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Wednesday, Oct 14 2020

Full Issue

Eli Lilly's Antibody Treatment Testing On Hold Over Safety Concerns

NIH paused clinical trials of Eli Lilly's monoclonal antibody treatment after one of the study groups "crossed a safety threshold." Separately, Reuters reports that FDA investigators discovered quality control issues at a plant manufacturing the experimental therapeutic.

It could be two weeks until there is news on a paused trial of Eli Lilly鈥檚 closely watched monoclonal antibody treatment for Covid-19. The National Institutes of Health said late Tuesday that it paused the trial because one of the two groups in the study 鈥 one had received the antibody, the other a placebo 鈥 was doing better than the other. Both groups also received remdesivir, a Covid-19 treatment from Gilead Sciences. (Garde and Herper, 10/13)

U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as 鈥渁 cure鈥 for the disease, according to government documents and three sources familiar with the matter. The Lilly antibody therapy, which is experimental and not yet approved by regulators as safe and effective, is similar to a drug from Regeneron Pharmaceuticals that was given to the president during his bout with COVID-19. Trump, who credits the Regeneron drug with speeding his recovery, has called for both therapies to become available immediately on an emergency basis, raising expectations among some scientists and policy experts that the administration will imminently release an Emergency Use Authorization (EUA) for the drug. (Levine and Taylor, 10/13)

Also 鈥

Johnson & Johnson hopes to know within days whether it can resume testing its Covid-19 vaccine, as the health-products company battles the virus on several fronts. An independent committee is investigating the unexplained illness of a study volunteer that prompted a pause in clinical trials of the company鈥檚 experimental Covid-19 vaccine, J&J Chief Financial Officer Joseph Wolk said in an interview Tuesday. The illness is 鈥渟till under investigation and we鈥檙e going to let that process play out,鈥 Mr. Wolk said. The company is hopeful that the pause will only last a few days, he said. (Loftus, 10/13)

Here is what we know about drugs and vaccines: If tested in rigorous clinical trials and shown to be safe and effective, they make the world a healthier place. Here is another thing we know about drugs and vaccines: They are not easy to develop. (Garde, 10/13)

Recent pauses to two large-scale COVID-19 vaccine trials and a treatment study should reassure people聽鈥斅爊ot frighten them聽鈥斅爒accine experts said, though it is a reminder of the messiness of science. 鈥淭his is an indication that the system is working as it was designed to work to protect human subjects in clinical trials,鈥 Lawrence Gostin, a public health and legal expert at Georgetown and Johns Hopkins universities, said Tuesday. 鈥淚t demonstrates that the ethical guard rails on vaccine trials are working.鈥 (Weintraub and Weise, 10/13)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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