Two Major COVID Clinical Trials Were Paused Over Safety Concerns

In news that shouldn’t surprise anyone yet it does, Trials for Eli Lilly’s antibody treatment and Johnson & Johnson’s COVID-19 vaccine were both paused this week.

via: BuzzFeed.News

Within 24 hours, two pharmaceutical companies separately confirmed that their COVID-19 clinical trials — one for a vaccine, the other for a therapy — were being paused over potential safety concerns.

A government-sponsored trial for Eli Lilly’s antibody drug was paused due to a “potential safety concern,” according to emails sent to testing sites on Tuesday. The company confirmed in a statement that an independent board overseeing the trial’s safety had made the decision “out of an abundance of caution.” Eli Lilly’s therapy is similar to another experimental treatment manufactured by Regeneron and used to treat President Donald Trump two weeks ago.

Study pauses, which are initiated by companies, are not uncommon occurrences in trials and are less severe than clinical holds, which are initiated by regulators. And “adverse” events — illnesses or other undesirable medical outcomes — are expected to some degree in all clinical trials, especially ones that involve large numbers of patients. Johnson & Johnson noted that it typically does not “communicate study pauses publicly,” but added that it proactively discloses any regulator-required holds.

Still, some medical experts have criticized pharmaceutical companies for not being more transparent about issues that could seem troubling to a lay audience, given the tremendous degree of interest in vaccines and treatments for COVID-19 and the importance of maintaining public trust.

These weren’t the first COVID-19–related trials to be paused. AstraZeneca has halted its vaccine clinical trial at least twice to investigate two cases of severe illness developed by participants. The first patient, in July, was deemed to have multiple sclerosis, unrelated to the vaccine. A second person in September developed neurological symptoms consistent with a rare but serious condition called transverse myelitis, according to news reports.

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