Benzinga | Nov 5, 2021 09:38AM EDT

Ocugen Reports Submission Of Emergency Use Authorization Request To FDA For COVID-19 Vaccine COVAXIN For Children Aged 2-18 Years

* COVAXIN(tm) (BBV152) was recently awarded Emergency Use Listing by the World Health Organization

* Pediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralizing antibody response as seen in a large adult Phase 3 clinical trial conducted in India

* COVAXIN(tm) (BBV152) uses same Vero Cell manufacturing platform as other childhood vaccines, including the inactivated polio vaccine

* COVAXIN(tm) (BBV152) elicited antibody titers against multiple antigens (S1, RBD, and N); and provided durable immunity against COVID-19 in Phase 3 adult trial in India

* No serious adverse events or hospitalizations were observed in Phase 2/3 pediatric study of COVAXIN(tm) (BBV152), including no events of special interest such as Guillain-Barre Syndrome, anaphylactic reactions, myocarditis, pericarditis, and vaccine-induced thrombotic thrombocytopenia.

MALVERN, Pa., Nov. 05, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ:OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced today that it has submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of Ocugen's COVID-19 vaccine candidate BBV152, known as COVAXIN(tm) outside of the U.S., for pediatric use. The vaccine candidate was developed by the company's partner, Bharat Biotech, and was studied in an immuno-bridging clinical trial conducted in India with children 2-18 years of age.

COVAXIN(tm) (BBV152) is a whole-virion, inactivated vaccine, manufactured using a Vero Cell manufacturing platform, as has been used in the production of the inactivated polio vaccine for the past 35 years, as well as of other traditional childhood vaccines.

The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India.