Covid Vax for kids! Covaxin gets emergency use approval for kids aged 2-18 years

New Delhi, October 12: In the major development, Bharat Biotech’s indigenously made Covid-19 vaccine Covaxin has got the Subject Expert Committee's approval on Tuesday for its usage on children belonging to the age group 2 to 18. The SEC has submitted its recommendation to the Drugs Controller General of India (DCGI) for final approval.

 

“After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency," the expert panel said in a statement.

  

It said that the emergency use authorization, however, is subject to four conditions. "The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol," SEC added.

 

 

As per the reports, Covaxin will be administered in two doses, with a gap of 20 days between the first and second dose.

 

It should be noted that Hyderabad-based Bharat Biotech had last week submitted Phase 2/3 clinical trials data of children's trials to the DCGI for its verification and subsequent approval for emergency use authorization (EUA) for the jab. Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India's ongoing COVID-19 vaccination drive.

 

After DCGI's nod, Covaxin will become the second COVID-19 vaccine to get emergency authorization after Zydus Cadila's three-dose DNA jab was allowed to be used on adults and children over 12.

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