The hiatus announced Monday is for all trials of the J&J vaccine, including a large Phase 3 trial that began in September and which aimed to recruit up to 60,000 people in the United States and several other countries.
J&J, of New Brunswick, NJ, said illness and other side effects are an expected part of any clinical study, and it has pre-specified guidelines for monitoring events.
Learn more about Covid-19 vaccine trials
The guidelines “ensure that our studies can be put on hold if an unexpected serious adverse event that could be related to a vaccine or study drug is reported, so that there can be careful review of all medical information. before deciding to restart the study, ”the company says.
The break had already been reported by Stat News.
J & J’s vaccine is one of the most advanced Covid-19 vaccines in development, among the few to enter the final stage of testing in the United States, after entrants from AstraZeneca, Moderna Inc.
and Pfizer Inc.
Company officials had estimated that the Phase 3 trial could start delivering results by the end of the year or early 2021, and injections could be cleared in early 2021.
Drug makers, including J&J, have grown their Covid-19 injections remarkably quickly. Vaccines typically take years to get to market, and many often don’t because they don’t work safely during testing.
Side effects often appear during clinical trials. Sometimes they are unrelated to the vaccine. But if independent experts overseeing the safety of the trial find a connection, the safety issue can derail the experimental shot.
The safety committee should assess whether the subject’s illness was related to the vaccine or not, said a person familiar with the subject.
J & J’s plan for its Phase 3 study sets out criteria for suspending testing, including whether a subject has a serious adverse event that is determined to be vaccine-related, or if someone has a severe allergic reaction, known as the name anaphylaxis, or urticaria, it cannot be attributed to anything other than the vaccine.
The company’s shot uses a weakened version of a common cold virus, which is designed to provide genetic instructions that teach cells in the body to make a protein resembling that found on the surface of the coronavirus. This, in turn, prompts the body’s immune system to develop defenses against the coronavirus if a person is subsequently exposed to it.
The cold virus used in the vaccine is modified so that it cannot reproduce and cause illness.
J&J co-developed the vaccine with Beth Israel Deaconess Medical Center in Boston.
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AstraZeneca trials have been suspended after a woman in a UK study of their vaccine had an unexplained illness, which a US health official described as a spinal cord problem. This followed an earlier hiatus in July in the UK study after another subject exhibited symptoms that researchers later concluded to be multiple sclerosis and unrelated to the vaccine.
UK authorities allowed the UK trial to resume in September after concluding it was safe to do so. Trials have resumed in several other countries, including Japan and Brazil, but the US trial remains on hold as AstraZeneca works with the Food and Drug Administration to review the information needed to make a decision on whether to resume the trial .
AstraZeneca’s vaccine also uses a weakened version of a common cold virus, but that of chimpanzees instead of humans.
Write to Peter Loftus at [email protected]
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