Research Roundup: Rwandan mRNA vaccine plant, African-produced HIV prevention rings, African clinical trial capacity-strengthening

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 Thursday, Gavi, the Vaccine Alliance, announced the African Vaccine Manufacturing Accelerator, which will invest up to $1 billion in boosting African manufacturing to address the inequality in vaccine access faced by Africans during the COVID-19 pandemic, as well as to produce vaccines to tackle diseases with a high burden on the continent, including cholera and malaria. The funding for the new scheme comes from leftover money from the COVAX initiative, which aimed to help the world’s poorest countries access COVID-19 vaccines during the pandemic. The accelerator is expected to launch in June of next year and hopes to ensure African manufacturers can offer competitive prices, even for new technologies like viral vector and mRNA vaccines.The startup NanoPin Technologies has developed an ultra-sensitive, blood-based test for difficult-to-detect tuberculosis (TB) cases now on the market, which is also the foundation for a multiplex TB and HIV test the company is developing. Both the NanoDetect-TB blood test, which is supposed to ease and speed up the detection of active TB, and the NanoDetect-TB/HIV multiplex assay, which uses quantitation of viral and bacterial loads to simultaneously detect HIV and TB, offer potential advantages over existing tools. Currently available tests, including the gold standard sputum-based methods for TB detection, can have low sensitivity to samples from patients with HIV and TB coinfection. Further research will be necessary to demonstrate that the multiplex test maintains efficacy in the field and that it can continue to be sensitive while reducing cost, complexity, and instrument requirements as much as possible.Last week at the International Conference on AIDS and STIs in Africa, researchers from the PrEPVacc trial that was testing two different vaccine regimens in Africa announced that the study has been shut down, leaving no HIV efficacy trials underway globally. The trial was halted after an independent data monitoring committee concluded there was little or no chance the study would demonstrate efficacy. The study had previously been dubbed the last chance for an HIV vaccine until the 2030s. PrEPVacc was a pioneering study as one of the first large, African-led HIV vaccine trials and one of the first trials to incorporate PrEP. However, the trial did use older vaccine designs that some scientists doubted would demonstrate adequate efficacy. The hope is that data from the halted trial can eventually inform future trials for new and innovative HIV tools.

Earlier this year, the US Agency for International Development (USAID) released its latest legislatively mandated report to Congress on its global health research and development (R&D) programs for fiscal year 2023. The report, which was recently shared with global health stakeholders following an October townhall with USAID Assistant Administrator for Global Health Dr. Atul Gawande, provides detailed information on individual products supported by the agency and key research advances in 2022, as well as budgeted funding for R&D across health areas.Because of USAID’s unique role as a key sponsor of global health product development, the Global Health Technologies Coalition (GHTC) closely tracks these annual reports to catalog the agency’s investments in its research pipeline and technological advances for low-resource settings.What has changed from last year?The most recent report, which comes on the heels of the agency’s new Global Health Research and Development Strategy 2023–2028, shows an increase from fiscal year 2021 (FY21) to fiscal year 2022 (FY22) in both products supported by the agency and budget allocated to advancing new lines of research and partnerships.The repeat details that the agency supported at least 63 individual products via its R&D investments in 2022, up 4 from 2021. Not surprisingly, the agency’s R&D portfolio in 2022 looked similar to 2021 in terms of the core health areas and product types financed.The report also revealed that in 2022, USAID budgeted $214 million in total baseline (non-supplemental) funding for global health R&D projects. This represents an increase of roughly $49 million from 2021, with the lion’s share coming from a plus up via the Global Health Security line for the Coalition for Epidemic Preparedness Innovations (CEPI), from $4 million in FY21 to $55 million in FY22. It is worth noting that in FY21, USAID allocated $50 million in COVID-19 supplemental funding from the American Rescue Plan Act for Global Health Security R&D. Thus, with supplemental funds included, FY21 funding numbers were more on par with FY22. This leads us to speculate that the supplemental increase in FY21 funds laid the groundwork for successfully justifying an increase in FY22 base funding for global health security-related R&D.While the $214 million budgeted for R&D in 2022 represents the highest non-inflation-adjusted baseline funding for R&D ever reported by the agency since 2006 (when R&D spending is viewed as a proportion of total USAID global health spending), the picture that emerges is far less rosy. While proportional spending on R&D rose slightly by 0.4 percent from FY21, bringing it to 5.5 percent—this was still far below the 8 percent peak that the agency spent on R&D in 2006 and unfortunately does not fundamentally shift the trajectory of the years-long decline in proportional R&D spending by the agency.The path aheadWhile GHTC is pleased to see the increase in base funding for global health R&D and R&D spending as a proportion of overall global health funding, as GHTC’s analysis indicates, there are still core gaps in the agency’s R&D investment areas and a need to better resource the global health R&D portfolio after years of decreased proportional investment since 2006. GHTC has been advocating for the creation of a new disease-agnostic fund for global health R&D at USAID, deemed the Supporting Innovative Global Health Technologies (SIGHT) Fund, to direct more dedicated resources to R&D. Earlier this month, we welcomed the first step towards that vision, with the House introduction of the bipartisan SIGHT Act (H.R. 6424), which would establish the programmatic structure at USAID for such a fund to be realized. We look forward to advancing the SIGHT Act, as well as what similar calls for greater investment in global health R&D spending can do for advancing health and well-being in all settings.