Breakthroughs Blog: NIH

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.Several recent news articles have claimed that new strains of COVID-19 have appeared that are more virulent or transmissible. These claims, however, should be highly scrutinized. Though some forms of COVID-19 with specific mutations have spread more widely, this is more likely due to chance and the movement and interactions of their human hosts, rather than evolutionary changes impacting the virus’s transmissibility or virulence.The National Institute of Health (NIH) launched a longitudinal study this week to investigate the impact of COVID-19 on children. The study will enroll 6,000 children from 2,000 families in 11 cities across the United States. Since only a fraction of COVID-19 patients to-date have been children, the study aims to assess whether children are more resistant or less likely to develop symptoms from SARS-CoV-2 infection. It will also investigate whether people with asthma or allergies are more resistant to COVID-19. Researchers will collect bi-weekly nasal swabs and questionnaire data on social distancing practices and potential exposures. For family members that indicate potential infection, researchers will collect blood and stool samples.The COVID-19 pandemic has caused labs across the country to shutter, disrupting countless research programs and threatening the careers of young academics. In particular, researchers' work that requires long start-up times—such as when animals are involved—could be set back by months or even years. This is especially worrisome for early-career academics who were planning to finish their graduate programs or who are losing critical work that would have laid the foundation for future projects.

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 Wednesday the National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx) initiative, a US$1.5 billion effort to develop new diagnostic technologies for COVID-19 in partnership with the US Food and Drug Administration (FDA), the US Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA). As part of RADx, NIH will host a $500 million challenge seeking promising proposals for point-of-care and at-home diagnostic tests. "We need all innovators, from the basement to the boardroom, to come together to advance diagnostic technologies, no matter where they are in development," said NIH Director Francis Collins. Finalists who are awarded funding will be paired with technical, business, and manufacturing experts to complete develop their products.The NIH National Institute of Allergy and Infectious Diseases (NIAID) and Gilead announced hopeful results from separate clinical trials of Gilead's drug remdesivir, the broad-spectrum antiviral initially developed by Gilead to treat the Ebola and Marburg viruses, against COVID-19. According to NIAID, the drug compared to a placebo reduced median time to recovery from 15 to 11 days, and results suggest the drug had a small positive effect on survival rate. These results aren’t game-changing, but in combination with results reported from a separate trial run by Gilead with similar outcomes, were enough for FDA to grant an emergency use authorization for remdesivir last Friday.The Trump Administration is reportedly planning ways to drastically accelerate the development of a SARS-CoV-2 vaccine through a program called Operation Warp Speed. The program will convene pharmaceutical companies, government agencies, and the military with the audacious goal of cutting the development timeline of a vaccine by as much as 8 months and producing 300 million vaccine doses by the end of 2020. Through Operation Warp Speed the government will absorb the cost of evaluating several vaccine candidates simultaneously, first in animal models, then in one large human master protocol trial that will evaluate several candidates concurrently. After filtering the pipeline, top candidates will enter late-stage clinical trials while the government invests in advanced construction of manufacturing facilities to ramp up mass production of the vaccines before knowing if they are safe and effective.The Jenner Institute, a nonprofit vaccine developer based at Oxford University, has leaped ahead in the race to develop a SARS-CoV-2 vaccine. According to The New York Times, the Institute, having already shown in previous trials that similar inoculations are safe, plans to enroll 6,000 people in a clinical trial by the end of next month to test the vaccine’s efficacy, putting it ahead of other vaccine trials. Pending emergency approval from regulators, the developer say they could have several million doses available by September. The technology in use has been in development at the Jenner Institute for decades in attempts to create a malaria vaccine.

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 National Institutes of Health (NIH) began enrolling patients in a study to test hydroxychloroquine—a malaria drug also used to treat rheumatoid arthritis and lupus—as a potential therapy for patients hospitalized with symptomatic COVID-19. Although President Trump has repeatedly touted hydroxychloroquine as a “game-changer” treatment in combating the novel coronavirus, the drug has yet to be proven safe and effective as a COVID-19 therapy in a clinical trial. This NIH-funded trial is one of 18 trials in the United States seeking to determine if hydroxychloroquine can treat COVID-19. The US Food and Drug Administration issued an emergency authorization allowing doctors to prescribe hydroxychloroquine and chloroquine to treat COVID-19—leading to a spike in demand and causing shortages.US researchers began clinical trials of a second experimental COVID-19 vaccine that uses a skin-deep shot instead of the usual deeper injection. This study is evaluating if two doses of Inovio Pharmaceuticals’ vaccine candidate is safe enough for efficacy larger tests. The Inovio vaccine works by packaging a section of the virus’ code inside synthetic DNA which is then injected into the skin. The cells act a mini factory, producing harmless protein copies which prompt the immune system to make protective antibodies against them should the real virus ever come along. After the injection, researchers use a device to give the injection site an electrical zap to help the vaccine more easily penetrate and get to work. This vaccine—like the NIH and Moderna’s vaccine candidate—is not made using the actual virus, meaning there’s no chance of getting infected from the vaccine and that it is able to be produced more quickly than traditional vaccines.Australian researchers have published a study showing ivermectin, a drug commonly used to treat parasitic infections, can also kill coronavirus in a laboratory setting in under 48 hours. Research was carried out on cell cultures in the lab, which does not always translate to effectiveness in people who have contracted the infection. The exact manner in which the drug kills the virus is unknown, but researchers say it was likely done by "dampening down" the ability of host cells to clear the drug. Ivermectin has already been studied and approved to treat other conditions, offering an advantage over new drug development—a long process that typically involves many years of studying safety and efficacy before being able to reach human patients. Further research is needed to determine whether the drug could be used to treat COVID-19.

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 clinical trial to test an experimental vaccine against the novel coronavirus is expected to kick off today. This initial trial will inject 45 healthy participants with different doses of the vaccine candidate co-developed by the National Institutes of Health and Moderna Inc. The goal for the initial trial is to check that the vaccine shows no worrisome safety side effects in order to set the stage for larger efficacy tests. Public health officials say it may take up to 18 months to fully validate the potential vaccine. Dozens of research groups and companies are racing to develop a vaccine against the novel coronavirus. A second vaccine candidates from Inovio Pharmaceuticals is expected to begin safety tests next month. A man initially known as the “London Patient” has become only the second person in the world to be cured of HIV. The man, Adam Castillejo, has decided to go public with his identity one year after being declared free of the virus and now 30 months after ceasing antiretroviral therapy. Mr. Castillejo was cured of HIV after receiving a stem cell treatment for cancer. The donors of these stem cells have an uncommon gene that gives them, and now Mr. Castillejo, protection against HIV by preventing the virus from replicating inside the body. In 2011, Timothy Brown, the "Berlin Patient" became the first person reported as cured of HIV, three and one-half years after having similar treatment. Although this high-risk therapy was primarily used to treat the patients’ cancer—and is not a feasible treatment for millions living with HIV worldwide—it offers hope to finding a cure for HIV using gene therapy. A new collaboration between Medicines for Malaria Venture and the Liverpool School of Tropical Medicine will establish pregnancy registries in malaria-endemic countries in Africa to fill the data gap on the use of antimalarials in one of the most vulnerable populations to malaria. The study will be conducted across three African countries and will capture data on the real-life use of artemisinin-based combination therapies (ACTs)—the standard care for malaria— during all stages of pregnancy, including the first trimester. The goal of the study is to collect enough safety and exposure data that, if positive, would allow for policy change on the use of ACTs in the first trimester of pregnancy. ACTs are currently not recommended in the first trimester of pregnancy owing to a historic lack of safety data.