American multinational corporation that develops medical devices, pharmaceutical, and consumer packaged goods Johnson & Johnson, has announced that it had temporarily halted its COVID-19 vaccine trial because one of its participants had become sick.
“We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” the company was quoted by the AFP news agency as saying.
A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened.
J&J said that serious adverse events (SAEs), such as accidents or illnesses, are “an expected part of any clinical study, especially large studies”.
Johnson & Johnson had committed over $1 billion toward the development of a not-for-profit COVID-19 vaccine in partnership with the Biomedical Advanced Research and Development Authority (BARDA) Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).
The halting of the trials sees one of the biggest covid-19 vaccine prospects fail. The lead US candidates that currently remain are being developed by Moderna, Pfizer-BioNTech, and Novavax.
On Sept. 8, a large study of another Covid-19 vaccine being developed by AstraZeneca and Oxford University was put on hold because of a suspected adverse reaction in a patient in the United Kingdom.
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