US Expands Investigation into Astrazeneca’s Covid Vaccine After Patient Developed Rare Spine Disorder During Trials
An investigation into how a patient became ill during testing of Astrazeneca’s potential Covid-19 jab has been expanded to the United States.
The Food & Drug Administration will review data from previous trials of similar vaccines developed by the same scientists, sources told Reuters.
It is a blow to the vaccine proposed by Astra – jointly developed by scientists at the University of Oxford and Astra – which is one of the most advanced among the global candidates, but which could now undergo new ones delays.
Trials of Astrazeneca’s potential Covid-19 vaccine were suspended in the United States on September 6 after a British trial participant developed what was thought to be a rare spine disorder
Large trials of the vaccine were suspended in the United States on September 6 after a participant in the British trials developed what was thought to be a rare inflammatory spinal disorder.
Trials have also been suspended in other countries such as the UK, but have since resumed there.
The data requested by the FDA is expected to arrive this week, according to reports, and will take time to analyze.
The FDA wants to determine whether any side effects experienced by the British patient in the Astra trials appeared in trials of other vaccines designed by the University of Oxford, Reuters reported.
Astrazeneca said yesterday, “We are continuing to work with the FDA to facilitate the review of the information needed to make a decision to resume the US trial. “