Suspension of Covishield trials in UK spells havoc for Astrazeneca and Serum Institute of India

The Drugs Controller General of India, Dr. V G Somani, in his show-cause notice has 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.

It further sought an immediate reply saying else "it shall be construed" that the company had no explanation to offer and "action deemed fit" would be taken.

"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 show-cause notice accessed by PTI.

"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 notice further said.

In the showcase notice, the drug regulator also mentioned that the clinical trials have been put on hold across countries where it is conducted i.e. USA, UK, Brazil, and South Africa. Last month, the DCGI had granted permission to the Pune-based SII to conduct Phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.

In response to the notice, SII stated that it will follow the instructions and protocols of the Central Drugs Standard Control Organisation (CDSCO).

"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 its instructions and abide by the standard protocols, " Serum Institute of India stated.

Commenting on the recent reports on AstraZeneca halting the trials in the UK, SII said in a statement: "We can't comment much on the UK trials, but they have been paused for further review and they hope to restart soon.

"It further added, "As far as Indian trials are concerned, it is continuing and we have faced no issues at all".

Meanwhile, SII, which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19, on September 9 said it is continuing with the trials in India.

SII is the partner of the University of Oxford's Jenner Institute to conduct vaccine trials. SII is currently progressing with the second and third phase study of the vaccine candidate at 17 trial sites across India.