US widens probe into Astrazeneca’s Covid jab after patient develops rare spinal disorder during trials
A probe into how a patient became ill during trials of Astrazeneca’s potential Covid-19 jab has been widened in the US.
The Food & Drug Administration will examine data from past trials of similar vaccines developed by the same scientists, sources told Reuters.
It is a blow to Astra’s proposed vaccine – jointly developed by scientists at Oxford University and Astra – which is one of the most advanced among global candidates but could now face further delays.
Trials of Astrazeneca’s potential Covid-19 vaccine were paused in the US on September 6 after a participant in the British trials developed what was thought to be a rare spinal disorder
Large trials of the vaccine were paused in the US on September 6 after a participant in the British trials developed what was thought to be a rare spinal inflammatory disorder.
The trials were also paused in other countries such as the UK but have since resumed there.
Data requested by the FDA was expected to arrive this week, according to reports, and will take time to be analysed.
The FDA wants to determine whether any side effects experienced by the British patient in Astra’s trials emerged in trials of other vaccines designed by Oxford University, Reuters reported.
Astrazeneca said yesterday: ‘We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial.’