The application submitted by the Covid 19 vaccine candidates SII and Bharat Biotech is being evaluated and the Central Drugs Standard Control Organisation's Subject Expert Committee asked the Serum Institute of India and Bharat Biotech to submit more data and information for emergency use authorisation (EUA) approval for their Covid-19 vaccine candidates. As per the media sources, the committee asked the SII to submit the updated safety data of the Phase 2/3 clinical trials, immunogenicity data from the clinical trial in UK and India, and outcome of the assessment of UK-MHRA for grant of EUA.
SII has presented their candidate proposal for grant of EUA of COVISHIELD, along with the interim safety data from Phase 3 clinical trial and interim safety and efficacy results of Phase 2/3 and Phase 3 clinical trials carried out in UK, other countries and India, before the committee. Bharat Biotech presented their proposal for grant of EUA, along with the interim safety and immunogenicity data of Phase 1 and 2 clinical trial carried out in the country before the committee.
After the detailed analysis, 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. Pfizer applied for EUA on Dcember 4 followed by Pune-based SII and Hyderabad-based Bharat Biotech who applied on December 6 and 7, respectively, but America's Pfizer did not give presentation before the committee as it requested some more time.
Fake news, SII and Bharat Biotech vaccines EUA rejected
Pfizer, Serum Institute and Bharat Biotech applied for emergency use approval
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