One of the world’s highest-profile COVID-19 vaccine trials has been stalled after an unexplained illness surfaced in a study participant, US drugmaker Johnson & Johnson said in a statement.
The clinical trial involving thousands was paused after a participant developed an illness of unknown origin, which the company says is not uncommon in similar large-scale trials.
The data is now being reviewed by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as the company’s internal safety testing physicians.
Johnson & Johnson said this is a ‘study pause’ and is different from a ‘regulatory hold’ that is ordered by healthcare watchdogs of respective governments.
A study pause ‘is a standard component of a clinical trial protocol,’ and is often regulated by the study sponsor which is overseen by ‘robust mechanisms’ to protect the safety of participants in its clinical trials.
But a regulatory hold is ‘a requirement by a regulatory health authority, such as the U.S. Food and Drug Administration (FDA).
Johnson & Johnson study hold comes after a similar large-scale clinical trial of a COVID-19 vaccine developed by AstraZeneca Plc. was put on hold in September due to an unexplained illness.
Subsequently, the vaccine trial co-developed by Oxford University was also stalled in other parts of the world like in the US, Brazil, South America, and the UK.
Johnsson & Johnson has said it will not disclose more information about the participant’s unexplained illness to protect the privacy and will disclose more data once all facts are gathered.
The company said in their study many participants are given a placebo, and it is not always clear if the participant who has developed the illness has received the shot of the placebo.
Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine told Reuters news agency that the pause is likely because of an adverse neurological disorder.
“If it was something like prostate cancer, uncontrolled diabetes, or a heart attack – they wouldn’t stop it for any of those reasons,” he said.
Johnsons and Johnsons last month announced its vaccine has enacted a strong immune response in study participants. The company has since kicked off a large-scale trial involving 60k people. J&J has backing from the US government.