An advanced-stage study of Johnson & Johnson’s (J&J) Covid-19 candidate vaccine was suspended Monday after it allegedly had an adverse effect on a participant. The participant’s “unexplained illness” is being investigated by the company and a statement was issued on Monday.
Accidents and other so-called adverse events “are an expected part of any clinical study, especially large studies,” the company said in the statement, adding that its doctors and a safety monitoring panel would attempt to determine the reason behind the illness. reported. Associated Press news agency.
While few disruptions of this nature are made public in typical drug trials, Covid-19 vaccine trials have a lot at stake, as infection cases worldwide have surpassed 37 million. More than 1 million people have lost their lives to the virus.
This is the second case of its kind in which trials of a late-stage study have been stopped. AstraZeneca and Oxford University’s vaccine trials are on hold in the US as officials examine whether a disease in their trial poses a safety risk. Elsewhere, however, trials have resumed.
This trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company said.
Health news site STAT was the first to report the pause of J & J’s candidate vaccine trial. J&J aimed to enroll 60,000 volunteers to show whether its single-dose approach is safe and protects against coronavirus, according to AP.
Currently, other candidate vaccines in the US require two injections.
(with contributions from the agency)
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