DCGI's SEC recommends regular market authorisation to Covishield & Covaxin, say sources

The Drugs Controller General of India's (DCGI) Subject Expert Committee (SEC) on Wednesday recommended regular market authorisation to COVISHIELD and COVAXIN, said sources. This comes a few days after the SEC had sought more data from the COVID vaccine manufacturers- Serum Institute of India and Bharat Biotech for granting them full market approval for their vaccines.

The SEC had asked both companies to submit more data to also study the vaccine’s efficacy and safety-related data thoroughly. The DCGI led SEC had held a meeting on Friday, January 14 to analyse the applications of Bharat Biotech and Serum Institute of India for full market approval of their vaccines. 

On December 31, 2021, both Bharat Biotech and Serum Institute of India had applied for the regular market authorisation of Covishield in India. 

Covaxin is now a universal COVID-19 vaccine 

In an official statement, Bharat Biotech, on January 13 had announced that Covaxin was now a 'universal vaccine' for both adults and children. The pharma giant revealed that its goals for developing a global vaccine against COVID-19 had been achieved and all product development for Covaxin's licensure had been completed. 

"COVAXIN is now a universal vaccine for adults and children. Our goals of developing a global vaccine against COVID-19 have been achieved and all product development for licensure has been completed," Bharat Biotech said in a statement.

Bharat Biotech had earlier also declared that Covaxin's booster dose was found to be effective against both the Omicron and Delta variants of COVID-19.

On January 3, India opened its COVID vaccination drive to children aged 15-18 years. As per guidelines issued by the Union Health Ministry, Bharat Biotech's Covaxin was approved as the only vaccine option for children in the said age group. In a statement, the Health Ministry informed, "Only Covaxin will be available for children in the age-group 15-18 years. The vaccination for them will begin on 3 January 2022."

India's vaccination coverage exceeds 158.88 crore 

India’s cumulative COVID-19 vaccination coverage exceeded 158.88 crores on Jan 19, as nearly 80 lakh vaccine doses were administered in the last 24 hours, as per the data shared by the Union Health Ministry. Also, it has stated that the country has crossed the vaccination of 70% of its adults within a year of its vaccination drive against SARS-COV-2 and 50% of children are jabbed with 1st dose.