Hours after the Drugs Controller General of India (DCGI) issued a show-cause notice Serum Institute of India (SII) asking for an explanation as to why the ongoing clinical trial of Covishield vaccine candidate has not been suspended till doubts about patient safety are cleared, the pharma company issued a statement that they will adhere to the instructions of top drug regulator.
ANI had first reported that the DCGI had issued a show-cause notice to Serum Institute. The Serum Institute said in its statement that they were not instructed to pause trials. It said that they (Serum Institute of India), were going by DCGI’s direction and were not instructed to pause the trials if DCGI had any safety concerns, they will adhere to their instructions and abide by the standard protocols.
The drug regulator’s move came 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 across countries where it was being conducted – USA, UK, Brazil and South Africa.
The notice to the Serum Institute was issued by Drugs Controller General of India Dr VG Somani. ‘In view of the above 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 on August 2 shall not be suspended till patient safety is established,’ said the notice, a copy of which is with ANI.
It said that Serum Institute “uptill has not informed” the central licensing authority regarding pausing of clinical trial 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 August 2 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 Serum Institute in India under technical collaboration with Oxford University/AstraZeneca and is called as 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.