SEC recommends Covaxin for children aged between 2-18

October 13, 2021 0 By CH Unnikrishnan

The Subject Expert Committee (SEC) of India’s Central Drugs Standard Control Organisation has recommended granting an emergency use authorisation to Bharat Biotech’s vaccine against coronavirus — Covaxin for children aged between 2-18. Following the Committee recommendation, the Drug Controller General of India is soon expected to approve the vaccine for inclusion in the ongoing vaccination drive. The dosage of Covaxin in children is also fixed as two shots with a gap of 28 days. 

“After detailed deliberation, the Committee has recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation,” the SEC said in a statement with reference to their Tuesday evening decision. 

An emergency use authorisation is typically granted with a set of conditions as the studies on such drugs or vaccines are not yet completed and there is more data expected from the use of the same in a much larger study group as per the approved clinical trial protocol as well as the prescription and post market surveillance data submission by the company. Bharat Biotech had last week submitted Phase 2 and 3 clinical trial data from the children’s trials to the DCGI.  The SEC recommendation is based on that. 

“We now await final regulatory approval from the CDSCO for the product launch and making it available in the market,”  said Bharat Biotech in a media statement. Once approved, Covaxin will be the second vaccine recommended for use in children in the country.  The drug regulator had in August, cleared ZyCoV-D for children aged 12 and above as well as adults. ZyCoV-D, which is developed and manufactured by Ahmedabad-based Cadila Healthcare (Zydus Cadila), is expected to hit the market shortly.