Johnson & Johnson is one of the companies working on a covid-19 vaccine and has been for a few months now. The study conducted by the company has been halted because a participant is presenting with an “unexplained illness.” The patient’s case is expected to be reviewed by an independent safety monitoring board along with internal clinic and safety positions.
Specifics about the illness or the participant effected has not been released, but Johnson & Johnson said that as pertinent information becomes available and worthy of sharing it will be shared.
In a press release Johnson & Johnson said that adverse effects such as illnesses or accidents can be expected in clinical studies, especially ones of such a large size. This particular study has around 60,000 participants. The release continued, “SAEs are not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants. Furhter, as many tirals are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.”
The data and safety monitoring board (DSMB) joined on Monday to review the case. Johnson & Johnson said that “it is not always immediately apparent” from cases similar to these whether or not the adverse effects are from the study treatment or a placebo.
AstraZeneca and Oxford University was also conducting a large vaccine study and it was put on hold temporarily, but has since resumed. It was paused because researchers suspected a patient was experiencing an adverse reaction in their spinal cord called transverse myelitis.
Johnson & Johnson were firm that events such as these are a possibility and that the review board and company are reviewing what happened and the it can be assumed that the study will resume as soon as ethically possible.
Sources: Washington Examiner, Stat News; Photo-Sci Tech Daily