CDSCO approves Covishield, Covaxin for restricted emergency use in India

Aditi Tandon
Tribune News Service
New Delhi, January 3

The stage is set for the commencement of COVID vaccination drive in India with the national regulator on Sunday approving both Covishield and indigenous COVAXIN for restricted use in emergency situations.

While Covishield is Serum Institute’s vaccine developed in collaboration with Oxford University and AstraZeneca, COVAXIN has been made by Bharat Biotech with ICMR partnership.

“After adequate examination, the CDSCO has decided to approve Covishield and COVAXIN for restricted emergency use in India,” Drug Controller General of India VG Somani said.

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He said both vaccines would be stored at 2 to 8 degree and are two-dose vaccines.

A decisive turning point to strengthen a spirited fight!

DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation.

Congratulations India.

Congratulations to our hardworking scientists and innovators.

— Narendra Modi (@narendramodi) January 3, 2021

“SII submitted safety, efficacy and immunogenicity data on 23744 subjects aged 18 or older from overseas and efficacy was found to be 70.42 per cent. Interim safety data from trials in India was found to be comparable with overseas data and SII’s ongoing phase 2 and 3 clinical trials in India will continue,” Somani said.

About Bharat Biotech vaccine he said it is based on the inactivated virus platform whose safety is well established in India and abroad.

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“Bharat Biotech submitted data from animal studies. Phase 1 and 2 trials were done on 800 subjects and results show safe, robust immune response. Phase 3 trials have been initiated on 25800 participants and 22500 have been vaccinated. The vaccine is safe as per data available. Subject experts have recommended restricted emergency use, which has been accepted,” Somani added.

The government said it is prepared for COVID vaccine rollout.

As soon as the approvals were announced the Congress raised concerns over the safety of Bharat Biotech and Covishield.

Congress leader Jairam Ramesh said “Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for Covaxin. Health Minister should clarify.”

Former minister Anand Sharma also raised concerns asking for safety data to be made available in the public domain.

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