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Tuesday, April 20, 2021

SARS study halted after volunteer has unexpected health side effects

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Johnson & Johnson paused a clinical trial of a vaccine for coronavirus infection for one of its volunteers who had been in the study.

The company on Wednesday provided the following statement:

“In mid-October, one of the volunteer patient samples requested during the operations of the antibody-based vaccine program, known as SAR3419, was not analyzed at the virology laboratory following the first analysis due to unspecific results. This report was provided to investigators by the local virology laboratory who notified the trial investigators and will continue to support the investigation of this incident.”

A spokesman for Johnson & Johnson added, “Although one of the SARS virus samples is still being tested by a different laboratory, investigators have informed us that it has tested negative for coronavirus.” SARS, or severe acute respiratory syndrome, was a lethal respiratory virus that swept across Asia in 2003, killing roughly 650 people.

In response to a request for comment, a spokesman for the Centers for Disease Control and Prevention declined to discuss Johnson & Johnson’s plans for the vaccine.

Lori Cohen, a Johns Hopkins University professor of pathology and immunology, confirmed that investigators had been notified of an incident of unexpected health side effects. She said that the investigation was focused on determining whether the volunteer experienced adverse reactions because of the vaccine, or whether the volunteers had also suffered side effects due to the virus. “We were told that the patient who was taking the placebo [vaccine] when she became ill was taking both the vaccine and the placebo, and that her result suggested that she also had an adverse reaction to the vaccine,” she said.

The unanticipated health side effects could arise from the same potential reason for the cause — that the volunteer’s immune system was pushed to its limits as a result of taking part in a widely prescribed and preventive vaccine. Cooperman cautioned that it was possible the patient had another effect from the virus on herself that was not simply infectious disease.

Cohen and other scientists are particularly interested in any findings linking the vaccine to the death of a nine-year-old girl in Iraq. In addition to being a “mystery,” the death was the first reported case of SARS-related cardiac failure.

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