The AstraZeneca Oxford University vaccine trial has been paused due to illness in a participant.
The much-publicised vaccine provoked a T cell response within 14 days of vaccination (white blood cells that can attack cells infected with the SARS-CoV-2 virus), and an antibody response within 28 days.
As part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial.
AstraZeneca says that 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 integrity of the trials is maintained.
In large clinical trials, illnesses will happen by chance and must be independently reviewed. AstraZeneca is working to expedite the review of the single event to minimise any potential impact on the trial timeline and is committed to the safety of its participants.
Pascal Soriot, Chief Executive Officer, said: “At AstraZeneca we put science, safety and the interests of society at the heart of our work. 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.”
Oxford University commented: “As part of the ongoing randomised controlled global trials of the coronavirus vaccine, our standard review process triggered a study pause to vaccination to allow review of safety data. This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the studies, while it is investigated, ensuring we maintain the integrity of the trials. In large trials illnesses will happen by chance but must be independently reviewed to check this carefully. We are committed to the safety of our participants and the highest standards of conduct in our studies.”
Image: Hyttalo Souza