Johnson & Johnson pauses Covid-19 vaccine trial after “unexplained illness”

13 October 2020
378 Views

Drugmaker Johnson & Johnson said Monday it has paused the advanced clinical trial of its experimental coronavirus vaccine because of an unexplained illness in one of the volunteers.

“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,” the company said in a statement. ENSEMBLE is the name of the study.
“Adverse events -illnesses, accidents, etc.- even those that are serious, are an expected part of any clinical study, especially large studies.” The pause was first reported by Stat News.
Johnson & Johnson’s Janssen vaccine arm is developing the shot. The company did not say what the unexplained illness was, but one point of clinical trials is to find out if vaccines cause dangerous side effects. Trials are stopped when they pop up while doctors check to see if the illness can be linked to the vaccine or is a coincidence.

“Based on our strong 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,” the company said.

Read more: CNN

You may be interested

US: There will be costs if Russia acts against Ukraine
DEFENCE
shares14 views
DEFENCE
shares14 views

US: There will be costs if Russia acts against Ukraine

Panos - Apr 12, 2021

U.S Secretary of State Antony Blinken on Sunday said: “it would be a serious mistake” for China to strike at…

Kikilias: The plan is for vaccinations of healthy people in their 40s to begin in June
GREECE
shares14 views
GREECE
shares14 views

Kikilias: The plan is for vaccinations of healthy people in their 40s to begin in June

Panos - Apr 12, 2021

If everything goes according to plan and deliveries for the second quarter are made on time, vaccinations of healthy people…

Euro 2021 with fans in stadiums, UEFA decides
GREECE
shares26 views
GREECE
shares26 views

Euro 2021 with fans in stadiums, UEFA decides

Panos - Apr 12, 2021

The Euro 2021, which was postponed last year due to the coronavirus, will be held next summer with fans allowed…

Leave a Comment

Your email address will not be published.