A Phase 3 clinical trial for a potential COVID-19 vaccine set to begin enrollment this week at sites throughout the country, including at the Indiana University School of Medicine in Indianapolis, is on hold. United Kingdom-based AstraZeneca plc (NYSE: AZN) says it put a pause on the study after an unexplained illness occurred in the trial currently underway in the UK.
The pharmaceutical company says the pause will allow an independent committee to review the safety data of a single event of the illness. Specific details of the illness were not released.
“At AstraZeneca we put science, safety and the interests of society at the heart of our work,” said Pascal Soriot, chief executive officer of AstraZeneca. “This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts. We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”
AstraZeneca says it will work to expedite the review the illness to minimize “any potential impact on the trial timeline.”
Last week, the IU School of Medicine said it is one of more than 80 sites in the U.S. to participate in the Phase 3 trial for the vaccine, known as AZD1222. The school was set to begin enrollment for the trial this week.
Both the school and AstraZeneca declined to comment on a potential timeline for resuming the study.