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AstraZeneca coronavirus vaccine clinical trials resume in U.K. after pause over safety concerns »

Phase three trials for AstraZeneca’s coronavirus vaccine have resumed in the U.Ok. after they have been halted earlier this week over safety concerns, the company announced Saturday.

AstraZeneca mentioned it obtained affirmation from the United Kingdom’s Medicines Health Regulatory Authority that it was secure to resume clinical trials. The firm declined to reveal medical details about the pause of the trial, however indicated earlier this week {that a} doubtlessly unexplained sickness was underneath investigation.  

The firm mentioned “the standard review process triggered a voluntary pause” to all international trials on Sept. 6 in order that impartial committees and inner regulators might assessment the safety knowledge. While trials can now resume in the U.Ok., the standing of trials elsewhere stays unclear. 

“The Company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic,” AstraZeneca mentioned in an announcement.

The University of Oxford, which developed the vaccine in partnership with AstraZeneca, mentioned Saturday that some 18,000 individuals have thus far obtained the vaccination in research. 

“In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety,” Oxford mentioned in an announcement. 

STAT News reported earlier this week that AstraZeneca’s CEO Pascal Soriot said during a private conference name that the “potentially unexplained illness” occurred in a lady in the U.Ok. who displayed neurological signs in step with a spinal inflammatory dysfunction referred to as transverse myelitis. The name was arrange by funding financial institution J.P. Morgan, STAT reported. 

On the identical name, Soriot additionally confirmed that AstraZeneca’s clinical trials had been halted as soon as earlier than in July after a participant skilled neurological signs, however the sickness was discovered to be unrelated to the experimental vaccine. 

AstraZeneca’s potential coronavirus vaccine, referred to as AZD1222, is among the many frontrunners in the race towards a secure and efficient vaccine that would put a dent in the worldwide pandemic. The firm launched its late-stage trials on the finish of August. It’s one among at the very least three vaccine candidates, together with Pfizer‘s and Moderna‘s, in late-stage trials.

The United States has invested more than $10 billion in six efforts to carry a coronavirus vaccine to market. On May 21, the U.S. introduced it could make investments $1.2 billion in AstraZeneca’s effort in change for at the very least 300 million doses if the candidate proves secure and efficient sufficient. 


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