SII says ‘will abide by DCGI instructions’ after drug regulator issues notice over continuing vaccine trial
The DCGI issued a show-cause notice to Serum Institute of India (SII) seeking an explanation as to why the ongoing clinical trial of Covishield vaccine has not been paused in India.
New Delhi: Serum Institute of India (SII) on Wednesday (September 9) said that the drugmaker will follow the central drug regulator's instruction on suspension of the Oxford-AstraZeneca COVID-19 vaccine trial in India.
The Drugs Regulator General of India (DCGI) on Wednesday issued a show-cause notice to pharma giant Serum Institute of India (SII) seeking explanation as to why it did not halt the ongoing clinical trial of Covid vaccine till doubts about patients’ safety are cleared.
The DGCI also sent the notice to SII for not informing it about AstraZeneca pausing the clinical trials of the Oxford vaccine candidate for COVID-19 in other countries and also for not submitting casualty analysis of the “reported serious adverse events”.
The show-cause notice was issued from the DGCI after reports surfaced that the human trials of the most promising COVID-19 vaccine candidate, being developed by the University of Oxford, have been put on hold after a UK participant had an adverse reaction to it.
"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.
Regarding the showcause notice issued by the DCGI, Serum Institute of India, said "We are going by DCGI's direction and so far, were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols."
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.
Serum Institute of India partnered with AstraZeneca to manufacture the COVID-19 vaccine candidate developed by the University of Oxford, for India and low-and-middle income countries. Pune-based vaccine maker earlier shortlisted 17 sites in India for the Phase II clinical trial of COVID-19 vaccine. At least 1,600 candidates aged between 18 to 55, will participate in the trial.