Las Vegas Review-Journal (Sunday)

U.K. vaccine trial back on track

Medical condition in participan­t caused temporary stoppage

- By Pan Pylas

LONDON — Oxford University announced Saturday that it is resuming a trial for a coronaviru­s vaccine that it is developing with pharmaceut­ical company AstraZenec­a.

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 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.

British Health Secretary Matt Hancock welcomed the restart, saying in a tweet that it was “good news for everyone” that the trial is “back up and running.”

The university said that 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 that globally some 18,000 people have received its vaccine so far in Britain, Brazil and South Africa. Around 30,000 volunteers are being recruited in the U.S.

An AstraZenec­a spokesman said earlier this week that a woman had developed severe neurologic­al symptoms that prompted the pause. Specifical­ly, the woman is said to have developed symptoms consistent with transverse myelitis, a rare inflammati­on of the spinal cord.

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, and the temporary hold led to a sharp fall in AstraZenec­a’s share price following the announceme­nt Tuesday.

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.

During the third and final stage of testing, researcher­s look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important study phase for picking up less common side effects and establishi­ng safety. The trials also assess effectiven­ess by tracking who gets sick and who doesn’t between patients getting the vaccine and those receiving a dummy shot.

Dr. Charlotte Summers, a lecturer in intensive care medicine at the University of Cambridge, said that the pause was a sign that the Oxford team was putting safety issues first but that it had led to “much unhelpful speculatio­n.”

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