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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. The World Health Organization’s COVID-19 Technology Access Pool and the Medicines Patent Pool last week finalized a licensing agreement with the Spanish National Research Council (CSIC) for its serological antibody test, marking the first non-exclusive license for a COVID-19 health tool. The CSIC test—a serological antibody test that evaluates for the presence of anti-SARS-CoV-2 antibodies developed either in response to a COVID-19 infection or to a vaccine—is relatively simple and suitable for basic laboratory infrastructure. The new license will allow the test to be offered royalty-free to low- and middle-income countries in order to promote equitable access to COVID-19 tools and facilitate rapid manufacturing and commercialization of the tool worldwide. Last Monday, Pfizer and BioNTech announced their COVID-19 vaccine was 100 percent efficacious in preventing infection among 12- to 15-year-olds from seven days to four months after administration of the second dose. The new results come from a longer-term analysis of a phase 3 trial—so far the only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 to 15 years of age. The vaccine has been authorized by the US Food and Drug Administration (FDA) for this age group since May and is fully licensed for individuals 16 years of age and older. The companies plan to submit the data to the FDA for an extension of their COVID-19 vaccine approval to cover the younger age group. The Coalition for Epidemic Preparedness Innovations (CEPI) plans to expand its centralized vaccine testing capabilities employed for COVID-19 to the development of vaccines for other epidemic and pandemic diseases. CEPI’s network, the world’s largest for assessing COVID-19 vaccines, comprises a global collection of labs, which more than 30 COVID-19 vaccine developers have used to access more than 15,000 clinical trial samples. The system will now be used to support vaccine development for other priority diseases, including chikungunya, Lassa fever, MERS, Nipah, Rift Valley fever, and Disease X. The testing network is intended to help quickly and accurately identify the most promising candidates with the best potential for late-stage clinical trial advancement and regulatory review, which also supports CEPI’s overarching goal of reducing the vaccine development timeline to just 100 days.

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. Pfizer signed a voluntary license agreement last week to share the patents and knowledge to manufacture its COVID-19 antiviral pill, Paxlovid, with the Medicines Patent Pool (MPP). The agreement will allow MPP to grant sublicenses to qualified generic medicine manufacturers to supply the treatment to 95 countries once regulatory authorization or approval is granted. Paxlovid, a five-day oral treatment regimen, was shown to reduce the risk of COVID-19-related hospitalization and death by 89 percent in phase 2/3 clinical trial results. The new licensing agreement will allow the rapid scale-up of manufacturing of the treatment, which is particularly well-suited for low- and middle-income countries and would contribute to global efforts to combat COVID-19, according to the executive director of MPP. AstraZeneca’s antibody cocktail is more than 80 percent effective at preventing symptomatic COVID-19, according to results released by the company Thursday. The study—in which more than 75 percent of participants had comorbidities that put them at risk of developing severe COVID-19—showed the long-acting antibody combination reduced the risk of symptomatic COVID-19 by 83 percent over a period of six months. There were also no cases of severe disease or death among those who received the antibody cocktail, which is administered as a one-time 300-mg dose in two separate, sequential shots. The preventative treatment is intended to help at-risk individuals, particularly those who do not develop an adequate immune response to the COVID-19 vaccine, to prevent serious illness from the virus. Merck KGaA (EMD Group) and the Pediatric Praziquantel Consortium have announced pivotal phase 3 trial results for schistosomiasis treatment arpraziquantel, indicating the drug has met the primary endpoint of clinical cure among children ages three months to six years. Arpraziquantel—an orally dispersible tablet derived from praziquantel, the formulation used for older children and adults—is tailored to the needs of the estimated 50 million preschool-aged children suffering from schistosomiasis, who currently have no treatment option. Merck KGaA intends to apply for a scientific opinion from the European Medicines Agency under a high-priority procedure for medicines intended for markets outside the European Union, which would facilitate prequalification by the World Health Organization as well as regulatory approvals in endemic countries. 

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 clinical trial is launching to evaluate a new Ebola vaccine that could protect against multiple species of the virus. While effective vaccines against Ebola have been developed in recent years, they have been approved for only one of the four species of the Ebola virus—the Zaire species, which is responsible for many outbreaks and has the highest mortality rate. Researchers at the University of Oxford are now starting human trials of a new vaccine designed to protect against the Sudan species in addition to the Zaire species, which together have caused almost all of the Ebola outbreaks and deaths. The vaccine is based on the same underlying technology used for the Oxford-AstraZeneca COVID-19 vaccine.Regeneron’s antibody cocktail reduced the risk of COVID-19 infection by 81.6 percent over a period of two to eight months, according to phase 3 trial results announced last week. Previously reported results from the trial had shown REGEN-COV to reduce risk of infection during the first month after administration; the new results demonstrate potential for the drug to provide more long-lasting preventive immunity, which could be an important tool for those who do not respond to COVID-19 vaccines, including people who are immunocompromised. The antibody cocktail is currently authorized in the United States and European Union to treat non-hospitalized patients who are already infected and at high risk of severe illness and in certain cases as a post-exposure prophylaxis.GlaxoSmithKline (GSK) and Vir Biotechnology announced on Friday that their COVID-19 antibody treatment, sotrovimab, works as well when given as a shot in the arm as when administered via standard infusion. Intramuscular injection could offer additional convenience for delivery of the treatment, as it can be performed by family doctors in non-hospital settings. Sotrovimab is authorized for emergency use in the United States to mitigate progression of mild and moderate cases of COVID-19, and the European Medicines Agency has greenlit its use by member states, though EU-wide approval is still outstanding. GSK plans to speak to global regulators, including the US Food and Drug Administration, about approval for the new method of administration.

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.