COVID-19 vaccine update: Astrazeneca gets regulator's nod to resume Oxford vaccine trial in UK
The advanced trial of COVID-19 vaccine developed by Oxford University and Astrazeneca were suspended this week after an illness in a study subject in Britain
PremiumBritish-Swedish firm Astrazeneca said that it had resumed Oxford University coronavirus vaccine trial in the United Kingdom following the confirmation by the Medicines Health Regulatory Authority (MHRA). The advanced trial of COVID-19 vaccine developed by Oxford University and Astrazeneca were suspended this week after an illness in a study subject in Britain.
"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.
"The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume," said the vaccine maker.
Oxford University said in a statement that the UK regulator had recommended that the trials resume after an independent review of the safety data.
Oxford University earlier said some 18,000 people have received “study vaccines" as part of the trials. “We cannot disclose medical information about the illness for reasons of participant confidentiality," it said.
Serum Institute of India had paused clinical trials of a COVID-19 vaccine in the country this week. The move came a day after Pune-based vaccine maker received a show cause notice from the Drug Controller's General of India (DGCI) V.G. Somani.
“We are reviewing the situation and pausing India trials till AstraZeneca restarts them. We are following DCGI’s instructions and will not be able to comment further on the same," Serum Institute said in a statement on Thursday.
Serum Institute of India partnered with AstraZeneca to manufacture the COVID-19 vaccine candidate developed by the University of Oxford, for India and low-and-middle income countries. Pune-based vaccine maker earlier shortlisted 17 sites in India for the Phase II clinical trial of COVID-19 vaccine. At least 1,600 candidates aged between 18 to 55, will participate in the trial.
The central drug regulator has asked Serum Institute of India to suspend recruitment in its clinical trials of AstraZeneca Plc's potential COVID-19 vaccine in the country until further orders, reported news agency ANI.
"Increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report. Submit clearance from DSMB, UK and DSMB, India to obtain clearance from this office prior to the resumption of future recruitment in the trial," read the statement by DCGI, according to ANI.
V.G. Somani, the drugs controller general of India, has also asked for increased safety monitoring of those already vaccinated with the experimental vaccine, according to ANI report.
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