Pune: Serum Institute of India (SII) on Thursday halted coronavirus vaccine trials in India after it was served with a show-cause notice by Drug Controller General of India (DGCI).
"We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following Drug Controller General of India's (DGCI) instructions and will not be able to comment further on trials," said Serum Institute of India on COVID-19 vaccine trials.
The development comes when SII was about to start Phase 3 trials of the Oxford vaccine in 17 clinical trial sites with 1,600 volunteers across India.
The declaration by the Pune-based vaccine manufacturer came a day after the Drug Control General of India (DCGI), V.G. Somani, issued a show-cause notice to them asking for an explanation as to why the institute decided to go ahead with the clinical trial of Covid-19 vaccine candidate while doubts about patient safety are yet unclear.
On Wednesday India's apex drug regulator, DCGI issued a show-cause notice to Pune based Serum Institute over safety concerns of ChAdOx1 vaccine during ongoing trials in the UK.
Issuing the notice, Drug Controller General Dr VG Somani said that SII 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 actions adverse event with the investigational vaccine for the continuation of phase II and III clinical trials in the country. The notice asked SII to give clarification over the safety issue of the patient.
READ: DCGI issues show cause notice to SII for not pausing trial of COVID vaccine
"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," the notice by DGCI read.
The DGCI further asked the institute why the authority does not suspend the permission given to the SII for the clinical trials of Covishield.
"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.
SII is the partner of the University of Oxford's Jenner Institute's to conduct the vaccine trials. SII is currently progressing the second and third phase study of the vaccine candidate at 17 trial sites across India.
Earlier, DGCI had given permission to SII for phase III clinical trial of the Oxford vaccine. The trial of the Oxford vaccine is put on hold in the UK too following suspected serious adverse reaction in a participant firing the clinical trial. ChAdOx1 was one of the strong vaccine candidate worldwide for Covid19 disease.
