MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) announced the recent 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, 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 Bharat Biotech, said, “We are glad to have Ocugen as a valuable partner to help bring COVAXIN™ to North America. Safety of the vaccine is critical for children, and we are glad to share that COVAXIN™ has proven data for safety and immunogenicity in children. We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children, for primary immunization and booster doses, making COVAXIN™ a universal vaccine. It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India.”
The low reactogenicity might make COVAXIN™ more acceptable in pediatric populations than the more reactogenic mRNA vaccines as Bharat Biotech’s pediatric Phase 2/3 study had no serious adverse events, deaths, or withdrawals due to an adverse event including no cases of Guillain-Barré syndrome, thromboembolic events, myocarditis, or pericarditis, or other adverse events of special interest being observed to date. We believe COVAXIN™ will be a valuable tool in the global immunization effort as it can be stored at 2–8°C, which is standard vaccine storage conditions. Follow-up studies to assess pediatric effectiveness are underway, but this study suggests that similar efficacy, measured by the ability of a vaccine to prevent disease, might be anticipated in children based on the observation of superior immunogenicity, measured by the ability of a vaccine to produce an immune response, as compared to adults.
The open-label, non-randomized study was conducted in six hospitals in India and included 526 healthy children. Two doses of COVAXIN™ were administered 28 days apart in three groups according to their ages, two to six years, six to 12 years, and 12 to 18 years. The results were compared with those from adults who participated in a previously reported Phase 2 study. The study is registered with the Clinical Trials Registry, India (CTRI/2021/05/033752) and ClinicalTrials.gov (NCT04918797).
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