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

The vaccine was found to be “safe, well-tolerated, and immunogenic” in phase 2/3 clinical trials on children in the 2-18 years age group, the Hyderabad-based firm noted in a statement.

Days after the Centre allowed the use of Covaxin (BBV152) among 15-18 year-olds, Bharat Biotech on Thursday said that its vaccine was found to be “safe, well-tolerated, and immunogenic” in phase 2/3 clinical trials on children in the 2-18 years age group.

Bharat Biotech on Thursday said that its vaccine was found to be ‘safe, well-tolerated, and immunogenic’ in phase 2/3 clinical trials on children in the 2-18 years age group.

The Hyderabad-based firm, in a statement, also said that neutralizing antibodies in children, on average, were found to be 1.7 times higher than in adults. No serious adverse event was reported during the trials, it added.

“Covaxin clinical trial data from the paediatric population is very encouraging. 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,” firm chairman and managing director Krishna Ella said.

“Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically,” Ella added.

As part of the firm’s phase II/III clinical trials and multicentre studies, as many as 374 subjects in the concerned age group were inoculated two 0.5 ml doses of Covaxin, which was the same formulation used in adults.

“Immunogenicity analysis (by PRNT) shows superior antibody responses were observed in children compared to adults, suggesting that BBV152 will also be efficacious in this age group,” the study uploaded in open access journal medRxiv said.

The trials in the paediatric population were conducted between June and September, and have shown robust safety, reactogenicity, and immunogenicity, it added.

While no serious adverse event took place, the subjects reported either mild or moderate severity symptoms, with 78.6 per cent getting resolved within a day. Pain at the injection site was the most commonly reported adverse event, the company said.

For the trial, 976 subjects were screened for Sars-CoV-2 using RT-PCR and ELISA testing (enzyme-linked immunoassay), out of which, 525 eligible participants were enrolled. Based on the age, participants were distinguished into three groups in an age de-escalatory manner.

Researchers involved in the trial said the report presents data obtained up to four weeks after the second shot, but the study is ongoing to collect safety data up to six months after the last vaccination, which will be reported separately.

The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021 and received emergency use nod for children aged 12-18 from Drug Controller General of India (DCGI) recently.

The approval on December 25 from DCGI came nearly 10 weeks after the subject expert committee of CDSCO recommended Covaxin’s use in children on October 12.