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


AstraZeneca’s building in Luton, Britain.

Tim Ireland | Xinhua News Agency | Getty Images

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

AstraZeneca said it received confirmation from the United Kingdom’s Medicines Health Regulatory Authority that it was safe to resume clinical trials. The company declined to disclose medical information about the pause of the trial. 

The company said “the standard review process triggered a voluntary pause” to all global trials on Sep. 6 so that independent committees and internal regulators could review the safety data. While trials can now resume in the U.K., the status of trials elsewhere remains 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 said in a statement.

The University of Oxford, which developed the vaccine in partnership with AstraZeneca, said Saturday that some 18,000 people have so far received the vaccination in studies. 

“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 said in a statement. 

AstraZeneca said on Tuesday, Sept. 8 that its late-stage trials were paused for safety concerns. STAT News first reported the pause of the trials.

“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials. In large trials illnesses will happen by chance but must be independently reviewed to check this carefully,” the company said at the time.

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STAT News later reported that AstraZeneca’s CEO Pascal Soriot said during a private conference call that the “potentially unexplained illness” occurred in a woman in the U.K. who displayed neurological symptoms consistent with a spinal inflammatory disorder called transverse myelitis. The call was set up by investment bank J.P. Morgan, STAT reported. 

On the same call, Soriot also confirmed that AstraZeneca’s clinical trials had been halted once before in July after a participant experienced neurological symptoms, but the illness was found to be unrelated to the experimental vaccine. 

AstraZeneca’s potential coronavirus vaccine, which was developed in partnership with scientists at Oxford University, is among the frontrunners in the race toward a safe and effective vaccine that could put a dent in the global pandemic. The company launched its late-stage trials at the end of August. It’s one of at least three vaccine candidates, along with Pfizer‘s and Moderna‘s, in late-stage trials.

The United States has invested more than $10 billion in six efforts to bring a coronavirus vaccine to market. On May 21, the U.S. announced it would invest $1.2 billion in AstraZeneca’s effort in exchange for at least 300 million doses if the candidate proves safe and effective enough. 



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