A Central Drugs Standard Control Organisation (CDSCO) expert panel meeting on December 9 to review applications of Pfizer, Serum Institute of India (SII) and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates.
The decision was taken after the Hyderabad-based Bharat Biotech became the third pharmaceutical firm to seek the Drugs Controller General of India (DCGI) nod for emergency use authorisation for its indigenously developed COVID-19 vaccine Covaxin.
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"Several points would be discussed in the meeting—for one, Bharat Biotech had changed its dosage during the trial. It had come to seek approval for the same. We will be reviewing this bit very carefully," sources told Business Standard.
Bharat Biotech changed the Covaxin dosage from 3 micrograms of antigen to 6 micrograms during the trial.
Explained: What is emergency use approval, why is it done, how is it done, grey areas, and more
The Indian arm of the US pharmaceutical giant Pfizer on December 4 sought approval for its vaccine from the drug regulator after the firm secured clearance in the UK and Bahrain.
The UK became the first country in the world to began immunizing its citizens against the viral disease when it rolled out Pfizer's vaccine on December 8.
The Pune-based Serum Institute of India sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6.
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After evaluation, the Subject Expert Committee (SEC) will give its recommendations to the DCGI on whether emergency use approval for the vaccine candidates should be granted.
Three COVID-19 vaccines—developed by Bharat Biotech, Serum Institute of India and Pfizer—were under active consideration of India's drug regulator and an early licence was possible for all or any of them, NITI Aayog member (Health) VK Paul said on December 8.
The same day, the Health Ministry released the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC)'s recommendation on prioritised population groups that need to be administered the vaccine first.
According to the recommendation, more than one crore healthcare providers and workers in both private and public hospitals would be administered the vaccine.
Frontline workers, including personnel from state and central police, armed forces, home guards, civil defence and disaster management volunteers and municipal workers, will be administered a shot when it becomes available.
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