The Subject Expert Committee (SEC) has given a recommendation to Drugs Controller General of India (DGCI) for the use of Bharat Biotech's Covaxin for 2-18-year-olds, news agency ANI reported on Tuesday, 12 October, quoting official sources.
“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 emergency situation,” the subject expert panel said in a statement, according to India Today.
This makes Covaxin only the second vaccine to be approved for children in India, and the first ever in the world to be approved for children below the ages of 12.
How safe is Covaxin for children? Do we have any data? Here's what we know till now.
How safe is Covaxin for children? Do we have any data?
Hyderabad-based manufacturer Bharat Biotech had completed Phase 2 and Phase 3 trials of Covaxin on children below 18 years of age in September.
However, the data has not been made public yet.
The DCGI had given a nod to the company to conduct Phase 2 and 3 clinical trials in May this year. The trial was conducted in June on 528 children with 28 days in between the doses.
The AIIMS chief had previously said that results were expected to be released by September.
How many doses of Covaxin will be given to kids?
Two doses of Covaxin, 28 days apart, will be given to children. However, there is no official release on this yet.
When will Covaxin be available for children?
We don't have clarity on this yet. However, the Centre had earlier indicated that vaccination for children under 18 will begin in October.
Which other vaccine has been approved for children in India?
Earlier in August, the Drug Controller General of India (DCGI) had given Gujarat-based Zydus Cadila’s COVID-19 vaccine emergency use authorisation for use in adults and children above 12 years of age.
The National Expert Group on Vaccine Administration for COVID-19 (NEGVEC) is likely to receive recommendation on using the ZyCoV-D DNA vaccine for children.
Is vaccination of children mandatory?
We do not know this yet. Notably, the Centre has not made it mandatory for those above 18 to be vaccinated against COVID-19 either. A detailed SOP by the Centre will give more clarity.