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LONDON: AstraZeneca resumed British clinical trials of its COVID-19 vaccine, one of the most advanced in development, after obtaining the green light from safety watchdogs, the company said on Saturday (September 12).
Late-stage trials of the experimental vaccine, developed with researchers at the University of Oxford, were suspended this week after illness in a study subject in Britain, casting doubt on an early launch.
“On September 6, the standard review process resulted in a voluntary pause in vaccination in all global trials to allow for review of safety data by independent committees and international regulators,” said AstraZeneca.
He added that safety reviewers had recommended to Britain’s Medicines Health Regulatory Authority (MHRA) that it was safe to resume British trials.
The patient involved in the study reportedly suffered from neurological symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.
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Cambridge-based AstraZeneca said it could not release further medical information.
“The company will continue to work with health authorities around the world and guide itself on when other clinical trials can resume to provide the vaccine on a comprehensive, equitable, and non-profit basis during this pandemic,” AstraZeneca said.
He declined to elaborate 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 Comptroller General of Drugs of India.
Brazil’s health regulator ANVISA said it was waiting for a notice from the British MHRA confirming that the resumption of trials was authorized before resuming them in Brazil.
The Federal University of Sao Paulo, which is carrying out the trials on hiatus, said in a statement that 4,600 of the 5,000 planned volunteers have been recruited and vaccinated with none of them reporting serious health problems.
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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 singled out AstraZeneca as the most promising.
The vaccine is in advanced stage clinical trials in the United States, Great Britain, Brazil, and South Africa, and additional trials are planned in Japan and Russia.
“WAKE UP CALL”
The trial pause came after reports that the United States was targeting fast-track licensing or approval of a vaccine before the November presidential election.
Leading vaccine developers in the US and Europe are committed to upholding scientific standards of safety and efficacy for their experimental vaccines and not giving in to political pressure to speed up the process.
AstraZeneca has already agreed to supply nearly 3 billion doses to governments around the world, more than any other vaccine project.
The WHO chief scientist said the trial pause should serve as a “wake-up call” that there would be ups and downs in vaccine development.
“Inevitably, with such a large trial, there will be times when safety concerns arise,” said Peter Openshaw, professor of experimental medicine at Imperial College London.
“We all have to hope that there are no future events and that the vaccine is safe and effective.”
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