India’s Drug Regulator Gives Greenlight for Oxford Vaccine & Covaxin for Emergency Pandemic Use: Some Worry Not Enough Transparency

India’s Drug Regulator Gives Greenlight for Oxford Vaccine & Covaxin for Emergency Pandemic Use Some Worry Not Enough Transparency

The Drugs Controller General of India (DCGI) issued emergency authorization for two vaccines, including ‘COVISHIELD’, produced by the Serum Institute of India (SII), which is actually licensed from  AstraZeneca as well as the locally developed vaccine produced by Bharat Biotech known as ‘Covaxis.’   The AstraZeneca product, known as AZD1222, was originally developed by the University of Oxford and called ChAdOx1 nCoV-19. The regulatory authority also approved the commencement of a Phase 3 clinical trial led by vaccine sponsor Cadila Healthcare Limited.  The ‘Subject Expert Committee’ (SEC) of the Central Drugs Standard Control Organization (CDSCO) met on New Years’ Day and Jan. 2, found sufficient positive data associated with immunogenicity and safety to recommend the greenlight for restricted use in this emergency while clinical trials will continue. There was considerable pressure to award the greenlight, given India’s number of COVID-19 cases and the fact that the UK’s regulatory authority recently also issued an emergency use authorization for AZD1222 (again the same vaccine as COVISHIELD).

Serum Institute of India (SII), the world’s biggest vaccine producer by volume, par...

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