Bharat Bio’s US partner Ocugen seeks FDA approval for Covaxin use in children

The vaccine candidate was studied in an immuno-bridging clinical trial conducted in India with children aged 2-18 years.

The World Health Organization on Wednesday granted emergency approval to Bharat Biotech’s Covaxin, allowing millions of recipients of the indigenously developed vaccine to travel abroad without any restrictions and set the stage for its export.

Covaxin is a whole-viral, inactivated vaccine manufactured using a Vero cell manufacturing platform, as has been used for the past 35 years in the production of inactivated polio vaccines, as well as other conventional childhood vaccines Huh.

The presentation, the company said, is based on the results of a phase 2/3 pediatric clinical trial conducted by Bharat Biotech with 526 children aged 2-18 years, which combined immunogenicity data into a larger, phase 3 safety and efficacy Clinical trials in approximately 25,800 adults in India.

A Phase 2/3, open-label, multicentre study in India from May to July to evaluate the safety, reactivity and immunogenicity of whole virus inactivated SARS-CoV-2 vaccine (covaxin) in healthy volunteers aged 2-18 years was conducted. of age.

Covaxin was evaluated in three age groups – 2-6 years, 6-12 years and 12-18 years. All participants received two doses of complete virion inactivated SARS-CoV-2 virus vaccine 28 days apart.

Neutralizing antibody responses against the wild-type strain in the pediatric age group of 2-18 years were comparable to adults 18+ years of age in Bharat Biotech’s large Phase 3 efficacy and safety trial.

A seroconversion rate greater than 90% was observed for antibody titers against S1, RBD, N proteins and the wild-type neutralizing antibody. These results suggest similar protection in children aged 2–18 years as demonstrated in adults over 18 years of age.

In 526 study subjects in a pediatric clinical trial, no serious adverse effects, such as death, hospitalization, myocarditis, pericarditis, Guillain-Barré syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions, were reported in the study . These were also not observed in surveillance data collected in India after administration of more than 59 million doses of Covaxin in adults. All other adverse events were mild or moderate in nature and generally resolved within 24 hours.

“Our research shows that people are exploring more options when choosing a vaccine specifically for their children. With a newer type of vaccine available, people can discuss with their pediatrician about their child’s contracting COVID-19. to discuss the best way to reduce the risk of exposure to the virus,” the Chairman of the Board, the Chief Executive Officer, and co. Founder of OcuGen. “The inactivated virus platform has been used for decades in vaccines for the pediatric population and, if authorized, we hope to offer another vaccine option to protect children under 2 years of age. “