In early September, 37 volunteers received their first dose of AstraZeneca's Covid-19 vaccine candidate at University Hospital at the University of Wisconsin, Madison.
Six weeks later, with the trial still paused, the participants have missed the window to receive their second dose. The researchers, it now appears, will essentially have to start from scratch. candidate at UW Health. As the trial remains on hold, hundreds of boxes stocked with supply kits sit untouched in a closet in the hospital's clinical research unit. Experimental vaccines remain in a freezer, unused.
The FDA, the drug manufacturer and the data and safety monitoring board must all agree on terms before continuing. The board could recommend the trial should resume, but add additional safety measures, such as extended follow-up for participants.
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