After clinical trials for AstraZeneca and Oxford University coronavirus vaccine resumed on Saturday in the UK, the Serum Institute of India (SII) said it will resume the trials in India once Drugs Controller General of India (DCGI) gives it requisite permission.
"Once DCGI will give us the permission to restart the trials in India, we will resume the trials," Serum Institute of India said in its statement.
In a tweet, SII CEO Adar Poonawalla said: "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."
AstraZeneca and Oxford University had on September 6 paused the trial of coronavirus vaccine (recombinant) as a volunteer developed an unexplained illness. It was also reported that the clinical trials had been put on hold in other countries including USA, UK, Brazil and South Africa.
Following the developments, India's top drugs regulator, DCGI, had asked SII to suspend any new recruitment in phase two and three clinical trials for COVID-9 vaccine till further orders. India's top drugs regulator granted permission to SII on August 2 to conduct phase II/III clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) at various clinical trial sites in the country to determine its safety and immunogenicity.
According to the reports on Saturday, clinical trials for 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.
AstraZeneca and the University of Oxford, as the trial sponsor, on Saturday said that they cannot disclose further medical information but confirmed that independent investigations concluded that the trials were safe to restart.
