Johnson & Johnson
said he stopped further dosing in all clinical trials of his experimental Covid-19 vaccine because a study volunteer had an unexplained disease.
The hiatus announced on Monday affects all J&J vaccine trials, including a large Phase 3 trial that began in September and aimed at enrolling up to 60,000 people in the United States and many other countries.
An independent data safety monitoring committee is reviewing the study subject’s disease, the company said. The company did not immediately disclose further information on the disease.
This is the second time a Covid-19 vaccine trial has been halted due to a safety concern. Last month,
PLC suspended clinical trials of an experimental Covid-1
J&J, of New Brunswick, N.J., said disease and other side effects are an expected part of any clinical trial and has pre-specified guidelines for monitoring events.
Learn more about Covid-19 vaccine trials
The guidelines “ensure that our studies can be suspended if an unexpected serious adverse event is reported that could be related to a vaccine or study drug, so there may be a careful review of all medical information before deciding whether restart the study, “the company said.
The hiatus was previously reported by Stat News.
The J&J vaccine is one of the most advanced Covid-19 vaccines in development, among the few that had entered the last phase of testing in the United States, after AstraZeneca participants,
Company officials had estimated that the Phase 3 trial could begin delivering results by the end of the year or early 2021, and the shots could be cleared for use in early 2021.
Drug makers, including J&J, have developed their Covid-19 shots very quickly. Vaccines typically take years to market, and many often fail because they don’t work safely during testing.
Side effects often show up during clinical trials. Sometimes, it turns out they don’t have a vaccine link. But if the independent experts monitoring the safety of the process find a link, the safety problem can derail the experimental shot.
J&J’s plan for its Phase 3 study sets out the criteria for discontinuing testing, including if a subject has a serious adverse event that is determined to be vaccine-related, or if someone has a severe allergic reaction known as anaphylaxis or hives , this cannot be attributed to anything other than the vaccine.
The company’s hit uses a weakened version of a common cold virus, which is designed to deliver genetic instructions that teach the body’s cells to make a protein similar to that found on the surface of the coronavirus. This, in turn, causes the body’s immune system to build defenses against the coronavirus if a person is subsequently exposed to it.
The common cold virus used in the vaccine is modified so that it cannot replicate and cause disease.
J&J developed the vaccine with Beth Israel Deaconess Medical Center in Boston.
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Appeared in the print edition of 13 October 2020 as “J&J Pauses Trials As Volunteer Ails”.