The Oxford COVID-19 vaccine may get the nod from India drug regulator by next week, while Serum Institute of India (SII) maybe given emergency authorisation use on manufacturing the shots, say reports.
Once the Oxford vaccine gets approval in the UK, the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine, said reports.
Meanwhile, in India, Bharat Biotech’s Covaxin might take time as phase 3 of the vaccine trial is still underway, and Pfizer is yet to make a presentation.
Pfizer has already been approved by several countries including the UK, the US, and Bahrain.
Last week, SII submitted some additional data required by the Drug Controller General of India (DCGI), as the subject expert committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) had sought additional safety and efficacy data for COVID-19 vaccines of SII and Bharat Biotech.
Pune-based SII has collaborated with the University of Oxford and AstraZeneca to manufacture the vaccine.
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