Serum Institute of India Says Will Restart Oxford Coronavirus Vaccine Trial after Drug Controller's Nod

The Serum Institute of India (SII) on Saturday said phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate will resume after receiving the green signal from the Drugs Controller General of India (DCGI). The development came shortly after pharma giant AstraZeneca said it had resumed clinical trials after getting the all-clear from British regulators.

“Once DCGI (Drugs Controller General of India) gives us permission to restart the trials in India, we will resume the trials,” said SII CEO Adar Poonawalla. In a tweet, he urged people to not “jump to conclusions until the trials are fully concluded”.

The statement came in response to AstraZeneca’s announcement that vaccine trials have resumed in the UK. “Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so,” the company said in a statement.

The Drugs Controller General of India, Dr VG Somani, had directed SII to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report. This was days after AstraZeneca said it had paused the trials because of ‘an unexplained illness’ in a participant in the study.

The central drug regulator authority had issued a show-cause notice to SII on September 9 for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries and also for not submitting casualty analysis of the “reported serious adverse events”.

The Pune-based firm on Thursday had said it was pausing the trials and reviewing the situation until AstraZeneca restarts them.

AstraZeneca’s vaccine candidate is one of nine around the world currently in late-stage Phase 3 human trials.