Oxford's COVID-19 vaccine trial "back up and running" after brief pause for safety check

CBS News ^ | 09/15/2020

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London — Oxford University announced over the weekend that it was resuming a trial for a coronavirus vaccine it is developing with pharmaceutical company AstraZeneca. The move came less than a week after the study was suspended following a reported possible side-effect in a U.K. patient.

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, if not the strongest contender 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 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."

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Although Oxford would not disclose information about the patient’s illness due to participant confidentiality, an AstraZeneca spokesman said earlier this week that a woman had developed 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 was “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 but the temporary hold led to a sharp fall in AstraZeneca’s share price following the announcement Tuesday.

The Oxford-AstraZeneca study had previously been 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.

[1Old Pro]

Although Oxford would not disclose information about the patient’s illness due to participant confidentiality, an AstraZeneca spokesman said earlier this week that a woman had developed 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.

They determined it was not caused by the vaccine I'm sure.

[jazzlite]

Good news. This is my favorite company. I could take their vaccine with confidence.

[mewzilla]

If their vaccine is as good as their modeling...

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RE: If their vaccine is as good as their modeling...

Here’s the difference — The vaccine is being TESTED. The models are... well, just models.

[1Old Pro]

Here’s the difference — The vaccine is being TESTED. The models are... well, just models.

Yep, with 30,000 Phase 3 participants, which is 29,100 more than most polls sample.