Bharat Biotech Asked For More Data By DCGI For Authorising Covaxin To Children Under 12

New Delhi: Bharat Biotech was asked for additional data on its Covid-19 vaccine, Covaxin, by the Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI) for administering it to children aged between 2-12 years according to ANI. The Subject Expert Committee discussed recommendations to review its emergency use authorisation (EUA) application for use of Covaxin among those aged two to 11 years.

According to the report, no recommendations have been made so far. However, after Thursday’s meeting, the SEC has recommended granting emergency use authorisation for Biological E’s COVID-19 vaccine Corbevax for children in the five to 11 years age group with certain conditions, official sources said on Thursday. 

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The Corbevax vaccine is currently being administered to children in the age group of 12-14 years. The vaccination drive for children in the age group of 15-18 years commenced on January 3 this year. They are being administered Covaxin.
Biological E’s Corbevax is being used to inoculate children against Covid-19 in the age group of 12 to 14 years. Covaxin has been granted Emergency Use Listing by the DCGI for the age group of 12 to 18 years on December 24, 2021.

“The SEC noted that the interim safety and immunogenicity data of Phase 2/3 clinical trials in subjects of five to less than 12 years is comparable to that of higher age groups. It also noted the safety data of vaccination in the age group of 12 to 14 years.

After detailed deliberation, it has recommended approval of the vaccine for 5 years and above for restricted use in an emergency situation with the condition to submit ongoing clinical trial data,” an official source said, according to PTI. 

 

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