Johnson & Johnson pauses COVID-19 vaccine trial
Updated: October 14, 2020
Johnson & Johnson announced it would be temporarily halting its novel coronavirus (COVID-19) vaccine candidate clinical trials due to an “unexplained illness” in a study participant, according to a statement released Monday by the company.
The company has paused further dosing in all its COVID-19 clinical trials, including the Phase 3 ENSEMBLE trial. The participant’s illness is being reviewed and evaluated by an independent Data Safety Monitoring Board (DSMB) as well as internal clinical and safety physicians, according to company officials.
A study pause differs from a regulatory hold, in that Johnson & Johnson made the decision to pause the trials. Study pauses happen frequently but are not typically communicated to the public. A regulatory hold is enacted by a regulatory health authority, such as the U.S. Food and Drug Administration. No official agencies have commented on the study pause as of press time.
The statement noted adverse events including illness and accidents are an expected part of any clinical study, especially large studies. Representatives said they plan to carefully review all medical information before deciding whether to restart the study.
Early in the COVID-19 pandemic, Johnson & Johnson committed to developing a vaccine by September 2020, later updating its goal of making the first batches available for emergency use authorization in 2021. The company has not released an anticipated timeline for its study pause.
The news follows AstraZeneca and Oxford University, who announced it would be pausing its Phase 3 clinical trial earlier this month. Shortly after Johnson & Johnson released its statement, Eli Lilly also paused its monoclonal antibody treatment for COVID-19 citing safety concerns.