COVID-19Regulatory

NIH: Halted vaccine study shows ‘no compromises’ on safety

September 9, 2020 / Associated Press

AstraZeneca’s suspension of final testing of its potential COVID-19 vaccine while it investigates a volunteer’s illness shows there will be “no compromises” on safety in developing the shots, the chief of the National Institutes of Health told Congress on Wednesday.

“This ought to be reassuring,” NIH Director Dr. Francis Collins said before a Senate committee. “When we say we are going to focus first on safety and make no compromises, here is Exhibit A of how that is happening in practice.”

Late Tuesday, AstraZeneca announced its final-stage studies are on temporary hold while the company looks into whether a test subject’s illness is a side effect of the shot or a coincidence. The company gave no details on the illness, but Collins said it involved a “spinal problem.”

Behind-the-scenes monitors known as the “data and safety monitoring board” in Britain paused vaccinations while alerting its safety counterparts in the U.S., said Dr. Moncef Slaoui of Operation Warp Speed, the Trump administration’s vaccine development program.

Late last month, AstraZeneca began recruiting 30,000 people in the U.S. for its largest study of the vaccine. It also is testing the vaccine, developed by Oxford University, in thousands of people in Britain and in smaller studies in Brazil and South Africa.

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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