In a big boost for India's fight against the Covid-19 pandemic, the Drug Controller General of India (DCGI) has granted emergency use approval to Hyderabad-based Bharat Biotech's Covaxin and Pune-based Serum Institute of India's Covishield.
The approval comes after the Subject Expert Committee (SEC) of the Central Drug Standard Control Organisation (CDSCO), India's drug regulator, on Saturday (2 January) recommended emergency use approval for the Covid-19 vaccine candidates from both the pharma firms.
The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.
After detailed deliberations on safety and immunogenicity data, Subject Expert Committee recommended for the grant of permission to Serum Institute's Covishield Covid-19 vaccine for restricted use in emergency situation subject to certain regulatory conditions, the Health Ministry said in a statement.
The SEC also reviewed the data on safety and immunogenicity of Bharat Biotech's Covid-19 vaccine and recommended for "grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains", the ministry said.
"After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of Serum and Bharat Biotech are being approved for restricted use in emergency situation," it said.
Both the vaccines have to be administered in two doses, the ministry said.
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