A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford has been voluntarily paused due to a suspected serious adverse reaction in a participant in the United Kingdom.
A spokesperson for AstraZeneca, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.”
In a follow-up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter.
The spokesperson described the pause as “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.” The spokesperson also said that the company is “working to expedite the review of the single event to minimize any potential impact on the trial timeline.”
An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution.” A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers.
In clinical trials for a pause, the event would need to be serious; something related to the heart, lungs, kidneys or other part of the body’s health system that required medical attention and was sufficiently serious to merit a pause to this very important vaccine trial in order to make sure it is safe, and that the adverse effect is not due to the vaccine itself. While it’s still unclear how severe and rare the adverse event may be, the finding could impact how quickly efficacy data from the U.K. trial will be available.
Leave a Reply