A day before a pan-India dry run of Covid vaccination by Center, the subject expert committee of the national drugs regulator Central Drugs Standard Control Organisation (CDSCO) is meeting on Friday to take a decision on the emergency-use authorization (EUA) application of Serum Institute of India’s Oxford-AstraZeneca and Bharat Biotech’s Covid vaccine candidates.
Serum Institute which is making the vaccine 'Covishield' developed by Oxford University and pharma major AstraZeneca and Bharat Biotech which has partnered with the Indian Council of Medical Research (ICMR) for its 'Covaxin' had made presentations before the panel on Wednesday. Pfizer had sought more time to present their data.
Earlier this week, the SEC had met a second time to review their EUA application, after UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency-use approval to the SII Oxford-AstraZeneca vaccine.
Bharat Biotech had applied to the DCGI for emergency use authorization for its indigenously developed COVID-19 vaccine Covaxin on December 7, while the Pune-based Serum Institute of India (SII) sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6.
Pfizer had applied for emergency use authorization (EUA) for its vaccine on December 4.
While considering Serum Institute's application, the subject expert committee (SEC) on COVID-19 has recommended that the firm should submit an updated safety data of phases 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA) for grant of emergency use authorization.
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