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FDA authorises restart of the COVID-19 AZD 1222 vaccine US phase III trial.- AstraZeneca
Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD 1222, have resumed across the world with regulators in the US, UK, Brazil, South Africa and Japan confirming that it was safe to do so. The FDA authorised the restart in the US, following the resumption of trials in other countries in recent weeks.
The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial.As part of the standard review process for trial safety events, a voluntary pause to vaccination across all global trials was triggered on 6 September to allow the examination of safety data by independent monitoring committees. The recommendations from these reviews have been supported by international regulators, who also confirmed that the trials were safe to resume..
Condition: Coronavirus/COVID-19 Infection
Type: drug
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