Two coronavirus trials paused over safety concerns
Setback for global efforts to counter Covid as human testing of antibody treatment and vaccine put on hold
Clinical trials of a potential vaccine for Covid-19 and a treatment for people with severe cases of the disease have been put on hold because of separate safety concerns.
The treatment, produced by US drug company Eli Lilly, is “similar to one taken by US President Donald Trump this month”, says the Financial Times. It involves an infusion of “monoclonal antibodies” - artificially produced cells that mimic the human body’s natural immune response to the coronavirus.
“Ambiguity” in Eli Lilly’s statements mean the reason for the pause is unclear, but a trial may be halted if a treatment “has a very low chance of working, based on the data so far” or if “patients in one group are faring much worse than those in the other”, The New York Times reports.
The Eli Lilly announcement came a day after Johnson & Johnson said trials of its coronavirus vaccine were being suspended after a patient in the study fell ill.
The injection is “one of six coronavirus vaccines being tested in the US, and one of four in the most advanced, Phase 3 stage”, reports CNN.
Trials of another vaccine in the final stage of testing, developed by Oxford University and AstraZeneca, were twice put on hold due to unexplained illnesses, but have now resumed in most participating countries.
“In large clinical trials, pauses are not unusual, and declines in health in volunteers are not necessarily the result of the experimental drug or vaccine,” says The New York Times.
“Such halts are meant to allow an independent board of scientific experts to review the data and determine whether the event may have been related to the treatment or occurred by chance.”
Dr Ashish Jha of the Brown University School of Public Health told CNN that delays of this sort were “completely expected” in a trial involving 60,000 people.
Johnson & Johnson said yesterday that its team had not yet established whether the ill patient had received the potential vaccine or a placebo.