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Researchers say it's unusual to pause vaccine trials

September 12, 2020. Summarized by summa-bot.

Vaccine clinical trials are notoriously difficult to conduct.

Most of the time, that health problem is not related to the vaccine being investigated, and the trial can continue.

On Wednesday, it came to light that pharmaceutical giant AstraZeneca had paused its coronavirus vaccine trial not once but twice because of adverse events.

While Dr. Robert Redfield, director of the US Centers for Disease Control and Prevention, on Wednesday implied that pausing a Phase 3 trial was a somewhat common occurrence, vaccine trial experts interviewed by CNN say it is not common.

AstraZeneca announced Tuesday it had paused global trials of its coronavirus vaccine because of an unexplained illness in one of the study participants.

Then on Wednesday, a company spokesperson revealed the trial had also paused briefly in July to investigate an illness in another study volunteer, who "was confirmed to have an undiagnosed case of multiple sclerosis, which an independent panel had concluded was unrelated to the vaccine. "

If it's believed that the illness might possibly be related to the vaccine, the DSMB might recommend that the trial pause while the illness is investigated.

On Wednesday, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, commented on the AstraZeneca trial pause.

Illnesses that necessitate a pause don't occur very often, according to three vaccinologists -- Frenck, Fichtenbaum and Dr. Saad Omer -- who, combined, have worked on more than 100 vaccine trials.

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