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Bharat Biotech Reports Positive Data From Covid-19 Vaccine In Children Aged 2-18 Years

Biopharmaceutical company Ocugen, Inc. (OCGN), Thursday announced that its partner, Bharat Biotech, posted results from a Phase 2/3 trial conducted in India of candidate vaccine, Covaxin, 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 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, 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.

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