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.  GlaxoSmithKline has licensed a promising tuberculosis (TB) vaccine candidate to the Bill & Melinda Gates Medical Research Institute in an effort to advance this vaccine for use in low- and middle-income countries. The institute will lead further development of the vaccine candidate and sponsor future clinical tests. The vaccine candidate, developed in collaboration with IAVI, was shown in mid-stage testing to be effective in approximately half of the people who were vaccinated for as long as three years. The only licensed TB vaccine that currently exists—called Bacillus Calmette-Guerin—prevents severe disease in infants and young children but gives limited protection to adolescents and adults. TB infects about 10 million people annually, killing about 1.5 million.A new research group at the National Institutes for Health (NIH) tasked with conducting human trials for vaccines against emerging health threats will be testing the first of likely many experimental vaccine candidates against the novel coronavirus that emerged in Wuhan China late last year. They hope to have a vaccine ready to test in just three months’ time. Chinese scientists quickly identified the genetic sequence and posted it publicly, allowing scientists to begin vaccine development without waiting for a sample of the virus. NIH scientists are now working with US biotech Moderna Inc. to develop an RNA-based vaccine, while additional candidates are in development by other funders and companies. According to Director of the National Institute of Allergy and Infectious Diseases Anthony Fauci, three months from gene sequence to initial human testing would be the fastest the agency has ever gotten such a vaccine off the ground. As of Friday, Reuters reports more than 800 people in China have been infected with the new coronavirus and 26 have been killed. Cases have also been confirmed in Thailand, Vietnam, Singapore, Japan, South Korea, Taiwan, Nepal, and the United States.According to a report by the Access to Medicine Foundation, the world is “precariously reliant” on a small number of pharmaceutical companies to develop new antibiotics, running the risk of a rise in superbugs. The biennial Antibiotic Resistance Benchmark report, which looks at pharmaceutical companies’ efforts to tackle antimicrobial resistance, found that only a core group of eight drug firms are developing antibiotics and that the pipeline of new products is very small. This report echoes a warning from the World Health Organization last week that a lack of private investment and innovation in the development of new antibiotics is undermining efforts to combat drug-resistant infections. Drug-resistant infections are predicted to kill 10 million people annually by 2050 if drug resistance continues to grow at its current rate—meaning that, increasingly, the treatments we rely on to kill infections are not working, and new ones are needed.

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.  According to a report by the AMR Industry Alliance, a private sector coalition, there is a “concerning shortfall” in investment in late-stage research and development (R&D) to battle antimicrobial resistance (AMR). Though in 2018 the Alliance’s members invested US$1.6 billion in R&D for antibiotics, vaccines, and disease diagnostics needed to tackle AMR,—a figure which dropped by one-third between 2016 and 2018—the report cited this investment as likely insufficient to deliver the tools needed to address growing AMR. It also cited a lack of access to quality and responsibly manufactured antibiotics as a significant challenge in low- and middle-income countries. The report calls on the public sector to provide greater R&D investment, particularly for later-stage research, and advance policy solutions like incentives to spur greater R&D investment and improve access. According to the United Nations, AMR is estimated to result in 700,000 deaths annually, a figure that is forecast to increase to 10 million by 2050. German researchers have developed the first diagnostic test for a new coronavirus that has emerged in central China. The virus was first detected in the city of Wuhan last year and has since sickened dozens of people with recent cases reported in Japan and Thailand. The diagnostic test developed at the Institute for Virology at Berlin’s Charite hospital will allow labs to reliably diagnose the new coronavirus “in a very short period of time,” according to its developers. The test protocol is being made available by the World Health Organization (WHO), and laboratories will be able to order a molecule from the German team to compare patient samples with a positive control. Until now, doctors have only been able to perform a general virus test and then had to sequence and interpret the genome—a difficult task for smaller labs, for facilities in countries where it’s not easy to transport samples or staff aren’t trained thoroughly, or those handling a large number of patients who need to be tested. Last week, WHO published its list of urgent global health challenges facing the next decade, which included climate change, infectious diseases, anti-vaxxers, and AMR, among other challenges. The list was developed with input from experts around the world and “reflects a deep concern that leaders are not investing enough resources in core health priorities & systems, putting lives & economies in jeopardy," according to a tweet by WHO Director-General Dr. Tedros Adhanom Ghebreyesus. Last year, WHO published a list of ten global health threats for the year 2019 which also included climate change, AMR, weak primary health care, and vaccine hesitancy. WHO noted that these challenges demand a response from the health sector, governments, communities, and international organizations.

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, Chinese authorities confirmed that a previously unidentified lung infection that affected 59 people in the city of Wuhan in December is a novel coronavirus—a member of a family of viruses that jump from animals to humans. To date, only six coronaviruses have ever been identified in humans, so the emergence of a new one may be cause for concern. Coronaviruses are fairly common and cause upper respiratory tract illnesses with mild to moderate symptoms, such as colds and coughs. However, two coronaviruses have proven to be particularly deadly— severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). The major focus of Chinese authorities will be to identify how easily the virus is transmitted from person to person, though right now it does not yet appear to be easily spreading. Information on the new virus in China is limited as preliminary tests have only been carried out on 15 patients.Scientists at Oxford University and the Royal Botanic Kew Gardens have developed a smartphone app to detect and differentiate disease-carrying mosquitoes using the acoustic signature of their flight tone. The app, Humbug, records the time and location at which the insect was identified, along with the mosquito flight tone and uploads the data to a central server where the species is identified using a suite of algorithms. This new technology provides researchers the ability to quickly upload, analyze, and share large amounts of data showing where mosquitoes can be found—a historically difficult process that requires trained mosquito experts to trap the insects and evaluate them under microscopes to identify the species. Thus, some countries have only a handful of samples measuring the prevalence of mosquitoes. Once mosquito distribution has been measured, this data can be compared with rainfall and temperature patterns to allow researchers to study and predict what causes the insect to spread and multiply. Humbug is currently being trialed in Tanzania and the Democratic Republic of the Congo.For the first time, primate research shows that a single dose of an antibody-based treatment can prevent HIV transmission from mother to child; however, timing of the dose is key. A study evaluating rhesus macaque monkey newborns found that they did not develop the monkey form of HIV, SHIV, after receiving a combination of two antibodies 30 hours after being exposed to the virus. In comparison, delayed treatment until 48 hours after exposure to the virus resulted in half of the baby macaques developing SHIV when they were given four smaller doses of the same antibody cocktail. The study also found that newborns who received antiretroviral therapy (ART) remained SHIV-free when they started a three-week regimen of that therapy 48 hours after exposure—suggesting a much shorter course of ART given after exposure could prevent transmission. Next, researchers plan to see if different antibodies, or a combination of antibodies and ART, could be even more effective in preventing HIV transmission from mother to child, and also aim to determine if the antibodies actually eliminate HIV or only prevent it from replicating.

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 team of Brazilian researchers are leading an international consortium to discover new drug candidates for malaria, visceral leishmaniasis, and Chagas disease. The organizations involved in the consortium include FAPESP (São Paulo Research Foundation), Medicines for Malaria Venture (MMV), Drugs for Neglected Diseases initiative (DNDi), Universidade Estadual de Campinas, and the University of São Paulo. The consortium has received US$10.7 million from the participating organizations for the next five years and will prioritize selecting and training researchers from São Paulo and investing inA new study has found that delivering the BCG (bacille Calmette-Guérin) tuberculosis (TB) vaccine intravenously better protected monkeys against infection than the standard administration method of injecting it into the skin. The BCG vaccine, which is the only licensed TB vaccine, is effective in preventing early-childhood forms of TB but provides limited protection against pulmonary TB, the dominant form in adults. Researchers have suspected that delivering the vaccine via other routes of administration, such as inhaled aerosolized vaccine or IV, could improve efficacy. In this study, researchers used rhesus macaque monkeys to compare the potency of intravenous needle injection to aerosolized and intradermal routes of vaccine delivery. Remarkably, nine of the ten monkeys that received the intravenous injection were highly protected from exposure to TB six months after vaccination—and six of the monkeys showed no signs of exposure. local institutions. DNDi and MMV will provide frameworks and resources for drug discovery, including MMV’s database of molecules.A new study has found that delivering the BCG (bacille Calmette-Guérin) tuberculosis (TB) vaccine intravenously better protected monkeys against infection than the standard administration method of injecting it into the skin. The BCG vaccine, which is the only licensed TB vaccine, is effective in preventing early-childhood forms of TB but provides limited protection against pulmonary TB, the dominant form in adults. Researchers have suspected that delivering the vaccine via other routes of administration, such as inhaled aerosolized vaccine or IV, could improve efficacy. In this study, researchers used rhesus macaque monkeys to compare the potency of intravenous needle injection to aerosolized and intradermal routes of vaccine delivery. Remarkably, nine of the ten monkeys that received the intravenous injection were highly protected from exposure to TB six months after vaccination—and six of the monkeys showed no signs of exposure.Researchers at the Institut Pasteur and the Centre national de la recherche scientifique have discovered a new route for developing antimalarial drugs. In studying the Plasmodium parasite and its ability to adapt between host environments in humans and mosquitoes throughout its life cycle, the researchers realized they could exploit this adaptability. The parasite uses a process called DNA methylation to modify which genes are expressed during different stages of its life cycle in humans and mosquitoes. The researchers tested 70 methylation-inhibiting molecules and found many that were effective, including some that killed the parasite within hours. The researchers also found that the most promising molecules were able to kill artemisinin-resistant malaria strains. This research could lead to new treatments in the future against treatment-resistant malaria strains.

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 US Food and Drug Administration (FDA) has approved an Ebola vaccine developed by Merck, making it the first Ebola vaccine to be approved in the United States. Merck’s vaccine, Ervebo, protects against the Zaire strain of the virus, which has been the most common cause of Ebola outbreaks and is responsible for the current outbreak in the Democratic Republic of the Congo (DRC). The decision by FDA to approve Ervebo follows the European Commission’s decision to license the vaccine last month. In securing approval by FDA, Merck also qualifies for a tropical disease priority review voucher. Merck announced it has also submitted Ervebo for approval to regulatory authorities in a number of African countries at risk of having Ebola outbreaks. The vaccine has also been prequalified by the World Health Organization, which could speed up regulatory approval in African countries.Scientists at the Massachusetts Institute of Technology have developed a microneedle patch that, when applied to a person’s skin, can simultaneously deliver a vaccine and embed a record of the vaccine using a pattern of fluorescent nanocrystals. The vaccine record, written in quantum dots that emit near-infrared light that is invisible to the naked eye but readable by a modified smartphone, does not require a link to a database and is not tied to any personal information. This device could help fill a gap in medical record keeping, especially in developing countries where resources to properly document immunizations may be lacking. Still in the prototype stage, the technology has been tested in the skin of human cadavers exposed to a simulated five years of sunlight, and its efficacy at delivering polio vaccine has been confirmed in rats. Further feasibility and human trials will be needed.Researchers at the University of Queensland and QIMR Berghofer Medical Research Institute have discovered that a virus can be “masqueraded” to resemble other viruses to help develop new, more effective vaccines against mosquito-borne diseases. The Binjari virus, which affects mosquitoes but is harmless to humans, can have its surface manipulated, so that it resembles other viruses. When these “chimera” Binjari virus cells are then used in vaccines, they prompt an immune response for the virus they are imitating without causing harm from that virus. This chimera virus is also much safer to work with compared to live viruses, which risk breaking biocontainment protocols during research and vaccine production. Researchers also noted that the Binjari virus is easy to re-dress, meaning scientists could quickly develop chimera viruses, reducing the time it takes to respond to an outbreak. Developing safe and effective vaccines for mosquito-borne viruses would be a major scientific breakthrough as vaccine coverage for this disease group is currently very limited.

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.  British drug maker GlaxoSmithKline (GSK) applied for a license to market its HIV drug, dolutegravir, in a child-friendly formulation that, if approved by regulators, will become the first new generation HIV medicine available in a child-friendly form. Developed by GSK’s HIV drug division ViiV Healthcare, this new formulation of dolutegravir is designed to be easier for babies and children to swallow. Because there is no licensed version of dolutegravir for children, doctors often prescribe older HIV medicines that can be less potent, harder to take, and have more side effects. GSK plans an initial rollout of the child-friendly formulation at “cost of production” early next year, pending licensure by US and European regulators, and is also planning licensing agreements with two generic drug makers who aim to make cheaper versions of the medicine available within months of the initial rollout. According to UNAIDS, approximately 1.7 million children are living with HIV, most of them in sub-Saharan Africa. According to reports released by Treatment Action Group (TAG) and the Stop TB Partnership, global funding for tuberculosis (TB) research and development (R&D) has reached an all-time high, though funding targets for efforts to eliminate the disease remain far from being met. According to the TAG report, TB R&D funding reached its highest level in 2018 at US$916 million, representing three consecutive years of funding increases. However, the Stop TB Partnership’s updated Global Plan to End TB—which aligns with the commitments made at the United Nations High-Level Meeting on TB in September 2018—calls for $2.6 billion per year for R&D for new diagnostics, drugs, and vaccines, in addition to the $13 billion needed for TB prevention and care. The Stop TB Partnership notes that reaching these funding goals would help provide care for 40 million people living with TB, enable 30 million to get preventive treatment, and put new diagnostics and treatment tools within reach by 2030. A new program approved by the board of Gavi, the Vaccine Alliance (Gavi), will fund a global emergency stockpile of Ebola vaccines that will be open for use by those in need of outbreak and prevention efforts. The program will be funded for $178 million through 2025 and will focus on low- and middle-income countries who will have access to the stockpile free of charge and will also receive support for the operational costs of vaccination campaigns. The World Health Organization’s SAGE Working Group on Ebola Vaccines and Vaccinations state that the stockpile should maintain 500,000 licensed doses of vaccines. In addition to the Ebola vaccine stockpile, Gavi will allocate another $1.6 million in funding for the RTS,S malaria vaccine implementation program from 2021-2023, which is ongoing in three African nations, which will evaluate the vaccine’s effectiveness in reducing childhood deaths when used in real word settings.