AstraZeneca resumes UK trials of COVID-19 vaccine halted by patient illness
Issuing time:2020-09-14 16:40Source:Reuters
FILEPHOTO: A test tube labelled with the Vaccine is seen in front of AstraZenecalogo in this illustration taken, Sept 9, 2020. [Photo/Agencies]
LONDON - AstraZeneca has resumed Britishclinical trials of its COVID-19 vaccine, one of the most advanced indevelopment, after getting the green light from safety watchdogs, the companysaid on Saturday.
The late-stage trials of theexperimental 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 standardreview process triggered a voluntary pause to vaccination across all globaltrials to allow review of safety data by independent committees, andinternational regulators," AstraZeneca said.
It added that safety reviewers hadrecommended to Britain's Medicines Health Regulatory Authority (MHRA) that itwas safe to resume the British trials.
The patient involved in the study hadbeen reportedly suffering from neurological symptoms associated with a rarespinal inflammatory disorder called transverse myelitis.
AstraZeneca, based in Cambridge, said itcould not disclose further medical information.
"The Company will continue to workwith health authorities across the world and be guided as to when otherclinical trials can resume to provide the vaccine broadly, equitably and at noprofit during this pandemic," AstraZeneca said.
It declined to elaborate further on whenother global trials were expected to restart.
The Serum Institute of India said itwould restart its trials once it had permission from the Drugs ControllerGeneral of India.
Brazil's health regulator ANVISA said itwas awaiting notice from the British MHRA confirming that resumption of trialshas 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 theplanned 5,000 volunteers have been recruited and vaccinated without any of themreporting any serious health issues.
Governments around the world aredesperate for a vaccine to help end the pandemic, which has caused more than900,000 deaths and global economic turmoil. The World Health Organization (WHO)had flagged AstraZeneca's as the most promising.
The vaccine is in late-stage clinicaltrials in the United States, Britain, Brazil and South Africa and additionaltrials are planned in Japan and Russia.
The pause of the trials came afterreports that the United States was aiming for fast-track authorization orapproval of a vaccine before November's presidential election.
Leading US and European vaccinedevelopers have pledged to uphold scientific safety and efficacy standards fortheir experimental vaccines and not bow to political pressures to rush theprocess.
AstraZeneca has already agreed to supplyclose to three billion doses to governments across the globe - more than anyother vaccine project.
The WHO's chief scientist said the pausein the trials should serve as a "wake-up" call that there would beups and downs in the development of a vaccine.
"Inevitably with such a large trialthere 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 nofuture events and that the vaccine proves both safe and effective."