Oxford, AstraZeneca resumes coronavirus vaccine trial

LONDON (AP) — 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.

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.

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.”

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.

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
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 the pause was a sign that the Oxford team
was putting safety issues first, but that it led to “much unhelpful
speculation.”

“To tackle the global COVID-19 pandemic, we need to
develop vaccines and therapies that people feel comfortable using,
therefore it is vital to maintaining public trust that we stick to the
evidence and do not draw conclusions before information is available,”
she said.

Scientists and others around the world, including
experts at the World Health Organization, have sought to keep a lid on
expectations of an imminent breakthrough for coronavirus vaccines,
stressing that vaccine trials are rarely straightforward.

Italy’s
health minister, Roberto Speranza, welcomed the resumption of the
vaccine trial, but warned that prudence was still necessary.

“Science is at work to give the world efficient and secure treatments
and vaccines,” he said. “In the meantime, the key continues to be our
behavior.”

Italy, which was ground zero for Europe’s outbreak, is one of the main countries investing in the AstraZeneca vaccine.

Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany’s BioNTech.

Nicole Winfield in Rome contributed.