CDSCO approves Covishield, Covaxin for restricted emergency use in India


Tribune News Service
New Delhi, January 3

Central Drugs Standard Control Organisation (CDSCO) on Sunday approved Oxford-AstraZeneca  Covishield and Bharat Biotech’s COVAXIN for restricted emergency use for immunisation against Covid-19 in India.

India’s COVID-19 tally of cases climbed to 1,03,23,965 with 18,177 new cases in a day, while 99,27,310 people have recuperated so far pushing the national recovery rate to 96.15 per cent on Sunday, according to the Union Health Ministry data.

There are now two vaccines on India’s pandemic management horizon with the government successfully conducting vaccine dry run at 259 sites in 116 districts pan India today. Around 1.14 lakh vaccinators have been trained and over 75 lakh beneficiaries (of first phase priority inoculation) registered on Co-WIN. Sources had said once approved by the DCGI, the vaccine rollout could start as early as next week.

Covaxin is yet to conclude phase-3 trials with recruitment of participants underway, but the subject experts have recommended its restricted use on the basis of interim analysis of the available data. The manufacturers have been told to continue presenting additional safety data.

The two-dose Covishield has demonstrated 90 per cent efficacy in phase-3 trials when the vaccine is administered as a halved first dose and a standard second dose after a month.

 

 



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