Ansley Kahn

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. An experimental drug, remdesivir, was shown to protect monkeys against infection with Nipah virus—an emerging pandemic threat for which there is no approved vaccine or cure. The only current treatment is a still experimental monoclonal antibody that was tested during an outbreak in India last year. Remdesivir is also being tested against the Ebola virus in the current outbreak in the Democratic Republic of Congo and has shown some effectiveness against Lassa fever, MERS coronavirus, and respiratory syncytial virus in other studies. In the new study performed by the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention, eight African green monkeys were given lethal doses of Nipah virus. The four monkeys who received intravenous remdesivir within 24 hours of infection and daily infusions for 12 days survived, while the four that did not died within eight days. If remdesivir wins approval, “it will give us an extra treatment that could be used relatively quickly,” said Emmie de Wit, a virologist at NIAID, noting that “the average person who reaches a hospital dies within two days, so it’s hard to protect them once they’re infected.” The next step is to test how long after infection the drug can be given and still cure the animals. Women make up just over half of the 35 million people living with HIV worldwide but are underrepresented in clinical trials of potential HIV treatments, cures, and vaccines. A 2016 study performed by amfAR, the Foundation for AIDS Research, found that women represented a mean of only 11 percent of HIV cure trials, 19 percent of antiretroviral drug trials, and 38 percent of vaccine studies. Despite the well-known differences in how the immune systems of men and women respond to the HIV infection and how women respond to some drug treatments, clinical trials continue to rely heavily on the participation of gay men in particular. Further complicating women’s participation in clinical trials is the US Food and Drug Administration’s (FDA) strict rules for including women of childbearing age, leaving most researchers to opt for the easy way out and just enroll men, collecting data from women only after the drug is on the market. As scientists continue to pursue cures for HIV in light of reports of the second patient cured of the infection, researchers must reckon with the longstanding obstacle of the lack of women in clinical trials. The FDA has authorized the first diagnostic test to detect Zika antibodies in human blood to be marketed in the United States. The diagnostic, known as ZIKV Detect 2.0 IgM Capture ELISA, detects the proteins produced by the body’s immune system when it tests for the Zika virus in blood. Though 18 other active tests to detect Zika exist, they have only been allowed under emergency use. This newly approved diagnostic test will only be usable by those with clinical signs and symptoms of Zika or on those who have traveled to regions with active Zika transmissions. FDA Acting Commissioner Ned Sharples noted that the marketing authorization of this Zika diagnostic demonstrates “FDA’s work to protect the public health in emergency response situations.”

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. World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus announced at the 72nd World Health Assembly that a WHO Foundation would be set up later this year. The foundation, which was first mentioned at the 144th Executive Board Meeting in January, aims to broaden the organization’s donor base and “enable us to generate funding from previously untapped sources,” said Dr. Tedros. Details about the proposed foundation’s structure, governance, operating model, and legal status are still being hashed out. According to WHO officials, the foundation would be totally independent of WHO—no longer requiring the approval of the World Health Assembly—but could potentially be linked by contract to WHO to help fundraise for the organization from the general public and high net worth individuals. WHO aims to raise US$14.1 billion between 2019-2023 to deliver on its triple-billion targets. On Wednesday, WHO officially declared Algeria and Argentina free of malaria. Algeria, the country where malaria was first discovered, is now the third African country—following Mauritius in 1973 and Morocco in 2010—to eliminate the disease, which kills more than 400,000 people annually. Argentina is the second country in the Americas, after Paraguay, in 45 years to eliminate the disease. Despite WHO declaring 38 countries malaria-free since 1955, progress against the disease has stalled as malaria-carrying mosquitoes have become resistant to certain drugs used to treat the disease and insecticides used in bednets that protect people from being bitten while sleeping. Researchers at McMaster University have developed an affordable, durable method of transporting temperature-sensitive vaccines to low-resource settings that is inspired by breath strips. The solution: mixing dried vaccines with two sugar powders used to create the dissolvable film structure of breath strips. By using this technique, vaccines can stay stable at temperatures up to 40 degrees Celsius for up to three months. This approach circumvents the need to maintain a “cold chain” during transport from supplier to patient—a task which poses logistical and financial challenges in the hot climates of developing countries where infectious disease threats are endemic. Water or saline can be added to dissolve the sugary combination, and the same reconstituted liquid can be used for injections or nasal sprays. The researchers have tested the approach in lab experiments, but not people, and are pursuing funding to refine and deploy the technology.

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, the World Health Organization’s (WHO) new Science Division unveiled a Health Product Profile Directory—an online resource to guide the research and development of new technologies to combat neglected diseases and other health threats, including antimicrobial resistance and diseases that pose a pandemic threat. The Health Product Profile Directory is a free, searchable database of target product profiles for needed health products to tackle the world’s most pressing global health issues. Each product profile outlines eight to ten key characteristics for development of various health products, including vaccines, medicines, and diagnostics. The directory currently contains 196 product profiles developed by 24 agencies, 91 of which are focused on infectious diseases. In this editorial piece, Dr. Madhukar Pai also discusses whether the product profiles should address affordability, the opportunity to leverage the directory to tap into the potential of emerging innovators in the Global South, and ways to improve the new WHO resource. Every year, 5.4 million people are bitten by snakes. Between 81,000 and 138,000 die as a result, and of those who survive, 400,000 suffer lifechanging injuries. Two years ago, WHO formally classified snakebite as a neglected tropical disease and later this month it will launch a global strategy aimed at halving the number of deaths and cases of disability caused by snakebite by 2030. Last week, two major funding announcements for snakebite research were made public. Wellcome Trust announced a new £80 million program to transform the way snakebite is managed globally, and the UK Department for International Development (DFID) released £9 million to fund the development of a universal snake antivenom. The DFID-funded consortium—which includes the International AIDS Vaccine Initiative, the Liverpool School of Tropical Medicine, and snakebite specialists from Kenya, Nigeria, the United States, and India—will leverage the technology and processes that led to the discovery of drugs to combat HIV to develop new antivenom therapies. It will run through 2021, when a pre-clinical prototype of antivenom is expected. TB Alliance was awarded a Center of Excellence in Translational Research grant by the National Institute of Allergy and Infectious Diseases to support the development of two new clinical stage tuberculosis (TB) drug candidates. The grant, spaced out over five years, will provide US$5.5 million in the first year and reach a total of $28.4 million by 2024. With this grant, TB Alliance and its research partners will focus on the development of compounds that address drug-sensitive and multidrug-resistant strains of TB. “Expanding the global portfolio of new TB drug candidates, from which we can assemble tomorrow’s shorter and simpler cures, is crucial in the fight against TB,” said Dr. Mel Spigelman, president and CEO of TB Alliance.

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. A report released by the Economist Intelligence Unit warns that the fight against drug-resistant tuberculosis (DR-TB) lags behind that of other diseases in terms of money and public attention. Deaths from DR-TB will cost the world economy nearly US$20 billion annually; however, international funding for TB is approximately one-eighth that of HIV and AIDS and about half that of malaria. The report calls for TB to be treated as a public health emergency and states that $9 billion is needed by 2020 to develop new drugs, diagnostics, and vaccines to address this disease—the world’s number one infectious disease killer. DR-TB can develop when patients fail to adhere to the notoriously grueling treatment regimen, which includes thousands of pills and painful injections, or because of poor-quality drugs. Last year, the United Nations held the first-ever High-Level Meeting on TB, determining that ending TB is a global priority after progress against the disease has stalled in recent years. The World Health Organization (WHO) announced plans last Tuesday to change its vaccination strategy in the Democratic Republic of Congo (DRC) in an attempt to better confront the country’s current Ebola outbreak, which has lasted nine months and claimed more than 1,000 lives. As part of the new vaccination strategy, WHO intends to launch “pop-up” vaccination campaigns in safe communities and shift to immunizing as many people in each target area as possible instead of relying solely on its current tactic of ring vaccinating health workers and the immediate contacts of each known case. To extend vaccine supplies, WHO also recommended offering smaller doses of the vaccine—developed by Merck—to those at high risk and low risk respectively, and eventually introducing a second vaccine made by Johnson and Johnson. A consortium, including the Coalition for Epidemic Preparedness Innovations and the London School of Hygiene and Tropical Medicine, is planning how to safely roll out the new vaccine. On Wednesday, the US Food and Drug Administration (FDA) released two new draft documents which provide guidance about how to study drug safety and efficacy in pregnant and lactating women. The draft documents provide insight to drug makers into the FDA’s thinking on when they should study a medicine in lactating women and how they can better monitor health outcomes in pregnant women who are taking medications that have already been FDA-approved. These documents follow 2018 recommendations made by a federal task force formed by Congress to study the lack of research involving pregnant and lactating women. Historically, the drug industry has excluded pregnant women from research out of concern that an experimental medication might harm a fetus. There is a similarly small amount of research on medications safety in lactating women. Once finalized, the documents will help companies collect more high-quality safety information about drugs used in pregnant and lactating women.

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. A landmark study found that men whose HIV infection was fully suppressed by antiretroviral drugs had no chance of infecting their partner—suggesting that if everyone with HIV were fully treated, there would be no further infections. Of the nearly 1,000 male couples across Europe who participated in the study, in which one partner with HIV was receiving treatment to suppress the virus, there were no cases of transmission of the infection to the HIV-negative partner during sex without a condom. According to Professor Alison Rodger, co-leader of the paper published in The Lancet, these findings “provide conclusive evidence for gay men that the risk of HIV transmission with suppressive ART [antiretroviral therapy] is zero” and that the study’s findings “support the message of the international U=U campaign that an undetectable viral load makes HIV untransmittable.” The Global Polio Eradication Initiative (GPEI) unveiled a new five-year strategy on Tuesday, which includes the use of novel oral polio vaccines—several of which are being developed by PATH and its partners—as well as the adoption of smartphone technologies to assist in disease surveillance and faster response. GPEI is also planning to establish a regional hub in Amman, Jordan to allow for easier coordination and increased technical support for polio vaccination programs in Afghanistan and Pakistan, two polio-endemic countries. Additionally, as part of the new strategy, GPEI is expanding its partnership with development institutions such as Gavi, the Vaccine Alliance. These new approaches, among others, will be implemented by GPEI under its new strategy from 2019-2023 in the hopes that this new strategy will be its last, with wild poliovirus successfully eliminated by 2023. The new strategy is currently facing a funding gap of US$3.27 billion, which organizers hope to fill with a pledging conference in November. On Wednesday, the US Food and Drug Administration (FDA) approved the first vaccine against dengue fever. The vaccine, Dengvaxia, has generated much controversy in recent months due to post-marketing research performed by its manufacturer, Sanofi Pasteur, which showed that the vaccine offers protection for people who have already had at least one bout of dengue, but increases the risk of severe infection in children who were dengue-naïve, or never infected when they were vaccinated. The FDA ruled that Dengvaxia can only be administered to individuals between the ages of 9-16 living in parts of the United States where the dengue virus is endemic, and that it can only be given to children and young adults who had one previous laboratory-confirmed case of dengue. Identifying these individuals with prior infection is currently a challenge, because there is no point-of-care diagnostic test available, though Sanofi officials say they have to have one ready for FDA submission by late 2020. Sanofi will earn a priority review voucher (PRV) by bringing Dengvaxia to market. A PRV is an incentive created to encourage pharmaceutical companies to develop drugs and vaccines for neglected diseases and, in exchange, allows a company to expedite the review of another product it wants to bring to market or sell the voucher to another company.

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 April 23, the world’s first approved malaria vaccine was rolled out in Malawi, with rollouts in Ghana and Kenya to follow shortly. This four-dose vaccine, called RTS,S, is designed specifically for children. Malaria is a top killer of children worldwide, particularly affecting those in sub-Saharan Africa. The vaccine took more than 30 years and more than US$500 million to develop. Its development was an international collaboration among the World Health Organization, PATH, the Bill and Melinda Gates Foundation, GlaxoSmithKline, and a network of African countries. In a large trial, the vaccine reduced the number of clinical malaria cases by about 40 percent and severe malaria cases by about 30 percent. The rollout of the vaccine in Malawi, Ghana, and Kenya will put the clinical trial results to the test in a real-world application. In this editorial piece, Dr. Soumya Swaminathan explains the World Health Organization’s (WHO) recent establishment of a new science division under her leadership. The division “brings together existing research groups focused on reproductive health, infectious diseases and health-care systems,” and aims to strengthen “WHO’s capacity to promote and establish guidelines on public health, preventive care, clinical medicine, and ethical research, and ensure that emerging technologies improve safety and well-being." By leveraging WHO’s two key advantages of credibility and convening power, the division will help spur innovation in areas often neglected by private industry and academia and help establish guidelines and fill knowledge gaps to improve health interventions and systems. Ultimately, through this new division, WHO aims to create greater coordination of the organization’s science activities. A mosquito-repellent body lotion that provides six hours of complete protection against the Anopheles gambiae mosquito that spreads malaria could help fill a critical gap in malaria prevention, according to its creator. The lotion, Maïa, is a combination of shea butter and DEET insect repellent and was developed by Gérard Niyondiko, an engineer from Burkina Faso—one of 30 finalists of the World Health Organization (WHO) Innovation Challenge. According to Mr. Niyondiko, many people in Africa spend a lot of time outside in the evening before they go to sleep and are therefore exposed to malaria-carrying mosquitoes. Since women typically wash their children and themselves in the early evening and put an ointment on their skin afterwards, Mr. Niyondiko sees Maïa as a complementary tool in the fight against malaria that taps into existing human behavior in much of Africa. Field studies testing Maïa are planned in Burkina Faso and Tanzania with the aim of gaining WHO accreditation as a vector control tool. Maïa is already being sold by women’s microfinancing groups ahead of the coming rainy season in Burkina Faso.