Drugmaker Johnson & Johnson confirmed it stopped the clinical trial of its COVID-19 vaccine because one of its volunteers has an unexplained illness
After the announcement, the online registration system was closed for the 60,000 patients who are part of the trail. The company said that serious adverse effects were “an expected part of any clinical study, especially a large one”.
The company did not say what the unexplained illness was. But, one of the points of the clinical trials is to see if the vaccines cause dangerous side effects. The trials stop as soon as they appear, while doctors check to see if the disease may be related to the vaccine or if it was a fluke.
“Based on our strong commitment to safety, all clinical trials conducted by Johnson & Johnson’s Janssen pharmaceutical companies have pre-specified guidelines. These ensure that our studies can be paused if an unexpected serious adverse event (SAE) occurs that may be related to a vaccine or study drug. So a careful review of all medical information can be made before deciding whether to restart the study,” Johnson & Johnson said.
In one report, Dr. Ashish Jha stated a pause in the study is not alarming and is actually expected. In fact, he shared it’s “ridiculous it is to try and meet a political timeline of having a vaccine before Nov. 3.”
“We must respect this participant’s privacy. We are learning more about this participant’s disease, and it is important to have all the facts before sharing additional information”, Dr. Jha added. “Serious adverse events are not uncommon in clinical trials, and the number of serious adverse events can reasonably be expected to increase in trials with large numbers of participants. In addition, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.”
Johnson & Johnson reported there is a “significant distinction” between a study break and a regulatory suspension of a clinical trial. The company shared the following on when a study is halted.
“A study halt, in which the study sponsor stops recruitment or dosing, is a standard component of a clinical trial protocol.”
Johnson & Johnson is the 10th laboratory globally to conduct phase 3 trials against Covid-19. In the United States, Johnson & Johnson is the fourth company to make it to this phase. The company received $1.45 billion from the government to carry out the process which started phase three last month.
The vaccine is based on a single dose of a flu-causing adenovirus. It is modified so that it does not replicate, combined with a portion of the new coronavirus it uses to invade human cells. Federal officials have stated they expect the test to be quicker than other vaccines. Those other vaccines — which require two doses — include those manufactured by Moderna and Pfizer.