Serum Institute halts coronavirus vaccine trials in India after notice from drug regulator

New Delhi, 10-Sep-2020

The Serum Institute of India (SII), which was conducting the India trials for the coronavirus vaccine being developed by Oxford University, has halted clinical trials of the vaccine in India. The coronavirus vaccine trials have been paused till further instructions from the Drug Controller General of India (DCGI). The Serum Institute of India has issued a statement making the declaration, days after the vaccine trial had to be halted in Oxford after a volunteer developed illness following the dosage. A Director General of Health Services (DGHS) notice, accessed by BusinessToday.In, says the "Serum Institute of India, Pune, up till has not informed the central licencing 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 contribution of the Phase II/III clinical trial of the subject vaccine in the country in light of the safety concerns." AstraZeneca, which is developing the vaccine with Oxford University researchers, said on Tuesday it had paused late-stage trials to allow an independent committee to review safety data, and it was working to minimize any potential impact on the timeline. Following the adverse results in the UK clinical trials, Serum Institute CEO Adar Poonawalla told India Today on Wednesday, "Nothing untoward has been reported during the vaccine trials in India." The drug regulator, however, issued a show cause notice to vaccine maker Serum Institute of India after trials of the AstraZeneca Covid-19 vaccine were halted in the UK. Sources earlier told that the showcause notice was issued to SII for not revealing to DCGI that the trial outcomes that have led to one participant falling ill in the UK trials of the AstraZeneca coronavirus vaccine. SII has partnered with the coronavirus vaccine developers at the Jenner Institute of Oxford University in collaboration with the British-Swedish pharmaceutical company AstraZeneca. The Oxford coronavirus vaccine was being considered to be the most promising Covid-19 vaccine candidate globally. 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.