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Research Roundup: Caution on hydroxychloroquine, BARDA director ousted, first at-home COVID-19 test

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PATH/ Patrick McKern

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

April 27, 2020 by Julien Rashid

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.

In the largest study yet of the malaria drug hydroxychloroquine’s effect on patients with COVID-19, there was a higher rate of deaths among those being treated with hydroxychloroquine and hydroxychloroquine plus the antibiotic azithromycin than those who received standard care. The study was a retrospective analysis of treatments for 368 patients rather than a rigorous, randomized controlled trial. It’s also important to note that patients who were treated with the drug were those who were the most sick. Yet, the study raises further questions about this treatment that has been widely used during the pandemic and promoted by President Trump. Reflecting on these findings, a panel of experts from the National Institutes of Health (NIH) released new COVID-19 treatment guidelines that specifically caution against the use of hydroxychloroquine and chloroquine, with and without azithromycin, outside of clinical trials.

Dr. Rick Bright has been transferred from his position as director of the Biomedical Advanced Research Authority (BARDA)—a key agency involved in developing COVID-19 medical countermeasures—for a more narrowly focused position at NIH, just as BARDA has received supplemental funding more than ten times larger than its base funding of US $562 million to support coronavirus product development. Dr. Bright is asserting he was removed from his position because he pressed for rigorous vetting of hydroxychloroquine, an anti-malaria drug that has been frequently touted by President Trump as a potential treatment for COVID-19.

The US Food and Drug Administration (FDA) approved under emergency use authorization the first of its kind at-home diagnostic test for COVID-19. Developed by LabCorp, the Pixel COVID-19 test includes an at-home collection kit, which will need to be ordered by a doctor, that provides patients with a nasal swab and saline solution for self-sampling. Patients will swab their noses, then mail their samples to LabCorp testing centers where LabCorp will use real-time PCR for diagnosis.

Categories: COVID-19, Diagnostics

About the author

Julien RashidGHTC

Julien manages congressional outreach, policy development, and legislative analysis to support the US advocacy work of the coalition. In this capacity, he serves as GHTC’s primary liaison with Congress and helps develop strategies to advance the coalition’s legislative priorities. Before joining the Global Health Technologies Coalition, Julien was an associate at FasterCures, a center of the Milken Institute, where he supported the organization’s programs on economic incentives, health data, and patient-centric biomedical research. Julien graduated from the University of Wisconsin-Madison with a double major in molecular biology and community and environmental sociology. He also has a certificate (minor) in global health. He is currently pursuing a Master of Public Health at the Johns Hopkins Bloomberg School of Public Health.

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Flickr/John Donges
May 4, 2020

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

Written by Julien Rashid / GHTC
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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.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.
PATH/Gabe Bienczycki
April 20, 2020

Research Roundup: Early data suggests COVID-19 patients are responding to remdesivir, Sanofi & GSK partner...

Written by Ansley Kahn / GHTC
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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. Early data from two phase 3 clinical trials at the University of Chicago testing Gilead Sciences’ antiviral medicine remdesivir among COVID-19 patients is showing rapid recoveries in fever and respiratory symptoms among the patients. The university recruited 125 patients with COVID-19 to participate in these studies, of which 113 had severe cases of the disease. Researchers overseeing the trials reported nearly all patients were discharged from the hospital in less than one week after receiving daily infusions, noting only two patients have died. Although public health experts largely view these results as encouraging, clinical trials of remdesivir, including those with randomized control groups, are being run concurrently at other institutions to determine if this drug is safe and effective against COVID-19. Positive results from these trials could lead to fast approvals by the US Food and Drug Administration and other regulatory agencies in what could be the first approved treatment for the disease.Sanofi and GlaxoSmithKline (GSK) are joining forces to develop a vaccine for COVID-19. Sanofi will test its experimental coronavirus vaccine with GSK supplying some of the adjuvants—additional ingredients that improve efficacy and make it easier to produce vaccines in larger quantities. The companies plan to start human trials in the second half of this year, with the goal of having a vaccine available by the second half of 2021 if the studies are successful. If this partnership does produce a vaccine, GSK has also committed to reinvest any short-term profit from the vaccine into COVID-19 research and long-term pandemic preparedness. This partnership is one among many working to develop a COVID-19 vaccine. Earlier this year, Sanofi partnered with the Biomedical Advanced Research and Development Authority, a US agency focused on funding research and development for global health threats. In a statement, both companies pledged to make any vaccine that is developed affordable and accessible worldwide.Last week, President Trump announced he was halting US payments to the World Health Organization (WHO) pending a 60 to 90-day review. In his announcement, President Trump cited the organization’s failure to properly investigate early reports of the virus’ emergence and to stop its spread after it first appeared in China as reasons for halting payments. President Trump accused WHO of being China-centric and alleged the organization was critical of his administration’s travel ban from China as COVID-19 continued to spread globally. President Trump’s announcement has prompted international outcry with many noting now is not the time to end support for WHO. The US government contributed nearly US$900 million to WHO’s 2018–2019 budget, representing one-fifth of the agency’s operating budget for those years.