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, launched in May seeking more than 12,000 volunteers, will have one out of 11 subgroups with children 5 to 12 years of age.


Top Stories

188 new cases of COVID-19 on Thursday

The Health Ministry announced 127 new COVID-19 cases on 22 October, out of 4,304 laboratory tests, taking confirmed infections to 3,154.   The break-down of new...

Confirmed COVID-19 cases in Ygia Polyclinic

Ygia polyclinic is informing the public that due to the fact that a small number of COVID-19 cases have been found among the staff...

President Anastasiades will not resign

President Nicos Anastasiades will not betray the decision of the big majority of the citizens and will complete his term, as the Constitution and...

Citizens request the resignations of those involved in illegal passports’ case

In an announcement, organized groups of people are requesting the immediate resignation of politicians directly or indirectly involved in the issuing of Cypriot passports...

New measures announced by Health Minister due to increase in number of COVID-19 cases

Face masks must be worn outside at all times, the Cabinet decided on Thursday. Moreover, stricter measures apply in all districts and partial lockdown...


Squash soup

Ingredients: 1 kg pumpkin, cut into small cubes, approximately 5 cups 2 medium (400g) sweet potatoes, cut into cubes, approximately 2 ½ cups 1 chopped leek, only...


No visit to Cyprus is complete without enjoying the traditional meal of many small dishes known as ‘meze’. This large feast, which has been a...

Prawns with fried cheese, barley shaped pasta

Put the barley shaped pasta into a small pan with salted water, bring to a boil and when tender, drain. Peal the prawns leaving...

Salmon and shrimp sheftalies

Mix all ingredients for tabbouli in a bowl and keep to one side so flavours can combine. Prepare the sheftalies: wash and soak the casing...