The Subject Expert Committee (SEC) has approved emergency use of Bharat Biotech's Covaxin for children in the 2-18 years age group.

Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and submitted the data to Drugs Controller General of India (DCGI) at the start of this month. In the trials, Covaxin was administered to 525 children in the 2-18 age group. The indigenous vaccine will be administered in two doses, with a gap of 28 days between the first and second dose. This will provide a major boost to the country’s vaccination program. 

In the case of children as young as 2 years, the accuracy of the dose is crucial. Unlike the Covaxin for adults and other Covid-19 vaccines currently being administered that are available in multi-dose vials, the paediatric Covaxin will use a pre-filled syringe or PFS mechanism. Pre-filled syringes are known to have a high-level accuracy, which makes them safer to use for children.

Meanwhile, the WHO is yet to grant emergency use authorisation to Covaxin. Back in August, India had also granted emergency use approval to ZyCov-D's Covid-19 vaccine for children between the ages of 12 to 18. The vaccine is developed by pharmaceutical firm Zydus Cadila and is the first DNA vaccine to be approved in the world. It is a three-dose needle free vaccine. The vaccine, however, is yet to be made available to the market.