Setback: Eli Lilly halts Covid vaccine trial over safety concerns
"Eli Lilly is supportive of the decision by the independent (Data Safety Monitoring Board) to cautiously ensure the safety of patients participating in this study."
Washington: The US pharmaceutical company Eli Lilly's late-stage trial of its leading monoclonal antibody treatment for the novel coronavirus has been paused by health regulators over potential safety concerns, CNBC reported.
"Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board has recommended a pause in enrollment," the report quoted Eli Lilly spokeswoman Molly McCully as saying.
"Lilly is supportive of the decision by the independent (Data Safety Monitoring Board) to cautiously ensure the safety of the patients participating in this study."
The ACTIV-3 trial is designed to test a monoclonal antibody developed by Eli Lilly in combination with remdesivir, an antiviral medication with emergency use authorization for the virus, the report said.
The trial is one of several that are part of the National Institute of Health's "Activ" program, which is designed to accelerate the development of novel coronavirus vaccines and treatments. The trial is backed by Operation Warp Speed, the Trump administration's effort to manufacture and distribute novel coronavirus vaccines.
Eli Lilly is testing a combination of two lab-engineered immune system proteins called monoclonal antibodies to treat severely ill patients with the novel coronavirus disease (VOCID-19). The treatment is similar to the one made by Regeneron that was given to President Donald Trump earlier this month after he tested positive for the novel coronavirus.
The decision by Eli Lilly comes after Johnson & Johnson announced that it learned of an "unexplained illness" in one of the volunteers that caused it to pause its Phase 3 coronavirus vaccine trial on Sunday.