The Nation

Oxford University vaccine trial resumes after pause over ‘volunteer side-effect’ concerns

[ad_1]

Trials of a Covid-19 vaccine being developed by AstraZeneca and Oxford University will resume after a reported side effect in a UK patient meant it had to be paused.

AstraZeneca said on Tuesday that late-stage studies had been halted while the company investigated whether the reported side effect was linked to the vaccine.

On Saturday, Oxford University confirmed that tests have the green light to resume across all UK clinical trial sites.

A statement said: “The ongoing randomised controlled clinical trials of the Oxford Coronavirus vaccine ChAdOx1 nCoV-19 will resume across all UK clinical trial sites.

 

”Globally, some 18,000 individuals have received study vaccines as part of the trial.

”In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety.

”On Sunday (06/09/2020) our standard review process triggered a study pause to vaccination across all of our global trials to allow the review of safety data by an independent safety review committee, and the national regulators.

“All routine follow-up appointments continued as normal during this period.

“The independent review process has concluded and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA, the trials will recommence in the UK.”

No details about the patient or the nature of the side effect were given due to patient confidentiality rules.

[ad_2]

Read the original article on The Nation

Leave a Reply

Your email address will not be published. Required fields are marked *