DGCI grants EUA to Covaxin for 6-12 years and Corbevax for 5-12 years age group

Finally, a sigh of relief for parents amid reports of schools recording a fresh surge in  the number of Covid-19 cases among children in tier-I cities across the country. The Drugs Controller General of India (DCGI) on Tuesday granted emergency use authorisation to Bharat Biotech’s Covaxin for 6-12 years and Biological E’s Corbevax for 5-12 years while ZyCoV has received the EUA for children above 12 years of age.  

This move is being welcomed by parents as well as the experts as it will pave the way for the rollout of the Covid-19 vaccination drive for those aged below 12 years. These approvals from the regulatory authority are significant and will give a major boost to efforts to protect children against Covid-19 infection. Currently Corbevax, is the vaccine which is being used in the 12-14 age group while Covaxin is being used for the population in the 15-18 years age bracket.

These approvals will expand the basket of vaccines available for almost all age groups.  Bharat Biotech Chairman and Managing Director Krishna Ella said, “We have established Covaxin as a universal vaccine for adults and children. Safety of the vaccine is critical for children and we are glad to share Covaxin has now proven data for safety and immunogenicity in children…” He further added “The clinical trials conducted in the pediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity and immunogenicity.”

Bharat Biotech has been asked to submit safety data, including the data on adverse events with due analysis every 15 days for the first two months and monthly thereafter up to 5 months by the DCGI. However, the emergency use authorisation for Corbevax may be the subject to certain conditions, as shared by the source familiar with the development. 

With an uptick in cases among children, the focus has shifted to children’s vaccines . With a fresh surge in Covid-19 cases, the Subject Expert Committee had sent the recommendations to the DGCI last week after reviewing the application of both the companies seeking emergency use authorisation for Corbevax and Covaxin for use in children of 5 to 12 years and 6 to 12 years age group, respectively. After getting the nod to the recommendation by the DGCI, the Union Health Ministry may give final approval to the vaccination soon. 

The Chairman and Managing Director of Medanta Naresh Trehan in his response to this significant development said, “It is a welcome move. This was a vulnerable group.  Now even the elders will be safe. It’s not that you can take shortcuts in vaccines. Safety and efficacy checks have been done.”

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