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Government asked India for more data on the safety and efficacy of vaccines

The Union Health Ministry said that the requests for emergency use of vaccines being manufactured by the Serum Institute and the Bharat Biotech were not cleared yesterday by a panel of health experts.

The Ministry said, “After detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration.” A person involved in the process said, “Now the ball is in their court. Once they submit the required data, the schedule for another meeting of the panel will be decided.”

On December 6, the Pune-based Serum Institute, the world’s largest vaccine-maker, requested approval for the Oxford-AstraZeneca vaccine candidate, Covishield while pharma giant Pfizer sought Indian approval after securing clearances in the UK and Bahrain. On December 7, Hyderabad-based Bharat Biotech became the third vaccine-maker to apply to the DCGI for emergency use authorization for its indigenously-developed Covid-19 vaccine Covaxin.

 

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