In a major development, the Drugs Controller General of India (DCGI) on Sunday granted “restricted emergency use” authorisation to the vaccines being manufactured by Serum Institute of India (SII) and Bharat Biotech. The move comes at a time when COVID-19 cases in the country have already crossed 1.03 crore and the death toll is nearing 1.5 lakh.
Notably, the Pune-based SII is manufacturing the vaccine jointly developed by AstraZeneca and the University of Oxford that has been already approved by the UK government for emergency use. The vaccine has been found to be around 70% effective in clinical trials. It has been named ‘Covishield’. The vaccine developed by Bharat Biotech is named ‘Covaxin’.
Vaccine approval based on experts’ recommendations
The approval was granted by DCGI on the basis of recommendations of the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO). The committee had met on January 1 and 2 to decide on the issue.
“After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation,” DCGI’s director-general Dr VG Somani told media.
“Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks,” SII chief Adar Poonawalla said.
Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks. pic.twitter.com/TcKh4bZIKK
— Adar Poonawalla (@adarpoonawalla) January 3, 2021
He also thanked Prime Minister Narendra Modi and Union health minister Harsh Vardhan for their support.
Over 1.03 cr cases
The health ministry on Sunday informed that 18,177 fresh cases of COVID-19 have been reported in India in the past 24 hours. The addition of the fresh cases has taken the COVID-19 case tally past 1.03 crore. Also, 217 COVID-19 related deaths were reported by the ministry during this period. The addition of the fresh fatalities has taken India’s death toll due to the deadly virus to 1,49,435.
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