The Drugs Controller General of India approved a COVID-19 vaccine developed by AstraZeneca and Oxford University for emergency use.
On Jan. 2, 2021, in a press conference, VG Somani, the Drugs Controller General of India, announced that the Subject Expert Committee of Central Drugs Standard Control Organisation(CDSCO) had formally approved two COVID-19 vaccines' emergency use. Oxford/AstraZeneca's Covishield and Bharat Biotech's Covaxin were the two COVID-19 vaccines that received emergency approval. The Oxford/AstraZeneca vaccine is being manufactured locally by the Serum Institute of India.
Mr. Somani said that the Serum Institute of India, Pune, presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University. The firm demonstrated safety, immunogenicity, and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies. Further, the Serum Institute was granted permission to conduct Phase-II/III clinical trials of 1600 participants within the country.
The DCGI further states that the CDSCO gave its approval, followed by the Subject Expert Committee's recommendation that suggested both vaccines for emergency use. Mr. Somani said DCGI would never approve anything if there is the slightest safety concern.
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