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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 Coalition for Epidemic Preparedness Innovations (CEPI) is investing US$34 million into the German biotech company CureVac to develop vaccine “printing” technology that could rapidly manufacture vaccines to treat multiple diseases. Specifically, this funding will help CureVac work on a prototype of its RNA printer product, a transportable automated printing facility for molecules known as messenger RNA (mRNA)—used to transport genetic information from DNA into a cell, instructing it to produce a specific antigen to induce an immune response. As part of this three-year deal with CEPI, CureVac will use its mRNA platform to produce vaccines for Lassa fever, Rabies, and Yellow fever. If preclinical tests are successful, two of the vaccine candidates will be developed through early-stage safety trials in people. As epidemics of infectious diseases can be unpredictable and fast-moving, CureVac’s vaccine platform could help improve our ability to defend against such pathogens. Treating bednets with an antimalarial drug could be a promising new approach to controlling the disease. Although insecticide-treated bednets have been credited with averting 68 percent of all malaria cases since 2000, scientists believe mosquitoes are developing a resistance to pyrethroid, the insecticide predominantly used to treat bednets. Researchers at Harvard University demonstrated that an antimalarial drug can be transmitted to mosquitoes through brief direct contact and effectively halt the transmission of the malaria-causing parasite. In the study, researchers coated a petri dish with atovaquone, a commonly used antimalarial drug. Mosquitoes landed on the treated surface for approximately six minutes and were then fed a blood meal rife with the malaria parasite. Results showed that none of the mosquitoes treated with antimalarial drugs harbored the parasite and demonstrated proof of concept that antimalarial-treated bednets could be a powerful new tool in the fight against malaria. The US Food and Drug Administration has granted Fast Track designation to the Themis Bioscience chikungunya vaccine candidate, which allows the product to receive an expedited agency review given its potential to meet an unmet medical need. Themis hopes this designation will support its phase 3 development efforts for the vaccine, which showed encouraging results in phase 2. Two other chikungunya vaccine candidates have also received Fast Track designation, though the Themis vaccine is the most advanced in development. There are no current treatments or vaccines for chikungunya, a disease for which symptoms include debilitating joint pain.

On February 15, President Trump signed into law a bipartisan spending bill—averting another partial government shutdown and ensuring full-year funding for the government for the remainder of fiscal year (FY) 2019. The move followed several days of speculation about whether discord between Congress and the President on funding for a border wall would imperil the spending measure passed by Congress to fund the remaining one-quarter of the federal government.The months-long saga ended with some great news for global health and research and development (R&D)—a roughly US$150 million funding increase for global health programs in the State and Foreign Operations (SFOPs) bill, as well as a significant boost to the Food and Drug Administration (FDA) under the Agriculture bill included in the package.The bill included some welcome increases to global health accounts which have been flat-funded for five years running, including a $50 million (1.16 percent) increase to the President’s Emergency Plan for AIDS Relief (PEPFAR) and a $2.5 million (2.5 percent) increase to the US Agency for International Development’s (USAID) Neglected Tropical Disease Program compared to FY 2018. Nutrition saw a $20 million (16 percent) increase and Maternal and Child Health got a $5.5 million (0.66 percent) boost. But perhaps the most notable win in the bill was a long-sought increase to USAID’s tuberculosis (TB) program. After TB was in the spotlight at the United Nations High-Level Meeting on TB in September, the United States backed up its pledge of additional support for the global fight against TB by including a $41 million (15.71 percent) increase to the program in the final spending package for FY 2019—the largest increase to the program in more than five years. All other global health accounts were level-funded compared to FY 2018, resulting in an overall increase of 3.23 percent for USAID Global Health—a stark difference from the 36 percent cut proposed in the President’s budget.While most accounts of relevance to global health R&D within the Department of Health and Human Services were funded for the entire fiscal year in a spending package passed in September, the FDA was one agency whose funding was still in limbo. The FDA’s unique funding structure—divided between budget authority, or discretionary funding (appropriated by Congress), and fees (paid by FDA users) —shielded the agency from some of the worst impacts of the partial government shutdown in December and January as it drew down on user fees to continue most operations. But the final FY 2019 funding package included a welcome $460 million (9 percent) increase for the agency, including a $269 million (9 percent) increase in budget authority.As the FY 2019 appropriations process lurched across the finish line, advocates were already gearing up for another budget battle for FY 2020. Check back for regular updates as appropriations hearings begin and GHTC continues monitoring the prospects for global health R&D accounts in the coming year.  For reference, the text of the Conference Report to accompany H.J. Res. 31, the Consolidated Appropriations Act, 2019, is available here, the text of the Joint Explanatory Statement is here (with the Global Health Program breakdown on page 454 of the PDF), and a division-by-division summary is available here.

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. Pregnant and breastfeeding women in Ebola-affected areas in the Democratic Republic of Congo (DRC) will now be able to receive the experimental Ebola vaccine—marking a reversal of a previous World Health Organization (WHO) decision. Due to the severity of the current Ebola outbreak in the DRC, the WHO Strategic Advisory Group of Experts (SAGE) on immunization recommended that pregnant and breastfeeding women should now be included in the vaccination campaign as long as they and their babies are monitored. Pregnant women have historically been excluded from similar immunization campaigns because vaccines against infectious diseases are rarely tested or approved for use in pregnant women. SAGE advised that the use of the experimental Ebola vaccine in pregnant and breastfeeding women should be continuously evaluated based on emerging data on its safety and efficacy—the review of which will inform vaccine recommendations for future outbreaks. For the first time, scientists have begun large-scale releases of genetically modified mosquitoes in a high-security laboratory in Terni, Italy. Using the powerful gene-editing technique known as CRISPR, scientists aim to see if they can eventually help to eradicate malaria by altering a gene in mosquitoes, known as “doublesex,” which impacts sexual development. This alteration causes the mouth of female mosquitoes to resemble that of a male—meaning they can’t bite and spread the malaria parasite—as well as deforms female mosquitoes’ reproductive organs so they cannot lay eggs. As more female mosquitoes inherit these modifications, more and more become sterile, which could eventually crash or drastically reduce populations of the Anopheles gambiae mosquito that spreads malaria. Researchers hope to know within six months whether these modified mosquitoes would be able to efficiently spread their lethal modifications in the wild, though a better understanding of the possible environmental impacts of their existence is necessary before any release would be permitted. Researchers at a half dozen universities are using the genome editing tool CRISPR to try to turn the immune system against viruses for which no vaccine exists. Vaccines work by inducing the immune system’s B cells to produce specific matching antibodies that bind to antigen molecules on a virus, setting the immune system into motion. However, to develop a vaccine, scientists have to identify the exact piece of an antigen that will trigger production of an effective antibody—an often challenging task. Researchers are trying to skip part of this process by instead using CRISPR to directly genetically reprogram B cells to produce the needed antibodies against viruses. CRISPR is used to splice open the DNA of B cells and then a harmless virus is used to introduce DNA for certain antibodies into the cells. The goal is for the cells to repair themselves and then start continuously producing the antibody. While the science still has a long way to go, researchers have achieved some promising early results in reprogramming mouse B cells against respiratory syncytial virus and human cells against HIV.

The 2019 global health multilateral calendar kicked off as it always does with the World Health Organization (WHO) Executive Board (EB) meeting in late January in Geneva. Opening the meeting, WHO Director-General Dr. Tedros Adhanom Ghebreyesus continued his emphasis on framing global health discussions as being about how to achieve universal health coverage and further emphasized the importance of innovation and data-driven approaches to achieving this ambitious goal. In this context, it is not surprising that this year’s session featured a packed agenda with significant implications for research and development (R&D).2020-2021 Program BudgetOne of the first and most important items on the agenda was WHO’s budget for the coming two years, which will directly impact R&D-related programs including the essential medicines and diagnostic lists and prequalification.WHO proposed an overall budget (base, polio, and emergency fund) of US$4.79billion—an 8 percent increase over the 2018‒2019 level of $4.42 billion. The base program budget—which covers funding for the essential lists and prequalification, among other items—would see a 13 percent increase over 2018‒2019 levels.In welcome news, the secretariat laid out five key priority areas in the budget, including one focused on increasing WHO’s investment to support innovation and data. How this focus translates concretely and what it means in terms of resources allocated remains unclear. It also remains to be seen whether WHO will be able to marshal the voluntary contributions needed from member states to reach this increased budget target.Access to MedicinesThe EB again took up the issue of access to medicines, which has been a controversial topic at EB meetings for several years. As directed by a 2018 World Health Assembly (WHA) resolution, the secretariat produced a draft roadmap outlining the organization’s proposed activities on access to medicines.Generally speaking, the plan was well received by member states, with the marked exception of activities related to intellectual property (IP) and pricing. A number of countries, led by the United States, argued that the only role WHO should play in these areas is as a member of the tripartite agreement with the World Intellectual Property Organization, and the World Trade Organization, and that any expansion of WHO’s mandate beyond this is inappropriate. On the opposite side, Brazil and aligned countries argued that IP and pricing impacts the right to health and that WHO therefore has a unique and outsized role to play. It appears that neither side is willing to budge, so we expect this to remain an area of friction as the plan undergoes further refinement before it is expected to be voted on at the WHA in May.Antimicrobial ResistanceFollowing on the 2016 United Nations High-Level Meeting (HLM) on Antimicrobial Resistance (AMR), EB members heard a progress report on commitments made in the HLM political declaration. Overall, progress has been steady although a number of areas lag behind, particularly regarding the overuse of antibiotics in agriculture and livestock.While there was no resolution anticipated on this topic, several member states including the United States jointly proposed a resolution containing very positive language for R&D.The resolution urged member states to “enhance cooperation at all levels for concrete action towards combatting AMR, including through…research and regulatory capacity and technical assistance, including, where appropriate through twinning programs that build on best practices, emerging evidence and innovation.” Additionally, it called on WHO’s Director-General to “support member states to mobilize adequate predictable and sustained funding and human and financial resources and investment through national, bilateral and multilateral channels to support…research and development on existing and new antimicrobial medicines, diagnostics, and vaccines, and other technologies.”It is fair to say that R&D fared well over the course of this year’s EB, and GHTC looks forward to moving these conversations forward heading into the WHA in May.