NIH Halts Phase 3 Study of Lilly's COVID-19 Antibody - COVID-19 Clinical Trial
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NIH Halts Phase 3 Study of Lilly’s COVID-19 Antibody

The National Institutes of Health (NIH) is hitting pause on a phase 3 study testing Eli Lilly and AbCellera’s COVID-19 antibody treatment in hospitalized patients. The reason? “An abundance of caution,” the company says. The trial’s independent data safety monitoring board recommended the company pause enrollment, a Lilly spokesperson told CNBC in an email Tuesday, adding, “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The news comes one day after Johnson & Johnson paused the phase 3 study for its COVID-19 vaccine because a patient had an “unexplained illness” and about a month after AstraZeneca suspended a trial for its COVID-19 jab because a patient developed transverse myelitis, a type of spinal cord inflammation that can be triggered by infections.

 Pfizer To Expand Trial To Ages 12 And Up

Pfizer announced this week that it has received FDA approval to enroll children as young as 12 years old in its COVID-19 vaccine trial. The expansion is aimed at understanding whether the vaccine would be safe and effective for adolescents. Until now, children under 16 have not been included in any of the COVID-19 vaccine trials in the U.S., and the average age of participants has skewed much older. ” I think this is a really big deal,” says L.J. Tan, chief strategy officer of the Immunization Action Coalition. “Without clinical trials actually done in children, the only way to actually extend the use of the COVID-19 vaccine into children would be to rely on the adult data,” Tan says, which is not ideal.

Earlier this month, the American Academy of Pediatricians wrote to top federal health officials urging them to take this step. “Children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns,” wrote AAP president Sara Goza in a letter, which was sent to Alex Azar, Secretary of the U.S. Department of Health and Human Services, and Stephen Hahn, Commissioner of the U.S. Food and Drug Administration.

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