NEW DELHI: India’s central drug regulator issued a notice to the Pune-based Serum Institute of India (SII) on Wednesday, asking why the company had failed to inform it of the “reported serious adverse events” that led to UK partner AstraZeneca to “temporarily pause” global clinical trials of the Oxford Covid candidate vaccine even as testing continues at 17 sites within the country.
India’s Comptroller General of Drugs VG Somani sought to know why the permission granted for Phase 2 and 3 trials should not be suspended until patient safety is established. Late on Wednesday, the SII said there was still no explicit directive to stop the trials.
Serum Institute of India Pvt Ltd, Pune, has also not submitted a causation analysis of the serious adverse event reported with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the vaccine in question in the country in light of security issues. said the DCGI.
The notice came even as Serum Institute Executive Director Adar Poonawalla said phase 2 and 3 trials would continue uninterrupted at all 17 sites despite the global hiatus from Tuesday after a UK volunteer showed a unexplained neurological side effect of the drug. “The vaccine is completely safe,” Poonawalla told TOI.
“When it comes to the trials in India, we have not faced any problems.” “We are following the direction of the DCGI, and so far they have not told us to stop the trials. If the DCGI has a safety problem, we will follow the instructions and comply with the standard protocols, ”said the statement from the Serum Institute. A total of 100 volunteers in India have already received the test dose of the Covishield vaccine which, if certified safe, will be manufactured by the Serum Institute in India.
India’s Comptroller General of Drugs VG Somani sought to know why the permission granted for Phase 2 and 3 trials should not be suspended until patient safety is established. Late on Wednesday, the SII said there was still no explicit directive to stop the trials.
Serum Institute of India Pvt Ltd, Pune, has also not submitted a causation analysis of the serious adverse event reported with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the vaccine in question in the country in light of security issues. said the DCGI.
The notice came even as Serum Institute Executive Director Adar Poonawalla said phase 2 and 3 trials would continue uninterrupted at all 17 sites despite the global hiatus from Tuesday after a UK volunteer showed a unexplained neurological side effect of the drug. “The vaccine is completely safe,” Poonawalla told TOI.
“When it comes to the trials in India, we have not faced any problems.” “We are following the direction of the DCGI, and so far they have not told us to stop the trials. If the DCGI has a safety problem, we will follow the instructions and comply with the standard protocols, ”said the statement from the Serum Institute. A total of 100 volunteers in India have already received the test dose of the Covishield vaccine which, if certified safe, will be manufactured by the Serum Institute in India.
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