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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 (WHO) last week announced its first COVID-19 vaccine license agreement through the COVID-19 Technology Access Pool (C-TAP) with Taiwanese manufacturer Medigen Vaccine Biologics Corp. The vaccine license was acquired through the Medicines Patent Pool, which also enabled last week additional agreements under C-TAP for a COVID-19 vaccine prototype and a test used to measure COVID-19 antibody levels. While C-TAP was launched at the height of the pandemic to promote technology sharing to improve access, particularly to vaccines, in low-income countries, major pharmaceutical companies have thus far declined to join the initiative.A clinical trial led by researchers at St George’s, University of London found that a higher dose of the antibiotic rifampicin for an abbreviated four-month treatment regimen for tuberculous (TB) was safe with no increases in side effects or toxicities, compared to the standard six months, which is WHO-recommended. The trial took place among adults with newly diagnosed pulmonary tuberculosis in Uganda, Guinea, Peru, Nepal, Botswana, and Pakistan. Experts say shorter treatment regimens will help lower costs and increase patient compliance, which will in turn reduce transmission and the development of resistance to available TB drugs. CSL Sequiris announced that it received an award from the Biomedical Advanced Research and Development Authority (BARDA) to deliver a vaccine for bird flu to the US government, increasing BARDA’s stockpile in case of an outbreak. The company will deliver one bulk lot of the H5N8 A/Astrakhan antigen to the US government, whose development has been supported by BARDA in recent years. The agreement is intended to improve US national vaccine preparedness and is especially significant as bird flu continues to be detected around the world, including a small number of human cases.

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. Last week, a landmark study published in The Lancet Infectious Diseases confirmed that the benefits of combining the RTS,S malaria vaccine with preventative antimalarial drugs in settings of high seasonable malaria transmission continue over five years. Specifically, the study found that the vaccine-drug combination reduced severe malaria cases and deaths in young children by nearly two-thirds compared to either RTS,S vaccination or seasonal malaria chemoprevention alone and that the efficacy of RTS,S in preventing malaria in highly seasonal settings was similar to seasonal malaria chemoprevention. These results underscore the importance of integrating multiple prevention tools into existing malaria control efforts to alleviate the remaining burden of malaria.The US Department of Health and Human Services (HHS) announced recipients for the first $1.4 billion round of funding for Project NextGen, the successor to Operation Warp Speed, which includes awards to develop more effective and longer-lasting COVID-19 vaccines, a new monoclonal antibody, and technologies to streamline manufacturing. Regeneron, the Global Health Investment Corporation, and Johnson & Johnson Innovation are among the first group of recipients. HHS said these awards are a catalyst to kick staff research and anticipates announcing additional awards for the $5 billion program by the end of the year.  The US Food and Drug Administration (FDA) last week approved Abrysvo, Pfizer’s respiratory syncytial virus (RSV) vaccine for pregnant people, which is aimed at protecting newborns from the virus in their first six months of life. The announcement follows the agency’s approval of Abrysvo for adults 60 and older. The US Centers for Disease Control and Prevention is expected to recommend the vaccine soon, hopefully setting the country up for a healthier fall and winter season ahead with AstraZeneca and Sanofi’s Beyfortus RSV monoclonal antibody for infants also approved earlier this summer and updated COVID-19 shots expected in the coming weeks. 

The health ministers of G20 nations concluded their annual meeting last weekend with the adoption of an “outcome document” that includes welcome commitments to advance the research and development (R&D) of health products. While normally such a ministerial-level meeting would end with the release of a formal consensus communique, broader geopolitics derailed this process, with Russia and China opposing the inclusion of language condemning the Russian war of aggression against Ukraine. Below we break down what R&D commitments are included in the outcome document, why it matters, and where conversations are expected to go from here. What’s in the declaration? At the highest level, G20 nations made commitments to strengthen the global health architecture and “build more resilient, equitable, sustainable and inclusive health systems equipped to address ongoing global health challenges and future public health emergencies with equitable access to safe, effective, quality-assured and affordable vaccines, therapeutics, diagnostics, and other medical countermeasures.” They also reaffirmed their commitment to ending the epidemics of AIDS, tuberculosis, and malaria; achieving polio eradication; advancing universal health coverage (UHC) and the Sustainable Development Goals (SDGs); and tackling antimicrobial resistance (AMR). On the latter issue of AMR, the ministers vowed to strengthen R&D for AMR and further the development of novel antimicrobials. They welcomed the work of various international initiatives and GHTC members including the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Global Antibiotic Research and Development Partnership (GARDP) and voiced continued support for the Global AMR R&D Hub, which was established under the German G20 presidency to promote AMR R&D coordination. On the broader issue of R&D for pandemic prevention, preparedness, and response (PPPR), G20 leaders agreed to support a World Health Organization (WHO)-led consultative process to develop an interim (and potentially later permanent) medical countermeasures (MCMs) mechanism to coordinate the end-to-end R&D, manufacturing, procurement, and equitable delivery of MCMs during health emergencies. They advised that such a mechanism should consider a “network of networks” approach, building off existing international and regional partnerships, and should be coherent with the outcomes of ongoing efforts to amend the International Health Regulations (IHR) and advance a binding pandemic instrument. Additionally, the ministers underscored the need to strengthen local and regional R&D networks and manufacturing capabilities, especially in low- and middle-income countries, as well as voiced support for what many call the “100 Days Mission” to develop and make available safe and effective vaccines, therapeutics, and diagnostics within 100 days of the identification of a pandemic or epidemic threat. They also noted the importance of public-private R&D partnerships—calling out the contributions of GHTC members the Coalition for Epidemic Preparedness Innovations (CEPI), Medicines Patent Pool (MPP), and FIND—and technology transfer and knowledge sharing “on voluntary and mutually agreed terms.”Why it matters?  G20 nations currently conduct and fund the majority of the world’s health R&D. Thus, it is great to see G20 leaders reaffirm the importance of R&D to achieving UHC, SDGs, and PPPR and demonstrate political will to accelerate R&D efforts. However, the outcome document is short on specifics as to how G20 countries intend to operationalize their many promises, and it disappointingly includes no new funding targets or commitments.  Additionally, going into this year’s G20 cycle, many observers and health advocates also expected that the G20 under the Indian presidency would play a more active role in envisioning and detailing a specific proposal for the creation of an end-to-end MCMs mechanism or platform to succeed and build upon the Access to COVID-19 Tools Accelerator. Instead, the G20 simply promised to support a WHO-led consultative process to design an interim mechanism and punted it to the International Negotiating Body (INB) process for a pandemic instrument to determine the prospects for a permanent MCMs platform. What’s next? With G20 nations offering few specifics on a vision to reimagine the global health architecture and advance an MCMs platform, the focal point for change is now squarely within the separate but interrelated processes now underway to amend the IHR, advance a pandemic accord that will create a more comprehensive framework for how countries will prevent and respond to outbreaks, and design an interim MCMs platform. While these processes have been ongoing, the deliberations have been stymied as countries struggle to reach consensus around thorny R&D topics like access and benefit sharing, with some pushing for more aggressive legally binding commitments for transparency, conditions on public R&D funding, patent waivers, and new supply chain mechanisms for ensuring low- and middle-income countries access to medical countermeasures. Questions remain on the full scope of some of the processes, and how they will delineate which issues will be tackled where and with the target date of May 2024 for the adoption of an instrument rapidly approaching and the INB and IHR processes largely behind schedule, it remains to be seen what tangible changes for R&D can be realized. While it is impossible to know what exactly what the future of these negotiations hold, GHTC promises to continue to watch, weigh in, and report back in the months ahead as these interrelated processes unfold. Stay tuned!