The Drugs Controller General of India (DCGI) has given BharatBiotech’s Covaxin restricted emergency use authorisation. This vaccine can now be used for children between the ages of 6 to 12. Along with Covaxin, Union Health Minister Mansukh Mandaviya announced the approval of Corbevax and ZyCov-D vaccines for children.

This action is taken on the recommendation of the Subject Expert Committee (SEC) on Covid-19 by the Central Drugs Standard Control Organisation or CDSCO. The SEC had last week received applications from BharatBiotech’s Covaxin (for age group 6 to 12) and from Biological E’s Corbevax (for age 5 to 12).

The SEC gave BharatBiotech the no-objection certificate after a two-month-long deliberation on the topic. The DCGI has also asked BharatBiotech to share their safety data and data on adverse events twice every month for 2 months. After these two months, the vaccine maker can monthly send 1 report for 5 consecutive months. 

In December 2021 the DCGI had given Emergency Use Listing (EUL) to Covaxin to be used for ages 12 to 18. Corbevax on the other hand has been used for the age group 12 to 14. Even Zydus Cadila’s two-dose regimen ZycovD vaccine against Covid-19 has been approved for children over the age of 12 years. ZycovD showed a 66.6% efficacy in the interim analysis during Phase 3 clinical trials. 

The vaccination drive started on March 1st for people above the age of 60 years. A month later, on April 1st, the vaccination drive began for people over the age of 45. From May 1st onwards, a vaccination drive for every adult (18 years of age) began. Next came the age group of 15 to 18, for whom the vaccination phase began on January 3rd.