AstraZeneca Pauses Vaccine Trial

By rmrd0000 on Wed, 09/09/2020 - 12:09am |

Only one adverse event, but vaccine trial protocol requires a thorough investigation.

The pharmaceutical company AstraZeneca halted global trials of its coronavirus vaccine on Tuesday because of a serious and unexpected adverse reaction in a participant, the company said.

The trial’s halt, which was first reported by Stat News, will allow the British-Swedish company to conduct a safety review. How long the hold will last is unclear.

URL:

https://www.nytimes.com/2020/09/08/world/covid-19-coronavirus.html?action=click&module=Top%20Stories&pgtype=Homepage#link-313b443d

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Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said the pause was not uncommon in vaccine development and that he hoped the company could proceed with its trial.

Dr. Anthony Fauci said that AstraZeneca’s decision to pause global trials of its experimental coronavirus vaccine was unfortunate but not an uncommon safety precaution in a vaccine development process.

“This particular candidate from the AstraZeneca company had a serious adverse event, which means you put the rest of the enrollment of individual volunteers on hold until you can work out precisely what went on,” Fauci said in an interview with CBS “This Morning.”

“It’s really one of the safety valves that you have on clinical trials such as this, so it’s unfortunate that it happened,” Fauci said. “Hopefully, they’ll work it out and be able to proceed along with the remainder of the trial but you don’t know. They need to investigate it further.”

https://www.huffpost.com/entry/fauci-response-astrazeneca-vaccine-trial-pause_n_5f58d81ac5b62874bc16dc66

by rmrd0000 on Wed, 09/09/2020 - 9:58am

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