(Adds India's Serum Institute, reaction)
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, but the Serum Institute of India said
it would restart its trials once it had permission from the
Drugs Controller General of India.
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.
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
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 trial 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, Editing by William Maclean and Pravin