Vaccine Trial Paused After Participant Reported Adverse Reaction
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Phase three trial for a coronavirus vaccine from AstraZeneca and the University of Oxford has been put on hold following a possible illness in one of the participants, according to the British drugmaker.
The pause is part of the standard review process to allow for a review of safety data, the company said.
"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials," AstraZeneca said in a statement.
An individual with knowledge of the news said researchers were told the hold came out of "an abundance of caution," according to STAT News, which was first to report the development.
Holds during clinical trials can happen, though it is not clear if the hold came from a regulatory agency or the company itself. It is also unclear how long the hold could last.
"In large trials illnesses will happen by chance but must be independently reviewed to check this carefully," AstraZeneca said. "We are working to expedite the review of the single event to minimise any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials."
The vaccine generated an immune response in healthy participants aged 18 to 55 during an early trial. Researchers said they found no safety concerns with the vaccine when the data was released in July.
Phase three trials for the vaccine expanded to the U.S. last month. The company did not disclose the site where the possible incident occurred, and it wasn't known if the pause would affect all trial sites.
AstraZeneca was one of the nine drugmakers to pledge on Tuesday to uphold standards for science and safety in their pursuit of a coronavirus vaccine.
Source: Stat News
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