- Ocugen Inc (NASDAQ:OCGN) announced the publication of positive pediatric Phase 2/3 study results in children aged 2–18 years for COVID-19 vaccine, Covaxin (BBV152), in The Lancet Infectious Diseases.
- Covaxin is developed and manufactured by Ocugen's India-based partner Bharat Biotech International Limited.
- It is under clinical investigation by Ocugen in the U.S. for use in adults aged 18 years and older.
- Related: FDA Removes Clinical Hold On Ocugen's COVID Vaccine Trial.
- The low reactogenicity can potentially make Covaxin more acceptable in pediatric populations than the more reactogenic mRNA vaccines.
- Bharat Biotech's pediatric Phase 2/3 study showed no serious adverse events, deaths, or withdrawals due to an adverse event, including no cases of Guillain-Barré syndrome, thromboembolic events, myocarditis, pericarditis, or other adverse events of particular interest being observed to date.
- Data comes from 526 children. Local reactions mainly consisted of mild injection site pain.
- Geometric mean titers of microneutralization antibodies at day 56 were similar to titers in vaccinated adults.
- Price Action: OCGN shares are up 4.63% at $2.26 during the market session on the last check Tuesday.
