Health Ministry reveals the names of SEC members for vaccine approval

After months of secrecy around the identity of the SEC members who approved Covaxin for restricted use despite no efficacy data, the Health Ministry finally revealed the names of the 10 members on March 23 in response to a question by Congress MP Syed Nasir Hussain.

The names of the 10-member Subject Expert Committee (SEC) that approved Covaxin for restricted emergency use after meetings held on December 30, 2020, and January 1-2, 2021 were made public on March 23. The identity of the SEC members, which has been kept under wraps, was finally disclosed by the Health Ministry in response to a Rajya Sabha question asked by Syed Nasir Hussain, a Congress MP.

Names of the ten members

Dr. Varsha Gupta, Professor, Department of Microbiology, Government Medical College Hospital, Chandigarh; 2) Dr. Archana Thakur, Medical Director, Professor and HOD (Microbiology), G.B. Pant Hospital, New Delhi; 3) Dr. Abhishek Agarwal, Emeritus Professor, Department of Medicine, SMS Medical College, Jaipur; 4) Dr. Sushant H. Meshram, Professor and Head, Pulmonary Medicine Department, Government Medical College & Hospital, Nagpur; 5) Dr. Anant Mohan, Professor and Head, Pulmonary Medicine, AIIMS, New Delhi; 6) Dr. A.P. Dubey, Professor of Paediatrics, ESI (PGIMSR) Hospital, New Delhi; 7) Dr. Arvind Bagga, Professor, Department of Paediatrics, AIIMS, New Delhi; 8) Dr. Dipendra K. Mitra, Professor and Head, Transplant Immunology and Immunogenetics Department, AIIMS, New Delhi; 9) Dr. B. Gupta, Professor, General Medicine Department, NDMC Medical College and Hindu Rao Hospital, New Delhi; and 10) Dr. D.S. Arya, Professor, Department of Pharmacology, AIIMS, New Delhi.

The identity of the members was first disclosed by Malini Aisola, Co-convener of the All India Drug Action Network (AIDAN) and a Public Health Researcher based in Delhi way back in mid-August 2020. She had culled the names from an official document. But the Health Ministry refused to reveal or officially confirm the names till March 23, 2021.

According to the response provided by the Health Ministry, nine of the 10 members participated in the virtual meeting held on January 2. Apparently, except Dr. B. Gupta from NDMC Medical College and Hindu Rao Hospital, New Delhi, who expressed concerns, the remaining eight members approved giving restricted use approval for Covaxin.

The recommendation of the SEC meeting held on January 2, 2021 has been posted on the website of the drug regulator too.

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

Published in The Hindu on April 5, 2021