AstraZeneca said that clinical trials for the AZD1222 Covid-19 vaccine candidate, have resumed in various parts of the world after regulators across the US, UK, Brazil, Japan, and South Africa confirmed that it was safe to continue them.

The US Food and Drug Administration (FDA) has authorized the restart of AZD1222 clinical trials in the US after the resumption of trials in other nations in recent weeks.

AstraZeneca said that the FDA looked into all safety data from trials in other parts of the world and came to the conclusion that it was safe to resume the Covid-19 vaccine trial.

It can be noted that AstraZeneca had to pause AZD1222 vaccination in all its global trials on 6 September to enable independent monitoring committees to examine its safety data. This was part of the standard review process for safety events for clinical trials, said the pharma giant.

The global trials for AZD1222, which was co-invented by the University of Oxford and its spin-out company – Vaccitech, were paused last month following an unexplained event of a participant becoming unwell.

AstraZeneca said that the recommendations from the reviews of the independent monitoring committees have been backed by international regulators, who also confirmed that the AZD1222 Covid-19 vaccine trials were safe to resume.

Pascal Soriot – CEO of AstraZeneca said: “The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic. We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”

AstraZeneca said that is not rare that in large scale vaccine trials, certain participants become sick, and every case has to be studied to make sure of the careful assessment of safety.

The pharma giant expects results from the late-stage trials later this year, based on the rate of infection within the communities where the studies are being held.

AstraZeneca will submit data readouts to regulators and publish them in peer-reviewed scientific journals. The pharma giant said that rolling reviews of the AZD1222 Covid-19 vaccine candidate have already commenced in countries where this regulatory pathway has been set up, giving regulators access to data as soon as they are ready.

  AstraZeneca, AZD1222, COVID-19, Novel Coronavirus, Pascal Soriot, University of Oxford, US FDA, Vaccitech, Wuhan Coronavirus