The tests carried out by the Johnson & Johnson Pharmaceutical about the vaccine covid-19 have been suspended due to an unexplained illness that one of the participants presented.
Initially, the news was released this Monday by Stat , citing NIH paused Eli Lilly Covid-19 antibody trial . Further, the US media made reference to a document sent to external researchers executing the clinical trial of 60,000 patients, whose text indicated that a “pause rule”.
They also indicated that the online system used to enroll participants in the study has been closed and that the data and security control board, an independent entity that ensures the safety of patients in the clinical trial, would be convened.
Disease assessment
Later, the company confirmed what happened through a statement posted on its website. “We have temporarily stopped additional dosing in all of our candidate clinical trials cradles covid-19, including essay Stage 3 Ensemble, due to unexplained illness in a study participant, “the firm noted.
On the other hand, Johnson & Johnson explained that “the participant’s illness is being reviewed and evaluated by the Data Security Monitoring Board (DSMB) independent of Ensemble as well as by our internal safety and clinical physicians. ”
Among other details, the pharmaceutical company noted that “adverse events (illnesses, accidents, etc.), even those that are serious, are an expected part of any clinical study, especially large studies. â€In this sense, he confirmed his commitment to the safety of those who are part of the trials.
Participant privacy
“We must respect the privacy of this participant. We are also learning more about this participant’s disease and it is important to have all the facts before sharing additional information,” the firm added.
At the beginning of October, Johnson & Johnson joined the shortlist of companies that have started an advanced phase of studies in the USA to administer an experimental vaccine against coronavirus on a large scale in humans. Since then, the firm has begun to dose its samples, being the first major trial of inoculation against covid-19 that can work after a single injection.
A similar episode occurred in September when the Third Phase of Oxford University Coronavirus Vaccine Clinical Trials and the pharmaceutical AstraZeneca .
The appearance of unexpected symptoms in two women who received their experimental vaccine in the United Kingdom twice forced the company to stop its testing.
Subsequently, the company stated that “an independent review” determined that in both cases” it was considered unlikely that these diseases were associated with the vaccine or that there was insufficient evidence to say with certainty that the diseases were related or not to the vaccine.”
