New Delhi | Jagarn News Desk: The Serum Institute of India (SII), who is manufacturing the Oxford University's ‘Covishield’ vaccine with pharma giant AstraZeneca, will pause the phase 3 trials from next week after the DCGI issued a show-cause notice to them.

The notice was issued after trials for the vaccine were stopped in four nations as a precautionary measure after one of the recipients in the UK showed some adverse symptoms.

In its reply to the notice, the SII has said that they have not received any formal request from Drug Controller General of India (DCGI) to pause the trials of COVID-19 vaccine.

"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 protocol", SII said in a statement.

The SII’s statement came after the DCGI issued a show-cause notice to the SII for not informing the drug regulator about AstraZeneca pausing the clinical trials of the Oxford’s COVID-19 vaccine candidate in other countries and also for not submitting casualty analysis of the reported serious adverse events.

"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 as reported by news agency 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.

The DCGI’s show-cause notice came in the backdrop of AstraZeneca halting the human trials of the Oxford University’s coronavirus vaccine candidate after a volunteer from the UK had an adverse reaction to it and developed an unexplained illness.

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 also mentioned that the clinical trials were stopped in the USA, UK, Brazil and South Africa where the trials were conducted.

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.

 

 

(With PTI Inputs)

Posted By: Talib Khan