Companies

AstraZeneca still waiting for FDA decision to resume US trial

Reuters | Updated on September 24, 2020 Published on September 24, 2020

File Photo   -  REUTERS

Vaccine candidate, initially developed by the University of Oxford, remains on hold while regulators investigate an illness in one of the participants

FRANKFURT, September 24 AstraZeneca is still waiting for the go-ahead from the US drug regulator to restart the clinical trial of its potential Covid-19 vaccine in the United States, Chief Executive Pascal Soriot said on Thursday.

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

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.

Also read:Vaccine trial illness unlikely to be linked to shot: University of Oxford

US Health and Human Services Secretary Alex Azar said on Wednesday the continued suspension showed the FDA took 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.

Follow us on Telegram, Facebook, Twitter, Instagram, YouTube and Linkedin. You can also download our Android App or IOS App.

Published on September 24, 2020
This article is closed for comments.
Please Email the Editor