10-member Subject Expert Committee had cleared Covaxin for restricted emergency use in January

Names of the 10-member Subject Expert Committee (SEC) that approved Covaxin for restricted emergency use in clinical trial mode — after meetings on December 30, 2020, and January 1-2, 2021 — were made public by the Health Ministry on March 23.

The identity of the SEC members, which has been kept under wraps, was finally disclosed by the Ministry in response to a Rajya Sabha question by Congress MP Syed Nasir Hussain.

The 10 members are: Dr. Varsha Gupta, Professor, Department of Microbiology, Government Medical College Hospital, Chandigarh; Dr. Archana Thakur, Medical Director, Professor and HOD (Microbiology), G.B. Pant Hospital, New Delhi; Dr. Abhishek Agarwal, Emeritus Professor, Department of Medicine, SMS Medical College, Jaipur; Dr. Sushant H. Meshram, Professor and Head, Pulmonary Medicine Department, Government Medical College & Hospital, Nagpur; Dr. Anant Mohan, Professor and Head, Pulmonary Medicine, AIIMS, New Delhi; Dr. A.P. Dubey, Professor of Paediatrics, ESI (PGIMSR) Hospital, New Delhi; Dr. Arvind Bagga, Professor, Department of Paediatrics, AIIMS, New Delhi; Dr. Dipendra K. Mitra, Professor and Head, Transplant Immunology and Immunogenetics Department, AIIMS, New Delhi; Dr. B. Gupta, Professor, General Medicine Department, NDMC Medical College and Hindu Rao Hospital, New Delhi; and Dr. D.S. Arya, Professor, Department of Pharmacology, AIIMS, New Delhi.

According to the Health Ministry, nine of the 10 members participated in the virtual meeting held on January 2. Except Dr. B. Gupta from NDMC Medical College and Hindu Rao Hospital who expressed concerns about the vaccine candidate, the other eight members gave restricted use approval for Covaxin.

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The minutes of the meeting have been posted on the website of the drug regulator.

The restricted use approval for Covaxin came under a cloud as there was no efficacy data available at the time. The Committee approved the vaccine for restricted use based on the safety and efficacy data from a non-human, primate challenge study where the vaccine has been found to be safe and effective.

The Committee’s approval came with riders saying it was 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”.

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