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A spokesperson for AstraZeneca said that “the company’s standard review process caused a pause in vaccination to allow for review of safety data.” It is unclear who had temporarily suspended the trial and how long the suspension will last.
The spokesperson described the pause as “a routine action that has to happen whenever there is a potentially unexplained illness in one of the trials, while it is being investigated, ensuring that we maintain the integrity of the trials.”
They added that the company is “working to expedite the review of the single event to minimize any potential impact on the testing schedule.”
AstraZeneca said in a statement: “As part of the ongoing, randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process caused a pause in vaccination to allow for review of safety data.
“This is a routine action that has to happen whenever there is a potentially unexplained illness in one of the trials, while it is being investigated, ensuring that we maintain the integrity of the trials.
“In large trials, diseases will happen by chance, but they need to be independently reviewed to check this carefully.
“We are working to expedite the review of a single event to minimize any potential impact on the trial schedule.
“We are committed to the safety of our participants and to the highest standards of conduct in our trials.”
AstraZeneca shares fell more than 6 percent in after-hours trading Tuesday following the news.
The company began its testing late last month and is one of three developers currently in the advanced stage of testing for a possible vaccine.
The other two companies, industry giants Pfizer and Moderna, began their trials in late July.
AstraZeneca’s early-phase trials in July looked encouraging after the company released favorable data.
At that time, the company reported no serious adverse effects.
However, some mild symptoms have been observed including fatigue and headache.
Other side effects were reported, such as pain where the injection was given, muscle pain, chills, and fever.
The company is currently in mitigation status to complete testing as close to its original completion date as possible.
The AstraZeneca trials had reached phase 3, the final stage before safety and efficacy reports can be submitted to regulators for authorization.
The trials were taking place at dozens of facilities in the United States and around the world.
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