Covaxin 
Hyderabad: Pharmaceutical firm Bharat Biotech Thursday said that its COVID-19 vaccine, Covaxin has proven to be safe, well-tolerated and immunogenic in the age group of 2-18 years. Bharat Biotech based its statement on the results of phase II/III study in paediatric subjects (volunteers).
Bharat Biotech International Limited (BBIL) said the clinical trial data is very encouraging.
“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,” said Krishna Ella, chairman and managing director, Bharat Biotech.
BBV152 (Covaxin) is Bharat Biotech’s whole-virion inactivated COVID-19 vaccine candidate. The vaccine maker had carried out phase II/III, open-label and multi-centre studies to evaluate the safety, reactogenicity and immunogenicity of Covaxin in healthy children and adolescents who fall in the 2-18 age group, a press release stated.
The release added that clinical trials that were carried out in paediatric subjects between June and September this year have exhibited robust safety, reactogenicity and immunogenicity. The data from the trial have already been submitted to the Central Drugs Standard Control Organisation (CDSCO). The vaccine has also been granted emergency use nod for children aged 12-18 by the DCGI.
The pharma firm said no serious adverse event was reported during the trial. Of all the participants, 374 subjects exhibited either mild or moderate severity symptoms. 78.6 per cent of these were resolved within a day.
As per the release, pain at the injection site was the most commonly reported adverse event.
The trial involved 976 subjects who were tested for SARS-CoV-2 using RT-PCR and ELISA testing (enzyme-linked immunoassay). Out of these, 525 eligible volunteers were enrolled.
The release stated that basis the age group, participants were divided into three groups in an age de-escalatory manner.