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Medicine

AstraZeneca Resumes Coronavirus Vaccine Study (usnews.com) 85

"Oxford University announced Saturday it was resuming a trial for a coronavirus vaccine it is developing with pharmaceutical company AstraZeneca, a move that comes days after the study was suspended following a reported side-effect in a U.K. patient," reports the Associated Press: In a statement, the university confirmed the restart across all of its U.K. clinical trial sites after regulators gave the go-ahead following the pause on Sunday. "The independent review process has concluded and following the recommendations of both the independent safety review committee and the U.K. regulator, the MHRA, the trials will recommence in the U.K.," it said.

The vaccine being developed by Oxford and AstraZeneca is widely perceived to be one of the strongest contenders among the dozens of coronavirus vaccines in various stages of testing around the world...

The university said 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." It said globally some 18,000 people have received its vaccine so far. Volunteers from some of the worst affected countries — Britain, Brazil, South Africa and the U.S. — are taking part in the trial... Brazil's health regulator Anvisa on Saturday said it had approved the resumption of tests of the "Oxford vaccine" in the South American country after receiving official information from AstraZeneca... The university insisted that it is "committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely."

Pauses in drug trials are commonplace... The Oxford-AstraZeneca study had been previously stopped in July for several days after a participant developed neurological symptoms that turned out to be an undiagnosed case of multiple sclerosis that researchers said was unrelated to the vaccine.

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AstraZeneca Resumes Coronavirus Vaccine Study

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  • I don't recall any news source mentioning in any blurbs exactly what the adverse event was. As long as they don't identify the patient surely it's not confidential...

    • by dgatwood ( 11270 )

      Transverse myelitis (paralysis and sensory loss caused by a virus screwing up a horizontal slice of your spinal cord).

      Unfortunately, this seems like it is probably an entirely predictable side effect of using adenovirus as a vector.

    • by ledow ( 319597 )

      UK sources are not allowed to tell - patient confidentiality and data protection.

      Somehow US sources leaked it.

      One of the many reasons that EU/US data protection is a waste of time.

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