BREAKING! Vaccine News: Johnson & Johnson Halts COVID-19 Vaccine Trial As Participant Becomes Seriously Sick
: Pharmaceutical giant Johnson & Johnson announced on late Monday that it had temporarily halted its COVID-19 vaccine trial because one of its participants had become seriously sick.
A spokesman for Johnson and Johnson told Thailand Medical News, "We have halted further dosing in all our COVID-19 vaccine candidate clinical trials globally due to a particpant developing serious illness and conditions."
The company later updated it website with a public statement for all saying, “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. Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.” https://www.jnj.com/our-company/johnson-johnson-temporarily-pauses-all-dosing-in-our-janssen-covid-19-vaccine-candidate-clinical-trials
The trial pause means the enrollment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.
Johnson & Johnson said that serious adverse events (SAEs), such as accidents or illnesses, are "an expected part of any clinical study, especially large studies." Company guidelines allow them to pause a study to determine if the SAE was related to the drug in question and whether to resume study.
The vaccine phase 3 trial had started recruiting participants in late September, with a goal of enrolling up to 60,000 volunteers across more than 200 sites in the US and around the world, the company and the US National Institutes for Health (NIH), which is providing funding, said.
Besides the US, the other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
Johnson & Johnson was the tenth maker globally to conduct a Phase 3 trial against COVID-19, and the fourth in the US.
America under the Trump administration has given Johnson & Johnson about US$1.45 billion in funding under Operation Warp Speed.
The COVID-19 vaccine by Johnson & Johnson is based on a single dose of a cold-causing adenovirus, modified so that it can no longer replicate, combined with a part of the new coronavirus called the spike protein that it uses to invade human cells. (read about adverse effects of adenovirus based vaccines.. https://www.thailandmedical.news/news/breaking-covid-19-vaccine-exclusive-possible-dangers-of-using-adeno-associated-virus-aav-vectors-for-covid-19-vaccines-
The potential vaccine, which is being developed by the company’s subsidiary Janssen in Belgium, is based on vector technology, the same used by
It was reported that Johnson & Johnson used the same technology in its Ebola vaccine which received marketing approval from the European Commission in July.
Initial pre-clinical testing on rhesus macaque monkeys that were published in the journal Nature showed it provided complete or near-complete protection against virus infection in the lungs and nose.
An early-to-mid stage clinical trial found the vaccine candidate produced a strong immune response against SARS-CoV-2, though it was unclear if older patients saw a similar result. The findings were published in late September. https://www.medrxiv.org/content/10.1101/2020.09.23.20199604v1.full.pdf
New vaccines or drugs go through multiple stages of trials on humans, looking first to see if they are safe and cause no serious adverse reactions. Each phase adds more people, with usually fewer than a dozen to start, rising to tens of thousands by Phase 3.
Similar to other phase 3 trials that are underway, Johnson & Johnson’s primary objective is to test whether the vaccine can prevent symptomatic COVID-19.
In mid-September, trials on the coronavirus vaccine developed by AstraZeneca and Oxford University were paused after a UK volunteer developed an unexplained illness. That vaccine was claimed to be one of the most advanced Western projects, having already been tested on tens of thousands of volunteers worldwide. (It is also based on the adenovirus vector platform!)
Clinical trials resumed earlier this month in Japan but not the United States, where AstraZeneca is working with regulators.
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