Ocugen Seeks FDA Emergency Use Nod For Covaxin COVID-19 Vaccine In Kids

Ocugen Inc OCGN said that it sent a request to the FDA for an emergency authorization for its COVID-19 vaccine candidate BBV152, known as Covaxin outside of the US, for just pediatric use.
The vaccine candidate is a whole-virion, inactivated vaccine and recently authorized by the WHO, developed by the Indian Company Bharat Biotech.
For kids ages 2-18 years, Ocugen said the vaccine was studied in an immuno-bridging clinical trial conducted in India that demonstrates comparable neutralizing antibody response as seen in a large adult Phase 3 trial conducted in India.
In terms of safety, the Company said no serious adverse effects among the 526 study subjects in the pediatric trial were reported.
In adults, Covaxin previously showed 77.8% vaccine efficacy against symptomatic Covid disease, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group.
Related Link: Ocugen's India Partnered COVID-19 Vaccine Gets WHO Approval: Report.
Price Action: OCGN shares are up 0.50% at $10.11 during the market session on the last check Friday.