Covaxin is safe for 2-18 age group in phase 2, 3 trials: Bharat Biotech

A total of 374 subjects reported either mild or moderate severity symptoms, with 78.6% getting resolved within a day, says Hyderabad-based vaccine maker

Hyderabad-based vaccine maker Bharat Biotech International (BBIL), on Thursday said BBV152 (Covaxin), its whole-virion inactivated Covid-19 vaccine candidate, has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase 2 and 3 studies. It effectively means that the vaccine is safe for children.

This comes after the Drugs Controller General of India (DCGI) approved the use of Covaxin for children aged 12 years and above. The subject expert committee advising the regulator had, however, cleared the vaccine for use in two-year-old children and above.

Bharat Biotech had conducted phase 2 and 3, open-label, multi-centre studies to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 age-group, the vaccine maker said. Immunogenicity of a vaccine implies whether it induces the desired immune response.

"Covaxin's 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," Krishna Ella, chairman and managing director, Bharat Biotech, said in a statement.

The company claimed that the clinical trials on children conducted between June and September 2021 have shown ‘robust safety’. 

The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October and Bharat Biotech has received emergency use nod for children aged 12-18 from DCGI recently. No serious adverse-effect was reported in the study.

A total of 374 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-effect, the statement said.

Meanwhile, Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now. BBV154, the intra-nasal vaccine, can be administered as a nasal spray or a drop but only in a clinical setting and cannot be taken at home.

The adenovirus vector-based vaccine helps to trigger generation of immunoglobulin or IgA antibodies which line the nasal mucosa. Bharat Biotech claims that the vaccine helps to reduce transmission of the Covid virus as it attacks the virus at its first point of entry – the nose and the upper respiratory part of the body. “We have done a lot of work to stabilise the spike protein. The antibodies in the nose are IgA which are also present in the upper respiratory tract,” a senior company official told Business Standard.

“We are scaling up the manufacturing of the intra-nasal vaccine now. The target is a billion annual doses for the nasal vaccine. The sites which produce Covaxin now (Bangalore, Hyderabad, Pune etc) will also have facilities to produce the nasal vaccine,” the official added. 

The vaccine maker is also looking for global partners to manufacture and distribute the vaccine overseas.