NEW BRUNSWICK, N.J. – Johnson & Johnson announced they have temporarily paused further dosing in all their COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. The participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as an internal clinical and safety physicians.
Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies, Johnson & Johnson says. Based on a commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study.
SAEs are not uncommon in clinical trials, Johnson & Johnson says, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.
Back in March as the Covid-19 pandemic began to ravage the United States, Johnson & Johnson announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine. The Company said then that it expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process.
President Donald Trump has long touted that a vaccine was “right around the corner” and that Covid-19 would simply “disappear one day.”
To date, well over 200,000 Americans have died from Covid-19 and many thousands more are expected to die by the end of the year.