The Drugs Controller General of India (DCGI) on Wednesday issued a showcause notice to pharma giant Serum Institute of India (SII) seeking an explanation as to why it did not suspend the ongoing clinical trial of Covishield vaccine candidate till doubts about patient safety are cleared.
The drug regulator’s move comes after AstraZeneca, which is developing the vaccine candidate against Covid-19 with researchers of Oxford University, paused its trial as a volunteer developed an unexplained illness. The clinical trial has been put on hold in the US, UK, Brazil and South Africa. Referring to reports of AstraZeneca halting the trials in the UK, SII, which is conducting the trials in India, said that the UK trials have been paused for further review.
“We can’t comment much on the UK trials but they have been paused for further review and hope to restart soon. As far as Indian trials are concerned, it is continuing and we have faced no issues at all,” it said.
The notice to the SII has been issued by DCGI Dr V.G. Somani.
“In view of the above Drugs Controller General of India and Central Licensing Authority hereby allow you to showcause as provided under rule 30 of the New Drugs and Clinical Trials Rules 2019 — why the permission granted to you on 2 August shall not be suspended till patient safety is established,” said the notice as per an ANI report.
It said that SII “up till has not informed” the central licensing authority regarding pausing of clinical trials carried out by AstraZeneca in other countries and has “also not submitted a casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase II/III clinical trial of the subject vaccine in the country in light of the safety concerns”.
“Your reply shall reach undersign immediately, else it shall be construed that you have no explanation to offer and action deemed fit will be taken against you,” it added.
The country’s apex drugs regulator had on 2 August granted permission to SII to conduct a phase II/III clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) at various clinical trial sites in the country to determine its safety and immunogenicity. The vaccine will be manufactured by SII under technical collaboration with Oxford University/ AstraZeneca and is called Covishield (SII-ChAdOx1 nCoV-19).
Covishield vaccine contains replication-deficient simian adenovirus vector ChAdOx1 containing structural surface glycoprotein (spike protein) antigens of SARS-CoV-2.
With inputs from ANI