The ACTIV-3 monoclonal antibody trial, backed by the Trump administration’s coronavirus vaccine initiative labelled Operation Warp Speed, was suspended “out of an abundance of caution” according to the spokesperson.
The statement read: “Safety is of the upmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment.”
Eli Lilly, a major American pharmaceutical company, was part of the “ACTIV" program launched by the National Institute of Health as part of the federal effort to rapidly produce, manufacture and ultimately distribute a vaccination for the novel coronavirus across the country.
News of its trial suspension comes after Johnson & Johnson executives said it will be a few days before they know more about an unexplained illness in one participant that caused a temporary pause in its late-stage COVID-19 vaccine study.
“It may have nothing to do with the vaccine”, Mathai Mammen, head of research and development for Janssen, Johnson & Johnson's medicine development business, said on Tuesday.
The company said they don't yet know whether the ill study participant received their experimental vaccine or a dummy shot.
Mr Mammen said Johnson & Johnson gave information on the case to the independent monitoring board overseeing the safety of patients in the study, as the research protocol requires. The board will recommend next steps.
The study of the one-dose vaccine called ENSEMBLE will include up to 60,000 people from multiple countries.
Johnson & Johnson said it expected to complete enrollment in the study in two or three months. The company wasn’t disclosing the nature of the illness, which it learned of Sunday and disclosed Monday night.
Such pauses are not uncommon in long clinical studies, as some participants come down with an unrelated illness.
Unlike a study hold imposed by government regulators, a pause is initiated by the sponsor of the drug trial and often can be quickly resolved.
The Associated Press contributed to this report
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