NEW DELHI: India’s central drug regulator Wednesday issued a notice to Pune-based Serum Institute of India (SII), asking why the firm hadn’t informed it about the “reported serious adverse events” that led its UK partner AstraZeneca to “temporarily pause” global clinical trials of the Oxford Covid vaccine candidate even as testing continues at 17 sites within the country.
Drugs Controller General of India V G Somani sought to know why permission granted for Phase 2 and 3 trials shouldn’t be suspended till patient safety is established. Late on Wednesday, SII said there was no explicit directive yet to pause the trials.
Serum Institute of India Pvt Ltd, Pune, has also not submitted causality analysis of the reported serious adverse event with the investigational vaccine for the continuation of Phase 2 and 3 clinical trials of the subject vaccine in the country in (the) light of safety concerns, the DCGI said.
The notice came even as Serum Institute CEO Adar Poonawalla said Phase 2 and 3 trials would continue uninterrupted across all 17 sites despite the global pause since Tuesday after a UK-based volunteer showed an unexplained neurological side-effect of the drug. “The vaccine is completely safe,” Poonawalla told TOI.
“As far as Indian trials are concerned, we have faced no issues at all.” “We are going by the DCGI’s direction, and so far haven’t been told to pause the trials. If the DCGI has any safety concerns, we will follow the instructions and abide by the standard protocols,” the Serum Institute statement said. A total of 100 volunteers in India have already received the trial dose of the Covishield vaccine that, if certified safe, will be manufactured by Serum Institute in India.


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