Despite pausing its phase 3 clinical trial this week, AstraZeneca should still know by the end of the year whether its experimental COVID-19 vaccine is safe and effective, CEO Pascal Soriot said Sept. 10, NBC News reported.
A safety committee is currently reviewing whether an adverse reaction in a patient in the U.K. was related to the vaccine.
If the committee advises AstraZeneca to resume its trial, “I still think we are on track for having a set of data that we would submit before the end of the year,” Mr. Soriot said.
But researchers don’t know how long the review will take, according to The New York Times. No vaccine doses will be administered to patients until the review is over.
The drugmaker hasn’t released details of the adverse event, but the participant was a U.K. woman who experienced neurological symptoms consistent with transverse myelitis, a rare but serious spinal inflammatory disorder, STAT reported.
Some experts have criticized how AstraZeneca announced the trial’s halt, saying the drugmaker lacked transparency and could hurt public trust in vaccines.
“I don’t think they realize how damaging the way they’re conveying information to the public is,” Peter Hotez, MD, PhD, co-director of the Center for Vaccine Development at Texas Children’s Hospital in Houston, told NBC News. “There’s an awful anti-vaccine movement out there and an anti-science movement, and now it’s globalizing.”
World Health Organization officials have said the trial halt is a reminder that vaccine development is “not always a fast and straight road,” CNBC reported.
But WHO Chief Scientist Soumya Swaminathan, MD, said Sept. 10 that there’s no need to be “overly discouraged” by the trial halt.
“I think this is a good … perhaps a wake-up call or a lesson for everyone to recognize the fact that there are ups and downs in research, there are ups and downs in clinical development and we have to be prepared for those,” she said.
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