SII’s Covishield Gets Emergency-Use Nod from DGCI

The Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI) has given emergency-use approval to the Serum Institute of India’s vaccine candidate-Covishield. The approval was given in the marathon meeting of the Subject Expert Committee.

Key Points

• Covishield is expected to be available for use in a week.
• Covishield is similar to the ‘Oxford vaccine’ which has already got emergency use approval in the United Kingdom.
• Covishield vaccine will be given in two doses at a distance of 4-12 weeks similar to the doses approved in the UK.
• The approval to Covishield in India has been given on the basis of approval by the UK regulator and on the basis of data from phase-1 studies and data from phase 2 trials on 100 volunteers in India.
• As per the Serum Institute of India (SII), the country will store up 100 million doses as of the first week of January.
• At present, in the phase 2/3 trial of Covishield, it is being tested on 1,600 volunteers.
• A close review of the phase 3 results is being done for the vaccine.

Another vaccine candidate Covaxin of Bharat Biotech has been asked to provide more data related to its efficacy for approval.

Serum Institute of India (SII)

It is a Pune-based immunobiological drugs manufacturer. It was founded in the year 1966 by Cyrus Poonawalla who is famous as the “Vaccine King of India”.