You are here: Home » International » News » Others
Business Standard

USFDA's Hahn plans significant work with AstraZeneca in Covid trial inquiry

The top US Food and Drug Administration official confirmed AstraZeneca's US Covid-19 vaccine trial is on hold

Coronavirus | USFDA | AstraZeneca


Photo: Reuters
Photo: Reuters

(Reuters) - The top U.S. Food and Drug Administration official on Tuesday confirmed Plc's U.S. COVID-19 vaccine trial is on hold, saying the agency is planning to do "very significant work" with the company as it conducts its investigation after an illness in a participant in Britain.

"We're here to protect the American public and we're going to do very significant work with the company to figure out if there's a significant safety issue or not," FDA Commissioner Stephen Hahn said during an Instagram Live interview with Republican U.S. Senator Tim Scott of South Carolina.

"We don't have all facts, so we don't know the causation per se of this, but we really need to look into it. And our prime responsibility is the safety of the American people," Hahn said.

Enrollment in the British drugmaker's global trials of the vaccine, which it is developing with researchers at Oxford University, was paused on Sept. 6, after a participant in its U.K. trial had a serious side effect thought to be a rare spinal inflammatory disorder called transverse myelitis.

The U.K. trial has resumed, as have the company's trials in Brazil and South Africa.

Reuters on Monday reported based on sources that the U.S. trial was still on hold pending FDA and safety panel investigations.

The U.S. government process for reviewing COVID-19 vaccine efforts is being closely watched as some scientists and public health officials fear President Donald Trump will rush to have a vaccine approved before the Nov. 3 presidential election to bolster perception of his handling of the pandemic.


(Reporting by Manojna Maddipatla in Bengaluru, writing by Caroline Humer; Editing by Arun Koyyur and Cynthia Osterman)

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

Dear Reader,

Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

First Published: Wed, September 16 2020. 09:05 IST