Press release
Ocugen Announces Publication of Positive Results of COVID-19 Vaccine Trial for Children 2-18 in The Lancet Infectious Diseases
Ocugen’s partner Bharat Biotech’s Phase 2/3 study of COVAXIN™ (BBV152) in 526 children showed safety, efficacy, and superior response to that shown in adults
About this update from Ocugen, Inc.
[{"type":"text","content":"Ocugen’s partner Bharat Biotech’s Phase 2/3 study of COVAXIN™ (BBV152) in 526 children showed safety, efficacy, and superior response to that shown in adults Ocugen has North American commercialization rights for COVAXIN™ MALVERN, Pa., June 21, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologicals, and vaccines, today announced the publication of positive pediatric Phase 2/3 study results in children aged 2–18 years for the COVID-19 vaccine COVAXIN™ (BBV152) in The Lancet Infectious Diseases (“The Lancet”). COVAXIN™ is developed and manufactured by Ocugen’s partner Bharat Biotech International Limited (“Bharat Biotech”), a global leader in vaccine innovation based in Hyderabad, India, and is under clinical investigation by Ocugen in the United States for use in adults aged 18 years and older. The Lancet article, entitled “Immunogenicity and reactogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged 2–18 years: interim data from an open-label, non-randomised, age de-escalation phase 2/3 study,” which was authored by Dr. Krishna Mohan Vadrevu, Siddharth Reddy, MSc, and others, was published on June 16, 2022. Ocugen has commercial rights for COVAXIN™ throughout North America and COVAXIN™ has emergency use authorization in Mexico for adults. Ocugen is continuing to explore pediatric emergency use authorization in Mexico. This data demonstrates that the same dose is effective in both pediatrics and adults (ages two and older) and would be an ideal option as the majority of Americans are looking for traditional vaccine options. Ocugen is continuing its effort to bring this vaccine to the North American Market. “We congratulate Bharat Biotech on the publication of the COVAXIN™ pediatric data in this prestigious peer-reviewed medical journal,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen. “Not only is this a strong validation of the work they are doing, but it is a very encouraging development in the effort to contain this pandemic, which needs a greater variety of vaccine options to combat the multiple COVID-19 variants. We believe the distinct features of COVAXIN™ offer benefits that could help improve public health.” Dr. Krishna Ella, Chairman and Managing Director of Bhar...