NEW BRUNSWICK, New Jersey (AP) – A late-stage study of Johnson & Johnson’s COVID-19 vaccine candidate has been suspended as the company investigates whether a study participant’s “unexplained illness” is related to the shot.
The company said in a statement Monday night that illnesses, accidents and other so-called adverse events “are an expected part of any clinical trial, especially large trials”, but that its doctors and safety monitoring panel will try to determine what may has caused the disease.
The break is at least the second such detention to occur among several vaccines that have reached large-scale final tests in the United States.
The company declined to disclose more details about the disease, citing participant privacy.
Temporary stops for major medical examinations are relatively common. Few have been made public in typical drug trials, but work to develop a coronavirus vaccine has raised the risk of these types of complications.
Companies are required to investigate any serious or unexpected reactions that occur during drug testing. Given that such tests are performed on tens of thousands of people, some medical problems are coincidental. In fact, one of the first steps the company said it would take was to determine if the person had received the vaccine or a placebo.
The suspension was first announced by the health news site STAT.
Testing of the latest stage of the vaccine by AstraZeneca and Oxford University continues to be delayed in the United States as officials check whether the disease in its study poses a safety risk. This study was stopped when a woman developed severe neurological symptoms corresponding to transverse myelitis, a rare inflammation of the spinal cord, the company said. Testing of this company has been restarted elsewhere.
Johnson & Johnson aims to involve 60,000 volunteers to prove that its single-dose approach is safe and protects against coronavirus. Other vaccine candidates in the United States require two shots.
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