The Serum Institute of India (SII) stated it is ready to restart coronavirus vaccine trials pending permission from the Drug Controller General of India (DGCI).
The SII had suspended recruitment for Phase 2 and Phase 3 India trials of the Covishield vaccine being developed by pharma giant AstraZeneca and the University of Oxford after concerns over the health of a trial participant in the United Kingdom. British regulators directed the UK trials to be halted.
The DGCI also demanded a report detailing symptoms of the UK patient and directed the SII to increase monitoring of trial patients who had already been vaccinated.
Replying to the notice, the SII said there had been no safety or health issues in the India trials, so far. Nevertheless, the Data Safety Monitoring Board recommended pausing further enrollment.
Responding to the statement that the SII is ready to restart trials, Adar Poonawalla, the CEO and founder of the company, tweeted.
"As I'd mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events is a clear example why we should not bias the process and should respect the process till the end. Good news, @UniofOxford," he said.
Hours earlier AstraZeneca said it had received permission to restart its UK trials. The company had "voluntarily paused" its trials after one of the participants fell ill.
"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.
