The world’s largest vaccine maker, the Serum Institute of India, has decided to stop trials of the Covid-19 vaccine in the country in the wake of AstraZeneca stopping it after an unexplained illness to a participant.
IBS has partnered with biopharmaceutical company AstraZeneca to manufacture the experimental Covid-19 candidate vaccine developed by the University of Oxford.
Following an unexplained illness to one participant, AstraZeneca on Tuesday had halted trials to allow an independent committee to review safety data, and was working to minimize any potential impacts on the timeline.
You will know the results of the Covid-19 vaccine by the end of the year if the trials are resumed: AstraZeneca
On Wednesday, the Comptroller General of Drugs of India (DCGI) sent out a notice of apparent cause to continue the trials even as it was stopped internationally.
“We (SII) are reviewing the situation and halting the India trials until AstraZeneca restarts the trials. We are following DCGI’s instructions and will not be able to comment further on the trials. You can connect with DCGI for further updates on this front.” the SII said in a statement Thursday.
DGCI Dr. VG Somani, in his notice of demonstrative cause, asked the SII why the permission granted to carry out phase 2 and 3 clinical trials of the candidate vaccine in the country is not suspended until the safety of the patient is established.
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The DCGI has noted that clinical trials have been suspended in the US, UK, Brazil, and South Africa.
IBS has been registered for phase II / III clinical trials on the Covid-19 candidate vaccine, Covishield, which is being developed by the University of Oxford-AstraZeneca, with the Clinical Trials Registry of India (CTRI).
The trials will be conducted on 1,600 healthy participants across India.m The Indian Institute of Medical Sciences, New Delhi and Bharti Vidyapeeth’s Bharti Hospital & Medical College in Pune are among the 17 locations where the trials are being conducted. essays.
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