As the Indian drug regulator gears up to have a possible vaccine roll-out by January, is reviewing the UK’s move regarding approving the Oxford’s Covid-19 vaccine in the upcoming week, prior to making the decision of giving emergency use authorization to the Serum Institute of India (SII) which is manufacturing the shots here.
When the UK drug regular will grant the approval for the Oxford’s vaccine, the Covid-19 expert committee at the CDSCO will hold a discussion and assess the safety and immunogenicity data of the clinical data evaluations prior to emergency use authorization thoroughly, according to the official sources.
As Bharat Biotech’s Covaxin is in the third stage of clinical trials and Pfizer is still to put forth a presentation, a source said, “Going by this, Oxford vaccine ‘Covishield’ is likely to be the first to be rolled out in India.”
According to sources, SII had also presented additional data as asked by the Drugs Controller General of India (DCGI).
Earlier this month, both Bharat Biotech and Pfizer had appealed to the DCGI seeking for emergency use authorization for their potential Covid-19 vaccine candidates. The subject expert committee (SEC) on Covid-9 of the Central Drugs Standard Control Organization (CDSCO) had asked for additional safety and efficacy data of the vaccines from SII and Bharat Biotech, whereas Pfizer has asked for more time for presentation before the committee.
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