Ocugen Partner, Bharat Biotech, Announces Positive Immunogenicity and Safety Data From COVAXIN™ (BBV152), COVID-19 Candidate Vaccine, in Children 2 – 18 YEARS

• COVAXIN™ whole virus inactivated vaccine generated broad antibody response comparable to those seen in a large phase 3 trial in adults 18+
• Adverse events were primarily mild, and no serious adverse events (SAEs) were noted
• Immunobridging trial demonstrated safety, reactogenicity and immunogenicity of COVAXIN™ in children from 2 years old and up
• No cases of myocarditis or blood clots were reported, as expected with inactivated vaccines

Excerpt from the Press Release:

MALVERN, Pa., Dec. 30, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced today that its partner, Bharat Biotech, posted results from a Phase 2/3 trial conducted in India of candidate vaccine, COVAXIN™ (BBV152), in children, aged 2 – 18 years, demonstrating a robust neutralizing antibody response and favorable safety profile on the pre-print server, medRXiv. Using a two-dose regimen administered 28-days apart, antibody responses in subjects were comparable to adult data from a previous phase 3 study. Those results demonstrated a greater than 93% reduction in severe disease. These pediatric data were the basis of Ocugen’s pediatric Emergency Use Authorization (EUA) submission in the United States for children 2-18 on November 5, 2021.

“These data represent the first positive vaccine data in children as young as two years of age and come at an important time as COVID-19 infections are seeing a spike across the globe,” said Shankar Musunuri, PhD, MBA, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen. “The results suggest that COVAXIN™, which is made on the same platform used in traditional polio pediatric vaccines for decades, when administered in a two-dose series to children between 2-18, may offer an option that is safe while delivering a robust immune response.”

In the study, immunogenicity against key COVID-19 proteins was measured using geometric mean titer (GMT), a test that measures the amount of antibodies in the blood in response to the presence of the virus. GMT was measured across three age groups and demonstrated strong immune response after the second dose. There were no serious adverse events such as myocarditis, pericarditis, or blood clots, reported in any of the three age groups.

This immunobridging trial was intended to determine if COVAXIN™ generates the same protective immunity in children as it does in adults. To be considered equivalent, pediatric participants needed to achieve comparable GMT’s to those generated by adults in a large phase 3 clinical trial. At Day 56, across all ages, the mean SARS-CoV-2 antibody GMT was more than 30% higher in children aged 2-18 than the mean GMT from Phase 3 clinical trial involving 25,800 adult subjects aged 18+. These data demonstrate children 2-18 generate antibody response comparable to adults fully vaccinated with COVAXIN^™ (BBV152).

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