After DCGI's show-cause notice, Serum Institute pauses Covid-19 vaccine trial
New Delhi/IBNS: Serum Institute of India (SII) on Thursday paused the trial of Covid-19 vaccine a day after it was served a show-cause notice by the Drugs Controller General of India (DCGI) for not informing the central drug regulator about the pause of study testing in other countries, media reports said.
In a setback for the medical fraternity, pharmaceutical giant AstraZeneca has halted the phase 3 trial of the Oxford Vaccine against Covid-19.
Pausing the trial of Covishield vaccine, the Serum Institute said in a statement as quoted by the media, "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following Drug Controller General of India’s (DGCI) instructions and will not be able to comment further on trials."
In its notice to the 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.
The 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."
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.