Serum Institute of India to resume COVID-19 Vaccine trials after DGCI Nod

The Serum Institute of India (SII) is all set to resume the clinical trials of AstraZeneca-Oxford’s COVID-19 vaccine candidate AZD1222 after receiving permission from the Drugs Controller General of India (DCGI), the company confirmed on Saturday.

“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 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 the Serum Institute of India to suspend till further orders new recruitment in Phase-II and Phase-III clinical trials of the vaccine candidate.

The late-stage trials of the experimental vaccine, developed with researchers from the University of Oxford, were suspended this week after an illness in a study subject in Britain, casting doubts on an early rollout.

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.

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