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.
Ha–ha enjoy your nanotechnology transhumanism remotely controlled body, ignorant herd
mint…could you do me a favor? I suspect I might agree with you, but you’re going to have to ‘dumb-down’ your posts for me to get it.
I hope the participant gets well soon and that the process can begin again soon. However, I will NOT rush to get any new vaccine until I know enough testing and time prove it’s safeness and effectiveness.
Kudos (big thank you!) to those brave enough to be guinea pigs for these trials, without them vaccines wouldn’t come into fruition.