News World AstraZeneca still waiting on FDA go-ahead to resume US trial

AstraZeneca still waiting on FDA go-ahead to resume US trial

AstraZeneca is still waiting for the US drug regulator to approve the restart of the clinical trial of its potential COVID-19 vaccine in the United States almost three weeks after it was paused due to safety concerns.

The US trial of AstraZeneca’s COVID-19 vaccine candidate, initially developed by the University of Oxford, remains on hold while regulators investigate an illness in one of the participants, even after a British study and other programmes outside of the United States have resumed.

“We are the sponsor of the US study. We then provided all this information to the FDA (US Food and Drug Administration) and we are waiting to hear their decision”, Soriot told a virtual World Economic Forum discussion.

US Health and Human Services Secretary Alex Azar said on Wednesday the continued suspension showed the FDA was taking vaccine safety seriously.

A document posted online by Oxford university last week stated the illness in a British participant that triggered the pause on September 6 may not have been associated with the vaccine.

Asked why the company had not disclosed details about the nature of the illness, Soriot said clinical trial regulators and independent supervisors were guarding participants’ privacy.

Still, the company would look into increasing transparency without compromising individual rights and while also preventing the public and volunteers from drawing wrong conclusions, which could endanger trial enrolment.

“We are discussing with other companies as an industry what information we can offer without compromising patient privacy but also without compromising the trial itself”, said the CEO.

Soriot also said that tests of the vaccine prototype on children had not started yet.

The British trial https://clinicaltrials.gov/ct2/show/NCT04400838, launched in May seeking more than 12,000 volunteers, will have one out of 11 subgroups with children 5 to 12 years of age.

(Reuters)

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