Udayavni Special

Serum Institute of India says ‘will resume Covid vaccine trials’ after drug controller’s nod


Team Udayavani, Sep 13, 2020, 9:56 AM IST

New Delhi: Serum Institute of India will resume clinical trials of AstraZeneca’s COVID-19 vaccine candidate after getting the permission from the Drugs Controller General of India (DCGI), the Pune-based vaccine maker said on Saturday.

Pharma giant AstraZeneca on Saturday said that clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that the trials were safe.

“Once DCGI will give us the permission to restart the trials in India, we will resume the trials,” Serum Institute of India (SII) said in a 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.”

The human trials resumed days after a pause had been announced in the trials after an adverse reaction in one of the participants.

Following the suspension, the DCGI directed Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the vaccine candidate.

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.

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