Johnson & Johnson said it suspended dosing in all clinical trials of its experimental Covid-19 vaccine because a study volunteer had an unexplained disease.
The hiatus announced on Monday affects all trials with J & J’s vaccine, including a large Phase 3 trial that began in September and aimed to enroll up to 60,000 people in the US and several other countries.
An independent data security monitoring body is reviewing the subject’s illness, the company said. The company did not immediately release any further information about the disease, saying it had to respect the patient’s privacy.
This is the second time studies for a Covid-19 vaccine study have been suspended due to safety concerns. Last month, AstraZeneca PLC suspended clinical trials of an experimental Covid-1
J&J, of New Brunswick, New Jersey, said disease and other side effects are an expected part of any clinical trial and it has established guidelines for monitoring the events.
More information on Covid-19 vaccine trials
The guidelines “ensure that our studies can be interrupted if an unexpectedly serious adverse event is reported, possibly related to a vaccine or study drug. Therefore, all medical information can be carefully reviewed before deciding whether to restart the study, “the company said.
The break was previously reported by Stat News.
J & J’s vaccine is one of the most advanced Covid-19 vaccines in development, among just a handful that entered the final stage of testing in the US according to participants from AstraZeneca, Moderna Inc.
and Pfizer Inc.
The company’s employees had estimated that the Phase 3 study could produce results either by the end of the year or early 2021, and the recordings could be approved for use in early 2021.
Drug manufacturers like J&J have developed their Covid-19 recordings remarkably quickly. Vaccines typically take years to get to market, and many often fail because they don’t work safely during testing.
Side effects are common during clinical trials. Sometimes they are unrelated to the vaccine. However, if the independent experts overseeing the safety of the experiment can find a link, the safety issue may derail the experimental shot.
The safety agency needs to assess whether or not the patient’s illness is related to the vaccine, said a person familiar with the matter.
J & J’s plan for the Phase 3 study includes criteria for suspending the test, such as: For example, if a subject has a serious adverse event related to the vaccine or if someone has a severe allergic reaction called anaphylaxis or hives. that cannot be attributed to anything other than the vaccine.
The company’s shot uses a weakened version of a cold virus that provides genetic instructions that teach the body’s cells to make a protein similar to one found on the surface of the coronavirus. This in turn causes the body’s immune system to build up defenses against the coronavirus when a person is subsequently exposed to it.
The cold virus used in the vaccine is modified so that it cannot replicate and cause disease.
J&J co-developed the vaccine with the Beth Israel Deaconess Medical Center in Boston.
Get a coronavirus briefing six days a week and a weekly health newsletter as soon as the crisis has subsided: Register here.
AstraZeneca’s studies were halted after a woman in a UK study about her vaccine had an unexplained disease that a US health official called a spinal cord problem. This followed an earlier hiatus in the UK study in July after another subject had symptoms that the researchers later concluded were multiple sclerosis and not vaccine-related.
The UK authorities allowed the UK trial to resume in September after deciding it was safe. Studies have resumed in several other countries, including Japan and Brazil. However, the US trial will be suspended while AstraZeneca works with the Food and Drug Administration to review the information needed to make a decision to restart the trial.
AstraZeneca’s vaccine also uses a weakened version of a cold virus, but one made by chimpanzees instead of humans.
Write to Peter Loftus at email@example.com
Copyright © 2020 Dow Jones & Company, Inc. All rights reserved. 87990cbe856818d5eddac44c7b1cdeb8