Astrazeneca’s large, late-stage US trial has been on hold since September 6
Astrazeneca’s Covid-19 vaccine trial in the United States could resume this week after the US Food and Drug Administration (FDA) reviewed of a serious illness.
The large US trial has been on hold since September 6, after a participant in the UK fell ill with what was suspected to be a rare spinal inflammatory disorder.
The FDA did not comment. It is requiring the drug firm’s researchers conducting the trial to add information about the incident to consent forms signed by participants.
British regulators reviewed the illness, concluding there was insufficient evidence to say for certain that it was or was not related to the vaccine.
They permitted the trial to resume enrolling participants, and have shared with Reuters a draft of a letter to those taking part in the UK, saying they had completed their analysis and vaccination in the US would resume shortly.
Astra said that it ‘cannot verify the content’ of the draft letter. ‘We also cannot comment on a pending FDA decision,’ it said.
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