Research Roundup: A WHO vaccine approval, first oral antiviral COVID-19 treatment, and Pfizer's COVID-19 pill

With the world still reeling from the pandemic and global inequities more exposed than ever when it comes to access to medical countermeasures and response capabilities, all eyes were glued on G20 leaders in Rome last week. This G20 heads of state meeting was supposed to be a key global moment for shaping effective, innovative, and equitable responses toward a new post-pandemic global health architecture, but world leaders failed to come together and deliver the necessary action to end the historic crisis still unfolding or create the structures to prepare for the next one. The meeting did offer a small glimmer of hope: research and innovation was firmly anchored as a core tenet of leaders’ strategies to address a myriad of global health challenges, whether COVID-19-related or focused on enduring health threats. While this very much feels like the G20 missed its opportunity, hope remains that the international community can utilize other upcoming forums to take up the torch.  Missing the mark As G20 leaders got together to hammer out agreements to address both current and future health challenges, expectations were high, as many global health advocates hoped the group would start taking concrete steps to act on the numerous initiatives and recommendations from the various review processes this past year. Unfortunately, the global health community was left disappointed, as G20 leaders failed to step up to the plate, providing little by way of concrete pledges, funding, or specific road maps on how to turn their words into action. While countries agreed to a target to vaccinate 40 percent of the world by the end of the year and 70 percent by the middle of 2022, they offered no concrete plans to achieve that goal and failed to make good on their earlier dose promises to COVAX by confirming actual delivery dates. Under current projections, close to 80 countries won’t hit that 40 percent mark by year’s end and would struggle to hit the target in the first quarter of 2022.  Funding also remains a concern, as G20 nations made no new commitments to help address the US$15.9 billion shortfall in monies needed by the Access to COVID-19 Tools Accelerator to accelerate the rollout of tests, treatments, and vaccines, as well as the continued investment needed in innovation to address variants as well as second-generation medical countermeasures that can be more easily deployed. There were also expectations that the G20 would agree to some framework for the creation of a financial intermediary fund for pandemic preparedness, a mechanism that would provide countries with financing to address their long-term preparedness capacity strengthening needs, including potential investments in surveillance, laboratory, clinical trial, and manufacturing infrastructure. However, the G20 didn’t jump at the opportunity to move this initiative forward at the summit, choosing instead to set up a finance-health task force to consider a potential financing facility, creating yet another process.  Silver lining on research and development Despite not spelling out major commitments, the G20 leaders did include several high-level pledges related to research and development (R&D) and broadly acknowledged that research and innovation are important cornerstones of pandemic preparedness and response capacity writ large. It is rare that the G20 leaders’ communique makes direct mention of R&D, so seeing that language included in the final document is remarkable in and of itself. What stands out in the declaration is a pledge by G20 countries to support science to shorten the cycle for the development of safe and effective vaccines, therapeutics, and diagnostics from 300 to 100 days following their identification. While this ambitious target was not supported directly by specific commitments, it does provide a principles framework for future discussions on R&D coordination and capacity strengthening. G20 leaders also had strong rhetoric on strengthening supply chains and manufacturing capacity in the long term, highlighting the need to support mRNA hubs in low- and middle-income countries in particular. Finally, it was also good to see explicit callouts underscoring the need to sustain investments in malaria, tuberculosis, and HIV/AIDS and tackle the growing threat of antimicrobial resistance.  Who will pick up the torch? While this year’s G7 and G20 processes did not lead to the kind of concrete commitments advocates were hoping for, there are still a few summits and milestones in the coming months that could help cement follow-through action to meet global vaccination targets, fully resource the global COVID-19 response including ongoing R&D needs, and enhance transparency around the global supply and delivery of COVID-19-related medical countermeasures. Today, US Secretary of State Antony Blinken will host a meeting with foreign ministers from several countries to discuss commitments to the global COVID-19 response in follow-up to the Global COVID-19 Summit in September. There are also the ongoing discussions being held by member states in the lead-up to the upcoming special session of the World Health Organization on how to strengthen the agency’s health preparedness capabilities, including a potential new framework convention or pandemic treaty. These deliberations have considered a number of changes to the global health security architecture, including developing and reforming governance and coordination mechanisms for R&D. The pressure is now on these forums to deliver solutions to the broad set of challenges that the G20 Ministerial didn’t deliver and to build on the strong rhetoric on R&D to create a fit-for-purpose global health system that provides true equitable access to the health tools the world needs. 

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.Pharmaceutical company Merck has announced an agreement to share its license for the oral COVID-19 drug molnupiravir with the United Nations–backed Medicines Patent Pool to expand access to the treatment in more than 100 countries. Molnupiravir, an easy-to-take pill, reduced hospitalizations and deaths by half among higher-risk COVID-19 patients diagnosed with mild to moderate illness in a global clinical trial. The agreement is the first public health license for a COVID-19 treatment or vaccine, allowing the medicine to be produced by all capable manufacturers—once the drug receives regulatory approval—to expand the drug’s availability, widen its manufacturing base, and potentially push down the price. Merck has applied to the US Food and Drug Administration for emergency use authorization, and the European Medicines Agency recently began a rolling review of the drug.The Access to COVID-19 Tools Accelerator (ACT-A) on Thursday launched its new strategic plan outlining a focus on addressing access inequities to tools in underserved areas. Over the next year, ACT-A—a global partnership set up to accelerate the development and delivery of COVID-19 tests, treatments, and vaccines—will aim to support low- and middle-income countries in vaccinating 70 percent of their populations, increasing their testing rates to at least 1 per 1,000 people per day, and treating up to 120 million COVID-19 cases through deployment of existing treatments and enabling access to new therapies. The plan outlines a required budget of $23.4 billion between now and September 2022, including $840 million for research and development.Inexpensive drug fluvoxamine could reduce hospitalization in adults with severe COVID-19, according to research published Wednesday in The Lancet Global Health. The findings, based on a clinical trial in Brazil evaluating high-risk, symptomatic adults who had recently contracted COVID-19, showed participants were less likely to require hospitalization or an extended emergency room stay when given a 100-milligram dose of fluvoxamine twice daily for ten days. Fluvoxamine is commonly prescribed to treat depression and obsessive-compulsive disorder and is known to reduce inflammation, which COVID-19 can cause throughout the body. The study findings, part of the larger TOGETHER Trial aiming to identify repurposed therapies effective against COVID-19 disease progression, have been shared with the World Health Organization and the US National Institutes of Health.