VG Somani, the Drug Controller General of India said on Monday that Covishield and Covaxin are ”safe and provide a robust immune response.”
India’s drugs regulator has given final emergency-use approval for two coronavirus vaccines, Serum Institute of India’s Covishield, developed by Oxford University and pharma major AstraZeneca, and Bharat Biotech’s Covaxin.
Also read: India approves SII and Bharat Biotech’s Covid-19 vaccines for restricted emergency use
During an interview, Somani said “We’ll never approve anything if there is slightest of safety concern. The vaccines are 110 per cent safe.”
The country is now expected to start a massive immunisation programme within weeks.
Drug Controller General of India (DGCI) chief VG Somani said both firms submitted data on their trial runs and both have been granted permission for “restricted use”.
“Safety immunogenicity data submitted by SII found efficacy was 70.42 per cent. Restricted use in emergency conditions allowed. The clinical trials will continue. Covaxin has been developed in collaboration with ICMR and NIV,” he said in a press briefing on Sunday.
Indian Prime Minister Narendra Modi called the approval a decisive turning point to strengthen a spirited fight and congratulated scientists and innovators.
A decisive turning point to strengthen a spirited fight!
Congratulations to our hardworking scientists and innovators.
— Narendra Modi (@narendramodi) January 3, 2021
He said, “The DCGI granting approval to vaccines of Serum Institute of India and Bharat Biotech accelerates the road to COVID-free nation.”
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