Research Roundup: COVID-19 diagnostics challenge, remdesivir results, and vaccine development at warp speed
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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.