Covaxin safe and immunogenic in 2-18 age group, says Bharat Biotech

Bharat Biotech said on Thursday that its Covid-19 vaccine Covaxin has proven to be safe, well-tolerated and immunogenic in the 2-18 age group. The government has already given approval to use Covaxin for vaccinating children in the 15-18 age group from January 3.

The Hyderabad-based company had conducted phase-2/3, open-label, and multi-centre studies to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 age group, it said.

Covaxin's clinical trial data from the paediatric population is very "encouraging", said Krishna Ella, chairman and managing director, Bharat Biotech.


"Safety of the vaccine is critical for children and we are glad to share that Covaxin has now proven data for safety and immunogenicity in children. We have now achieved our goal of developing a safe and efficacious Covid-19 vaccine for adults and children," Ella said.

The trials were conducted between June and September this year in children.

The data was submitted to the Central Drugs Standard Control Organisation in October and received emergency use nod for children aged 12-18 from the DCGI recently.

According to the company, no serious adverse event was reported in the study. A total of 374 subjects reported either mild or moderate severity symptoms, with 78.6% getting resolved within a day. Pain at the injection site was the most commonly reported adverse event. The findings were posted online on the medRxiv preprint server.

The trial involved 976 subjects who were tested for SARS-CoV-2 using RT-PCR and ELISA testing Out of these, 525 eligible volunteers were enrolled.