this year in China and the European Union, as well as emergency use listing from WHO, which would clear the vaccine for use by the COVAX vaccine-sharing facility, to which Clover has agreed to provide up to 414 million doses. The shot is stable under normal refrigeration conditions for at least six months, making it well-suited for global distribution.

Last week, the world waited with bated breath to see whether G20 health ministers would seize the moment at their annual summit to take bold and necessary action to end the pandemic, build the global health architecture for the future, and recommit to health priorities that have taken a back seat during the past two years.The answer was rather muddled. The G20 health ministers did agree on several key principles and high-level priorities, many of which were positive, but their health declaration stopped short of providing a clear road map to translate these ambitions into concrete actions. Advocates were particularly disappointed in the lack of immediate actions, including calls for specific financial commitments, to address the shameful inequities in rollout and ongoing acute needs for COVID-19 vaccines and other tools.While the G20 didn’t provide much specificity regarding new pledges, it did highlight the importance of research and development (R&D) in all aspects of global health, including bolstering pandemic preparedness, combatting antimicrobial resistance (AMR), achieving universal health coverage (UHC), and strengthening digital health. As discussions in other forums such as the United Nations (UN) General Assembly, the World Health Organization (WHO), and the Global Health Security Agenda ramp up, G20 leaders have set the framework from which to build concrete reforms to the international system.Putting R&D at the core of the agenda This year’s G20 health declaration included strong language on R&D throughout. In discussing the Access to COVID-19 Tools Accelerator, pandemic preparedness initiatives, and reinvestment in key programs to achieve the Sustainable Development Goals (SDGs) and UHC, G20 leaders put R&D front and center. One particularly encouraging sign was the explicit callout from health ministers acknowledging R&D as a central pillar of pandemic preparedness, something that was notably absent in global health security frameworks, including the International Health Regulations, prior to the start of the pandemic. The COVID-19 crisis has exposed the need to enshrine greater global governance and coordination of R&D into the global health security architecture. The mention by G20 health leaders acknowledges a political shift on the issue and increases the prospects that R&D coordination and governance provisions will be integrated into a potential pandemic treaty and other WHO reform discussions in the coming months. The G20 health declaration also underlined the continued commitment toward combatting AMR, including by developing new safe and effective antimicrobials and sustaining reliable supply and production of existing antimicrobials. For the past few years, the agenda for the G20 has consistently included AMR with a focus on multidrug-resistant tuberculosis (TB), which is estimated to account for one-third of all AMR-related deaths globally. Leaders recognized that sustainable and robust resources for TB R&D are needed to accelerate development of new tools and deliver on previous commitments from the G20 and the UN high-level panels on TB, AMR, and UHC.Health ministers underscored the need to strengthen the resilience of supply chains; increase and diversify global, local, and regional vaccine manufacturing capacity; and build expertise for low- and middle-income countries (LMICs). Acknowledging that equitable access to medical countermeasures continues to be a major challenge, global leaders recognized the need to develop more balanced systems and infrastructure that provide greater coverage and capacity in LMICs. G20 leaders also reiterated that while vaccines have been at the top of everyone’s agenda, we must ensure that all countermeasures, especially therapeutics including oxygen therapies and diagnostics, are reprioritized as key elements of global response efforts and that the pipeline for new countermeasures continues to receive investments. Given the accelerated development of new diagnostic tools and the scale of testing needed for COVID-19, it was a positive development that G20 nations acknowledged that the introduction of testing capabilities should also be leveraged for other infectious diseases including TB, malaria, and HIV. To achieve the SDGs by 2030, the systems that are being built to respond to the pandemic must also serve to strengthen health systems overall and help in the fight against other disease threats.Where do we go from here?G20 health ministers reaffirmed their commitment to global solidarity, including by working toward equitable distribution of vaccines and supporting WHO’s goal of vaccinating 40 percent of the global population by the end of 2021. Despite this, no specific pledges were made to provide additional funding to the Access to COVID-19 Tools Accelerator, nor did leaders commit to increase vaccine dose sharing to address the acute needs of LMICs.The lack of specific targets or road maps for how to achieve the outlined principles and new investment pledges by G20 countries means that leaders must now work out how to operationalize these ideas in other multilateral meetings this fall. Many advocates are now pinning their hopes on the Biden administration’s call to convene heads of state at a Global COVID-19 Summit next week on the sidelines of the UN General Assembly and looking for tangible actions during the G20 Joint Health and Finance Ministers’ Meeting or World Health Assembly deliberations on a new pandemic treaty or framework convention.These forums will now have to pick up the baton, since we need global governance to be more inclusive, equitable, and accountable. This G20 health ministers’ declaration was a step in the right direction, as it set a framework for improving global health R&D coordination and governance, but it put the onus on other forums to follow through with concrete actions. Global leaders must now seize the moment and deliver on their promises.