Oxford COVID-19 vaccine: SII pauses trials in India following show-cause notice

• The Serum Institute of India has paused the Phase II/Phase III human trials of Oxford’s coronavirus vaccine candidate across all 17 locations.
  
• The Drug Control General of India (DCGI) issued a show-cause notice, seeking an explanation as to why the institute decided to go ahead with the clinical trial of COVID-19 vaccine when doubts about patient safety were yet unclear.
  
• The notice was issued after AstraZeneca halted the late-trials of its coronavirus vaccine over safety concerns.
  

The Serum Institute of India has paused the Phase II/Phase III human trials of Oxford’s coronavirus vaccine candidate across all 17 locations as a precaution, following a show-cause notice. SII says there have been no issues in India. It is a precautionary measure, and it will restart the trial as soon as AstraZeneca does.

"We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials. You can connect with DCGI for more updates on this front," SII said.

The Drug Control General of India (DCGI), VG Somani, issued a show-cause notice to it asking for an explanation as to why the institute decided to go ahead with the clinical trial of COVID-19 vaccine when doubts about patient safety were yet unclear.

"The 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 by DGCI read.

The DGCI further asked the institute as to why the authority did not suspend the permission given to SII for the clinical trials of Covishield.

The notice was issued after AstraZeneca halted the late-trials of its coronavirus vaccine over safety concerns. According to reports, one of the participants in the United Kingdom reported a severe adverse reaction after being administered a booster dose of Covishield, a vaccine candidate developed jointly by pharma giant AstraZeneca and the University of Oxford, on Tuesday.

AstraZeneca was conducting human trials at over 60 locations including the US, Brazil and South Africa.

SII is the partner of the University of Oxford's Jenner Institute to conduct vaccine trials. Last month, the DGCI had granted permission to SII for the second and third phase study of the vaccine at 17 trial sites across India.

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