Johnson & Johnson has paused its coronavirus vaccine trials after a participant suffered an “unexplained illness”, the company said on October 12, 2020. J&J has confirmed that they are unclear about if the patient received a vaccine or placebo in this 60,000-patient study.
“We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the statement continued. The illness is being investigated by the company as well as an independent board.
J&J emphasised that adverse events like illnesses, accidents, and other medical outcomes are an expected part of a clinical study. They also emphasised the difference between a study pause and a clinical hold. “The vaccine study is not currently under a clinical hold,” said J&J.
A pausing rule has been met, the online system used to register patients in the study has been closed and the Data and Safety Monitoring Board (DSMB), an independent committee that watches over the safety of patients in clinical trials, will be called, said the company.
Johnson & Johnson began enrolling volunteers for its Phase 3 study on September 23, 2020.
This is the second setback to hit one of the last stages of immunisation. A coronavirus vaccine trial from British drug maker AstraZeneca faced a similar setback in September. They had paused the trial after a potential adverse reaction. While the division in the UK has resumed trials, trials in the US have still not resumed and are being investigated by the US Food and Drug Administration.
Pharmaceutical brands like Pfizer and Moderna are in the late stage of vaccine trials and are expected to yield results by this year. While the vaccines under development by these two will require two doses, Johnson & Johnson’s will only need one.