AstraZeneca resumes US COVID-19 vaccine trial

The Food and Drug Administration has 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. AstraZeneca's US trial was paused since September 6 after the UK-based biopharma giant had announced that the phase 3 testing of its COVID-19 vaccine has been put on hold due to a suspected serious adverse reaction in a participant.

London: The clinical trials for the AstraZeneca Oxford coronavirus vaccine -- AZD1222 -- have resumed in the United States after approval by the Food and Drug Administration (FDA), the company said on Friday (local time).

According to an official statement issued by AstraZeneca, "The FDA has 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."

"Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, 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 statement added.

AstraZeneca's US trial was paused since September 6 after the UK-based biopharma giant had announced that the phase 3 testing of its COVID-19 vaccine has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.

The trials of the third phase of AstraZeneca's coronavirus vaccine had resumed in the UK in September.

The company said in its statement, "It is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety."

AstraZeneca is working with the UK's University of Oxford to develop the coronavirus vaccine, one of four that started late-stage, Phase 3 trials in the US, CNN said.

According to the latest update by Johns Hopkins University, globally 4,20,20,333 people have tested positive for coronavirus and 11,40,953 deaths have been reported so far.

(With inputs from ANI)