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AstraZeneca Plc and Johnson & Johnson to resume COVID-19 vaccine trial

AstraZeneca Plc and Johnson & Johnson to resume COVID-19 vaccine trial

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Arunachal Arunachal

AstraZeneca Plc and Johnson & Johnson plan to resume COVID-19 vaccine clinical trials that had been paused by U.S regulators.

In a statement on Friday, Johnson & Johnson said that it is preparing to resume recruitment in the late-stage trial of its vaccine after consultation with the U.S. Food and Drug Administration.

The study was paused earlier this month after a patient became sick, but the company said no clear cause of the illness had been identified.

J&J is studying its candidate in a 60,000-person trial that is expected to read out data before the end of the year. The company has suggested it could approach U.S. regulators for an emergency-use authorization as soon as the outset of 2021.

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AstraZeneca said in a statement Friday that it isn’t unusual for some participants to become unwell in large-scale vaccine trials. Results from its late-stage trials are anticipated later this year, the company said.

“We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use,” Chief Executive Officer Pascal Soriot said.

Earlier, AstraZeneca said it had been cleared by the FDA to restart a trial that had been halted in the U.S. after a volunteer participating in a U.K. trial of the shot had fallen ill. The company said the agency had reviewed data from global studies and decided it was safe to proceed.

Allowing the studies to go forward removes a shadow that had been hanging over the effort to find a vaccine in recent weeks. The AstraZeneca trial had been in limbo for more than a month, while J&J’s study had been paused since Oct. 12.

The companies are among the front-runners in the quest for a vaccine, alongside rivals Pfizer Inc. and Moderna Inc.

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Edited By: Admin
Published On: Oct 25, 2020