Benzinga | Nov 5, 2021 01:40PM EDT

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

* Ocugen Inc (NASDAQ: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.