COVID-19 | Subject Expert Committee rejects Serum Institute’s application for Covishield booster dose

The SEC met on December 10 to review the applications made by both Serum Institute, which manufactures Oxford-AstraZeneca’s COVID-19 vaccine Covishield in India, and Biological E which makes Corbevax coronavirus vaccine.

Minister of State for Health Bharati Pravin Pawar informed Parliament earlier today that the national drugs regulator, the Central Drugs Standard Control Organisation, has granted permissions to two firms for conducting clinical trials for the administration of vaccine booster doses.

Bharat Biotech has been given permission for administration of booster doses in phase II part of ongoing phase I/II clinical trial of the Whole Virion Inactivated Coronavirus Vaccine.

Biological E has also been given permission for conduct of phase II/III clinical trial of its COVID-19 vaccine containing Receptor Binding Domain of SARS-CoV-2 (RBD antigen of SARS CoV-2 (Covid-19) (CORBEVAX), which also includes a study of administration of booster doses.

Also read: Omicron-Fueled Drive for Boosters May Hurt Access to First Shots in Poor Nations

Besides, the national regulator has granted permissions to two firms for conduct of clinical trials for administration of mixed vaccine regimen.

The Christian Medical College, Vellore, has been given permission to conduct phase IV study with Covishield of SII and Covaxin of Bharat Biotech to compare immunogenicity of mixed vaccine regimen.

India has already administered 132 crore doses of COVID-19 vaccine since the mega vaccination drive kick-started on January 16 this year. Many health experts have been speaking in favour of India rolling out booster doses amid the Omicron variant scare.

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