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AstraZeneca trial still on hold, FDA not saying why


The trial of AstraZeneca's COVID-19 vaccine remains on hold in the US, but the FDA commissioner does not say why.

AstraZeneca trials still on hiatus in US 1:07

(CNN) -

AstraZeneca's coronavirus vaccine trial is still on hiatus in the United States after a participant developed a serious illness, but the Commissioner of the Food and Drug Administration (FDA) does not say why.

At the US Pharmaceutical and Biotechnology Summit organized by the

Financial Times

on Wednesday, FDA Commissioner Stephen Hahn was asked why the trial is still on hold in the country when it has already been reopened in Europe.

Hahn said he couldn't answer.

  • LEE: Questions from the audience about coronavirus: Can the vaccine be applied to a person who already had covid-19?

"I cannot talk about confidential business information and this summit knows it very well," he said.

“The career officials of our agency generally take the issue of security very seriously, (they take) the protection of the American people very seriously (…).

We will examine each and every data and make a decision when we have the information available on any topic, be it safety or effectiveness, "he added.

Hahn said he could not speak about a "specific issue" that the AstraZeneca trial might involve.

"What I can tell you is that the FDA is working on looking at all the safety and efficacy issues for all medical products," he said.

AstraZeneca trial in Great Britain, Brazil and South Africa

An AstraZeneca spokesperson previously told CNN that regulators in Britain, Brazil and South Africa decided to resume the trials.

"We continue to work with the FDA to facilitate the review of the information necessary to make a decision on the resumption of the trial in the United States," the spokesperson said.

"Regulators in each country determine when trials can start and do so in their own time frame," he explained.

AstraZenecaFDACoronavirus Vaccine

Source: cnnespanol

All news articles on 2020-10-01

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