Ocugen, Inc. has submitted a request to the FDA for emergency use authorization (EUA) of their COVID-19 vaccine candidate for use in children aged 2 to 18 years.
Ocugen, Inc. has submitted a request to US Food and Drug Administration for emergency use authorization of their COVID-19 vaccine candidate BBV152 for use in children aged 2 to 18 years. The submission is supported by an immuno-bridging clinical trial that was conducted in India. The vaccine a whole-virion, inactivated vaccine, which was manufactured using a Vero Cell platform.
The company submitted results from a phase 2/3, open-label, multicenter study that ran from May 2021 to July 2021 that evaluated the safety, reactogenicity and immunogenicity of the vaccine in pediatric volunteers aged 2 to 18 years. The participants were separated into 3 age groups: 2-6 years, 6-12 years and 12-18 years. Every participant was given 2 doses, 28 days apart. The results indicated a similar level of protection in the pediatric population to that seen in earlier adult trials. No serious adverse effects, such as myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions, were reported in the group. Reported adverse events were all mild to moderate in nature and typically resolved within 24 hours of onset.