Hyderabad: Covishield, the Oxford-AstraZeneca vaccine, was on Friday recommended for emergency use authorisation (EUA), becoming the first vaccine to reach this stage in the approval process in India. Covishield is manufactured by Serum Institute of India (SII).
The recommendation on Covishield has been forwarded to the Drugs Controller General of India (DCGI), which is likely to take a final call soon.
The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), which recommended Covishield, asked for more data on Covaxin, which is being developed by Bharat Biotec, before it can be recommended for emergency use authorisation.
The EUA has been recommended for Covishield with regulatory provisions including that the vaccine dose is indicative for active immunization in individuals of 18 years or more in preventing the disease. It should be administered intramuscularly in two doses at an interval of four to six weeks.
SII has to…