New Delhi: The Subject Expert Committee (SEC) Tuesday recommended Covaxin, India’s ‘first’ indigenous Covid-19 vaccine, for use on children in the 2-18 age group.
The SEC will now send its recommendations to the Drugs Controller General of India (DCGI).
The SEC has, however, recommended that the study of Covaxin in children continues as per the approved clinical trial protocol.
“This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thanks the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of COVAXIN for Children,” Bharat Biotech said in a statement.
Clinical trials in children
The clinical trials were conducted on 525 children between the 2-18 age group, recruited in multiple centres across India, including Meditrina Institute of Medical Sciences in Nagpur, AIIMS Patna, and JLN Medical college in Ajmer.
While the vaccine is the same for adults and children, the difference is reportedly in how it is administered.
Covid-19 vaccines for adults come in vials that contain vaccines for multiple doses. The paediatric Covaxin will, however, come in pre-filled syringes, which are used for better dose accuracy.
The vaccine dosage for children would be 0.5ml, the same as for adults.
Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is an inactivated vaccine, which means that it contains a ‘deactivated’ version of the virus so that it can no longer cause infection. However, parts of the virus can still be identified by the body’s immune system and can trigger an immune reaction.
Trials in adults have already demonstrated 77.8% vaccine efficacy against symptomatic Covid-19 disease. The efficacy against severe symptomatic Covid-19 disease is shown to be 93.4%.
The efficacy data demonstrates 63.6% protection against asymptomatic Covid-19.
Bharat Biotech has said the vaccine can neutralise the various emerging variants — B.1.1.7 (Alpha), first isolated in UK, P.1 (Gamma), and P.2 (Zeta), first isolated in Brazil, B.1.617 (Kappa), first isolated in India, B.1.351 & B.1.617.2 (Beta & Delta).
Efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant, which had caused the devastating second wave in India.