(Adds Brazilian comment)
By Michael Holden
LONDON, Sept 12 (Reuters) - AstraZeneca has resumed
British clinical trials of its COVID-19 vaccine, one of the most
advanced in development, after getting the green light from
safety watchdogs, the company said on Saturday.
The late-stage trials of the experimental vaccine, developed
with researchers from the University of Oxford, were suspended
this week after an illness in a study subject in Britain,
casting doubts on an early rollout.
"On 6 September, the standard review process triggered a
voluntary pause to vaccination across all global trials to allow
review of safety data by independent committees, and
international regulators," AstraZeneca said.
It added that safety reviewers had recommended to Britain's
Medicines Health Regulatory Authority (MHRA) that it was safe to
resume the British trials.
The patient involved in the study had been reportedly
suffering from neurological symptoms associated with a rare
spinal inflammatory disorder called transverse myelitis.
AstraZeneca, based in Cambridge, said it could not disclose
further medical information.
"The Company will continue to work with health authorities
across the world and be guided as to when other clinical trials
can resume to provide the vaccine broadly, equitably and at no
profit during this pandemic," AstraZeneca said.
It declined to elaborate further on when other global trials
were expected to restart.
The Serum Institute of India said it would restart its
trials once it had permission from the Drugs Controller General
of India.
Brazil's health regulator ANVISA said it was awaiting notice
from the British MHRA confirming that resumption of trials has
been authorized before resuming in Brazil.
The Federal University of Sao Paulo, which is conducting the
paused trials, said in a statement that 4,600 of the planned
5,000 volunteers have been recruited and vaccinated without any
of them reporting any serious health issues.
Governments around the world are desperate for a vaccine to
help end the pandemic, which has caused more than 900,000 deaths
and global economic turmoil. The World Health Organization (WHO)
had flagged AstraZeneca's as the most promising.
The vaccine is in late-stage clinical trials in the United
States, Britain, Brazil and South Africa and additional trials
are planned in Japan and Russia.
'WAKE-UP CALL'
The pause of the trials came after reports that the United
States was aiming for fast-track authorization or approval of a
vaccine before November's presidential election.
Leading U.S. and European vaccine developers have pledged to
uphold scientific safety and efficacy standards for their
experimental vaccines and not bow to political pressures to rush
the process.
AstraZeneca has already agreed to supply close to three
billion doses to governments across the globe - more than any
other vaccine project.
The WHO's chief scientist said the pause in the trials
should serve as a "wake-up" call that there would be ups and
downs in the development of a vaccine.
"Inevitably with such a large trial there will be times when
safety issues arise," said Peter Openshaw, professor of
experimental medicine at Imperial College London.
"We must all hope that there are no future events and that
the vaccine proves both safe and effective."
(Reporting by Michael Holden
Additional reporting by Radhika Anilkumar in Bengaluru and
Anthony Boadle in Brasilia
Editing by William Maclean, Pravin Char and Helen Popper)
Astrazeneca (AZN)
