Johnson & Johnson stated that this has prevented it from moving forward in all clinical trials of its experimental Kovid-19 vaccine because a study volunteer had an unexplained disease.
The pause announced on Monday affects all Jammu and Kashmir vaccine trials, including a major Phase 3 trial that began in September and aims to recruit more than 60,000 people in the US and several other countries.
This is the second test for a Kovid-19 vaccine trial that has been stopped due to safety concerns. Last month, AstraZeneca plc stopped clinical trials of an experimental Kovid-19 vaccine after a participant in a study in the UK had an unexplained disease. The study of Britain resumed, but a large study of America is still ongoing.
J&J of New Brunswick, NJ, said diseases and other side effects are an expected part of any clinical study, and it has set guidelines for monitoring the incidence.
More on Kovid-19 vaccine trials
Guidelines “to ensure that our study can be prevented if an unexpected serious adverse event that may be related to a vaccine or study drug is reported, so all therapy before the study is resumed The information can be reviewed carefully. ” The company said.
The halt was previously reported by State News.
The J&K vaccine is one of the most advanced Kovid-19 shots in development, among just a handful that entered the final stages of testing in the US, following entry from AstraZeneca, Modern Inc.
And Pfizer Inc.
Company officials had speculated that Phase 3 testing could begin providing results by the end of the year or early 2021, and the shots could be authorized for use in early 2021.
Drug manufacturers including J&J have developed their Kovid-19 shots remarkably quickly. It usually takes years to bring vaccines to market, and many times they do not because they fail to work safely during testing.
Side effects often change during clinical trials. Sometimes, they do not link to the vaccine. But if an independent expert monitoring the safety of the test finds a link, the safety issue may derail the experimental shot.
J & J’s plan for its Phase 3 study sets criteria for stopping the test, including whether a subject has a serious adverse event that is determined to be related to the vaccine, or if any Has a severe allergic reaction, known as anaphylaxis, or urticaria, cannot be attributed to anything other than the vaccine.
The company’s shot uses a weaker version of a common cold virus, engineered to deliver genetic instructions that teach body cells, to make proteins composed of proteins found on the surface of coronoviruses. This, in turn, leads the body’s immune system to form a defense against coronovirus if a person later comes into contact with it.
The common cold virus used in the vaccine is modified so that it does not replicate the disease.
J&J co-developed the vaccine with Beth Israel Deaconess Medical Center in Boston.
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Write Peter Loftus at [email protected]
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On 13 October 2020, the print edition appeared as ‘J & J Pauses Trials As Volunteer Ails’.
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