India's drugs controller approves 2 COVID-19 vaccines

Release time: 2021-01-04 09:06:23  Hits: 10

NEW DELHI - The Drugs Controller General of India (DCGI) on Sunday gave its approval to two vaccines for emergency use.


Addressing media, DCGI Dr. V.G. Somani said the permission was granted for "restricted use in emergency situation."


He said that the Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) met on Jan 1 and Jan 2, making recommendations in respect of proposal for restricted emergency approval of COVID-19 virus vaccine of "Serum Institute of India (SII)" and "Bharat Biotech" as well as Phase 3 clinical trial of "Cadila Healthcare Limited."


The SII, situated in southwestern city of Pune, presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University, said a DCGI statement.


"The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the 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 clinical trial ongoing within the country by the firm will continue," he told media.

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