AstraZeneca Covid-19 Vaccine: Why India's Serum Institute Got A Show Cause Notice

Pune’s Serum Institute of India (SII), that is running trials of the Oxford Covid-19 vaccine, got a show cause notice from the Drugs Controller General of India (DCGI) even as British-Swedish pharmaceutical firm AstraZeneca announced on Tuesday that it was stopping the trial of the vaccine after an unexplained illness  in a study participant.

This was a huge set-back as the Oxford vaccine was one of the front runners of the number of vaccine trials happening across the world. 

Why did SII get a show-cause notice? 

According to reports, even as AstraZeneca paused its trials, the SII failed to inform the same to the DCGI. 

So far at least 100 volunteers in India have received the vaccine in phase 2 of human trials by SII, the largest vaccine maker in the world. SII has signed an agreement to manufacture the vaccine by the Jenner Institute of Oxford University. 

Drugs Controller General of India Dr VG Somani asked the SII in the notice why the phase 2 and phase 3 of human clinical trials be not suspended. 

PTI quoted the notice as saying: 

“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.

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 as provided under rule 30 of the New Drugs and Clinical Trials Rules, 2019, why the permission granted to you August 2 shall not be suspended till patient safety is established.” 

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”.

It’s not just the UK. US, Brazil and South Africa too have stopped the trial. 

SII, after the notice, has said it will follow DGCI’s orders. LiveMint quoted the SII saying in a statement, “We are going by DCGI’s direction and so far we’re not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.”

SII had said it will continue trials 

Earlier, even as AstraZeneca had said it was halting trials, SII had said trials in India will continue. 

Hindustan Times had quoted a statement from the SII as saying, “We (Serum Institute of India) can’t comment on reports of AstraZeneca pausing the trials in the UK, other than that they have been paused for review and shall restart soon. The Indian trials are continuing and we have faced no issues at all,” SII said in a statement.”

The DGCI had granted permission to SII to conduct phase 2 and 3 human clinical trials of the vaccine in August. 

(With PTI inputs)