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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. 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.

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 Friday, February 15, President Trump signed into law a spending bill covering funding for State & Foreign Operations (SFOPs) for fiscal year (FY) 2019. The bill provides US$8.8 billion to the overall Global Health Programs account at the State Department and US Agency for International Development (USAID), which is a $150 million increase from the FY18 enacted level and $2.1 billion above the President’s FY19 request. Funding for all global health programs at the State Department and USAID either increased or remained flat compared to the FY18 enacted level and were also well above the President’s budget request. The World Health Organization (WHO) is working to contain an unprecedented outbreak of Lassa fever in West Africa, which has killed 59 people in recent weeks. This Ebola-like virus is transmitted to humans via exposure to contaminated rate urine and droppings, as well as from person-to-person. Although Lassa fever is endemic in parts of West Africa with outbreaks occurring yearly, health officials have confirmed at least 275 cases in Nigeria—the epicenter of the outbreak—since the beginning of the year. WHO has expressed concern regarding the high number of cases so early in the Lassa fever season, which is due to last another four months. Controlling Lassa fever is a challenge because its symptoms can be vague, such as headaches and chest pain, making the disease difficult to diagnose, and there is no licensed vaccine yet available. To contain the current outbreak, WHO is forming a regional coordination mechanism to share, process, and evaluate information regarding suspected cases and is also intensifying public awareness efforts about how to deter rats. In experimental studies conducted in mice, an antibiotic drug called AN12855 was shown to be more effective against tuberculosis (TB) than isoniazid, one of the standard treatments available. The new drug demonstrated both a much lower tendency to develop resistance, and it remained in the tissues where the bacteria that causes TB resides for longer, thus killing the bacteria more effectively. Further studies are required to determine if these outcomes will translate to improvements in treatments for humans. Current treatment for TB can range from six months to more than a year; thus, researchers are working to develop new drug regimens that shorten and simplify treatment.

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.Over the next three years, Wellcome has committed to provide the Drugs for Neglected Diseases initiative (DNDi) more than £10 million to develop new oral treatments for leishmaniasis, a parasitic disease transmitted by the bite of a sandfly that affects over one billion people worldwide and causes tens of thousands of reported deaths each year. Until now, DNDi’s leishmaniasis research and development efforts have focused mostly on improving existing treatments, which can involve toxic drugs and often long, painful treatment courses. Bernard Pécoul, executive director of DNDi, said he is hopeful this new collaboration will enable DNDi to “radically overhaul the treatment landscape, by developing entirely innovative oral drugs that are safe, effective, affordable, and easy to administer.” Scientists at the Fred Hutchinson Cancer Research Center constructed an atlas of HIV mutations that they believe could aid researchers working to develop an effective vaccine. One of the challenges to developing vaccines against HIV is the virus’ ability to mutate in order to evade broadly neutralizing antibodies released by the immune system. Mutations can occur in the virus’ “envelope,” a protein layer that shuttles the virus into host cells and interacts with antibodies. Using a deep mutational scanning technology, researchers created a library of viruses with all the possible mutations that occur in the gene that encodes HIV’s envelope protein, and then by testing those against broadly neutralizing antibodies, were able to observe how each mutation affected the virus’ ability to escape the immune response. With more research, the scientists were able to pinpoint the structural area that contributed to the antibodies’ ability to block HIV. Broadly neutralizing antibodies remain a focus of HIV research, though drug makers have had limited success in developing vaccines focused on the viral envelope. Scientists at M.I.T., Harvard, and Novo Nordisk have developed a device capable of delivering medicines made of molecules too large to be absorbed through the stomach or intestines, such as insulin, without injections. Inspired by the angled shape of a leopard tortoise’s shell, which helps the tortoise roll onto its feet no matter which way it falls, the Soma device is designed to predictably land on the stomach wall after being swallowed. Within the device is a small post containing an insulin needle held in place by a thin disc of sugar. After five minutes, the disc dissolves and the post is cued to painlessly inject the insulin into the wall of the stomach, where it is able to enter the bloodstream. The device then travels through the colon and is eventually eliminated by the patient. The Soma device has proven to work in rats and pigs though more safety testing is required. Researchers hope to start testing this device in humans in three years and hope that it can be used for an array of injectable drugs.