Indian Drug Firm Gets Notice After Oxford Covid Vaccine Trial Paused
Notice was issued to Serum Institute of India following reports that human trials of the COVID-19 vaccine candidate being developed by the University of Oxford have been put on hold after a British participant had an adverse reaction to it
The central drug regulator has issued notice to Serum Institute of India (SII) for not informing it about pharma giant AstraZeneca pausing the clinical trials of the Oxford vaccine candidate for COVID-19 in other countries and also for not submitting casualty analysis of the “reported serious adverse events”.
The notice was issued following reports that human trials of the COVID-19 vaccine candidate being developed by the University of Oxford have been put on hold after a British participant had an adverse reaction to it.
The Drugs Controller General of India, Dr VG Somani, in the notice asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country be not suspended till patient safety is established.
“Whereas, Serum Institute of India Pvt Ltd, Pune, till now has not informed the Central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty 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 light of the safety concerns,” said the notice.
“In view of the above, I Dr V G Somani, Drugs Controller General of India and Central Licensing Authority hereby give you an opportunity to show cause… why the permission granted to you August 2 shall not be suspended till patient safety is established,” the notice said.
The DGCI sought an immediate reply saying else “it shall be construed that you have no explanation to offer and action deemed fit will be taken against you”.