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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. On Monday, the COVAX vaccine-sharing facility and the World Bank launched a new financing mechanism to increase access to COVID-19 vaccines in low- and middle-income countries. The scheme builds on the existing COVAX advance market commitment (AMC) mechanism by allowing AMC-eligible countries to make additional advance purchases through COVAX—beyond the fully donor-subsidized doses AMC-eligible countries are already receiving—based on aggregate demand across countries, using financing from the World Bank. The new plan will also provide participating countries with greater transparency on vaccine availability, prices, and delivery schedules, enabling them to implement vaccination plans more effectively. COVAX has so far delivered around 150 million doses to 137 countries and aims to deliver 2 billion doses by the end of this year, in addition to 1.8 billion next year.BioNTech intends to begin clinical trials for a “safe and highly effective malaria vaccine,” based on the mRNA technology behind its COVID-19 vaccine, by the end of next year, the company announced last week. Developing a vaccine able to induce a strong, long-lasting antibody response against malaria is difficult, as the genome of the parasite that causes malaria is more complex than viruses, according to researchers—however, insights from developing an mRNA-based vaccine against COVID-19, combined with a growing understanding of how malaria works, could make this an optimal time to address the challenge, a BioNTech representative said. BioNTech is also looking to establish an mRNA vaccine production facility in Africa, bolstering manufacturing capabilities on the continent and ultimately producing various mRNA-based vaccines beyond COVID-19.Researchers were able to wipe out a population of malaria-transmitting mosquitoes using a genetic engineering method that renders females infertile, according to study results published Wednesday. The gene-drive technology aims to bypass natural selection by plugging in a set of genetic instructions that rapidly spread through a population and pass on an infertility trait—far faster than could be achieved through conventional selective breeding. The new study tested whether gene drive of a sex determination gene—which has been previously tested, successfully, in a smaller trial—would spread and cause the same population collapse in closer to real-world conditions. Researchers plan to continue with more comprehensive gene-drive testing and environmental risk assessments before moving to larger field trials. The self-sustaining and fast-acting technology is meant to work alongside existing tools, such as bednets, insecticides, and vaccines.

The Biden administration has proposed a new, cutting-edge research entity that has the potential to benefit global health the way the Defense Advanced Research Projects Agency (DARPA)—the research agency behind the internet, GPS, and self-driving cars—benefited the rest of society. This proposal, the Advanced Research Projects Agency for Health (ARPA-H), could lead to transformative health innovations for neglected diseases and address gaps caused by market failures, ultimately bolstering global health research and development (R&D). What is ARPA-H? Initial proposals from the Biden administration and allies in Congress have described ARPA-H as a driver of scientific breakthroughs for innovations to prevent, detect, and treat diseases that will be housed within the National Institutes of Health (NIH). The idea for ARPA-H was originally conceived by the Suzanne Wright Foundation, a pancreatic cancer advocacy organization, which outlined a Health Advanced Research Projects Agency that would focus on overcoming market failures by de-risking investments from the private sector. Now that the proposal has been taken into the mainstream by the Biden administration and biomedical R&D champions like Representatives Diana DeGette (D-CO) and Fred Upton (R-MI), advocates hope this mandate of addressing market failures might also encompass global health issues including HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases. The scope of research to be conducted under ARPA-H has not yet been set in stone, even though the president’s fiscal year 2022 (FY22) budget request lists as initial focus areas cancer, diabetes, and Alzheimer’s in its $6.5 billion request for the agency. NIH has organized listening sessions, including one for allergies, infectious diseases, and global health, to further discuss the potential research areas for ARPA-H.  To promote high-risk, high-reward research, ARPA-H will likely be modeled after DARPA, which has a flat and nimble organizational structure and a large budget with limited oversight. In contrast to NIH’s sometimes slow-moving peer review process and multiyear grants, DARPA utilizes program managers who make unilateral funding decisions based on research milestones achieved. If the agency is stood up, GHTC supports an ARPA-H funding framework that is similar to DARPA, as it could enable easy, flexible collaborations with product development partnerships—nonprofit partnerships that address public health goals.The Biden administration’s proposal to house ARPA-H within NIH has raised concerns among some advocates and skeptics that this could limit its flexibility and independence, two critical aspects of the ambitious high-risk, high-reward ARPA-H agenda. An additional concern is that placement within NIH could eventually limit growth of top-line funding available for other NIH institutes and centers, and the lack of clarity regarding the scope of focus areas for research has created hesitancy among congressional appropriators to fund the full $6.5 billion proposed. However, if ARPA-H is created with the flexibility and independence of DARPA, and its funding is additive so as not to diminish work on any other NIH program, the agency holds great promise for global health innovations. Global health potential With the right influence from advocates, ARPA-H has the potential to advance research that could benefit the lives of people living in impoverished and underprivileged communities worldwide. Poverty-related and neglected diseases (PRNDs) affecting these communities remain inadequately addressed by the market, as they offer little commercial incentive for the private sector to invest in developing medical products to diagnose, treat, or prevent them. The lessons of the COVID-19 pandemic highlight the need to address gaps in existing PRNDs as their impacts are exacerbated during health emergencies. With a focus on PRNDs, ARPA-H could make a substantial impact toward developing innovations to address the world’s most overlooked diseases.GHTC is not the only stakeholder that recognizes the global health potential for ARPA-H. During a Senate budget hearing for FY22 on NIH, Dr. Francis Collins, NIH’s director, said that one focus for ARPA-H could be the development of a universal vaccine that protects against the ten most common infectious diseases in a single shot. The opportunity for further influencing the scope and mission of ARPA-H remains open. Just recently, Representatives DeGette and Upton, lead sponsors of the landmark 21st Century Cures Act of 2016 who are now developing a follow-up bill, issued a request for information on the possible authorization of ARPA-H in their bill, with questions including, “To ensure it has the biggest impact, on what activities or areas should ARPA-H focus?” In response, GHTC submitted feedback advocating for a focus on PRNDs, including HIV/AIDS, tuberculosis, malaria, and neglected tropical diseases, as well as antimicrobial resistance, arguing that a focus on these areas of historic market failures holds the greatest potential for ARPA-H’s societal impact. ARPA-H could produce transformative health innovations in chronically underfunded areas. If the agency is authorized, GHTC and other advocates should encourage lawmakers to ensure R&D for PRNDs is prioritized. The innovations that result could yield additional advancements across the entire field of biomedical R&D, improving health for all.

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 International Vaccine Institute (IVI) and Coalition for Epidemic Preparedness Innovations (CEPI) have announced a new clinical research program that will aim to improve and expand access to COVID-19 vaccines in Africa. CEPI will provide approximately $12.7 million to the Expanding Access and Delivery of COVID-19 Vaccines in Africa (ECOVA) initiative, which will be led by IVI, to conduct clinical trials of Sinopharm’s BBIBP-CorV vaccine. The BBIBP-CorV vaccine is already being deployed in more than 50 countries, and the COVAX vaccine-sharing facility is set to distribute around 170 million doses based on a deal announced July 12. However, there have been no clinical trials assessing BBIBP-CorV in African populations or against the variants of concern circulating in southern Africa. The ECOVA research initiative will aim to collect data that informs the utilization of the shot in Africa, as well as potentially expand its use to people with HIV/AIDS.On Wednesday, Pfizer and BioNTech announced a new partnership with Biovac to produce more than 100 million doses annually of their mRNA-based COVID-19 vaccine for distribution within the African Union. Cape Town-based pharmaceutical company Biovac will manufacture the vaccine at the “fill-and-finish” stage using active ingredients produced by facilities in Europe. Technical transfer, on-site development, and equipment installation will begin immediately, according to the announcement, but manufacturing of finished doses will not begin until early 2022—meaning the deal will not have impact in the near term on vaccine supply shortages in the region. At full operational capacity, the facility will exceed 100 million doses produced per year, all of which will be distributed within the 55 member states of the African Union.The US Food and Drug Administration (FDA) last week approved fexinidazole as the first all-oral treatment for both stages of sleeping sickness, also known as human African trypanosomiasis. About 65 million people in sub-Saharan Africa are at risk of sleeping sickness, which is transmitted by the bite of an infected tsetse fly and is almost always fatal if left untreated. Fexinidazole—developed by a partnership between the Drugs for Neglected Diseases initiative (DNDi), Sanofi, and national sleeping sickness programs of the Democratic Republic of Congo and Central African Republic—is the first all-oral treatment that works for both the first stage of the disease and the second stage of the disease in which the parasites cross the blood-brain barrier. The ten-day, once-a-day treatment method will expand options beyond those requiring hospitalization for infusion or injection. As a result of the approval, a priority review voucher (PRV) was also awarded to DNDi under the FDA’s Tropical Disease PRV program.