New Delhi: A subject expert committee (SEC) on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold a meeting on Wednesday (December 9) to review the claims of several companies on the coronavirus vaccine. The expert committee will then submit its recommendations to the Drugs Controller General of India (DCGI) for emergency use authorisation for the COVID-19 vaccine.
The expert committee will consider the applications of Pfizer, Serum Institute of India, and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates.
The SEC will review the clinical trial data of these companies, and then give its recommendations to the DCGI on whether emergency use approval for the vaccine candidates should be granted or not.
The SEC's key consideration will be:
- Trial size and trial variety of these vaccines will also be important
- Pfizer, Serum Institute of India, and Bharat Biotech have given applications
- These three companies have sought permission for emergency use authorisation
- Pfizer had already got approval emergency use authorisation in UK and Bahrain
- Pfizer sought relief from the local trial in India
- Pfizer has claimed over 90% effectiveness of its vaccine
- AstraZeneca vaccine claims to be 70% effective on an average
- The clinical trial of Bharat Biotech is still under phase 3 trial
- Bharat Biotech's claims on the effectiveness of its vaccine are not public
