The second vaccine to have gone on hold in the US, Johnson & Johnson has now put its COVID-19 vaccine trial on hold, due to an unexplained illness that has been contracted by one of the volunteers.
On Monday, the top contender announced that the Phase 3 trials were temporarily halted. The only single-shot vaccine that is currently being developed in the US, Johnson & Johnson’s JNJ-78436735 vaccine is one of four large-scale, final-stage COVID-19 vaccine trials currently underway in the nation.
Although it hasn’t been confirmed that the illness is related to the vaccine, global protocols mandate that until the reason of the health condition isn’t obtained, trials require a pause. This is the second time such a hindrance has taken place, after Astrazeneca’s vaccine going on hold on September 8th where a participant was diagnosed with a neurological condition.
An independent review committee in Britain allowed AstraZeneca’s trial to resume in mid-September, but the U.S. Food and Drug Administration has kept the American trial on hold to ensure and be extra sure of the fact that it does not pose any threats to US citizens.
As of now the ailing volunteer’s illness is being reviewed and evaluated by an independent Data Safety Monitoring Board as well as the company’s clinical and safety physicians. The independent Data Safety Monitoring Board, which oversees the trial, will review what happened and decide whether it is safe to resume the trial.
Presumably a run of the mill glitch faced by most vaccines, J&J has refrained from disclosing details about the patient and his/her condition, saying “We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”
In the US, two other federally funded candidate vaccines under President Trump’s ‘Operation Warp Speed’ are currently in the Phase 3 trials. One is being made by Pfizer and a German biotech firm BioNTech, and another by Moderna, a Cambridge, Massachusetts-based biotech.