On Oct. 23, 2020, AstraZeneca announced that the clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, had resumed across the world with regulators in the US, UK, Brazil, South Africa and Japan confirming that it was safe to do so.

The Food and Drug Administration (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.

Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the communities where the clinical trials are being conducted. Data readouts will be submitted to regulators and published in peer-reviewed scientific journals. Rolling reviews of the vaccine programme have already begun in countries where this regulatory pathway has been established, providing regulators access to data as soon as they become available.

While trials are ongoing, AstraZeneca and Oxford University will continue to provide information to regulators, study investigators and participants according to clinical trial and regulatory standards.