AstraZeneca to resume coronavirus vaccine trial after unexplained illness in UK – National

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Clinical trials testing a potential COVID-19 vaccine developed by AstraZeneca and the University of Oxford are set to resume after a six-day hiatus due to “potentially unexplained illness” in the UK.An independent safety review was conducted on September 6 in what has been called a “routine action” to maintain “test integrity.” It concluded on Saturday.

In a statement to Global News, the University of Oxford said the study vaccines were given to some 18,000 patients as part of the trial.

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AstraZeneca suspends COVID-19 vaccine trial after unexplained illness in UK

“In large trials like this, some participants are expected to become ill and each case should be carefully evaluated to ensure a careful safety assessment,” the statement said, adding that they were not. unable to disclose patient medical information due to “participant confidentiality.” ”

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On Thursday, a spokesperson for AstraZeneca said the brief pause was triggered after a woman developed “severe neurological symptoms” after taking the experimental COVID-19 vaccine.

AstraZeneca said that “the company’s standard review process has triggered a pause in the study of vaccination in all of our global trials to allow for review of safety data by an independent safety review committee. and national regulators.

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“All of the routine follow-up appointments continued as normal during this period,” they said.








Coronavirus: WHO scientist calls AstraZeneca vaccine trial a “wake-up call”

Coronavirus: WHO scientist calls AstraZeneca vaccine trial a “wake-up call”

“We are committed to ensuring the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.”

On Thursday, Dr Soumya Swaminathan, the chief scientist of the World Health Organization, urged not to become “too discouraged” by stopping the Oxford and AstraZeneca vaccine trial.

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Instead, she said the break should serve as a “wake-up call” for the global community to recognize the inevitable “ups and downs in clinical development.”

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“It is a normal procedure, it is good clinical practice because the safety is the highest priority in any clinical trial, ”she said.

AstraZeneca is considered one of the many pharmaceutical companies most likely to help produce the world’s first viable COVID-19 vaccine.

Executives at these companies made what they called a “historic commitment” to “uphold the integrity of the scientific process” on Tuesday amid growing fears that drugmakers would bypass safety procedures in the face of political pressure of US President Donald Trump to rush the vaccine.










Coronavirus: UK says pause on Oxford vaccine clinical trial ‘not unusual’


Coronavirus: UK says pause on Oxford vaccine clinical trial ‘not unusual’

“We believe that this commitment will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and can ultimately be approved,” the commitment states.

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AstraZeneca, an Anglo-Swedish multinational pharmaceutical and biopharmaceutical company, is working with the University of Oxford to manufacture 2 billion doses of the COVID-19 vaccine.

Dr Adrian Hill, director of the Jenner Institute at Oxford University, said in a previous interview that high-risk groups could be vaccinated by December, but “there will definitely be a million doses in. September ”, due to a“ manufacturing scale ”-up. ”

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© 2020 Global News, a division of Corus Entertainment Inc.



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