Covid-19 Vaccine
After Oxford Covid-19 Vaccine trial pause, DCGI sends show-cause notice to Serum Institute
New Delhi/IBNS: After pharmaceutical giant AstraZeneca halted the Phase 3 study testing of the Oxford Vaccine against Covid-19, the Drugs Controller General of India (DCGI) on Wednesday issued a show-cause notice to Serum Institute of India (SII) for not informing the central drug regulator about the pause of trials in other countries.
The Oxford Vaccine trial got halted after a suspected serious adverse reaction was seen in a participant in the United Kingdom, media reports said.
In its notice to Serum Institute, DCGI's Dr VG Somani sought an explanation from the pharmaceutical company that why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine in India be not suspended till patient safety is established.
Serum Institute has also been show-caused for not submitting casualty analysis of the "reported serious adverse events".
“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,” the notice available with media reads.
"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.
Seeking an immediate reply, Somani said failing of the same “shall be construed that you have no explanation to offer and action deemed fit will be taken against you."
Serum Institute also responded to the notice with a tweet stating that: "We (Serum Institute of India), were going by DCGI's direction and were not instructed to pause the trials. If DCGI has any safety concerns, we will adhere to their instructions and abide by the standard protocols."
We (Serum Institute of India), were going by DCGI's direction and were not instructed to pause the trials. If DCGI has any safety concerns, we will adhere to their instructions and abide by the standard protocols. pic.twitter.com/u0yaGAU0Eo
— SerumInstituteIndia (@SerumInstIndia) September 9, 2020
On Tuesday, AstraZeneca announced that "as parts of the randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process triggered a pause to vaccination to allow review of safety data."
The nature of the suspected serious adverse reaction was not immediately known.
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